Modern Pharmaceuticals September 2010

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September 2010 Modern Pharmaceuticals 15

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Editor: Manas R Bastia

Making a markEditorial Advisory Board

Ajit SinghChairman, ACG Worldwide & Head, ISPE

Dr Abraham Patani Past President, IDMA & CMD, Inga Laboratories

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah Chairman, IGPA & Secretary General, IPA

Daara Patel Secretary General, IDMA

gone are the days when the country, as perceived globally, had to leverage its ‘cost-effectiveness in manufacturing’ credentials. As of

today, with outsourcing of pharma machinery and ancillaries becoming commonplace, India seems to have arrived on the global stage. Of course, the learning curve has been steep and it has taken time to offer world-class ‘quality products’ and more importantly, a solution-centric approach.

The pharma machinery sector has come a long way from a negligible base in the 70s to the present size of 700 manufacturing entities, and is still growing at an impressive pace. As more multinational pharma majors get India-bound, it is quite natural for the global machinery giants to realign their India-specific investment strategies. In addition, this can potentially open up numerous opportunities for providers of related plant design consultancy and allied services.

Going forward, the fast evolving biotechnology industry, rise in the demand for products related to lifestyle disorders, new drug delivery technologies and growing CRAMS business promise to propel the pharma machinery sector to a higher orbit. At the same time, the challenges include mounting global competition in terms of value-addition, making available service support & spare parts, seamlessly executing the technology

transfer, retaining intellectual property rights, to name a few.

In a nutshell, the mantra to excel in the pharma machinery & ancillaries sector seems to be the right combination to offer the latest technologies combined with value-added technical services at affordable prices. For a detailed perspective, turn to the ‘Industry Update’.

Another vibrant segment is pharma packaging where uninterrupted innovation and double-digit annual growth have been the order of the day in recent years. However, counterfeiting is taking a toll on its growth, and hence, warrants immediate global attention. Of course, it is critical for a drug producer to ensure that medicines are neither contaminated nor contain incorrect ingredient. In this regard, innovative packaging and branding solutions including digital printing can go a long way in effectively combating counterfeit drugs. The ‘Market Trends’ offers an insight into the contemporary world of pharma packaging.

Interested to know what if India decides to become a part of the proposed patent pool for HIV drugs? The ‘Roundtable’ has various viewpoints from the industry.

Manas R [email protected]

Modern Pharmaceuticals September 201016

CONTENTS

FEATURES4646

REGULAR SECTIONSEditorial ............................................................. 15

National News................................................... 18

World News....................................................... 26

Tech Updates ..................................................... 34

Events Calendar ................................................ 67

Technology Transfer ......................................... 69

Book Shelf ......................................................... 71

Fresh Arrivals .................................................... 72

Product Update................................................. 74

Product Inquiry ................................................ 85

Advertisement Inquiry ..................................... 87

Product Index ................................................... 89

Advertisers’ List ................................................. 90

Highlights of Next IssueSector Watch: BioinformaticsMarket Trends: HR issues and Policies in PharmaIndustry Update: Biotechnology

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4343

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Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise

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LEADERS SPEAK 38'The Indian pharma market would triple to $ 20 billion by 2015' ...says Sandip Parekh, Executive Director, Unimark Remedies Ltd

ROUNDTABLE 40HIV drug patent pool for India: To be or not to be?

FACILITY VISIT 43Sipra Labs: Customised solutions under one roof

INDUSTRY UPDATE 46Pharma ancillary industry: Set for an outsourcing route?

MARKET TRENDS 52Pharma packaging: What’s in a pack?

MARKETING 56Drug prescription trends: Keeping the ‘winner’ brand alive

CLINICAL RESEARCH 59Cold chain logistics: Need of the hour

Jayanti Vaidyanath

VP-Administration, Legal & Clinical Trials Supplies Management,

SIRO Clinpharm

INDUSTRY INSIGHTS 62Parkinson’s disease therapeutics market: Balancing the disease burden and patient expectations Courtesy: GlobalData

TECHNOFOCUS 64Texture analysis: Uncoding the coats in a tablet

Jo Smewing

Applications Manager, Stable Micro Systems Ltd


N AT I O N A L N E W S

ALLIANCE

EHCL in alliance with POLAElder Health Care Ltd (EHCL), part of the Elder Group, has entered into an in-licensing agreement with POLA Chemical Industries, Inc, Japan’s advanced skincare, body care and cosmetic manufacturing company, in order to introduce POLA‘s state-of-the-art skin care & cosmetic products in India. Dr Anuj Saxena, Managing

Director, Elder Health Care Ltd, said “To begin with we will be launching ‘Bihaku’ whitening range viz white wash, white lotion, white gel and white mask through the Over-The-Counter (OTC) as well as dermatologist/cosmetologists route within the next two months and are targeting the high-end, socially active consumers.” This is Elder Health Care Ltd’s 10th in-licensing agreement for providing health goods with

therapeutic properties through the OTC and dermatology / cosmetology route.

Further Dr Saxena added, “Extensive market research has given us valuable insights into consumer preferences enabling us to introduce innovative and high-quality products.”

COLLABORATION

Aurobindo & AstraZeneca sign a licensing and supplying agreement

Aurobindo Pharma recently declared that it has entered into licensing and the supplying agreements with AstraZeneca, one of the biopharmaceutical businesses

in order to supply several solid dosage and sterile products for the emerging markets.

The agreements will support AstraZeneca’s investment in branded generics sold in emerging markets. These products come under a broad range of important therapeutic segments such as anti-infective, Cardiovascular System (CVS) and Central Nervous System (CNS). However, financial terms were not revealed in the declaration.

Commenting on the alliance, P V Ramprasad Reddy, Chairman, Aurobindo

Pharma, said, “Aurobindo’s proven track record in building strong, collaborative working relationships is one of the key drivers for these strategic agreements with AstraZeneca, which will accelerate our growth and support our earnings.”

Further, on the agreement, Kaushik Banerjee, Head-Branded Generics Operations, AstraZeneca, said, “These agreements will help us to extend the range of branded medicines that we are able to offer patients in emerging markets, where we see opportunities to grow our business.”

ACQUISITION

Piramal concludes sale of formulations business to Abbott Piramal Healthcare has declared that it has concluded the first part of its $ 3.72 billion deal to sell its domestic formulations business to Illinois-based Abbott Healthcare.

In a regulatory filing with the Bombay Stock Exchange (BSE), Piramal Healthcare

that owned popular brands such as Phensedyl, Paraxin and Pentids, informed that the sale include 350 trademarks, as also its manufacturing facility at Baddi in Himachal Pradesh.

Piramal Group informed that it would retain its business of custom drug manufacturing for third parties, critical care, over-the-counter products, pharmaceutical ingredients, vitamin, diagnostic medical devices and clinical research. Ajay Piramal,

Chairman, Piramal Group, said, “We are pleased to see our 22-year domestic formulations segment now becoming a part of a value-driven company.”

GRIEVANCE PANEL

Panel to address pharma sector woes

Since most Indian pharmaceutical companies are being taken over by foreign multinationals, the Centre has decided to implement a task force that will handle the problems of the domestic pharma industry. Ghulam Nabi Azad, Union Health Minister, said, “The task force will look into all policy-related, inter-ministerial and centre-state issues in the health sector.” Azad has given assurance that the

government would offer support to the industry to facilitate growth of the pharma sector and asked the industry captains to ensure that the essential drugs reach the poorer sections of the society.

He further added, “Thus, with this mission in view, the government would look into drug price control–related issues and bring up a long-term policy for the pharma industry.” Ghulam Nabi Azad

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NAME CHANGE

Scientific Products is now Cole-Parmer

Scientific Products India Pvt Ltd, the company delivering solutions to the scientific community, recently declared its change of name to ‘Cole-Parmer India Pvt Ltd’.

The company has also shifted its Mumbai office to a new location. The new office, located in Delphi Building, Hiranandani Gardens in Powai, Mumbai. The office also serves as one of Cole-Parmer’s locations for the strategic sourcing of laboratory supplies, equipment and instruments.

On the occasion, Rakesh Aggarwal, Director, Cole-Parmer India said, “With this move, we look forward to continuing to strengthen our position as a market leader.

With this milestone, as we move forward, we remain committed to maintaining our strong relationships with our customers and suppliers and to the continued growth of our business. It not just demonstrates our deep commitment and enhanced support for all our local customers, but also underscores our dedication to carrying out our corporate mission of a global presence supported by first-class local service for our customers.”

LOGISTICS

Government may expand drugs storage space on airportsSeveral demands by the pharmaceutical industry have made the government agencies to consider the possibility of having cold chain facilities at airports for drugs storage.

A senior official from the Department of Pharmaceuticals (Ministry of Chemicals and

Fertilisers), said, “About 21 possible airports have been identified for adding cold chain capacity. The official added, “In the first phase, we are looking at Delhi and, possibly, Chennai airports and talks are on with these airport operators. The airport operators will be allowed to charge a user development fee for leasing out space.” The additional capacity at Delhi and Chennai airports is expected to be deployed over the next two

to three years. Delhi International Airport Ltd (DIAL) is expected to create 3,000-4,000 sq m of additional cold room facilities for pharma products.

STEM CELL BANKING

LifeCell records impressive growth in Q1 2010

LifeCell, India’s one of the umbilical cord stem cell banks, engaged in the collection and preservation of newborn stem cells

from umbilical cord has reported 94 per cent revenue growth in the first quarter of 2010, up from that in the first quarter of 2009. This growth is significant because of the combination of substantial increase in marketshares and capturing of new markets.

Mayur Abhaya, President & Executive Director, LifeCell, said, “This growth is impressive from the perspective that we are operating in a niche segment with low awareness and increasing competition every year that was more intense in the past one year.”

Abhaya further added, “LifeCell has no long-term debts and our operations are cash flow positive. This increases the company’s ability to expand operations, launch new services and further invest in R&D.”

As an innovative approach to the industry, LifeCell had approached celebrities Hrithik Roshan and his wife Sussane Roshan as brand patrons in order to promote the concept of stem cell banking. Having preserved their children’s stem cells with LifeCell, Hrithik’s endorsement as a client worked effectively in enhancing awareness.

EXPANSION

Abdul Monem Group to expand to meet growing demand Abdul Monem Group is set to expand in the pharmaceuticals sector with the aim of providing high-quality products at affordable prices. Novus Pharmaceuticals Ltd is a Strategic Business Unit (SBU) of Abdul Monem Group. ASM Mainuddin Monem, Managing Director, Novus, said, “As an entrepreneur, we believe it to be our responsibility to help improve the

healthcare situation and ensure health equity in the country. And, I believe that business is an initiative but service is the priority.” Although the healthcare situation has considerably improved mainly in the last decade, low-income groups are yet to get full benefits. He said, “This is what interested us in getting involved in pharmaceuticals.”

Novus is entering the sector at a time when most of the top 10 revenue earning pharmaceutical companies are increasing production capacities to meet the growing

demand. Initially, the company plans to produce primary and chronic healthcare items, eg paracetamol and omeprazol, in order to reach out to common people.

Monem further added, “We will gradually shift to produce anticancer and anti-AIDS items in the next three to five years.”



PHARMA LICENCING

Pharma units await clarity on compulsory licencing

The discussions of laying down norms for the issuance of Compulsory Licensing (CL) for medicines under the Indian Patent Act 1970 have brought the issues like the affordability and the access to medicines at the forefront.

The topic was raised through a draft discussion paper issued and circulated by the Department of Industrial Policy and Promotion (DIPP). Dilip G. Shah,

Secretary General, Indian Pharmaceutical Alliance (IPA), a body representing Indian pharmaceutical players, said that statistics indicated the Indian pharmaceutical market as $19 billion. Further he added, “Over the last five years, the share of multinational pharmaceutical companies has risen from 15 per cent to 25 per cent and in five years could exceed half the market.

NEW APPOINTMENT

Hilleman Laboratories appoints Dr Akshay Goel as CSO MSD Wellcome Trust Hilleman Laboratories, Research and Development JV between Merck & Co, Inc, (that operates in India as MSD Pharmaceuticals Pvt Ltd) and the Wellcome Trust, which is a UK-based research charity, recently declared the appointment of Dr Akshay Goel as Chief Scientific Officer. MSD Wellcome Trust Hilleman Laboratories will operate

with a not-for-profit business model and is focussing on developing affordable vaccines in order to prevent diseases that commonly affect low-income countries.

Dr Goel brings to Hilleman Laboratories experience of clinical & commercial manufacturing of vaccine candidates in the US (Pfizer and Baxter) and India (Serum Institute of India). He is also credited with the development and commercialisation of Meningococcal C conjugate Vaccine

(NeisVac-C) in the UK, and Haemophilus influenzae type B and Meningococcal A conjugate (for sub-Saharan Africa) vaccines in India.

APPROVAL

Bafna Pharma receives TGA approval As a part of its expansion plans, Bafna Pharmaceuticals, a Chennai-based pharma-ceutical company, engaged in the business of manufacturing of pharmaceutical formulations of Betalactam and Non-Betalactam received approval from the Australian Therapeutic Goods Administration (TGA) for manufacturing of both

prescription and non-prescription products in the Australian market. The dosage of prescription and non-prescription could be available in the forms of tablets, caplets & hard gelatine capsules.

Commenting on the approval, Bafna Mahaveer Chand, Chairman & MD, Bafna Pharma, said, “The TGA process will provide momentum to our plans for expanding in the Australian market, and thereby expand our business.”

Following this development, Bafna Pharma aims to be one of the few Indian Pharma companies to get the TGA approval. Through this achievement the company predicts huge profit in the long term business in Australia.

CORPORATE QUIZ

Advinus Therapeutics wins Mumbai Regional Finals of BioQuizitive 2010

Suraj Menon and Siddhartha De of Advinus Therapeutics won the Mumbai Regional Finals of BioQuizitive 2010, India’s first life sciences quiz for corporates. More than 20 teams from all over Mumbai and Pune contested in the regional rounds. Arnab Bhattacharya and Anand Kant Das of Tata Institute of Fundamental Research (TIFR) were declared runners up. This corporate quiz was hosted by the Bengaluru-based Lotus Clinical Research Academy.

Commenting on the Mumbai rounds, Sudhir Pai, Managing Director, Lotus Clinical Research Academy, said, “It has given usimmense satisfaction to host the inaugural round of BioQuizitive 2010 in Mumbai, and we are fascinated by the level of quizzing and the sharp minds revealed during the contest. Moving forward, we would like to see enhanced participation and many more cities covered.”

Dr Akshay Goel

From L-R: Suraj Menon, Siddhartha De, Prakash Subbarao, Sudhir Pai, Dr Sandhya



MARKET RESEARCH

Pharma firm to raise ` 6 crore via pvt placements

Pharmaceutical firm Zenox Lifesciences would raise ` 6 crore through ‘private placements’ over the next few months.

S A Manikandan, Managing Director, -Zenox Lifesciences, said, “We are in the process of raising funds of ` 6 crore through private placements. This would be utilised for new business opportunities to expand our presence in the country.”

He said that the funds would be utilised for buying brands and substantiate the company’s growth. “The Indian Pharma market was estimated to be 10th largest in the world by 2015,” he said.

Arun Kumar, Executive Director, Zenox Lifesciences, said, “Initially, We will target with the products in these markets and then take it up for across India.”

The company currently has 150 field operators, which would be increased

rapidly. The company aims to touch ` 15-crore revenues in the first six months and has set a target of reporting ` 100 crore revenue by 2013.

PRICE CONSTRAINT

Cancer drug prices stay firmly high

At a time when the government is thinking of ways to regulate the

price of cancer medicines, a research, conducted by Cancer Patients Aid Association (CPAA), a Mumbai-based patient group, shows that despite many not-on-patent ones available, their prices remain high.

The research intended to find out the pricing, patent applications, usage and dosage of cancer medicines by interviewing doctors, chemists and by acquiring data from publications like

Drugs Today, Current Index of Medical Specialties, etc.

YK Sapru, Chairman and CEO, CPAA, said, “It is noted that the prices remain high despite the drugs not currently having patents, and with several players manufacturing them.” He further said, “With about 50 per cent of the population living in a hand-to-mouth situation, and earning less than ` 100 per day, cancer treatment remains a distant dream.”

COURT RULING

Supreme Court of Israel rules in favour of Sun Pharma Supreme Court of Israel has dismissed the appeal by Taro Pharmaceutical Industries Ltd (Taro) of the previous ruling by the Tel-Aviv District Court, holding that the Israeli Special Tender Offer (STO) rules do not apply to the Tender Offer by Alkaloida

Chemical Company Exclusive Group Ltd, the subsidiary of Sun Pharmaceutical Industries Ltd, to purchase all outstanding ordinary shares of Taro for $ 7.75 net per Ordinary Share in cash. The Court also lifted its temporary order that prohibited the closing of the Offer prior to its ruling.

The three-judge bench of the Supreme Court of Israel concluded that

there were neither legal nor moral grounds on which Sun required to comply with the STO rules.

INDUSTRY WATCH

Pharma FDI checks to shield local companies

The government’s nodal policy-making body for foreign investment has suggested

that acquisitions of Indian companies by global drugmakers can be subjected to regulatory approvals, as such deals can weaken the local industry’s ability to supply low-cost medicines to consumers.

A discussion paper by the Department of Industrial Policy and Promotion (DIPP) suggested that the drug industry might be taken off the list of sectors where Foreign Direct Investment (FDI) is allowed automatically, which could include all Mergers and Acquisitions (M&A) proposals. “The acquisitions of Indian pharmaceutical

companies by multinationals in the past have led to articulation of public concern on its impact on the availability of low-cost medicines,” said Anand Sharma, Commerce and Industry Minister, said in a letter referring to the suggestion mooted by the department.

Consequently, the marketshare of MNCs in the local drug retail market has surged to nearly 25 per cent from about 15 per cent in 2007, and many industry watchers predict this to grow to about 50 per cent in the next five years.

Cancer cells


W O R L D N E W S

COLLABORATION

Roche, Aileron form alliance to develop stapled peptide drugs Aileron Therapeutics and Roche recently announced that they have entered into a collaboration to discover, develop and commercialise a new class of drugs called Stapled Peptide Therapeutics. These are potential solution to drug as-yet intractable disease targets, including those originating from long coveted intracellular protein-protein interactions.

As part of this agreement, Roche will work with Aileron to develop drug candidates against up to five undisclosed targets selected from Roche’s key therapeutic areas, eg oncology, virology, inflammation, metabolism and CNS.

Under the terms of the agreement, Roche will provide Aileron guaranteed funding of at least $ 25 million as technology access fees and R&D support. Aileron will receive payments of $ 1.1 billion after achieving

discovery, development, regulatory and commercialisation milestones, if drug candidates are developed against all five targets. Aileron will also receive royalties on future sales for any marketed products resulting from the collaboration.

INAUGURATION

Boehringer Ingelheim inaugurates its ‘Center of Competence’ in Shanghai

Boehringer Ingelheim recently inaugurated its new ‘Center of Competence’ (CoC) in Shanghai.

As part of the company’s EUR 100 million expansion project in China, the CoC entails an investment of EUR 10 million and will specialise in optimising Active Pharmaceutical Ingredients (APIs) and chemical intermediates procured in China. Thus far, more than 20 highly qualified organic and analytical chemists have been recruited for the CoC.

The new CoC consists of the two departments—Process Development (PD)

and Quality Control (QC). The main functions of PD are to focus on the production process optimisation and the corresponding technology transfer to the company’s partners within China so as to increase the production efficiency and precision.

The company had announced in 2009, a EUR 100 million expansion plan in China to extend its production capacity in Shanghai Zhangjiang High-Tech Park and also set up a centre of competence, which is now open.

ACQUISITION

Pfizer to acquire FoldRx Pharmaceuticals Pfizer Inc and FoldRx Pharmaceuticals, Inc, a privately held drug discovery and clinical development company, recently signed an agreement under which Pfizer will acquire FoldRx.

FoldRx conducts clinical and pre-clinical studies for investigational compounds to treat diseases caused by protein misfolding, which is an underlying

cause of many chronic neurogenerative diseases. The company’s lead product candidate, tafamidis meglumine, is under registration as an oral, disease-modifying therapy for transthyretin (TTR) amyloid polyneuropathy (ATTR-PN), a progressively fatal genetic neurodegenerative disease, for which liver transplant is the only treatment option currently available. FoldRx has filed a marketing authorisation application for tafamidis with European Medicines Agency, and is currently in

communication with the FDA to define its pathway for filing in the US.

While specific financial terms were not disclosed, Pfizer will make an upfront payment and contingent payments if certain milestones are achieved. The closing of the transaction is subject to regulatory approval in the US and may occur later this year.

CLINICAL TRIALS

GSK begins phase III trial for herpes zoster vaccine to prevent shingles

GlaxoSmithKline recently confirmed that the company has commenced the phase III clinical trials programme of its candidate herpes zoster vaccine

currently being developed for the prevention of shingles. These clinical trials will study more than 30,000 patients globally and will evaluate the efficacy, safety and immunogenicity of the candidate vaccine.

“The commencement of the phase III programme for our candidate herpes zoster vaccine is a significant milestone. Shingles is an often debilitating condition for which limited treatment and prevention options are available.

Hence, the progression into late-stage development of our herpes zoster vaccine is an important milestone in ongoing efforts to potentially help address an important unmet need,” said Norman Begg, Chief Medical Officer, GSK Biologicals.

Herpes zoster is said to be caused by varicella-zoster virus (VZV) and can occur at all ages, with an estimated 1 million herpes zoster cases occurring every year in the US.


W O R L D N E W S

AWARDS

Novartis awards 2010 Immunology Prizes at the 16th International Congress of ImmunologyThe Novartis 2010 Immunology Prizes were recently presented at the 16th International Congress of Immunology in Kobe, Japan. These prizes recognise individual achievement and provide financial support for conducting further research by recipients.

At the event, Professor Michael Bevan, Howard Hughes Medical Institute, University of Washington, Seattle, USA, received Basic Immunology Prize for his research on T-cell selection and regulation and memory formation of CD8+ cytotoxic T cells in response to pathogens. Further, Professor Charles Dinarello, University of Colorado at Denver, USA, and Professor Juerg Tschopp, University of Lausanne, Switzerland, shared the Clinical Immunology Prize

for their contributions to the discovery & regulation of Interleukin (IL)-1 beta and its biological properties and use of IL-1 beta antagonists for successful treatment of inflammatory diseases like gout and periodic inflammatory syndromes.

MILESTONE PAYMENT

Chroma Therapeutics receives milestone payment from GSK

Chroma Therapeutics Ltd said that it had advanced its novel macrophage-targeted HDAC inhibitor, CHR-5154, into pre-clinical

development, triggering an undisclosed milestone payment from partner GlaxoSmithKline (GSK).

HDAC inhibitors have been demonstrated to have broad anti-inflammatory activity, along with their activity in various cancers, and may be useful for treatment of disorders like rheumatoid arthritis. CHR-5154 utilises the company’s proprietary Esterase-Sensitive Motif (ESM) technology, which targets compounds to specific

cells in the inflammatory disease process. Chroma entered into collaboration with GSK, through its Center of Excellence for External Drug Discovery, in June 2009. Under the agreement, Chroma will take up four discovery & development programmes to identify small molecule therapeutics and is eligible to receive milestones, option fees and tiered royalties based on compounds arising from the collaboration.

FELLOWSHIP SUPPORT

Shire announces support for IBD fellowships Shire plc, the global specialty biopharmaceutical company, recently announced its support for Inflammatory Bowel Disease (IBD) fellowships at leading medical institutions across the country. The six fellowships will begin in 2011 and will provide one-year training in IBD management to physicians who recently completed a fellowship in gastroenterology.

“We are proud to support the education of future medical professionals. As a company committed to advancing gastroenterology, we hope that the individuals completing the Shire-supported fellowships will contribute to improving patient care,” said Roger Adsett, Senior Vice President - Gastroenterology Business Unit, Shire. The institutions receiving support from Shire in the form of charitable contributions have been selected based on the centre’s existing fellowship programmes. These

centres are Cedars-Sinai Medical Center (Los Angeles), Cleveland Clinic, Mayo Clinic (Rochester, Minnesota), Mount Sinai Medical Center (New York), University of California, San Francisco and University of Chicago Medical Center.

APPROVAL

Merck’s Cladribine Tablets approved in Australia to treat MS

Merck KGaA recently said that the Australian Therapeutic Goods Administration (TGA) has approved Cladribine Tablets for the

treatment of relapsing-remitting Multiple Sclerosis (MS). These tablets will be registered in Australia, under the trade name Movectro®.

“Approval of Cladribine Tablets in Australia is another step forward in our commitment to fight the devastating disease of MS by providing new therapeutic options to fulfil the unmet needs,” said Elmar Schnee, Member, Executive Board, and Head, Merck Serono

division. He further added, “Australia is the second country to approve Cladribine Tablets and we will continue our efforts to gain approval of Cladribine Tablets in other countries so that more patients can benefit from this oral disease-modifying therapy.”

Cladribine Tablets, trade name Movectro, became the first oral MS treatment in the world to gain marketing authorisation after health authorities in Russia approved it in July 2010.

Representation of an inflammed bowel


W O R L D N E W S

CLINICAL TRIALS

Positive phase III results for Eisai’s Perampanel for partial seizures treatment Eisai Inc recently announced the results of a phase III study for the investigational compound perampanel (E2007), a first-in-class, highly selective non-competitive AMPA-type glutamate receptor antagonist. It is being developed for treatment of partial seizures in patients with epilepsy.

The double-blind, placebo-controlled, parallel-group study (Study 306) showed that perampanel was well-tolerated and effective in reducing median seizure frequency & increasing responder rates, which are the primary outcome measures in the US and European Union (EU), respectively. The findings were highly statistically significant in 4 and 8 mg doses compared to placebo.

Study 306 is the first in a series of phase III clinical trials as part of

Eisai’s development programme for perampanel, with two more global phase III studies underway. Eisai plans to submit the studies as part of global applications and results are expected within one year.

LAUNCH

Somaxon Pharmaceuticals launches insomnia drug, Silenor in US

Somaxon Pharmaceuticals, Inc, a specialty pharmaceutical company, recently announced that Silenor® (doxepin),

indicated for the treatment of insomnia characterised by difficulty with sleep maintenance, is now commercially available by prescription in the US.

The company has implemented a wholesale and retail stocking programme to disseminate Silenor 3 and 6 mg dose packs to pharmacies across the country.

The company looks forward to promoting this product to healthcare providers along

with its co-promotion partner, Procter & Gamble. Richard W Pascoe, President & CEO, Somaxon also stated that along with the deployment of their field-based promotion, a comprehensive marketing programme will be launched that would utilise web-based initiatives and directed towards physicians not called on directly by their sales force as well as patients with sleep maintenance insomnia.

DISCOVERY

Novartis and collaborators discover novel antimalarial drug candidate

Novartis recently announced that scientists at the Novartis Institute for Tropical Diseases (NITD), in collaboration with researchers

from the Genomics Institute of the Novartis Research Foundation (GNF), the Swiss Tropical and Public Health Institute and The Scripps Research Institute, have discovered a novel compound that shows promise as a next-generation treatment for drug-resistant malaria.

Published recently in Science, the findings demonstrate that the antimalarial candidate, spiroindolone NITD609, is effective against both strains of the malaria parasite, Plasmodium falciparum and P. vivax. Through a novel mechanism, NITD609

rapidly clears plasmodium in a malaria mouse model and shows pharmacological properties compatible with a once-daily dosing regimen.

Further, regulatory pharmacological and safety evaluation is currently going on and, if the outcome of these studies is favourable, the compound could progress to phase I human trials.

Wellcome Trust, the Medicines for Malaria Venture (MMV), A*STAR, Singapore and the US government have supported the project.

ORPHAN DRUGS

Stromedix receives orphan drug status for STX-100 Stromedix, Inc, a biotechnology company focussed on innovative therapies for fibrosis and fibrotic organ failure, has said that its lead clinical candidate STX-100 has been granted orphan drug status by the US Food and Drug Administration (USFDA) for the treatment of idiopathic pulmonary fibrosis (IPF).

Currently, there are no FDA approved treatments for IPF, which is a debilitating and almost uniformly fatal disease in which patients experience progressive difficulty in breathing due to fibrosis of the lung. In 2011, the company plans to initiate a phase II clinical trial in IPF patients.

“We are excited for the potential of this compound that targets a key pathway in the initiation and progression of pulmonary fibrosis, and thus may ultimately become a much needed treatment option for IPF

patients,” said Dr Michael Gilman, CEO, Stromedix. Orphan drug designation is granted by the FDA to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders.


W O R L D N E W S

LABORATORY SOLUTIONS

Thermo Fisher Scientific adds Vialis AG paperless laboratory solutions to its global partner alliance Thermo Fisher Scientific, Inc, has extended its reach across Central Europe by making Vialis AG the latest member of its Informatics Global Partner Alliance. Vialis AG, based in Switzerland, will provide local services and support for the full range of Thermo Scientific informatics solutions, including Laboratory Information Management Systems (LIMS),

chromatography data systems, electronic laboratory notebooks & spectroscopy software, as well as comprehensive laboratory automation and integration solutions.

Vialis AG has built a unique business consultancy based on providing technology and support solutions that deliver on the goal of creating a ‘paperless lab.’

“By offering best-in-class Thermo Scientific Informatics software, we are able to provide our customers with a comprehensive solution for managing their data and helping ensure that their laboratory

workflow meets the demanding business and regulatory requirements in life sciences and other industries,” said Dr Ulf Fuchslueger, CEO, Vialis AG.

ACCORD

Bristol-Myers Squibb to acquire ZymoGenetics Bristol-Myers Squibb and ZymoGenetics, Inc, have signed a definitive agreement providing for the acquisition of ZymoGenetics by Bristol-Myers Squibb, for $ 9.75 per share in cash. Boards of directors of both companies have approved the transaction, with an aggregate purchase price of about

$ 885 million, or $ 735 million net of cash acquired.

“The acquisition of ZymoGenetics brings us full ownership of a promising investigational biologic that strengthens our diversified Hepatitis C portfolio. Building on our leadership in virology, we are developing a strong portfolio to help patients with Hepatitis C,” said Lamberto Andreotti, CEO, Bristol-Myers Squibb.

Andreotti further informed that ZymoGenetics brings proven capabilities with therapeutic proteins and revenue from a marketed specialty surgical biologic and that this acquisition was another example of their strategic, targeted approach to business development.

ACCREDITATION

Quintiles Central Laboratory in Japan receives CAP accreditation

Quintiles recently announced that its new laboratory in Tokyo, Japan, has received accreditation from the

College of American Pathologists (CAP), joining the largest network of fully harmonised, CAP-accredited central laboratories worldwide.

“CAP accreditation has become the international gold standard for quality, and Quintiles is committed to delivering quality laboratory services that meet complex regulatory requirements in the New Health landscape. The Tokyo facility is the 10th laboratory in Quintiles’ network to have CAP certification,

validating our efforts to achieve high-quality, consistent delivery across every region and clinical trial,” said Thomas Wollman, Senior Vice President, Quintiles Global Central Laboratories.

Quintiles began providing laboratory services in Japan in 2008 through an alliance with Medca Japan. And in March 2010, Quintiles opened its own central laboratory in Tokyo to strengthen its capability to efficiently serve customers in Japan and the Asia-Pacific.

Dr Ulf Fuchslueger

PATENT

BioAlliance Pharma receives European patent for Acyclovir Lauriad®

BioAlliance Pharma SA, has announced the grant of a European patent protecting its

product Acyclovir Lauriad®. This patent is now validated in all European countries. This first patent validation is a major step and the procedures up to the grant are going on in other major global areas - America and Asia. This patent specifically protects the muco-adhesive tablet containing acyclovir, its process for manufacturing and its clinical application.

“Acyclovir Lauriad® enables a treatment of recurrent herpes labialis according to one tablet application

immediately after the first signs of infection appear. We are now looking for the adequate commercial partner for this innovation in the herpes labialis market. The agreement of the European and US Health Authorities, obtained this summer, to plan a registration dossier submission in 2011, together with the progress of our patents are obviously key steps in this process,” stated Dominique Costantini, CEO, BioAlliance Pharma.

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T E C H U P DAT E S

Microchip to mimic human lungThe researchers at Harvard University, Harvard Medical School and Children’s Hospital Boston have developed a novel lung-on-a-chip microdevice. The device follows a new approach to tissue engineering by placing two layers of living tissues—the lining of the lung’s air sacs and the blood vessels surrounding them—across a porous, flexible boundary. When air is delivered to cells lining the lung, a rich culture medium flows in the capillary channel, which mimics blood and the cyclic mechanical stretching of the structure mimics breathing.

The researchers tested the reaction of this device to inhaled live bacteria Escherichia coli so as to determine how well the device replicates the natural responses of living lungs to stimuli. The investigators, however, have not yet demonstrated the system’s capability to mimic gas exchange between the air sac and bloodstream.

The size of the device is similar to that of a standard rubber eraser. It is created using a microfabrication strategy that utilises clear rubbery materials. It is translucent, providing a window into the inner workings of the human lung without having to invade a living body. It has the potential to be a valuable tool for testing the effects of environmental toxins, absorption of aerosolised therapeutics, and the safety & efficacy of new drugs.

CytoStar-T microplates from PerkinElmer are designed for use with beta-emitting radio-labelled biomolecules. Radioactive decay is captured as blue light output with extraordinary signal clarity. The signal is detectable by using any plate-based scintillation counter. At the same time, the bases of the sterile and tissue culture-treated plates are transparent, enabling visualisation of cells with the help of an inverted microscope throughout the experiment.

CytoStar-T microplates were available in a 96-well format, but due to demands for a high-throughput solution, a 384-well version has now been released. The microplates are sterilised by gamma irradiation and treated for adherence of cells by plasma discharge, which renders the cell attachment surface hydrophilic. The plates also incorporate a design feature in the lid that minimises the evaporation occuring during incubation.

Among the applications suitable for use with CytoStar-T microplates are studies of cell adhesion, cell signalling , cell motility, cell proliferation, normal cellular metabolism,

metabolite transport as well as drug processing. The format of a CytoStar-T scintillating microplate is readily adaptable to automated applications in high-throughput screening.

Scintillating microplates for high-throughput studies

Patent for making spray-dried drug dispersions with pressure nozzlesThe US formulation services provider Bend Research has received a new patent titled ‘Method for Making Homogeneous Spray-Dried Solid Amorphous Drug Dispersions Using Pressure Nozzles’ for the process of producing spray-dried solid amorphous dispersions of drugs using single-fluid pressure nozzles. The patent, which adds further protection to the company’s Spray-Dried Dispersion (SDD) technology, can be used to make solid amorphous dispersions with larger particle sizes and minimal fines (eg, small particles). Spray-drying with a pressure nozzle creates relatively larger droplets that dry to form dense particles, with good properties for making solid dosage forms, eg, tablets.

“This patent is an important addition to our spray-drying patent portfolio. Customers come to Bend Research for the quality of our science, engineering, and clinical-supply manufacture, and our ability to move fast. Having patents that protect intellectual property offers them another key benefit of adding value to the formulations that our scientists and engineers produce,” said Rod Ray, President and CEO, Bend Research.

Cytostar-T™ Scintillating Microplates

Kimberly-Clark Professional has launched Kimtech Pure A5 cleanroom coveralls for sterile and non-sterile environments to provide an affordable way to reduce the risk of contamination. By introducing the products into its Kimtech range, Kimberly-Clark believes that it will be better equipped to meet the needs of clients working in cleanrooms with International Organization for Standardization (ISO) class 5 or higher.

In order to achieve these goals, the non-sterile variant is made from Kimberly-Clark’s Spunbond-Meltblown-Spunbond (SMS) material that has cloth-like comfort. An elasticated waist and back helps the design to reduce loose-fitting material that could contact work surfaces. The garment also has built-in thumb loops to prevent the sleeves from rolling back and exposing the user’s arms and a mandarin collar that provides additional protection by coming higher up the neck.

Damon Larkin, Scientific Apparel and Mask Category Manager, Kimberly-Clark Professional, explained, “The products

are made to provide reliable protection required in cleanroom environments, reduce the chance of contamination and help provide peace of mind. These comfort and design advantages may provide greater satisfaction among wearers and better productivity, as workers feel more comfortable.”

Kimtech cleanroom coveralls to reduce the risk of contamination

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Kimtech cleanroom coveralls


T E C H U P DAT E S

PAT integration with SIMATIC SIPAT V3.0SIPAT, Siemens’ software solution, will support Process Analytical Technology (PAT) implementation efforts and use of PAT tools in development and manufacturing. SIPAT enables the increase in process understanding and allows continuous process improvement during manufacturing operations and process development.

According to the Food and Drug Administration (FDA), PAT is a system for designing, analysing and controlling manufacturing processes based on timely measurements of critical quality & performance attributes of raw materials, in-process materials and processes with the goal of ensuring final product quality. PAT allows real-time follow-up of the product quality and enhances increased process understanding.

SIPAT is Siemens’ software solution to support PAT implementation efforts and use of PAT tools in development and manufacturing. The main features include data collection, data mining and real-time prediction of quality parameters. Besides reducing complexity, it allows standardisation, permits modular & scalar architecture and assures ease of operation. It supports easy and fast process validation. It comprises 21 CFR 11 for version management, raw data storage with user access rights. There is a provision for online visualisation as well as reporting and analysis of historical data.

The DMA 5000 M from Anton Paar is the most accurate density meter in the market that is ideal for numerous fields of application and successful continuous operation in the laboratory said a company press release.

It further adds that the DMA 5000 M provides unparalleled ease of use and complete transparency and traceability of the sample filling and measurement process. It is frequently in use in the pharmaceutical industry because it exceeds the conventional measuring limits. It is used for quantifying alcoholic strength in binary mixtures, measuring concentration of infusion solutions or checking the density of liquid ingredients. It gives fast and reliable measurement results with great accuracy (0.000005 g/cm3) by using only one millilitre of sample.

The device is equipped with a digital camera, thus making the entire sample being measured clearly

visible. In case of potential filling problems, the operator is warned and the image of the measuring chamber is stored automatically, which is a useful feature. Thus, the quality of the filling, and therefore the quality of the results, can be verified at any time.

High-accuracy density meter

Multifunctional microplate reader for researchersThe BioTek Instruments’ Synergy H1 hybrid multi-mode microplate reader is a flexible monochromator-based multimode microplate reader. The monochromator optics uses a third-generation quadruple-grating design that allows working at any excitation or emission wavelength with one-nanometre step. This system supports top and bottom fluorescence intensity, UV-visible absorbance and high-performance luminescence detection. It can handle all standard microplate applications found in life science research laboratories.

A filter module is available as a completely independent add-on that includes its own light source, and a high-performance dichroic-based wavelength selection system. A dual-reagent injection system is available to automate inject/read assays such as ion-channel assays or flash luminescence assays.

“Synergy H1 provides robust performance and, for the first time, makes ‘Hybrid Technology’ available to life science, academic and small biotechnology companies at a competitive price,” said Gary Barush, Director - Marketing and Sales, BioTek.

DMA 5000 M

Synergy H1 hybrid multi-mode microplate reader

New molecule effective in Alzheimer’s disease model

Addex Pharmaceuticals Ltd, an allosteric modulation company, has announced that it observed efficacy in a model of Alzheimer’s Disease (AD), using a recently discovered orally available drug candidate. The proprietary molecule specifically inhibits a receptor subtype called the metabotropic glutamate receptor 2 (mGluR2) via Negative Allosteric Modulation (NAM). An Addex mGluR2 NAM is scheduled to enter Phase I clinical testing in healthy volunteers during 2011.

“Specifically targeting the signalling of the neurotransmitter glutamate by using mGluR2 NAM is one of the most promising avenues of research for treating cognitive symptoms of AD. We are excited that our mGluR2 NAM is able to improve memory in this pathophysiologically relevant model. Although it is early to say whether the drug will work in humans, recently published academic research suggests that mGluR2 inhibition also may slow the progression of this devastating disease,” said Vincent Mutel, CEO, Addex.

mGluR2 is a G-Protein Coupled Receptor (GPCR) expressed in the brain on pre-synaptic nerve terminals where it slows glutamate release. Research has shown that excessive signalling by mGluR2 may negatively impact the survival of brain cells involved in memory, contributing to the cause of AD. Additional research

suggested that mGluR2 inhibition could improve working memory, even in cases where memory is already impaired.


T E C H U P DAT E S

New lab-scale tablet coating system to cut capital expenseO’Hara Technologies has launched Labcoat M/MX 3-in-1—a laboratory-scale tablet coating system that incorporates a blender and tray dry oven inserts to cut capital expense and Good Manufacturing Practice (GMP) space needed to perform these tasks. By combining these pieces of equipment into one machine, O’Hara believes that it can help pharmaceutical facilities involved in numerous phases of production simplify their operations.

In addition to reducing expenditure, both in terms of initial capital investment and GMP space needed, combining the three technologies increases equipment utilisation. Further, for increasing flexibility for the user, O’Hara has designed a portable Labcoat M/MX. Moreover, the system is equipped with an anti-beading spray nozzle, built-in peristaltic pump, supply & exhaust fans and a user-friendly operation panel. The equipment is fully validated and requires minimum installation efforts.

The launch of Labcoat M/MX 3-in-1 is a continuation of O’Hara’s efforts to combine multiple technologies into single pieces of equipment, which it believes to bring numerous benefits to the user. Labcoat M/MX 3-in-1 joins the Fluid Bed Dryers Granulators (FBGT) 1 BT in O’Hara’s portfolio of multipurpose machines. FBGT 1 BT is a fluid bed system for processing fine particles and pellets. The system can be used for pellet coating, drying, granulating and pelletting.

Recombinant albumin albucult® benefitting a range of applications

Novozymes Biopharma, part of Novozymes A/S, world leader in bioinnovation, has recently announced that the US Food and Drug Administration Center for Biologics Evaluation and Research (FDA -CBER) accepted a Type IV Master File for its recombinant albumin, albucult®. The dossier, which contains proprietary information on the manufacture and safety of albucult®, can help support the company’s customers in applications like drug formulation & medical devices. By providing customers with access to a single source of information filed with the FDA as part of their product applications, Novozymes can help accelerate the regulatory process for products that use albucult®.

Derived from Novozymes’ proprietary yeast expression technology, albucult® delivers unprecedented performance and quality benefits to a range of applications including drug & vaccine manufacture, device coating, sealants, IVF media & cell therapy applications. In addition, albucult® ensures batch-to-batch consistency, which can significantly reduce the burden of lot testing for clients.

Wayne Prestwood, Principal Regulatory Associate, Novozymes Biopharma, said, “The company is always looking for the most effective ways of supporting our customers’ applications through regulatory processes and we are pleased to have a master file for albucult® accepted by CBER. “

Credit card-size microflow system can save drug resistant strains of bacteria

A group of scientists from the Institute of Physical Chemistry of the Polish Academy of Sciences (IPC PAS) headed by Dr Piotr Garstecki have built a microflow system that allows merging of streams of drops containing various solutions. The new system enables producing and controlling concentrations of reaction micromixtures precisely. It also operates at faster speed and with smaller volumes of liquids than the microtitre plate method currently popular with laboratories.

The microflow system constructed in the IPC PAS is a miniature chemical reactor with the size of a credit card. Reactions proceed inside droplets moving along specially designed small channels. Volumes of the droplets are controlled with the help of a computer and are typically equal to about one microlitre.

“The device developed by us will allow tens of thousands of biochemical experiments to be conducted daily,” said Dr Garstecki. The microlab may considerably affect the way in which experiments are performed with respect to chemical synthesis, medical diagnostics and biotechnology.

The microflow system may be especially useful in searching for new medicines, particularly composed of several antibiotics. This apparatus can quickly identify the interesting pairs of antibiotics that could prevent one of the basic problems of modern medicine—the creation of drug-resistant strains.

The new ‘Mirrorball’ system, manufactured by TTP LabTech, is a high-sensitivity laser scanning instrumentation for advance antibody discovery. In addition, Mirrorball is the first laser-scanning microplate cytometer to offer simultaneous laser scanning.

Mirrorball operates at high sensitivity, enabling detection of only those proteins that are found in low quantities. This ensures that the instrument is suitable for mix-and-read assays for hybridoma screening and cell-surface receptor expression. The simultaneous laser scanning results in superior multiplexing and analytical capabilities that enable robust and rapid data generation. Label-free detection takes place concurrently with fluorescence measurements that results in improved object recognition and fewer false negatives, based on individual object count.

Dr Wayne Bowen, CSO, TTP LabTech, said, “Mirrorball is TTP LabTech’s response to requests from scientists for novel technologies in antibody discovery. We have heard, developed and now delivered a high-sensit ivity microplate cytometer for fluorescence cellular screening.”

Highly sensitive laser scanning for advanced antibody discovery

The Mirrorball laser scanning microplate cytometer

L E A D E R S S P E A K

‘The Indian pharma market would

triple to $ 20 billion by 2015’

…says Sandip Parekh, Executive Director, Unimark Remedies Ltd (URL). Having guided the organisation with about two decades of rich experience in producing Active Pharmaceutical Ingredients (APIs), Parekh has played a key role in the establishment and operation of three manufacturing facilities along with a state-of-the-art Research and Development (R&D) centre for process development of generic APIs. In a candid interaction with Saloni Vora, Parekh discusses the various factors affecting the pharma industry today, outlining the importance of R&D and the various challenges that India needs to overcome, in order to emerge as a leading player on the global front.

Modern PharmaceuticalsModern Pharmaceuticals September 2010September 201038

Beginning of Unimark Remedies as a marketing company in 1983, and its venture into APIs space...After having established ourselves as one of the leading companies for marketing of APIs, we realised that API manufacturing was also a business with a high margin. Hence, in 1995, we acquired the technology for producing nalidixic acid and commenced manufacturing at our unit in Vapi, bought over by us for ` 75 lakh with payments spread over two years. It was an import substitute and, fortunately, we did not experience any local competition at that time. This enabled the company to rapidly scale up its business, as demands mainly arose from non-regulated markets without any entry barriers. However, we soon began to experience and learn about the complexities of the API manufacturing business as well.

Key diversifications made by you since the company was founded...Over the years, we have diversified into critical care business in order to meet the hospital needs of Indian patients in oncology, anti-infectives and medical devices segments. On the API front, we have strengthened our capabilities to develop innovative and cost-competitive products and are ready to launch the products on the day of patent expiry. Further, we have invested in acquiring talent, in order to help the organisation meet its business goals.

Global operations of the company and its major revenue earning source...We export APIs worth crores and are involved in servicing approximately 375 customers, spread in 65 countries. Antibiotics and anti-hypertensives account for the company’s major revenues.

Manoeuvres for staying above the crowd...Our focus is clearly on costs, so as to become the most competitive player inour product segments.


L E A D E R S S P E A K

Also, we have diversified into innovative technologies like biocatalysis to tap product opportunities at a cost that is difficult to imitate by our competitors.

On handling competition from China in the API space, China is currently the largest producer of APIs in the world and dominates in the segment of products that are manufactured using fermentation technologies and those that require economies of scale. However, it still lags behind us in terms of producing complex, multi-step synthetic products that require circumventing intellectual property issues & stringent regulatory specifications.

On mergers and acquisitions in the Indian pharma space... Weak R&D productivity since 2004, now aggravated by pricing pressures for even patented products in the West are some of the reasons that have forced innovators to turn towards India like never before. Unlike generic markets in the US, markets like India require significant marketing and distribution strength to sell branded generics. A good example is that of Abbott’s acquisition of Piramal’s domestic formulations business. Moreover, almost all large companies like Pfizer, GSK and Sanofi-Aventis have been looking for acquisitions in India because of the immense promise & potential that the country holds as an emerging market.

The growth path for CRAMS industry for APIs in the future...The size of global Contract Research and Manufacturing Services (CRAMS) outsourcing market (excluding clinical trials) is approximately $ 50-52 billion. API and its intermediates constitute the largest portion of the total outsourcing market that is valued at approximately $ 21-22 billion with an estimated Compounded Annual

Growth Rate (CAGR) of 13 per cent during 2007-10.

Further, decreased R&D productivity, patent expirations and pricing pressures coupled with fewer & smaller blockbuster drugs have placed enormous pressure on pharma originators to improve their operational efficiency. The industry is responding to some of these issues through cost reduction programmes. Almost all big pharma companies have large unutilised manufacturing capacities, which have been targeted for disinvestments. This step will

benefit them by reducing their fixed costs, thereby providing huge opportunities for outsourcing API and its intermediates.

Need for innovative R&D in Indian pharma space and the R&D activities and key research areas at URL...Indian companies have the lowest costs, for both filing & production and should be able to survive any pricing pressure in the near term. However, with the administration and compliance costs escalating due to rapid urbanisation, companies that are surviving on cost differentiation alone will be under tremendous performance pressure. This model will not be a sustainable one. A

company can outperform rivals only by establishing a difference that it can preserve. Also, we have realised the importance of innovation, and have diversified into areas of biocatalysis & comprehensive solid form R&D programmes.

Hurdles that the Indian pharma sector needs to overcome, in order to join the league of leading players in the global space...India can match up with global players only if it develops capabilities to discover, develop & launch innovative new chemical entities into the global market. In my opinion, India lacks a culture of innovation due to issues like low availability of funding to encourage & incubate innovation, inadequate educational infrastructure and insignificant collaboration between the industry & academia.

I believe that the government initiative to make the country one of the top five pharma innovation hubs by 2020 through the public-private partnership model is an approach in the right direction, to enable the Indian pharma industry make its mark in the global space.

Future prospects in the Indian pharma industry... If the Indian economy continues with its current high growth trend, the Indian pharma market would triple to $ 20 billion by 2015, and secure a place among the top 10 pharma markets worldwide. Further, healthcare has grown from four per cent of average household income in 1995 to seven per cent of the same in 2005, and these figures are expected to elevate to 13 per cent by 2025. Increasing disposable incomes and an upward shift in income demographics will shape up the major growth for the generic industry brands, as drugs worth $ 99 billion will be going off patent in the US in the next five years.

Decreased R&D

productivity, patent

expirations and pricing

pressures coupled

with fewer & smaller

blockbuster drugs

have placed enormous

pressure on pharma

originators to improve

their operational

efficiency.


ROUNDTABLE

HIV drug patent pool for India

To be or not to be?

Dr Glory AlexanderMD & Director, ASHA Foundation

In the early 2000s, when India started generic

manufacturing of first-line drugs, the cost of drugs declined

dramatically, making it affordable to people of all economic sections.

Middle-income people were able to afford the drugs, and the government was also able to provide the drugs free of cost to those who could not afford. Further, antiretrovirals (ARVs) brought in a big difference to people living with HIV (PLHIV). However, at present, with PLHIV developing resistance to first-line drugs, the second- and third-line drugs have become expensive. Also, because of the patent rules, new drugs can be manufactured only after the existing drugs complete the original patent period of 20 years, which is too long. Thus, in such situation, a good option for India seems to join the patent pool of UNITAID,

as this could help overcome the problems arising due to 20-year patent ownership. I hope that this venture would help bring down the cost of the drugs. Because India and other countries that are part of the patent pool will have to pay royalty to the original patent owner, the PLHIV will have to bear this cost. But as this will be done through UNITAID, the royalty will hopefully be reasonable and negotiable. This venture has a number of advantages. New and less toxic drugs will be available earlier than the patent expiry period of 20 years. Also, fixed-dose combinations will be available, which will be a boon to PLHIV as far as adherence is concerned. Paediatric formulations will be available for children living with HIV. Further, more employment opportunities will be generated for Indian researchers, thereby leading to an opportunistic situation for Indian pharmaceutical companies.

However, close observation reveals that this venture brings with it several disadvantages as well. For instance, competition may occur among different countries within the pool, which might result in compromising the quality of drugs. I hope that the competition results in lower prices, though it can bring up a few undesirable aspects also.

On February 5, 2010, the UNITAID Executive Board met in order to discuss the issues pertaining to an analysis of the appropriate legal structure for the drugs patent pool and its relationship with UNITAID. Shivani Mody and Chandreyee Bhaumik present the views of some industry experts who analyse the pros and cons in case India decides to become a part of the patent pool for HIV drugs.

UNITAID, which procures low-cost drugs for HIV, malaria and tuberculosis, currently has $ 4 million as the start-up funding. Further, the officials expect that the developing countries will be able to save more than $ 1 billion a year, as they will now have access to low-cost drugs for HIV treatment. In the meeting held in February this year, several humanitarian groups had raised issues stating that middle-income countries like India, Brazil, China, South Africa and Thailand would be restricted from accessing the patent pool. Again, the originator companies apprehended that patent pooling could be a threat to their process of Research and Development (R&D). Yet, UNITAID dispelled the doubts and fears, saying that both low- and middle-income countries would benefit from this initiative.


ROUNDTABLE

Dr Mandar KubalConsultant Infectious Diseases

and HIV AidsInfectious Diseases and Pulmonary Care (IDPC)

Access to uninterrupted, quality certified, cheap, state-

of-the-art medications is the ideal situation for every HIV

infected individual for leading a normal productive life in resource

limited countries like India. Part of this dream was being fulfilled by the generic pharmaceutical manufacturers in India (which were protected by the process patent adopted

by the Indian Patent Law), by making cheap generic versions of innovator (patented) molecules and by creating unique fixed dose combinations not available in the US and Europe.

Patent pool looks promising and attractive for the sole reason that newer drugs may reach Indian homes earlier than before, when we had to wait for a generic version to be created and at a cost relatively cheaper than their US and European counterparts.

There is a danger of the pool collapsing if not managed or governed correctly as has been the history of patent pools in other segments and or leading to cartelisation by pharmaceutical majors. But, we have to deal with this if we want newer advances in healthcare to be available to our population.

Jayant SinghIndustry Manager – Healthcare,

Frost & Sullivan

Most drugs for treatment of AIDS were created before the patent era and are now

available at low costs. The cost-effectiveness of these drugs is an

advantage for countries like India and Africa. A patent regime for the

drugs for AIDS will be in the interest of Multinational Companies (MNCs) who will gain more

from the initiatives. A patent for AIDS drugs will help companies receive royalties and thus bring in profits. The sale of AIDS drugs at a higher cost may not be affordable to a wider section of the society. At present, these drugs are expensive in markets of the US and Europe. With a patent regime, countries like Africa, which has a high prevalence of AIDS, will be at a disadvantage.

A majority of AIDS virus develop resistance against drugs, and hence constant R&D innovation is the key here. Obtaining a

patent for existing drugs does not benefit the country. However, the society may benefit from a patent pool, if the MNCs make the source code for the drugs available for further development. The MNCs should readily share the data as well. India has an advantage with regard to these drugs. We need to build on our expertise and being a part of the patent pool will not be a great edge for the country. Moreover, most drug patents are nearing expiry in the next few years. It would be reasonable to wait till the timelines have ended.

Considerable work is going on in the area of drugs for AIDS. Thus, having a patent pool for the drugs will be more of a Corporate Social Responsibility (CSR) for the company. However, it does not imply low-cost or better drugs. Before deciding on a patent regime, the policies and strategies should be worked out. An ultra low-cost model is needed when considering drugs for AIDS. In case of a patent pool, countries can experiment with the CSR model for the drugs. Here, companies with the drugs patent can get a royalty and World Health Organization (WHO) or the Bill Gates Foundation can finance the production. This will be a win-win situation for all stakeholders, and developing nations can access good quality drugs at affordable prices.

Dr J K ManiarMD, Consultant in HIV Medicine,

Jaslok Hospital & Research Centre, and The President, AIDS Society of India

One should not be particularly favouring India to become a part

of the patent pool for HIV drugs. Generic medication is the best practice

to be followed because of the price factor.

Today, Indian pharma companies supply 65 per cent of the ARVs. When a company comes up with a new drug, the patent protection that it acquires lasts for almost 20 years. This patent right does not permit other companies to either produce or sell the drug. This patent right also bars the drug from being used for research purpose.

On the flip side, multi-patent pharma companies sometimes even tend to copy the combinations. Though this is distressful and unfortunate, it is true that the people who claim for patent rights are those who are indulging in only copying the existing combinations.


ROUNDTABLE

S D JoagHonorary General Secretary, Indian Pharmaceutical Association

The pharmaceutical industry has two types of patent—drug

patent and process patent (for drug formulation). As HIV drugs are

life-saving drugs, they should not be patented. Moreover, the drugs existing in the market cannot be patented. Thus, the question of patent pertains to new drugs only, thereby raising the question, that whether India can be a part of the patent pool for HIV drugs is a proposition. In this situation, India

will not benefit by joining the patent pool for HIV drugs. In a country where the disease is spreading at a rapid pace, getting a patent on the drugs will increase the price of the drugs.

However, from a market perspective, the situation indicates a good marketshare for exports of these drugs. It is not only India that needs these drugs. The disease is spreading across the world. If the drugs are effective, they will surely be picked up by the world market, thereby increasing the foreign exchange. Another advantage is that getting a patent on the HIV drugs in India will add another feather to its success quotient of patent rights.

Again, a clear disadvantage is evident. There will be deficiency in the market, as all sections of the population will not be able to buy and access these patent-received, and hence comparatively expensive, drugs. Thus, the demand supply gap will widen, which may also result in smuggling of the drugs.

Leena Menghaney

A c c e s s C a m p a i g n Manager - India, Medecins Sans Frontieres (MSF)

The patent pool foundation has been set up to facilitate

access to generic ARVs for the developing world.

Competition in generics manufacturing has become the

cornerstone of national AIDS programmes in Africa, Asia and Latin America, as it brings with it the benefits of multiple quality suppliers, local Food & Drug Administration (FDA) registration and significant price reductions.

No discount scheme can match the benefits brought in by generics production to treatment of AIDS in the developing countries. For example, Tenofovir, a key HIV drug, is now available at less than $ 200 per patient per year with increased generics production. Tenofovir cost thousands of dollars and was not even available in developing countries in 2004.

The initiative to set up the patent pool comes in the wake of a globalised World Trade Organization patents regime that has increased barriers in accessing key second-line ARVs under generics production, eg Atazanavir, but not available to AIDS programmes because of local patent barriers.

Further, we are increasingly concerned that this patent regime, after implementation in developing countries with manufacturing capacity like India, will increasingly discourage the development and manufacture of generic versions of new pipeline ARVs. Another issue to speculate is these new pipeline ARVs that are considered crucial for patients, as in the coming years, patients will develop resistance to existing first- and second-line drugs.

An example of such a patent is the one on Raltegravir in India which discourages generics manufacturers from developing the

API (raw material), investing in process technology, obtaining preliminary manufacturing licences for sample batches, investing in bioavailability and stability studies for pre-qualifying the drug with the WHO.

Currently, in India, the maximum retail price for this drug is about $ 7 per day, which is approximately $ 2,555 per patient per year - a price difficult for governments to pay, as they provide universal access to AIDS treatment to millions of patients in the developing world.

The underlying objective of the pools is to manage this crisis by providing a mechanism to pharmaceutical MNCs who have obtained substantial intellectual property monopolies in the developing countries, so as to contribute their patents for licensing by the patent pool to generic producers. Any private or public sector generics manufacturer, including Indian companies, should be able to obtain a licence, provided that the pharmaceutical MNCs contribute their patents into the pool.

The success or failure of the pool depends on pharmaceutical companies and the way they share their patents. If they do not contribute patents on crucial ARVs, or do it conditionally, eg, excluding middle-income countries or delaying negotiations, then they deepen the funding crisis that is threatening to disrupt the progress made by the Global Fund and governments for increasing access to AIDS treatment, including ARVs in countries affected by HIV/AIDS.

If companies fail to come to the table, India has a crucial role to play, as the absence of generics production and supply from its pharmaceutical companies will also affect patients at MSF and PLHIV who are under treatment by other governments. It must then support AIDS programmes across the developing world by issuing licences that authorise speedy generics production of the patented medicine, its fixed-dose combinations (FDCs) and paediatric versions, which are necessary for simplifying treatment and increasing access of children to doses appropriate for their needs.


FA C I L I T Y V I S I T

established 16 years ago as an analytical testing laboratory, Sipra Labs initially operated from a facility with an area of 4,000 sq ft. With its increasing portfolio

and services, the company expanded the facility to a 20,000 sq ft area. On encountering space constraints during its initial years, in December 2009, Sipra Labs set up another facility (with 165,000 sq ft area) to become a one-stop research solutions provider for the drugs, pharmaceuticals and the healthcare industry. Today, the company has made strides and come a long way, providing services for formulations development, technical dossiers, clinical trials, bioequivalence studies and analytical method development validations.

Sipra Labs is a contract research organisation registered with the US Food & Drug Administration (USFDA) and approved by Department of Scientific and Industrial Research (DSIR). Engaged in providing drug development support services to the pharma industry, the centre has a team of 150 scientists working on different innovative research projects for global regulatory submissions. Today, the company has earned recognition as a research organisation from its clients across the globe, taking into account the array of services that it provides under one roof. Dr V Satyanarayana, Managing Director, Sipra Labs, says, “We aim to provide end-to-end solutions for pharma and healthcare industry, all under one roof. Not limiting

As a one-stop research solutions provider to the drugs & pharmaceuticals industry, Sipra Labs is recognised for its work by both the private as well as the government players. Commencing operations at its new centre in Hyderabad in December 2009, the company is all set to expand its domestic services, and tap opportunities in the exports segment as well. Taking a look at its journey and future plans, Shivani Mody finds out the differentiation provided by Sipra Labs and its way forward.

Customised solutions under one roofSipra Labs

FA C I L I T Y V I S I TFA C I L I T Y V I S I T



ourselves to just the domestic industry, we want to tap potential opportunities in the global services market as well.”

Some of the specialised services offered by Sipra Labs include crystallography studies, genotoxicity, detecting impurity profile, conducting metabolic studies, novel drug delivery system, method validation, performing stability studies and cytotoxicity. Further, the laboratory’s facilities are currently utilised by several national and multinational companies such as Amide Inc (USA), Eurodrugs (Holland), Pliva DD (Croatia), Dr Reddy’s Laboratories, Sun Pharma, Aurobindo Pharma, Torrent Pharmaceuticals Ltd, Hetero Drugs Pvt Ltd, Orchid Chemicals & Pharmaceuticals Ltd, etc. Recently, the company has started conducting Phase III clinical trials and pre-clinical toxicity studies.

Formulations departmentAs a full-fledged activity, Sipra Labs undertakes formulations development, analytical method development & validation, stability studies and dossier preparation. Hence, as a total solutions provider for pharmaceutical researchers, the centre helps reduce the time to market and efforts.

Sipra Labs is currently developing various pharmaceutical dosage forms, using state-of-the-art technology, machinery and materials. It performs controlled operations for tablets, capsule formulations, suspensions & syrups, injections and ointments. Informs Dr Satyanarayana, “Nearly 94 per cent of the formulations services is for exports market. We also have a diagnostics and chemical laboratory that conducts real-life experiments. For instance, the diagnostics laboratory has a machine that replicates

functions of the stomach for conducting drug trials. The machine is connected to the client server, and regularly provides actual, live information.”

Working closely with the analytical development group, the validation experiments are designed, conducted & documented to ensure reliability, consistency and accuracy of data.

Analytical research servicesInvesting in high-end instruments, Sipra Labs provides analytical services to more than 1,100 clients in India and overseas, including the top 700 pharma companies. Dr Satyanarayana mentions, “In keeping with the compliance requirements and international standards, we have invested in high-end machines as well. These machines are also utilised for validation studies. The laboratories are currently being used at 35 per cent of their total capacity, which we plan to increase in the future.”

Some of the major instruments available at Sipra Labs are LC-MS/MS (API 4000, 3000 & 2000), GC-MS (Clarus 500), Network GC System (Agilent Technologies), XRD (Shimadzu), TGA (Perkin), DSC (Perkin), HPLCs (Quaternary Autos and Binary Autos with PDA, RI, Fluorescence, Dual-wavelength UV detectors), Atomic Absorption

Spectrophotometer (Perkin Elmer), Liquid Borne Particulate Counter Hiac/Royco), Particle Size Analyzer (Malvern UK), Head Space Gas Chromatograph (Fisons, Italy), Auto Gas Chromatograph (Shimadzu), FTIR (Perkin & Elmer), Auto Titrator (Metrohm-Swiss), Air borne Particle Counter (Met One-USA), CHNSO Analyzer (Elementar), Tristar 3000 Surface Area and Pore Size Analyzer (Micromeritics - USA).

Bioequivalence/Bioavailability (BA/BE) studies Meeting international standards, Sipra Labs provides clinical research studies for pharma companies. Its laboratory is equipped with the latest technology & equipment and uses the biometric identification system. Dr Satyanarayana avers, “We have over 15,000 registered volunteers who are ready to take part in BA/BE studies. Also, a significant number of walk-ins come inquiring for the studies and are interested in participating in these. Further, we use beds fitted with the latest technology, monitors and automatic systems. We have an intensive care unit with 20 beds, which is connected to a central monitoring system. Even clients can view the study in real-time, to be assured of the credibility of the study.”

Pre-clinical studies facilitySipra Labs also boasts of an animal facility, which is registered with the Committee for the Purpose of Control and Supervision of Experiments on Animals (India) (CPCSEA). All studies are conducted as per the guidelines of the Organization for Economic Cooperation and Development (OECD). Located 3 km away from the main building, the facility conducts tests on animals

Dr V SatyanarayanaManaging Director

We aim to provide end-to-end solutions for pharma and healthcare industry, all under one roof. Not limiting ourselves to just the domestic industry, we want to tap potential opportunities in the global services market as well.

Chemical laboratory at Sipra Clinical laboratory at Sipra



according to international guidelines and standards. The animal species used in the studies include Wistar rats, Swiss albino mice, New Zealand white rabbits and Beagle dogs. In order to maintain the testing facility and animal care, Sipra Labs has tied up with the government to carry out the operations. Dr Satyanarayana informs, “Performing tests on animals are expensive, as maintenance after tests is complex and incurs huge expenses. However, animal testing is necessary before testing a medicine on humans, and hence it cannot be eliminated. We also have expertise in management of toxicology studies in rodent and non-rodent species, all accompanied by on-time reporting.”

Training facilitiesFocussing on the growing need for conferences and training, Sipra Labs facility houses a training area with a capacity of 50-60 people. Dr Satyanarayana informs, “As a government-certified laboratory, we conduct training sessions for the police department, government-owned food processing departments, etc.” The company also carries out awareness campaigns for the industry and delegations from different countries. Working in tandem with the government, Sipra Labs has been conducting awareness programmes for entrepreneurs in India and delegations from South Africa for various quality norms, testing and validation regulatory environment for the pharma and food & beverage industries.

The way forwardAs part of the eco-friendly initiative, the facility is a ‘green building,’ and uses natural light during the day. Most machines in the

microbiology laboratory use robotic arms so as to maintain a dust-free environment. Currently, Sipra Labs provides services mainly for the domestic market and conducts pilot studies for international markets. Local clients are mostly serviced for chemical analysis, while international clients are serviced for pilot studies and analytical projects. Dr Satyanarayana says, “About 85 per cent of our work is for domestic business and 15 per cent for exports. As we want to be a one-stop solutions provider for the pharma & drug companies and also increase exports, we have built a futuristic capacity. With a focus on high quality and reliability, our analytical and testing services are growing steadily in the domestic market. Our current capacity is five times the requirement, and we are actually using only 35 per cent of our existing capacity. Five years from now, we will be using the facility to its maximum potential, as we expect more international opportunities.”

Presently, looking at national and international opportunities, Sipra Labs is expanding all its services. The company provides food safety services as well. The food & beverage laboratory is accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL) and recognised by Bureau of Indian Standards (BIS) for the analysis of safety & quality measures products like fruits & vegetables, nuts, dairy products, water & beverages including fruit concentrates. The food & beverage laboratory comprises chemical and microbiological department, spread over an area of about 15,000 sq ft, designed as per the regulatory bodies. The laboratory is built at a cost of ` 30 crore, and boasts of sophisticated

instruments, cold storage facility of 5,000 ltr, sterile rooms, safety hoods, fume hoods, etc. Also, the laboratory is maintained by a team of 15 qualified and dedicated scientists. Dr Satyanarayana says, “With stricter European Union standards, food testing is set to grow in the domestic market. A test conducted in the EU can cost ` 2 lakh, while in India it will cost ` 10,000. This shows immense potential for exports services as well. Another growth area for this company is in testing of marine products.”

Moving into new geographies, Sipra Labs is now looking to provide validation services in the regions of Africa. Dr Satyanarayana concludes, “As countries now concentrate on providing quality and reliable products, the focus on analysis and testing is increasing. New methods and equipment are being developed regularly to cater to the changing needs of patients. Also there is a major requirement for skilled workforce, with an experience in adequate procedures and validation methods. Further, there is a need for creating awareness among the industry regarding the various quality and standard requirements.”

� USFDA registered cGMP control

testing laboratory

� Department of Science & Industrial

Research approved R&D centre

� Drugs Controller General of India

(DCGI) approved BA/BE centre

� Department of Biotechnology

approved Institutional Bio-Safety

Committee (IBSC) for RCGM

products

� NABL accreditation for Chemical

and Biological as per ISO - 17025,

Medical Testing as per 15189

� ISO-9001:2000 Quality

Management Systems

� Drugs Control Administration

(Andhra Pradesh)

� Recognised by Bureau of Indian

Standards

Accreditation

Formulation development Clinical trials


I N D U S T R Y U P DAT E

India’s expertise in engineering coupled with the

government support through tax benefits, and the

growing interest of MNCs in the country can make it a

destination for outsourcing pharma machinery. But it is

yet to be ascertained how beneficial this development

would be for Indian companies. Arshia Khan explores the

reasons that may change the course of Indian pharma

machinery manufacturing companies...





the market size of the pharma machinery segment is steadily increasing (current annual growth, 15-20 per

cent). However, in the 70s, this market, like the domestic pharma industry, was also practically non-existent, but as the country went through shortage of foreign exchange, the Indian government introduced high import duties and restrictive import licensing policies. This compelled the domestic companies to manufacture machines locally, thus giving a tremendous thrust to the development of this industry in India. After more than three decades, the pharma machinery industry has now become a partner of choice for most MNCs setting shops in India.

Nevertheless, an interesting trend being observed is that MNCs are also looking at outsourcing opportunities from Indian machine manufacturers. As Ajay Mehra, Director, ACE Technologies and Packaging System, says, “The pharma machinery outsourcing industry is in its initial stages and the impact is not drastic in the present scenario. However, international companies are now identifying the potential and aiming at good Indian machinery companies to carry the brand responsibility on their shoulders. Like in any business, the trend is to have a marketing tie up initially and then move into the market with full-fledged set-ups, once the fundamentals are clear.”

In contrast, Karan Singh, Director ACG Worldwide, says, “Acceptance of the ‘India’ quality in regulated markets will ensure that more and more multinationals move their manufacturing to India by setting up their own units, through acquisition (eg, Abbott’s takeover of Piramal’s domestic formulations business) or out-licensing of manufacturing. The advantages of cost, availability of skilled manpower and world-class equipment already exist in the country.”

India is considered to be a worthy partner in pharma machinery manufacturing. Big manufacturers view India as a profitable location in the

domain. This is clear from a few deals that have taken place. Hitesh Gajaria, Executive Director, KPMG - India, highlights, “ACG Worldwide collaborated with Korsch AG of Germany to develop and produce tablet compression systems in India. Tablet compression systems are now manufactured through ACG-PAM, the Mumbai-based engineering company of ACG Worldwide. Besides, ACG Worldwide has manufacturing partnerships with Glatt, Alcan and Theegarten Pactec of Germany, Honeywell of the US and Proditec of France.” Indeed, these examples indicate that India is now viewed as a potential destination in this field. He further elaborates, “PAM-Glatt was set up as a Joint Venture (JV) between ACG Worldwide and Glatt GmbH, Germany, which are the pioneers of fluid bed technology, for the manufacture of world-class FBE fluid bed processors in India.” This indicates that India already has the required skill and infrastructure. Also, a number of reputed international equipment manufacturers have approached ACE Technologies and Packaging System for representing their equipment in Indian markets. “We are

evaluating the equipment for our further growth prospects,” informs Mehra.

Why India?For international companies looking at India, initially, the major factor was ‘Cost’, but with global players, there is no compromise on ‘Quality’. However, this has changed gradually. What now gives a boost to companies outsourcing pharma machines to India is the rich engineering talent, adherence to quality standards and cost-effectiveness. As Mehra notes, “The major factor is the well-educated engineering population and the aggression to achieve western standards for two-way benefits - first, to learn and improve our quality and, second, to aim for international approval of their equipment.”

More so the major international pharma giants like Abbott, Pfizer, Glaxo and Sanofi have expressed their plans to make huge investments in India, thus inviting the world machinery majors to rethink about India as their manufacturing base. Also, there are ample opportunities for pharmaceutical plant design consultancy

Ajay MehraDirector, ACE Technologies and Packaging System

The major factor is the well-educated engineering population and the aggression to achieve western standards for two-way benefits; first, to learn and improve our quality and, second, to aim for international approval of their equipment.

Karan SinghDirector, ACG Worldwide

Indian companies have increased capacities and MNCs are looking for a local source for pharmaceutical equipment and consumable products like empty hard capsules and barrier packaging films.



and related services, especially for companies adopting US Food and Drug Administration (USFDA) and UKMCC standards. Therefore, the future for this industry seems promising, with big names looking to collaborate and set up plants in India. This is because Indian machine manufacturers are giving more importance to FDA or International Organization for Standardization (ISO) accreditations and approvals, opines Gajaria.

Signalling towards?The general impact of outsourcing on the Indian allied pharma industry has been positive. “As a result, Indian companies have increased capacities and MNCs are looking for a local source for pharmaceutical equipment and consumable products like empty hard capsules and barrier packaging films,” informs Singh. Also Indian companies have been approached by MNCs to make them partners in machine supplies. As Mehra informs, ACE Technologies and Packaging systems represents some major names in the global pharma machinery in India for marketing their range of equipment as well as manufacturing its own dry syrup filling machines.

Offering a contrasting opinion, Suresh Pareek, Managing Director, Ideal Cures Pvt Ltd, says, “Outsourcing pharma machinery is a futuristic plan. Moreover, rational outsourcing of such machines would help local manufacturers to upgrade their services & set-up and be at par with international quality standards, which will also ensure a sustained business for the local players.”

This will in turn enable companies to gain a major boost in their belief and potential. And in doing so, the next step that most companies adopt is to pick up ideas to establish good manufacturing setups by utilising guidance from their foreign counterparts. Then, if the situation is apt, most companies offer themselves to be taken up by their partner companies for the long term.

Explaining the science behind outsourcing, Aasif Khan, Managing Director, Fabtech Technologies International Pvt Ltd, elaborates with the help of the strategy adopted at Fabtech, “Thus far, we have grown without any collaborations, by working with consultants and hiring them in the final stages of product development. The consultants guided us on the areas that we needed to strengthen. Our in-

house team of scientists and engineers with their formidable skills has helped us to develop the best of machines. However, moving ahead, we are definitely open to such outsourcing collaborations.”

Fabtech follows a ‘high-volume low-margin’ and ‘low-volume high-margin’ route, depending on the market (India, China or Europe). The company has strong marketing networks and low-cost manufacturing options for its non-critical components. It has acquired a facility -FabtecLite - in China. Here, the company utilises the blend of Chinese economy and Fabtech’s design and production capability of typical components.

To tap the various opportunities, ACG has launched a new division, ACG Inspection, a company that manufactures camera-based inspection systems. These systems are mandatory to ensure the highest level of quality check for products exported to regulated markets. With the launch of camera-based systems like Blis-i, Cart-i, Label-i and the latest track & trace system Verif-i, customers now have the widest choice of some of the best inspection technologies in the world from ACG Inspection.

Where will the demand come from?The Indian pharma machinery industry is growing at a Compounded Annual Growth Rate (CAGR) of 15-20 per cent. Currently, more than 700 pharma machinery manufacturing companies exist in India, catering to various segments of pharmaceutical manufacturing that includes tableting, capsulation, powder processing, material handling, R&D equipment and instrumentation, coating, bulk drug plant installation, etc.

“However, moving ahead, growth of the biotech sector, increase in the demand of products related to lifestyle disorders and new technologies like Dry Powder Inhalation (for asthma), Liquid in Hard Capsules (for poorly soluble drugs), etc, will drive the machinery industry forward,” believes Singh. He further adds that with contract research on the rise in India, support to drug development & contract

Hitesh GajariaExecutive Director, KPMG – India

German companies are known to manufacture best-quality machinery and India-made machinery has still not been able to reach the same pinnacle in terms of quality. Therefore, building upon quality and ensuring state-of-the-art equipment is the first step to being the market leaders in this domain.

Aasif KhanManaging Director, Fabtech Technologies International Pvt Ltd

Outsourcing will definitely help companies to grow internally and take competition to the highly regulated markets. But, this is possible only if the Indian government provides us funds for carrying out R&D, tax sops like that in the US and EU.



research will be important. Whereas Mehra believes, “The vaccines industry (machines) will boost the growth.”

Besides, India presently has the highest number of FDA-approved facilities outside the US.

The pharma packaging industry presently is a highly lucrative domain and shows significant potential for growth. Horizontal and vertical form-fill-seal machines for different dosage forms (solids, granules or liquids), blister packing & cartoning machines, form-fill-seal machines for flat-top and flat-bottom models, bag-in-box systems, sterilisation and filling technologies for vials & ampoules as well as filling & sealing machines of metal containers are technologies and equipment that are currently in huge demand.

What will drive the wheels?The biggest factor to accelerate the growth of the pharma machinery industry is the fact that the world leaders in pharma are setting up or planning to set up their manufacturing bases in India, which will drive most of the international machine manufacturers to follow suit. Most companies aim for certification from the USFDA or other accredited agencies for which they require sophisticated technology. “However, as India is a cost-sensitive market, the machine manufacturers need low-cost manufacturing bases in India to be able to maintain the leadership position even in India in the face of stiff local competition. At the same time, the awareness of superior quality in terms of equipment output and reliability will ensure that international machinery companies have an edge in this industry as well,” remarks Mehra.

With continuous improvement in drug administration and R&D of Novel Drug Delivery Systems (NDDS), the need for novel pharma machinery cannot be underestimated. Besides, India also enjoys a considerable cost advantage, as the manufacturing cost is comparatively lower than that in other countries in North America and Europe, according to Gajaria. On a similar note, Singh says, “The pharma

equipment sector has seen a double-digit growth, which is a fairly healthy trend. However, introduction of new technologies would be an important factor.” For example, ACG’s high-speed e n c a p s u l a t i o n machine with patented ZRM technology, the new range of specialised tablet tooling and the upgradation of tablet press—Legacy 6100 from ACG Pam have helped the Indian pharma industry keep pace with global competition. Moreover, there have been innovations even in the blister cartoning lines from ACG Pampac, which now have smaller footprints and higher speeds to meet the ever-increasing production demands.

Need to ramp up In India, at present, more than 700 facilities, including small-, medium- and large-scale enterprises, are engaged in manufacturing pharma machinery. The sector constitutes about 5-7 per cent of the global market in terms of value. The estimated turnover as of FY 2010 is approximately $ 428 million, of which about 40 per cent is currently exported. India exports machinery to about 80 countries, including various developed countries such as the US, UK and other European countries. However, the export scenario is likely to face some roadblocks due to the following reasons:� Intense competition in the field

– With Chinese manufacturers offering services at low prices, Indian manufacturers may face difficulty in convincing importers of their worth.

� Building confidence in quality – The process of building the confidence of foreign importers in Indian quality may pose a challenge that would need to be resolved for a smooth transition.

Elaborating on the roadblocks, Singh says, “Many companies moving their manufacturing facilities to India from Europe or the US tend to bring their old equipment and commission them in India. These companies have major issues because service support and spares parts are not available in India.” Further Singh continues, “It is only a matter of time that the industry would acknowledge that it is more economical to buy new equipment from an Indian supplier rather than transfer old equipment from other countries. We are promoting this concept to customers globally in order to have a changein mindset.”

Explaining the difficulties that may crop up in buying new Indian equipment, Mehra says, “The major



challenges would be the ease or difficulty in carrying out the technology transfer, not only from the perspective of the manufacturing facility but also from that of the attitude as well. Another major challenge will be to retain its intellectual property, as it will be easily available to other local machine manufacturers as well.”

Citing other areas that could present a challenge, Prashant Kavale, Managing Director, GMP Technical Solutions, says, “The bigger challenge will be in changing the mindset of the auditors and clients, with regard to the quality of our products. People are willing to pay even double the price for good quality products.”

Taking note of all these challenges, Khan makes an interesting point, “If we want to make India an outsourcing hub for machines, our government needs to extend help too.” Outsourcing will definitely help companies to grow internally and take competition to the highly regulated markets. But, this is possible only if the Indian government provides us funds for carrying out R&D, tax sops like that in the US and EU.”

Designing the blueprintsAlthough India enjoys a substantial cost advantage and the machines that are manufactured in India are 5-10 times less expensive than their counterparts manufactured in developed countries Indian manufacturers need to take certain measure to ensure a bright future.

Gajaria highlights a few potential measures, “German companies are known to manufacture best-quality machinery and India-made machinery has still not been able to reach the same pinnacle in terms of quality. Therefore, building up on quality and ensuring state-of-the-art equipment is the first step to being the market leaders in this domain.” Taking the thought forward, Khan says, “MNCs are looking at India due to its rich engineering base and the ability to re-engineer products/machines already made in the EU, Germany or Japan. Indian companies are excellent at reverse engineering the already manufactured products. Thus, now is the time for them to look at innovation as well, which until recently, has been extremely sluggish, and negligible .”

Therefore the need of the hour is the ability to deliver value-added engineering services along withthe integration of latest technologies at affordable prices. As Gajaria says, “India is competing with China and other South Asian countries on this front. In order to maintain the demand for the India-made machinery, it is important to be technology-orientated and fast in adopting the latest that the industry offers.”

This needs to be done in a strategic manner, believes Khan. He remarks, “Although outsourcing brings huge opportunities to India to learn, grow, adopt and adapt to international standards, this should happen without compromising on the brand name (ie, of the local company). Outsourcing can happen with co-branding so that the growth of the local company is not hampered.”

On the same lines, Mehra opines, “We are open to the idea of being a support base for any of our international principal that we represent and give them a sound platform. Thus, we are setting up a new facility near Mumbai to give them a ready base as well as to boost our own manufacturing activity in Dry Syrup Filling.”

Growth prospectsIn the current scenario, with companies focussing on an innovation-based approach and processes like packaging and NDDS, the importance of machinery is only increasing. Companies are adopting new technologies and trying to deliver the most valuable product at the best price. Factors like intense competition, of course, make this process more efficient.

With the increasing role of pharma machinery in medicine manufacturing and the evolution of new technologies like lasers, software, etc, the growth of this industry is definitely comparable, if not exactly complementary, to the growth of the domestic pharma industry in India.

Prashant KavaleManaging Director, GMP Technical Solutions

The bigger challenge will be in changing the mindset of the auditors and clients, with regard to the quality of our products. People are willing to pay even double the price for goodquality products.

Suresh PareekManaging Director, Ideal Cures Pvt Ltd

Outsourcing pharma machinery is a futuristic plan. Moreover, rational outsourcing of such machines would help local manufacturers to upgrade their services & set-ups and be at par with international quality standards, which will also ensure sustained business for the local players.

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An invite that rewards as well...


M A R K E T T R E N D S

a candy without a cover is a common sight, but a pill without its package is surely rare and, of course, an undesirable

phenomenon. However, when given an option, a drug without its package is preferable over the packaging that offers incorrect information. Definitely, in this case, nothing seems better than something. The role of a quality packaging in the pharmaceutical industry ends not only with the manufacturing and expiry date information but extends well beyond this meagre information. Explaining one of the importance of pharma packaging, Pradeep Tamhane, Managing Director, Wincoat Colours and Coding Pvt Ltd, avers, “The

packaging should protect the product from atmospheric conditions. Although aesthetic, the packaging should also be affordable.” Citing an example, he continues, there should be a specialised packaging for a particular product, eg, the bottle of Calcium Sandoz.

The market scenarioAccording to reports from Freedonia, an international business research company, worldwide the demand for drug packaging will grow 6.3 per cent annually through 2013. One of these reports state that in the global market of pharma packaging, while developed countries will dominate the demand graph, China, India and Brazil are among the

The adage, ‘Do not judge a book by its cover’, is a common occurance. But in certain cases, where

a cover or the package is the gateway for the product, the same should not only be appealing in

its aesthetic sense, but should also promise to attach ‘value’ to the product. Thus, quality pharma

packaging is the need of the hour. Chandreyee Bhaumik explores the importance of pharma

packaging, highlighting the market scenario, difference between the packaging of clinical trial

materials and pharma packaging, along with the challenges and ways to overcome them.

Pharma packaging

What’s in a pack?

Cou

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Con

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The need of proper pharma packaging



fastest growing countries. With the technological advancements, the types and forms of pharmaceutical packaging are undergoing a dimensional makeover. Drug packers are constantly making efforts to reduce the cost of packaging and, consequently, the industry is also growing rapidly. Market research reports by FIND/SVP Inc, the New York–based business research and consulting firm, show that during 1993-97, pharma packaging market had grown by 4.9 per cent, and is expected to increase substantially in the coming years. Further, various market surveys reveal that by 2011, the market is expected to grow by 5.4 per cent annually.

In case of most industries, the situation of domestic market varies from that of the Western market. Moreover, Indian pharma packaging market is different from those in the US and UK. Explaining the difference, Appadurai, Business Development Manager, Imaging & Printing Groups, Hewlett-Packard India Sales Pvt Ltd, avers, “The governing rules that exist in the US and UK are not applicable in India. In India, only the manufacturing and expiry dates are printed on the package. Thus, this is not a customised packaging. In contrast, in the US, each package has two-dimensional (2D) or three-dimensional (3D) barcode. These countries follow a smart label authentication method.” Further, on scanning a barcode, it is found to be unique.

Commenting on the national and the global market scenario, Suresh Pareek, Managing Director, Ideal Cures Pvt Ltd, gives a mixed response, “The present situation reveals a rudimentary picture. The formulations in India are excellent, but they do not have quality packaging. There is lack of research on packaging to suit the requirements of a medicine. Also, manufacturers should know that research on packaging has evolved and cost-effective solutions would help in reducing their production costs.”

Constant growth and development in the pharma packaging industry has further accelerated the demand. As Pareek explains, “The pharmaceutical packaging market is constantly advancing and has experienced annual growth of at least five per cent in the past few years.” Constant innovation is the primary reason behind the rapid growth of the industry. He further elaborates, “These changes have made a large impact on the packaging industry and there is an increasing need to provide tailored, individual packaging solutions, which guarantee the effectiveness of medicines’ humidity, there is often a direct link between packaging and a remedy’s effectiveness.”

For some, pharma packaging seems to be a novel concept. To this Raj K Menon, owner, Karishma International, avers, “In India, the pharma industry has only recently started focussing more on packaging. In fact, at one point of time, Indian pharma companies had the lowest investment in the packaging division, irrespective of it being in machinery

or materials. This has happened mainly because the demand from the overseas markets for our pharma products has increased gradually and substantially, and to cater to these markets, adhering to the packaging standards was extremely important.” However, Tamhane provides an interesting take on the market scenario, “Countries like China apparently appear more competitive, though we are more effective & economical.”

Countering the counterfeitsA report by World Health Organization (WHO) shows that the global trade in counterfeit drugs is estimated to be worth £ 75 billion and will continue to grow at a rate of 13 per cent per year. The report claims that the threat is all the more impending on Internet. Almost 50 per cent of the drugs purchased on illegal online pharmacies are considered counterfeits. Along with the manufacturing of fraudulent drugs, counterfeiters also seek to infiltrate the legitimate supply chain. This permits

Pradeep TamhaneManaging Director, Wincoat Colours and Coding Pvt Ltd

There is a dearth of appropriate

machines and adequate raw materials.

In such a situation, the Government should

provide some concessions for the import

of raw materials.

Suresh PareekManaging Director, Ideal Cures Pvt Ltd

There is lack of research on packaging to

suit the requirements of a medicine. Also,

manufacturers should know that research

on packaging has evolved and cost-effective

solutions would help in reducing their

production costs.



them to curb the authentic shipment rules and redirect them to other markets, re-selling them for their own profit.

Thus, counterfeiting has become one of the conspicuous issues in the present pharma space. There is a concern for medicines being contaminated or containing incorrect or no active ingredient. The US Food & Drug Association (USFDA) has undertaken several initiatives to combat the growing public health problem of counterfeit drugs. It had implemented rule 21 CFR Part 211, which demarcated present Good Manufacturing Practice (GMP) for finished pharmaceuticals. The rule indicates that tamper-evident packaging be applied for Over-The-Counter (OTC) human drug products. It also shows that a tamper-evident package has one or more indicators, which if breached, can be expected to provide visible evidence of the breach.

The USFDA is also endeavouring with several other agencies and the private sector for protecting the country’s drug supply from the grips of counterfeiting. Appadurai explains the way counterfeiting occurs. He observes, “Counterfeiting takes place at three levels. Usually, it occurs at the level of manufacturing, then at the pharmacy or retail level and, finally, at the consumer level.” However, every impending problem hints at a consolidated effort towards countering this threat. He opines, “Generally, counterfeiting happens because we do not have the ability to determine it. We need to scan the bar code with

a mobile phone. Immediately, the data is converted to the pharma companies’ server, and from here the consumer receives information on the nature of the drug. This phenomenon is applicable at the pharmacy level also. At the level of manufacturers, tracking is done to determine the location of the products, if someone is selling the products.”

Thus, to combat pharma industry needs to adopt innovative packaging and branding solutions. Pareek explains, “The present methods to combat counterfeit drugs are expensive but not effective. We see embossing, hologram, etc, among other methods, being used to fight against counterfeiting. But, considering that a large part of our population is illiterate, such methods are not effective, as many people are generally unable to notice them.

Moreover, such holograms and embossing can be easily copied. The only way to tackle such counterfeits is to be more creative and develop more designs (shape/sizes) to establish brand identity.” Elaborating on the company-specific initiative, Pareek continues, “Ideal Cures has developed a range of coating systems to counter the problem of counterfeit drugs. InstaCoat SMART offers the advantage of creation of unique brand identification, and thereby reducing counterfeiting. InstaCoat Spectrum is a multi-colour coating technology, which does not require any new equipment, and is useful in creating exclusive brand identification.”

Setting apartThe market scenario is however not uniform. As the levels of functioning are different, the packaging of the clinical trial materials and the pharma packaging revolve and primarily deal with two different arenas. Appadurai remarks, “Packaging for clinical trial materials is done in laboratories or hospitals, whereas pharma packaging is done at the manufacturing level. Usually, the materials in clinical trials are labelled by a desktop printer at the laboratory level, whereas in pharma packaging, labelling is done at the manufacturing level in factories.”

However, clinical trial is also a vast arena, and there are differences with regard to its packaging. Arun Nair, National Operations Manager, World Couriers, discusses, “Dangerous goods can be classified into nine types based on the hazards they present. Class 6.2 is bifurcated into two categories: A and B. While category A deals with highly infectious substances like HIV, category B deals with biological substances like human or plasma samples. Thus, the packaging for different samples in clinical trial packaging is different.” The packaging norms usually adhere to the several documents required for the process. He adds, “In case of packaging infectious samples,

Raj K MenonOwner, Karishma International

The demand from the overseas markets for our

pharma products has increased gradually and

substantially, and to cater to these markets,

adhering to the packaging standards was

extremely important.

Counterfeiting has

become one of the

conspicuous issues

in the present pharma

space. There is a

concern for the

medicines being

contaminated or

containing incorrect

or no active

ingredient.



documents like Dangerous Goods Declaration (DGD) are required, whereas, in case of biological samples, a completely different set of documents is needed. Hence, DGD is not an essential an aspect here.”

Crossing overThe journey of any industry is not accomplished without impediments. Pharma packaging industry also faces its own set of challenges. According to Appadurai, several obstacles hinder the progress ofthis industry. He discusses, “There is a challenge to produce packaging material in the shortest possible timeframe. Time pressure becomes a pressing problem sometimes.” However, he believes counterfeiting to be the biggest threat that the industry faces today. While discussing the way to counter the problem, he continues, “Digital printing is an effective solution for an obstacle such as this. It ensures variable data, 2D barcodes, coloured tiles and many other aspects that aid in the fight against the challenge. The barcode offers an attribute of uniqueness to the product that differentiates the original from the fraudulent and duplicate.”

Discussing the challenges, Menon explains, “Low-cost imports from China are a threat for the Indian pharma industry. Imported packaging goods are still favoured because of their superior quality and better documentation. Even with our advantage of pricing, if not backed up by proper documentation, it will be difficult to compete.” Further elaborating on the same, Tamhane says, “There is a dearth of appropriate machines and adequate raw materials. In such a situation, the government should provide some concessions for the import of raw materials.” However, on a positive note, he concludes, “Since pharma is an important sector, the potential for growth of the pharma packaging sector is tremendous. We can even export to various African and Asian countries.”

Co

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Dae

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The process of packaging at work


MARKET ING

Drug prescription trends

When a physician consistently prescribes a drug of a particular brand, the brand becomes

his favourite. This preference for a particular brand is termed as brand loyalty, which directly

influences the sales graph of the manufacturer. At times though, this loyalty shows a decline, as

a result of a shift in the physician’s interest towards another brand. This article outlines various

factors responsible for this shift in brand loyalty.

Dr Rajan T D

the international soft drink major, Coca cola, has been a part of the Indian market landscape for several years. During the

1970s, Coke scored over several local brands, as many Coke consumers in the country considered the choice of this particular soft drink a matter of prestige. Over the years, the beverage market grew manifold and local brands like Thums Up entered the fray. Gradually, many faithful Coke drinkers switched over to the new cola. It was surprising for the company

Coca Cola to observe that a large section of the population, which swore by their ‘international taste’ in the secret formula could suddenly lose its marketshare.

Taking a clue from the above example of the soft drink major, it has been noted that many drug molecules, eg, atenolol, amoxicillin, clotrimazole, co-trimoxazole, doxycycline, ibuprofen, pheniramine, paracetamol, pentoxifylline, ranitidine, etc, have had a long and successful run. Some of these drugs are original research molecules by the manufacturers, and hence these are taken up by physicians immediately after launch. Some other molecules become heavy ‘grossers’ over time as a result of their strong brand image and the company’s astute marketing techniques.

Physicians continue to prescribe these brands even as several newly discovered molecules are introduced in the market. These ‘winner’ brands then become synonymous with the disease being treated.

Tumbledown“Septran, Rantac, Betnovate, Soframycin, Avil, etc were at one point of time in an invincible position and no doctor could practise without writing at least one prescription among these formulations every day,” says Dr Sudhir Patil, Treasurer, Indian Medical Association, Mumbai. On the present status of these drugs, he adds, “With safer and better alternatives available today, these brands have been pushed into a corner.”

Keeping the ‘winner’brand alive


MARKET ING

A number of factors are attributed to the sudden or gradual loss of brand loyalty. In the earlier example of the soft drink Thums Up, the younger generations preferred the supposedly stronger taste of the new drink as opposed to the ‘lighter’ taste of the traditional Coke. However, the reasons for a physician to shift his loyalty cannot be summarised in such straightforward terms but on the basis of observations made by practising doctors, some of the probable reasons for the shift in loyalty can be attributed to the following factors.

New molecule in competition: The launch of a new molecule for treating the same condition is the most common reason for a physician to try out the new drug. For instance, when the antifungal agent, ketoconazole cream, was first launched about two decades ago, there was a temporary shift in physician’s prescription pattern.

Physicians who were satisfied with prescribing the older antifungal,

clotrimazole, switched to the new molecule. During this phase, the marketshare of the older drug plummeted considerably. However, in case of this new antifungal, the novelty wore off in a short time and the physicians returned towards prescribing the older agent. Therefore, the older drug may regain its position over time, depending on the final opinion of the physician.

Presumably, such a shift happens because the physician wants to make his own observation about the safety, efficacy and cost-benefit ratio of a new molecule vis-à-vis the older and established drug. Many doctors do not want to simply be influenced by the research reports submitted by the manufacturer and prefer to draw their own conclusions about the new molecule.

Out of focus: Most drug companies promote a molecule for a few years till the physicians start prescribing it on

preference. As soon as the sales graph escalates, the company starts working on their next big dream. Consequently, the earlier brand that has been consistently bringing in huge returns is no more promoted by the field staff on a regular basis, and thus may lose attention or mention during marketing calls.

At this time, the physician too gradually develops interest in another brand of the same molecule or an entirely different drug. A short-term experiment with the alternative brand in a few patients is sufficient for the physician to forget his original favourite brand. It is then that the manufacturer realises that their winner brand is no longer the physician’s first choice.

Beating the predictability pattern: Every doctor has a distinct style of practice with respect to prescribing medication. While some follow a scientific pattern, others follow evidence-based medicine. Still others experiment with their own analysis and observations


MARKET ING

based on personal experiences. The combination of drugs that the physician decides on for a particular disease then becomes personalised.

Often, chemists and patients observe the standard prescribing pattern of the physician. The brands chosen for a particular disorder are occasionally repeated in the same sequence in every prescription that the physician thinks is the best combination for the patient.

Some physicians try not to be repetitive in prescribing brands. For this, they start prescribing another brand of the same molecule in order to avoid the ‘predictability pattern’. Such a shift usually dents the sales of the physician’s ‘once favourite’ brand.

Two family members: Occasionally, more than one family member may consult the physician and they could be suffering from the same illness. In such a situation, most general practitioners and specialists follow a common tactic so as to not lose the patient’s faith.

If the doctor were to prescribe identical drugs to both members of a family, some patients may not feel sufficiently rewarded for the money spent. In such a case, the physician tends to prescribe another equally good brand, instead of his favourite, to one of the patients so as to increase his treatment compliance. In contrast, less literate patients may not understand if the same brands are prescribed to both the patients when their symptoms seem to be different.

Smart marketing: An engaging marketing manoeuvre may influence some physicians to switch their loyalty to another brand. The technique may include some medical event being organised to garner support to their brand or a simple tactic as gifting journals or books that support the manufacturer’s claim.

Brand tinkering: In India, the government induces stringent regulations with respect to the prices of drugs sold in the open market. Occasionally, the Drug Price Control Order (DPCO) fixes a ceiling on the

price of certain essential drugs. Often, pharmaceutical manufacturers make minor variations in the active ingredient or add certain excipients to make it appear as a new drug, while selling it under the older brand name.

There are numerous instances where the active ingredient of a brand has been altered while retaining the brand name. For example, erythromycin gel was replaced by clindamycin in several anti-acne preparations, yet the brand names (Acnesol, Erytop, etc) have remained unchanged. In the case of a topical corticosteroid, the shift to a more potent cortisone was disliked by many dermatologists. Yet, the manufacturer continued to use the same brand name by adding an innocuous suffix (eg, Dipsalic F).

Most physicians are troubled by such measures, and this often leads to a loss of brand identity. Consequently, the physician then begins searching for an equally efficient alternative.

Chemist counter confusion: Some companies are so enamoured by their winning brands that they introduce further novel brand extensions. For example, the success of betamethasone dipropionate cream (Diprovate) had brought forth a series of brand extensions by Ranbaxy Ltd, viz Diprovate RD, Diprovate S, Diprobec, Diprobec RD, etc. Such a step leads to a chaotic situation at the chemist’s counter. The chemist may mistakenly dispense the wrong brand, thus bringing disrepute to the entire spectrum of drugs.

Consequently, the patient does not feel the desired relief, which disturbs

the physician’s peace of mind. Thus, this confusion in brand names eventually leads to a prescription of wrong medicine by the physician.

Nondescript field work: Occasionally, reshuffling of medical representative (MR) working zone or resignation by an MR results in some physicians encountering new people. In such a situation, there have been instances of overenthusiastic MR who asks the doctor the dangerous question, “How many prescriptions of Brand X do you write per week, sir?” The doctor who initially had supported brand X could feel offended and may discontinue all prescriptions thereafter. Moreover, the company also realises only after a long time that the slump in sales figures was because of the new MR on the job.

The ‘winning’ brand An old saying, ‘heavy lies the head that wears the crown’, is apt even in the field of pharmaceutical marketing. Thus, no brand manager can afford to take things for granted at any stage.

An alert watch on the competitor’s movement, a deep understanding of the physician’s psyche and the ability to restrain from needless manipulation of the active ingredient are essential requirements to prevent the winner brand from a sudden, unexpected collapse.

Dr Rajan TD (MD, DVD, DNB) is an alumnus of Mumbai University and practises as a Specialist in Skin & STD in Mumbai since 1991. He regularly

writes in various periodicals on several social issues as well as those relating to the pharmaceutical industry. He has been the Associate Editor of ‘My Doctor’. He advises pharmaceutical industries on drug development, promotion and marketing strategies. Dr Rajan is an Honorary Consultant to ONGC, Indian Airlines, Air India and Larsen & Toubro Ltd. He also teaches at CMPH Medical College, Mumbai. Email: [email protected]

The launch of a new

molecule for treating

the same condition

is the most common

reason for a physician

to try out the

new drug.


C L I N I C A L R E S E A R C H

Jayanti Vaidyanath

clinical trials are becoming increasingly complex, as biopharmaceutical companies respond to growing concerns over the cost and safety of new drugs. Clinical studies

have moved beyond primary cities and towards more remote investigator site locations. Components of a clinical trial often occur in different countries, which follow their own regulations for the clinical trial process. There is a growing awareness on the importance of cold chain requirements for temperature-sensitive pharmaceutical products. Sponsors and Clinical Research Organisations (CRO) alike have realised the need to focus on the investigational products that are being distributed, stored & handled at right temperatures along with the traceability to prove this maintenance. These complexities have resulted in a significant shift in the balance of power towards clinical supply chain specialists.

For the industry, four per cent of the cold chain shipments en route the destination experience temperature fluctuations (commonly called ‘shipping excursion’) that makes the supplies unusable, even if temporarily. A shipping excursion is a negative event that occurs during shipping, wherein the product exceeds its specified temperature limits. Stability data on the product on investigation will result in a release or destruction of the excursion product. On an average, about 2-4 per cent of the cold chain supplies never arrive in a usable condition. The average cost for shipping excursions can exceed $ 150,000 and commits over 2,300 staff hours for an average cold chain-related study. For a large pharmaceutical company, which may have 15-20 studies per year, such excursions may multiply costs by millions of dollars, as noted by Roy Goff, Pharma Outsourcing.

Growing requirements of cold chain Today, the global biopharma cold chain market is

estimated at $ 5.1 billion, and is expected to grow to $ 6.6 billion by 2011. Pharmaceutical Commerce has published ‘Cold Chain Biopharma Logistics Sourcebook 2010’, a first ever study of the booming business in temperature-controlled shipping of biopharma products, which assesses the impact of new regulations, new packaging & shipping technologies and the faster-than-average growth of biopharma products that require cold chain shipping. While the North American market is expected to grow by 15 per cent during the 2008-11 period (or about 5 per cent annually, in line with the overall pharma market), the global market will show a growth rate that is double this amount.

The study has surveyed growth rates for pharmaceuticals, biotechnology, vaccines, blood products & clinical materials, US & international regulatory bodies like US Food and Drug Administration (FDA), United States Pharmacopeia (USP), Parenteral Drug Association (PDA), International Air Transport Association (IATA), Medicines and

Cold chain logistics

Supply chain demands specialised handling for sensitive goods, like certain temperature-sensitive

drugs, during transportation, irrespective of the transit route taken. Also, ensuring the arrival of

sensitive goods in a usable condition calls for the use of cold chain during transport. This article

delves into the various challenges encountered in this area and ways to overcome them.

Need of the hour

Courtesy: SIRO Clinpharm

Modern Pharmaceuticals September 2010�60


Healthcare products Regulatory Agency (MHRA), etc, as well as air, ground & ocean carrier modes. It also includes packaging materials & technologies, refrigeration systems and instrumentation.

Nick Basta, Editor-in-Chief, Pharmaceutical Commerce, and co-author of the report on Biopharma Logistics, observes that the global biopharma industry is growing more towards biologics and projects. Seven of the top 10 global pharma products in 2014 will require cold chain handling. Further, while significant attention has been given in the past year towards preparations for the H1N1 flu season, a simultaneous and dramatic growth has been observed in the world vaccine market, both for infectious diseases and other conditions. Various industry sources estimate the vaccine market to grow on an average of 8 per cent per year through the next five years.

Meanwhile, the clinical trials industry, which has been expanding globally in recent years, will add more volumes to this growth in future. Clinical trials materials (CTM) have evolved to the extent where they require specialised logistics market. For example, it has been reported that recently, a single CTM shipment required its own chartered jet to carry 65 metric tonnes of temperature-controlled material, from Europe to the Far East.

Compliance officers and supply chain managers have several options of validated technologies and transportation processes, particularly for real-time monitoring of a shipment’s condition, many of which are affordable. All biologics may not necessarily require cold chain handling but trends indicate that even products stored at room temperature will soon require additional monitoring steps, which may thus add complexity to the transportation process.

Monitoring product circulationExcellent cold chain monitoring & packaging systems maintain the integrity of the pharmaceutical or investigational products during the manufacturing and supply chain processes. Highly efficient & user-friendly monitoring systems automatically & continuously monitor the environmental conditions during

handling, storage and transportation of pharmaceutical or investigational products. A number of monitoring solutions like the wired or wireless sensor networks, data loggers and thermocouples effectively monitor manufacturing facilities, warehouses & storage areas, during transportation & shipment.

Shipping, insulation and packaging technologies are now offering better materials such as the inner polystyrene container with Vacuum Insulation Panels (VIP), polyurethane and phase change materials. Reusable temperature-controlled containers are also available for international shipments. Another important tool that helps in land transport is the availability of temperature-controlled trucks.

Challenges & ways to counter themA number of factors act as impediments for the pharmaceuticals transport management. Of these, cold chain logistics and storage depots face substantial challenges in the way of proper functioning.

Cold chain: The complexity in the transportation process poses new challenges that involve maintaining cold chain during movement of goods to remote locations, more exchange & drop-off points and varying distribution environments, which often involve lengthy clearance procedures at customs end. Moreover, some of the other challenges include various modes of transportation, lack of adequate logistics infrastructure, numerous carriers & couriers, specialty packaging solutions, different climate zones and seasonal changes. Large studies may involve shipment of large volumes of refrigerated patient kits worldwide while maintaining and documenting appropriate temperature conditions.

Temperature excursions during storage, handling or distribution of temperature-sensitive CTM pose significant safety and financial risks.

One way to counter this challenge is to collect the necessary data and information upfront to have a clear understanding and knowledge of the storage & transport conditions, which will prevail throughout the supply chain. The pharmaceutical

manufacturer, logistics provider, packaging designer and data logging supplier should together discuss the project to ensure maintaining clarity throughout the process. The storage conditions during shipment may involve encountering uncontrolled environments through various transport operators, during different seasons, several storage warehouses and depots or pharmacies, etc. While pharmaceutical warehouses and storage areas are generally controlled environments with easier validation, uncontrolled environments during the transportation and distribution of drug products by ground, sea or air represent the greatest challenge to sponsors.

Storage depots: CTM storage depots with local presence play a significant role in ensuring proper storage and delivery of Investigational Product (IP) to sites within their country. They have a good understanding of the regulatory requirements, storage conditions, distribution and logistics challenges according to seasonal requirements. It is therefore inevitable that sponsors rely on their experience, expertise & infrastructures and use them as their local depot. This lowers the risk of delays due to the import processes as well.

Storage depots should ensure compliance with cold chain regulations by acting on the following quality aspects of cold chain:1. Carry out temperature excursion

test studies2. Update their cold chain quality system

by ensuring regular revisions of standard operating procedures and personnel training

3. Carry out regular validation of all cold chain processes and equipment by mapping the warehouses & storage areas

4. Carry out dummy shipments to study temperature data during movement of goods to validate the qualification of temperature-controlled transport storage shippers.

Major guidelines to followApart from the regulatory requirements of individual countries, relevant guidelines



are also available to ensure maintaining high levels of security and safety for the drug products throughout the supply chain, from the manufacturing facility up to the final end-users or patients. Some of these major guidelines include Good Laboratory Practices (GLP) for the drug development aspect, Good Manufacturing Practices (GMP) for the manufacturing side, Good Clinical Practices (GCP) for the clinical trial side and Good Storage & Distribution Practices (GSDP) for the pharmaceutical supply chain aspect.

Looking forwardSumming up, it can be stated that the aim of conducting a clinical study is to mitigate and ultimately eliminate the bottlenecks so as to deliver the supplies on time and in a condition that satisfies the enrollment or quality needs of the study sites. This activity is for both project and risk management.

According to Goff, certain activities essential for project and risk management include identifying the locations of the

sites where the clinical study is to be carried out and identifying any special requirements for logistics planning at sites, eg, narrow corridors that cannot allow passage of a pallet, winding staircases, small refrigerators, etc. One should track the study transportation routes from the distribution location to clinical trial site and look at the likely temperature variation situations that may occur en route. Another

important step to consider is calculating the duration, date or time for the movement of supplies to ensure that delivery does not occur on a holiday, ie, when the site is closed. Temperature range or duration of shipments needs to be verified against shipping container specifications to determine any special shipping container design needs. Verification processes should be carried out so as to avoid leaving out any specialised cold chain activities. People involved in this activity should work with partners in order to seek feedback from sites, couriers, freight forwarders, CROs and contract manufacturers to obtain the optimum approach for the study, country & site.

Jayanti Vaidyanath is Vice President Administration, Legal and Clinical Trials Supplies Management at SIRO Clinpharm.

For further details contact Corporate Communications-Head: Aniruddh Patwardhan, email:[email protected]

Key risks due to cold chain failure�� Patient could be administered an

unsafe product�� Lack of compliance with global

regulatory and standards-based requirements can increase liability

�� Thermal variability can lead to inconsistent results between and within batches

�� Shipment can be rejected by the quality department, leading to costly delays—increasing the complexity of trial management

Courtesy: R H Bishara, Good Cold Chain Management Practices for Clinical Trial Materials, Pacific Region Clinical Supplies

(PARCS), San Diego, CA.


I N D U S T R Y I N S I G H T S

pD is the world’s second most common form of neurodegenerative diseases. In 2009, the global market for PD therapeutics was estimated

to be worth $ 3,178 million. It was also forecast to grow at an annual rate of0.9 per cent for the next seven years to reach $ 3,384 million by 2016. This modest growth is ascribed to patent expirations, subsequent entry of generics, weak developmental pipeline as well as to the fact that the cause for the disease is still unknown. These factors also continue to pose significant

challenges for prospective market entrants that are expected to keep the market stable. Further, the ageing population would be a key driver for this market.

The global PD therapeutics market is not well served with current product options and unlimited scope is available for new entrants to capture value from underserved segments. Designing disease-modifying drugs instead of drugs that provide symptomatic relief is one of the key challenges faced by the players in this market that could provide significant market for any company. Overall, the late-stage pipeline comprises drugs thatare aimed at symptomatic treatment of the disease. There is a need to balance the pipeline considering the enormous burden of the disease and the high expectations of patients. Without such a balance, the pipeline would be considered weak. The epidemiological factors in the top seven markets will propel the PD therapeutics market. On the other hand, the ever-increasing aged population in the US, UK, Japan, Spain, Italy, Germany and France will further increase the use of generics drugs.

Scope for new treatment options Considering the current therapeutics options in the PD market, a combination of Levodopa & Carbidopa can be inferred as the cornerstone of the treatment options. The current therapeutics market is primarily driven

The exact unknown etiology of the disease and a frail drug pipeline continue to be the challenging

forces to the Parkinson’s Disease (PD) therapeutics market. Further, considering that current

therapies for PD only provide symptomatic relief to PD patients, there is an urgent need to design

& develop drugs that would either stimulate the brain to release dopamine or address disease

modification to spur growth prospects in this market. This article analyses the different factors

influencing this market and the way forward.

Parkinson’s disease therapeutics market

Balancing the disease burden and patient expectations

Co

urt

esy:

MD

Bec

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Part

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I N D U S T R Y I N S I G H T S

by combinations, reformulations and indication expansions. Among the branded products, Boehringer Ingelheim’s Mirapex/Sifrol registered the highest sales in the 2008. This was followed by products by Glaxo’s Requip/Requip XL and Orion/Novartis‘ Stalevo. Boehringer Ingelheim, GlaxoSmithKline (GSK), Orion/Novartis and Teva/Lundbeck remain the leading competitors inthe global PD therapeutics market. The competitive landscape is populated by four major products, none of which is significantly stronger or more dominant than the others. Azilect, which has shown promising results in the Phase III ADAGIO trials, is indicated to inhibit disease progression and is expected to positively impact the market.

As these drugs are capable of only treating the disease symptomatically, the market sustains a high unmet need, which is expected to rise in the forecast period. The current treatment options, eventually become functionally ineffective and the patient stops responding to the drug. As a result, the market presents a wide scope for new entrants. In the current market scenario, any drug or therapy that can potentially induce the brain to secrete dopamine will capture value in the market. However, development of a drug

that can cause disease modification still remains a challenging task.

Lack of innovation is increasingly hampering the global PD therapeutics market. Any company targeting to capture the unmet needs, will need to overcome the prevailing product weaknesses such as adverse effects (dyskinesis, psychiatric side effects & obsessive compulsive behaviours) and limited efficacy, which are the biggest drawbacks of products presently in the market.

There are 181 products in different stages of development in 2010. The Phase III stage includes a mix of dopamine agonists and some drugs, which are being developed to relax the disease progression. In addition, several promising stem cell-and gene-based therapies are in early stages of clinical development.

However, considering the fact that these therapies are still in their early developmental stages, it is difficult to predict their success and time of commercialisation.

PD pipeline in the future Among all companies working onPD pipeline molecules, Merck Serono, Acadia, Axxonis, Solvay, Avicena and Impax are envisaged to be the key players of the future market. Merck Serono and Avicena have one molecule each in the Phase III stage for PD. On the other hand, Axxonis has the patch and subcutaneous forms of Lisuride in Phase III, targeting the patient compliance element/factor; Acadia has one molecule in Phase III and one in the pre-clinical stage while Solvay has two drugs in Phase III development; and Impax has one molecule in Phase III. Safinamide, Pimavanserin, PD-02 and SLV 308, currently in Phase III, are the key products in this pipeline. Safinamide, with features like manifold mechanism of action and a high therapeutic index, remains the most keenly watched product in the pipeline. However, these pipeline products do not differ significantly from the marketed drugs for addressing the unmet need and offering superior medical benefits.

Courtesy: GlobalData

The epidemiological

factors in the top seven

markets will propel

the PD therapeutics

market to grow from

$ 3,178 million in

2009 to $ 3,384 million

by 2016.

Opportunity & unmet needs in the Parkinson’s disease market, 2010

Note: Size of the bubble represents opproximate cost effectiveness of the product unmet needs indicate the efficacy and safety associated with the drugs

EfficacyLow

Safe

ty

Hig

hLo

w

High

Unmet need is high (34% for PD

Unmet need=34%X$3,178m =$1,080m

Next steps unmet need can be fulfilled only by efficacious and safe products which are likely to be me-toc drugs in dopmine class or first-in-class products.

Stalevo Azilect Generics

Requip XL Mirapex

Global Parkinson’s disease market forecast ($ million) 2001-2016

CAGR (2009-2016): 0.9%

CAGR (2001-2009): 2%

2001 2009 2016

4,000

3,500

3,000

2,500

2,000

1,500

1,000

500

0


TECHNOFOCUS

Powder compaction rig Three point bend test Bilayer tablet shear

Jo Smewing

the pharmaceutical industry has fully embraced the unique benefits offered by controlled delivery drugs that enable manufacturers to determine

the rate, site or time of targeted release. The competitive advantage of systems lies in improving patient compliance & convenience as well as prolonging product lifecycle. Controlled-Release (CR) dosage forms are divided into two conventional types: Delayed-Release (DR) and Extended-Release (ER). The appropriate type depends on whether the dose is required at one time, or times differing from administration, or if a higher concentration of an active ingredient needs to be gradually released over a

prolonged period so as to lessen the necessity for frequent medication.

Although a variety of administration methods exist, oral delivery accounts for 90 per cent of all prescribed medication. The drug dispensed in the form of a tablet, capsule, pellet or elixir is degraded by stomach acid and enzymes, passed through liver metabolism and then absorbed.

Quality control with texture analysisCR drugs have become increasingly popular in the context of chronic ailments, including heart disease and cancer, and in increasingly common conditions such as Alzheimer’s disease or obesity. In order to maintain functionality, the mechanical properties responsible for manipulation of biological barriers or regulation of diffusion rate

Maintaining optimal physical structure and texture of dosage forms is important for maximising

efficacy and minimising adverse effects of a drug. To ensure this, drugs undergo extensive testing

for their properties and identification of optimal formulations to enable a stable and long-term

performance. This article outlines several new methods that are now available for measuring pivotal

physical characteristics of controlled-release pharmaceutical products.

Texture analysis

Uncoding the coats in a tablet


TECHNOFOCUS

have to undergo stringent quality control during manufacturing. For achieving the desired results, it is advisable to first test the properties of individual ingredients, followed by the finished product. Use of the texture analysis method allows pharmaceutical manufacturers to safeguard pre-defined quality standards in the physical characteristics of individual ingredients and final products.

Testing time for tablets As the most prominent dosage forms in pharmaceutical industry, the range of tablet formulations includes fast-dissolving, self-repairing or ER. Compact tablet formulation is determined by the compressibility and compactability of each component. Thus, to evaluate the performance characteristics of bulk and individual solid dosage forms, it is necessary to first test powder compressibility and the effect of tooling geometry in tablets. Further, to measure the compression properties of powders, a powder compaction rig, attached to a TA.HDplus texture analyser, can be used as a compaction simulator on ‘F’ tooling sets. In this rig, two vertical probes, with indentations to accommodate the powder, compress the sample into the shape of a tablet. The force required to compress a sample is measured, indicating the compaction properties of the powder.

Tablets come in all shapes and sizes; thus, a comparison between different types is possible only on the basis of their tensile strengths. Tensile strength

is a good indicator of a tablet’s ability to withstand the rigours of manufacturing processes, transportation and usage. A number of methods are available to measure the tensile strength of tablets. As tablets usually fracture along the diameter, diametrical compression is a commonly used method, whereby the sample is compressed from both sides. The test determines the force required for a tablet to fail. The TA.XTplus and TA.HDplus texture analysers are widely used to perform these diametrical crushing tests. Another known method for measuring mechanical strength & fracture characteristics is the three-point bend test. The tablet is mounted on two lower supports and a central upper support is lowered onto the tablet until it fractures. The brittleness of the product is then calculated.

Double actionFor additional efficacy over time, bi-layer dosage forms are often used to provide a combination of immediate-release dose for fast-acting relief and a dose of CR to maintain the therapeutic effect. The bi-layer tablet shear rig has been specifically developed to assess the physical characteristics of high-load Active Pharmaceutical Ingredients (APIs). These often require bespoke manufacturing formulations to overcome barriers such as low melting points or poor compressibility. In order to assess the force required to separate the layers of a bi-layer tablet, a sample, placed in the central cavity of a guillotine-like blade, is compressed

until the two components are sheared apart. This test enables manufacturers to optimise the formulation in order to achieve a perfect adhesion between the two tablet components.

Cracking coatingsFilm tablet coatings are popular owing to their multiple roles – from aesthetics and masking taste & odour to eased ingestion and prolonged product shelf-life. On the negative side, aqueous film coatings tend to act as local stress concentrators and promote cracking, edge splitting & peeling. For assessing these risks accurately, Stable Micro Systems has developed a tablet coating adhesion fixture, which calculates the force required to separate a tablet from its coating. A scalpel is used in order to remove the coating from around the circumference of the tablet, leaving the coating only on the upper and lower surfaces. The lower & upper fixture cavities are covered with double-sided foam tape, and the prepared tablet is then positioned in the lower cavity. In this test, the upper fixture descends onto the tablet at a specific force for a defined time. After the sample is fully compressed into both cavities, with full coating contact with the adhesive, the upper fixture is withdrawn, either removing the upper coating or leaving the lower one in the stationary fixture. The maximum force required to separate the tablet from its coating is known as the ‘tablet coating adhesion force’.

Conventionally, tensile or pneumatic grips were used to assess the tensile

Tablet coating adhesion fixture Compression of a single granule Granule compaction rig


TECHNOFOCUS

properties of polymeric films, but the reproducibility of results is compromised because of uneven distribution of pressure across the sample surface. By comparison, the Film Support Rig can hold small sections of film in a drum configuration, which means that the pressure is evenly distributed around the circumference of the sample. A puncture test performed by a spherical probe determines the film’s burst strength as well as resilience, stiffness and relaxation.

Similarly, some of the most popular pharmaceutical dosage forms are hard two-piece capsules. Accurate testing of their hardness and flexibility is invaluable in early formulation screening. It determines their ability to withstand various manufacturing and storage conditions. The capsule tensile rig provides a new method for calculating the force required to split open one half of a hard gel capsule. In softgel capsule applications, the TA.XTplus texture analyser can also be used to measure their seal strength and burst point. The test requires a cylinder probe that exceeds the size of the capsule being tested. Subsequently, depending on the force applied, the probe punctures or compresses the capsule along the seal line.

Small yet powerfulPharmaceutical powders often undergo particle modification, such as granulation,

before compaction. This inevitably changes their deformation and densification properties. The same is also true for pellets, whose round shape facilitates easy application of polymer coatings, making them ideally suited for controlled drug delivery. A cylinder probe can measure the fracture strength of a single particle, which indicates its dissolution and drug release rates. However, in areas where the granules or pellets are irregular in form, single particle testing compromises the accuracy and consistency of results, because sample parameters may show significant variation. Hence, it is preferable to test a larger fixed sample area, as it creates an averaging effect. By using a cylinder probe of a diameter similar to that of the testing area, the granule compaction rig measures the hardness and compressibility of various samples.

Ease of swallowingWith an increasingly ageing population, come associated health issues such as the decline in the ability to swallow medicine. Soluble or granulated medication allows easy and convenient drug administration to people of all ages. For evaluating new dosage forms, quantifying their release properties is crucial. In a simple test for calculating tablet disintegration & dissolution times, a sample is attached to a flat-ended cylinder probe, which is then lowered into a volume of simulated saliva or water. The TA.XTplus texture analyser is then used to measure the change in distance during disintegration of the submerged tablet.

Another critical parameter in both CR and ER formulations is dimensional change associated with matrix hydration and subsequent swelling. Once hydrated, tablets form gelatinous layers that dissolve one after another. In CR systems, where an active agent is released through sequential swellings of its surface layers, measuring gel thickness is paramount. For simulating gel dynamics, a sample is affixed to a petridish and placed in a dissolution vessel filled with a medium so as to allow thorough ingression of the liquid. Swelling can be quantified by calculating the change in

force required to compress the sample as it swells, or measuring the difference in distance travelled under constant force.

Microcapsules & alginate beads are commonly used for slow drug release in water-soluble applications where a drug’s performance depends on capsular membrane properties. Using a cylinder probe, the texture analyser quantifies the resilience of a bead’s surface by measuring the force required to compress the sample. The same probe can also be used to measure the bead’s burst characteristics by adjusting the impact distance of pressure applied, ie, from 25-90 per cent. The probe can perform a relaxation test by adjusting the resilience test option to continue applying the force for a defined time.

In a nutshellDespite their complex structure & sophisticated release mechanisms, CR dosage forms are increasingly prevalent among the popular Over-The-Counter (OTC) products, eg, vitamins and pain relief medication. Having an optimal physical structure maximises efficacy and minimises adverse reactions. This is achieved by active agents that function exclusively on areas that require prolonged or recurring medical intervention.

Facilitating repeatable & reliable testing of various mechanical properties of CR dosage forms, texture analysis enables pharmaceutical manufacturers to evaluate and evolve their products. Extensive tests help in identifying optimal CR formulations, which promote stability and long-term performance of a product.

With this view, Stable Micro Systems has developed the innovative equipment to ensure best-practice quality control, which is crucial in this stringently regulated and competitive industry.

Jo Smewing ia an Applications Manager at Stable Micro Systems LtdFor further details

contact, Ekaterina Kalinina, or email: [email protected]

Tablet disintegration rig

E V E N T S C A L E N DA R

September 2010� Modern Pharmaceuticals 67

Biosimilars India 2010The 2nd Annual Biosimilars India 2010 conference, a two-day strategic event that will provide an opportunity to drive the development and registration of biosimilars products both in India and overseas; September 30-October 01, 2010; at Le Royal Méridien, Mumbai

For details contact:UBM India Pvt Ltd, Mumbai Tel: +9122 6612 2600 Fax: +91 22 6769 2462Email: [email protected]: http://www.biosimilars-india.com

PROMACH 2010An exhibition featuring cutting-edge technologies and process plant & machinery for an array of industries including the pharmaceutical industry; October 01-04, 2010; at Bangalore International Exhibition Centre, Bengaluru

For details contact:Bangalore International Exhibition Services Pvt Ltd, BengaluruTel: +91 80 6583 3234Email: [email protected]: http://www.promach.co.in

13th IDMA-APA PAC 2010At 13th Indian Drug Manufacturers’ Association (IDMA) and Association of Pharmaceutical Analysts’ (APA)

Pharmaceutical Analysts’ Convention (PAC) 2010, eminent technical personnel from Indian pharmaceutical industry, research and academia will converge and get-together to interact on various recent developments; October 14-15, 2010; at Hotel Hyatt Regency, Mumbai

For details contact:IDMATel: +91 22 24974308Fax: +91 22 24950723Email: [email protected]: www.idma-assn.org

India Chem 2010An international exhibition & conference on pharmaceuticals, chemcials, plastics and process plant machinery; October 28-30, 2010; at Bombay Exhibition Centre - NSE Exhibition Complex, Mumbai

For details contact:FICCI (Federation of Indian Chambers of Commerce & Industry), New DelhiTel: +91 11 23738760-70 Fax: +91 11 30910411 Email: [email protected]: www.indiachem.in

P-MEC India 2010An exhibition showcasing state-of-the-art pharma machinery and equipment for pharmaceutical operations; December 01-03, 2010; at Bombay Exhibition Centre

- NSE Exhibition Complex, MumbaiFor details contact:CMP India (UBM India Pvt Ltd), MumbaiTel: +91 22 66122600, Fax: +91 22 66122626Email: [email protected]: www.pmec-india.com

2nd India Lab Expo 2010A scientific and laboratory instruments exhibition in India, this expo willhave more than 250 exhibitors from different countries showcasing their innovative products; December 10-12, 2010; at Pragati Maidan, New Delhi

For details contact:Scientificdealers.comTel: +91 11 2760 4500, Fax: +91 11 2760 4600 Email: [email protected] Website: www.indialabexpo.com

Plastivision India 2011An exhibition organised by AIPMA, Plastivision India 2011 is the 8th in series, and this event will highlight the key developments & growth of the plastics industry; January 20-24, 2011; at NSE Complex, Mumbai

For details contact:AIPMA, MumbaiTel: +91 22 67778899, Fax:+91 22 28252295Email: [email protected]: www.plastivision.org

National

India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumactics, Process Machinery & Equipment,

Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

For details

Infomedia 18 Ltd, Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4649/51 Fax: 022 3003 4499 • Email: [email protected]

One of the largest advanced design and manufacturing events in India featuring Machine Tools, Hydraulics & Pneumactics, Process Machinery & Equipment,

Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

Concurrent ShowsMUMBAI

MaharashtraFebruary 17-19, 2011

Bombay Exhibition Centre

INDOREMadhya Pradesh

Jan 7-10, 2011Maharaja Shivajirao School

Grd, Chimanbaug

CHENNAITamil Nadu

Mar 11-13, 2011Chennai Trade Centre

PUNEMaharashtra

Nov 19-22, 2010Auto Cluster

Exhibition Ctr, Chinchwad

AHMEDABADGujarat

Dec 10-13, 2010Gujarat University

Exhibition Hall


E V E N T S C A L E N DA R

8th Annual Cold Chain Distribution for Pharmaceuticals Global ForumThis event organised by Pharma IQ features insights from pharmaceuticals, logistics partners and non-profit agencies on streamlining distribution operations and overcoming challenges involved with managing temperature controlled medicines for both domestic and international supply chains; September 20-23, 2010, Pennsylvania Convention Center, Philadelphia, PA

For details contact:IQPC Tel: +91 80 4322 4100 Fax: +91 80 4322 4103 Email: [email protected]: www.coldchainpharma.com

SIPEC 2010A pharmaceutical trade show that provides a good opportunity to network and generate new clients, while gaining an insight into the developments in the industry; September 28-30, 2010; at Parc des expositions d’Orléans, France

For details contact:Sipec, FranceTel: +33 (0)2 38 95 30 49Fax: +33 (0)2 38 95 24 29Email: [email protected]: www.sipec.net

BIOTECHNICA 2010An event for the biotechnology and lifesciences industry. It covers various elements in the field of biotechnology, including fundamentals, equipment and bioinformatics & services. An opportunity for associated people to find new customers and partners for their products & services, and to network with

various professionals from the industry; October 05-07, 2010; at Deutsche Messe Hannover, Germany

For details contact:Deutsche Messe AG Hannover, GermanyTel: +49 (0)511 89 0Fax: +49 (0)511 89 32626Email: [email protected]: www.messe.de

Expopharm 2010An exhibition highlighting the current trends and developmentsin the pharmaceutical sector. More than 500 exhibitors from diverse fields catering to the pharma industry are expected to be present at the event. The event presents an ideal opportunity to network with different visitors and generate new contacts; October 07-10, 2010; at Munich, Germany

For details contact:WUV (Werbe- und Vertriebsgesellschaft Deutscher Apotheker mbH), GermanyTel: +49 (0)6196 - 928 412Fax: +49 (0)6196 - 928 404Email: [email protected]: www.expopharm.de

CMEF autumn 2010China International Medical Equipment Fair (CMEF), founded in 1979, is held twice a year - spring and autumn. This autumn, the expo will exhibit a wide range of medical equipment, related products and services from the medical device market; October 12 - 15, 2010, Shenyang Exhibition Center, Shenyang City, Liaoning Province, China

For details contact:Reed Sinopharm Exhibitions Co Ltd

Tel: +86 10 84556692Fax: +86 10 82022922 Email: [email protected]: http://www.cmef.com.cn

FoodPharmaTech 2010An international trade fair for machinery, packaging and ingredients of the pharma as well as food industries. This year’s event will focus on four areas: efficient production, product safety, energy & environment and knowledge sharing. Professionals from the pharmaceutical , biotechnology and cosmetic sectors are expectedto be present at the event; November 02-04, 2010; at Exhibition Centre Herning, Denmark

For details contact:Messecenter Herning, DenmarkTel: +45 99 26 99 26Fax: +45 99 26 99 00Email: [email protected]: www.foodpharmatech.dk

Bio-Europe 2010Considered to be one of Europe’s largest partnering conferences, the event attracts biotechnology and pharmaceuticals professionals. It provides an ideal opportunity to identify and enter into strategic relationship with companies of interest; November 15-17, 2010; at International Congress Centre, Munich (ICM)

For details contact:Bio (Biotechnology Industry Organization)Tel: +1 (202) 962 9200Fax: +1 (202) 488 6301Email: [email protected]: www.ebdgroup.com

International

The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharmaceuticals


T E C H N O LO GY T R A N S F E R

Share Your Technology PropositionsThe mission of Modern Pharmaceuticals is to spread the technology culture. We offer you an opportunity to participate in this

endeavour by publishing the best technology ideas. Technology developers/sellers are invited to furnish the techno-commercial details (with environmental benefits, if any) for publication in the Technology Transfer column of Modern Pharmaceuticals.

R&D organisations, technical consultancy organisations and individuals assisting small and medium enterprises may send the relevant literature, indicating the scope & services and the areas of specification.

Contact: Modern Pharmaceuticals

Infomedia 18 Ltd, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3003 4669/4671 � Fax: 022-3003 4499 � Email: [email protected]

As part of our endeavour to spread the technology culture, this section provides a means to promote and facilitate exchange of select technologies.

We strive to bring together suppliers of such technologies with suitable users for negotiations and industrial collaboration.

Technology Offered

Anti-ulceritic APIsAn Indian company offers anti ulcer drugs like omeprazole, pantaprazole, omeprazole sodium, omeprazole magnesium and esomeprazole magnesium for operations in manufacturing processes.Areas of application

Formulation industriesForms of transfer

Consultancy

Natural preparation for anxiety relief A company offers food supplement in the form of tablets that effectively relieves mild to moderate anxiety problems. The ingredient is an herbal extract, which has been scientifically proved for its efficacy. Efficient decrease of anxiety symptoms, quick onset of action and no side effects are reported to be the advantages of this product. Moreover, this product has already been launched in American market. Areas of application

Pharmaceutical industryForms of transfer

Equipment supply

Clorsulon and its intermediatesAn Indian company offers clorsulon, a highly potent anthelmintic drug, which is administered to de-worm the intestines of sheep and cattle.Areas of application

Pharmaceutical industry

Forms of transfer Consultancy

Filter cleaning system An Indian company offers an automatic filter media cleaning equipment with drying system. It consists of air wash, water wash, and drying facilities.Areas of application

Filter media cleaningForms of transfer

Joint venture, equipment supply

Herbal formulation for psoriasis and eczema An Indian company offers an innovative herbal formulation that has the ability to control & cure psoriasis and eczema within one month of application of the formulation.Areas of application

Herbal medicine Forms of transfer

Joint venture, technical services, technology licensing

Intravenous fluidsAn Indian company offers the technology for the production of intravenous fluids (IV). The company has a large volume IV plant and can offer complete support for setting up a new IV plant. Investment required for the fully automatic plant is around Rs 15 crore. The company can offer consultancy services/technical support to set up an IV plant on loan and license basis initially. Later, the collaborating party

can set up its own factory when it is ready for investments. Areas of application


Joint venture, technical services

Purified microfine red sanders wood powder An Indian company offers red sanders wood, which is a precious crude drug in the ayurvedic system of treatment. Pulverising by conventional technologies generates very high temperature, which in turn leads to high ash in the sanders wood powder.

Red sanders powder so produced will be rich in drug and colour values. The powder will be microfine and free from ash and other impurities. Red sanders wood powder is used to apply on the face and skin to remove chicken pox marks, marks from burns, skin discolourations and pimples. It is also used to add in several drugs, processed foods, cosmetics and toiletries. The powder can be exported in large quantities as a value-added item. The technology for microfine pulverising of red sanders wood was developed with the support of DSIR, under the Ministry of Science and Technology.Areas of application

Ayurvedic pharmaceutical, food and cosmetics industriesForms of transfer

Turnkey, others


T E C H N O LO GY T R A N S F E R

Information courtesy: Dr Krishnan S Raghavan, In-Charge, Technology Transfer Services Group, United Nations - Asian and Pacific Centre for Transfer of Technology (APCTT), APCTT Building , C-2, Qutab Institutional Area, New Delhi 110 016

Tel: 011 - 2696 6509, Fax: 011 - 2685 6274, Email: [email protected], Website: www.apctt.org

For more information on technology offers and requests, please log on to www.technology4sme.net and register with your contact details. This is a free of cost platform provided by APCTT for facilitating interaction between buyers and seekers of technologies across the globe. After submitting technology offer or request to this website, you are requested to wait for at least two weeks

for receiving a response from a prospective buyer / seeker through this website, before contacting APCTT for further assistance.

Biotechnology for wastewater treatment system A Thailand-based company, a wastewater service provider, is involved in the research and development of new technology for water, wastewater and waste treatment. It requires new ideas related to technology for developing its strength in the field of wastewater; which includes cleaning canals, removing sediments from waterways, biogas, microbiology detector and treated system quality.Areas of application

Biotechnology, engineering, new technologyForms of transfer

Consultancy

Calcium gluconateAn Indian company requires the technology to manufacture calcium gluconate.Areas of application


Technical services, project reports, others

Cell lines A Thailand-based, ANH Scientific Marketing Co Ltd has been working in the field of life sciences in the country for more than 20 years. In order to complete the company’s product lines, and service customers/researchers/scientists from the beginning to the end of the process, it would like a company to provide commercial cell lines of human and animals.

Areas of applicationCell culturing - molecular biology

Forms of transferMaterial supply

Extract of medicinal and aromatic plantsAn Indian company is interested in putting up a multi-purpose herbal extraction plant for the extraction of medicinal and aromatic plants and herbs like artemisinin/quinine sulphate and other alkaloids. Areas of application


Others

Glove automation equipment An Indian company requires technology to produce glove by automation process.Areas of application

Manufacturing industries, especially rubber industry and latex industryForms of transfer

Consultancy

Kite grading engineering technologyA Fiji-based company offers the technology of kite grading, which is a subservient of genetic therapy research particularly for the cardiovascular novice. It seeks assistance from a potential partner to provide equipment and technical support staff.Areas of application

Medical researchForms of transfer

Joint venture, partnership

Medical productsAn Indian company wants to manufacture intravenous fluids, saline, dextrose and related products used in the medical field. The company is involved in non-medical activities at present. The only medical involvement is its general practice in the UK. It plans to commence a nursing home project in Sri Lanka and would be interested in a joint venture with a suitable partner for its saline project. The project has been approved for tax concessions and its partner is expected to contribute in machinery production and know-how.Areas of application

Medical and surgicalForms of transfer

Others

Methyl cobalmineAn Indian company requires technology for production of methyl cobalamine, which is an importantbasic drug. Areas of application

To be used in pharmaceutical industries Forms of transfer

Others

Pharma grade mannitolAn Indian company requires the know-how for manufacturing pharma grade mannitol. The estimated production capacity is 600 tonne per annum. Areas of application

Pharmaceuticals Forms of transfer

Others

Technology Requested


B O O K S H E L F

Focussing on the importance of patents as far as safeguarding of intellectual property is concerned, the book ‘The Chemist’s Companion Guide to Patent Law’ provides information on the legal concepts in a precise and comprehensive manner, with clarity.

Divided into nine chapters, which are further subdivided into several sections, the book cites examples from both case law and real-world situations to elucidate the diverse aspects of intellectual property law that will be of immense help to the chemists. The book contains a table of cases that categorises and lists several pertinent court cases concerning chemicals. While a section of one chapter deals with patent maintenance fees, another section deals with the re-issue of applications and patents. The book also provides information on the six requirements of patentability. In brief, the book provides an insight into the whole concept of patent and offers explanations on several patent terminologies, including ‘novelty’ and ‘non-obviousness’. Explaining the latter concept, the book explores Graham factors analysis of obviousness. Also, another section deals with the application of the TSM test to chemical arts.

The book may be useful for professionals working in the chemical, pharmaceutical and biotechnology industries. It will assist them to comprehend the concepts of patents. Further, the book may also benefit students by enabling them to better understand their work.

Discussing the cost reduction strategies followed by pharmaceutical companies, the book offers an insight into how Indian pharma companies function in terms of reducing the cost of manufacturing, along with complying with international regulatory authorities.

Divided into several chapters, this book offers a scientific analysis of cost rationalisation in production. This is further explained with the help of numerous examples, tables/charts, case studies and other illustrations. The book also emphasises on cost rationalisation through the route of supply gaps and opportunities. It details manufacturing-related issues, and thus improves Cost of Goods Sold (COGS). The book has chapters pertaining to working of capital-related issues, minimisation of the selling expenses in order to measure the marketing productivity and various strategies related to QA/IP issues. Some of the chapters also discuss different project management techniques while creating new facilities for manufacturing of pharmaceutical products as well as upgradation of the existing facilities.

The book may be helpful to professionals in the pharma industry, especially those in the production department and assist them to strengthen their theoretical as well as practical knowledge in this field. Further, it may prove useful to researchers in accomplishing their work.

Cost Rationalization in Pharmaceutical Production:Supply Chain Gaps and Opportunities

Editor : Dr G B R K Prasad Price : Rs 1,200

Mehul Book Sales, Shop No 1, Lokagutchh Jain Upashraya Building, W H Marg, Fort, Mumbai 400 001For purchase inquiries, please contact, Tel: 022-2265 4657 / 2269 4145, Fax: 022-2265 4657

The Chemist’s Companion Guide to Patent Law

Editor : Chris P Miller Price : Rs 4,938

Modern Pharmaceuticals September 2010�72

F R E S H A R R I VA L S

The miVac Quattro from Genevac, available in a variety of formats, is a high-capacity sample concentrator for laboratories looking to concentrate larger numbers of biological samples. The miVac Quattro rapidly removes a variety of solvents, ranging from volatile organic solvents through to water, making it an ideal system for concentrating important samples in applications like oligo-synthesis, peptide preparation, sequencing, molecular biology, etc. The miVac Quattro can use a four-swing position rotor to simultaneously accommodate up to 20 shallow-well microplates or 8 deep-well plates that enables significant increases in throughput. It slashes the drying times. A wide variety of available rotors means that the miVac Quattro can remove water and organic solvents from biological samples in various formats including tubes, microplates and vials. The miVac Quattro is noiseless while in use and its compact size saves valuable bench space. Solvent removal productivity can be further enhanced by addition of the unique miVac SpeedTrap refrigerated condenser.

VeriPac inspection systems evaluate and analyse package integrity with precision and repeatability. These systems can be easily integrated into the packaging process to improve quality, reduce waste and provide operators with a clearer understanding of package quality.

VeriPac’s inspection method is more reliable, cost-effective and efficient than the destructive methods. It also eliminates subjective and misleading results that vary from operator to operator.

VeriPac’s non-destructive technology is capable of detecting package leaks and invisible defects with the use of an absolute or differential pressure transducer leak test system. Test components are optimised according to the type of package being tested and the level of sensitivity required. VeriPac leak testers are designed to inspect flexible, rigid and semi-rigid packaging, including Tyvek® trays.

The FreeZone®-105°C 4.5-ltr benchtop freeze dry systems have ice-holding capacity for light to moderate loads. They have dual refrigeration systems for samples with very low eutectic points, including those containing small amounts of methanol or ethanol. They have a compact benchtop design and include a 12-port drying chamber. A vacuum pump and sample containers, such as

flasks, are the only additional components necessary for a complete system.

The freeze dry system removes over 4 ltr of water in 24 hours. The features include brushed stainless steel & epoxy-coated steel exterior, Liquid-Crystal Display (LCD) that displays system operating parameters, set-up parameters & alarm messages, Chlorofluorocarbons (CFC)-

free refrigeration systems and red alarm light. It also features Light-Emitting Diode (LED) vacuum & temperature wave graphs, patented moisture sensor, vacuum control/break valve, rear-mounted RS-232 port, automatic start-up switch for collector cool-down & vacuum pull-down with manual over-ride switches, retractable collector drain line and power switch.

105°C FreeZone® benchtop freeze dry system

ILC Dover recently announced the advancement of its DoverPac® SF family to state-of-the-art buffer/media preparation for the biopharmaceutical industry with single-use flexible systems.

By using ILC’s durable ArmorFlex® materials three-dimensional disposable vessels are created that will facilitate powder transfer while assuring a robust construction. The DoverPac® SF replaces the

rigid polybottle for split butterfly valve powder transfer applications. DoverPac® SF offers better than 99.5 per cent product recovery, 25-ltr volume, charging & offloading applications, requires less storage space than polybottles, no cleaning validation required and uses ArmorFlex® 104 film, which is a static dissipative US Food and Drug Administration (FDA) and European Union (EU)-approved material.

The company offers the product in a range of standard sizes and sanitary flange interfaces. It also customises designs to meet specific customer applications. Models are available with and without external restraints.

DoverPac® SF customised to meet biopharmaceutical needs

VeriPac 400 Series

miVac Quattro: Genevac’s high-capacity biological sample concentrator

miVac Quattro concentrator

FreeZone®-105°C 4.5 ltr benchtop freeze dry systems

DoverPac® SF

VeriPac 400 Series


F R E S H A R R I VA L S

FTS Vapor traps are mechanically refrigerated cold traps, which protect expensive vacuum pumps from harmful vapours that can shorten their life. In addition, Vapor traps eliminate the expense and potential hazards associated with the refilling and monitoring of Liquid Nitrogen (LN2) or dry ice traps.

FTS Vapor traps consist of a well-insulated stainless steel chamber cooled by direct expansion of refrigerant in refrigeration lines that are bonded directly to the outside of the chamber walls. This method is a highly efficient and energy-saving means of heat removal. Vapor traps are available with operating temperatures of -50°C or -90°C. Vapours enter the chamber through a port in the vacuum top plate. While circulating in the chamber, the vapours strike the sides and freeze due to the low temperature of the chamber wall. The system traps all condensable vapours that have freezing points higher than the operating temperature of the Vapor trap. Non-condensable vapours and gases are evacuated through a second port in the lid by the vacuum pump. Traps are rated to accommodate vacuum pump flow rates of up to 250 ltr per minute.

FTS Vapor traps are used for gel drying, evaporators, dryers, protection of oil-sealed vacuum pumps and dehydration of gas streams.

FTS Vapor trap

The Mettler Toledo FBRM® C35 Ex monitors the changes in granule distribution in real-time. This enables formulators and engineers to adjust for changes in particle count and dimension during cohesive wet or dry particle processing.

FBRM® C35 Ex ensures targeted granule size and consistent granule distribution, which are critical in fluid-bed coating and high-shear wet granulation applications. The type of inline measurement provided by FBRM® C35 Ex allows Quality by Design (QbD) throughout product development, scale-up and manufacturing. Users can

identify a distribution that corresponds to the ideal batch end-point. Real-time distribution can then be tracked relative to this targeted end-point to ensure consistent downstream particle flow. Engineers and formulators can then identify and troubleshoot unexpected changes. This helps minimise batch failures and improve yield and ensures smoother scale-up and technology transfer.

Formulation scientists and engineers can now use the Mettler Toledo FBRM® C35 series to quickly correlate particle system dynamics to processing conditions, with fewer experiments. This helps improve time-to-market by ensuring downstream particle flow, resulting in consistent tablet roller-compaction and subsequent dissolution. Also, the in situ design of the FBRM® C35 allows improved understanding and optimisation of manufacturing processes.

For manufacturing situations where view-probe window fouling is an issue, a proprietary, patent-pending scraper keeps the FBRM® C35 probe window clean. This allows the FBRM® C35 to track agglomeration, compaction and breakage directly in the processing vessel in even the most cohesive particle conditions.

Share Information on your New Machinery & MaterialsThe mission of Modern Pharmaceuticals is to spread the technology culture. We offer you an opportunity to participate in this endeavour

by publishing information on your newly developed technologies that are applied in pharma and allied sectors. Manufacturers, developers and sellers of pharma-related products, machinery, materials and software are invited to furnish details for publication in this section of Modern Pharmaceuticals.

R&D organisations, technical consultancy organisations and individuals assisting small and medium enterprises may send the relevant literature, indicating the scope & services and the areas of specification.

Write to us: Modern Pharmaceuticals

Infomedia 18 Ltd, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3003 4669/4671 � Fax: 022-3003 4499 � Email: [email protected]

The information published in this section is as per the details furnished

by the respective manufacturer/distributor. In any case, it does not

represent the views of Modern Pharmaceuticals

FBRM® C35 Ex tracks granule distribution in real time

The new Zeta Plus® Maximizer™ EXT filter from CUNO extends depth filtration capacity and protects the downstream membranes, thereby extending filter life and lowering overall

filtration costs. Zeta Plus® Maximizer™ EXT Series is a family of advanced dual-zone depth filters designed to provide optimal clarification of bioprocess, biological and pharmaceutical fluids.

The Maximizer™ EXT series filters consist of two distinct layers or zones of filter media with the upstream zone more open than the downstream zone. This structure reduces premature plugging, and thus extends service life. The two filter zones can independently be selected and combined to optimise performance.

New Zeta Plus® Maximizer™ filter cartridges

FBRM® C35 Technology

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FTS Vapor trap

Co

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Zeta Plus® Maximizer™


P R O D U C T U P DAT E

Sterilisation-in-place (SIP) systemsIndustrial Equipwash offers sterilisation-in-place (SIP) systems to sterilise a collection of process equipment after a batch of product is completed. The process equipment includes bioreactors, fermentors and the accompanying tubing. It comes with a dedicated clean-steam generator, which is used to provide the necessary volume, temperature and pressure of

steam needed to sterilise each system. To ensure that each component and all areas of the piping reach the sterilisation temperature for the requisite time, temperature sensors are placed in critical areas as well as in hard-to-reach locations to facilitate complete sterilisation. During the entire process, modulating valves are utilised to maintain the required clean steam pressure, temperature and flow levels. The system is equipped with clean-steam traps, which ensure timely and adequate removal of the condensate, which, in turn, helps maintain the high temperatures needed for the sterilisation cycle.

Industrial Equipwash Inc - Mumbai - MaharashtraTel: 022-2679 7941, Fax: 022-2679 2936Mob: 09869231815Email: [email protected]

Stoppering machineAutomated Machine Technologies offers servo rotary stoppering machine, which is crafted for clean room productions. Its compact size allows for a side-by-side

configuration, doubling the speed and matching the speed of the liquid filling machines for over 200 vials per minute side. The system will perform full and partial insertion and can be easily changed over to different stopper and bottle sizes. The multi-axis servo system synchronises stoppers with bottles, thus eliminating the need for difficult mechanical adjustments over years of operations. Vibratory feeder bowl orients and supplies stoppers, and is servo driven for programmable changeover to a different bottle height.

Automated Machine Technologies Inc - North Carolina - USATel: +1-919-361 0121, Fax: +1-919-481 2120Email: [email protected]

In-line filling and stoppering machineIMA - Industria Macchine Automatiche offers ‘Sterifill F200’ in-line filling and stoppering machine for aseptic environments, which can reach an output of up to 320 pcs/min. The machine standard is designed to accept LAF, RABS or isolator. There are no change parts in a defined vial range due to the puck transport system. A narrow basement allows the operation from one machine side only and the wall installation as well. It is manufactured in AISI-304 or AISI-316 L and is fully compliant with cGMP standards.

The company also offers high-shear mixers, whichare designed to perform wet granulation processes, combining active products and excipients by adding a binder solution. The granulation process is carried out quickly due to the high energy transmitted to the product by the turbulence caused by the combined action of impeller and chopper blades. The impeller is specially designed to reduce product sticking to the blades, and can be easily removed for cleaning. The machine lid is pre-arranged for automatic product loading, binder or solvent addition, installation of washing nozzles, internal light and inspection window.

IMA - Industria Macchine Automatiche SpA - Bologna - ItalyTel: +39-051-783-111, Fax: +39-051-784-422Email: [email protected]

Lab extruderSteer Engineering offers ‘Omicron 12’ co-rotating twin-screw lab extruder. It is specifically designed & developed for pharmaceutical industries. The key feature of the the lab extruder is that it can generate outstanding dispersive & distributive mixing, and assures a consistent, good quality product every time. It can also produce material at an extremely low output rate, which helps in lowering the cost in the development of new products. It offers the widest flexibility available in the market for R&D.

Steer Engineering Pvt Ltd - Bengaluru - KarnatakaTel: 080-2372 3310, Fax: 080-2372 3307Email: [email protected]



Capsule filler, encapsulation machineCapplus Technologies offers ‘CPT CF50’ capsule filler, encapsulation machine. It is equipped with PLC control system with 10” colour touchscreen control panel mounted on swing out arm. This machine is available with AC variable speed frequency control, four swing-up acrylic doors, two capsule magazines with nine

feeding trucks, two capsule raceways, side pushers and down pushers. It is provided with SS-316 powder hopper, powder chamber, dosing disk, 12 upper & lower capsule segments (6 holes each), capsule-separating station and segment-cleaning station (pneumatic operation). The capsule filler, encapsulation machine is manufactured with FDA-approved contact parts. It is fitted with inching step drive button.

Capplus Technologies - Arizona - USATel: +1-623 582-2800, Fax: +1-623 582-4099Email: info@ capplustech.com



Medical refrigeratorSigmatech Scientific Products offers ‘Sigmazk’ medical refrigerator with glass door manufactured by Zhongke Meiling Cryogenics Ltd, China. The medical refrigerator is a specialised equipment for cold storage of pharmaceutical and biological products. It is suitable for hospitals, drugstores, pharmaceutical factories, sanitation & anti-epidemic stations and clinics. This medical refrigerator is provided with microprocessor-based temperature control system, combined with two sensors monitoring the chamber temperature and one sensor monitoring the ambient temperature. A stable and accurate chamber temperature can be maintained at ambient temperature ranging from 0°C to 32°C. Forced air circulation system provided with this refrigerator ensures temperature uniformity.

Sigmatech Scientific Products - Hyderabad - Andhra PradeshTel: 040 - 6453 4491, Mob: 098496 32904, Fax: 040-4003 1896Email: [email protected]

Bottle capperUS Bottlers Machinery Company offers rotary chuck-style bottle capper, which is designed to apply and rotate a pre-sorted cap on a container, based on a predetermined applied torque. The containers are fed onto the rotary chuck-style capper and are separated and positioned on individual capping stations. The caps are pre-sorted and fed on the sliding table of the machine. The continuously rotating chucks pick up and secure the caps, & then apply the caps to the containers. When the preset applied torque value is achieved, the magnetic clutch disengages, the chuck releases the cap and the closed container is discharged from the machine. It is available in several frame sizes, tangential infeed and discharge configurations. The capper has magnetic clutches with one-point torque adjustment and tool-less, quick-release container handling attachments. All drive train components are located inside the machine base.

US Bottlers Machinery Company - North Carolina - USATel: +1-704-588 4750, Fax: +1-704-588 3808Email: [email protected]



FermentorShree Biocare India offers fermentor. It is developed and designed for microbiology, pharma, DNA proteins, cell culture, bio-fertiliser, vaccine, bio-pesticide, bio-fuels and also for customer

application & requirement. It is available in glass vessel (jacketed), glass vessel with SS jacket, complete SS vessel autoclavable or in situ (in-place sterilisation) controlled parameters like agitation, aeration, pH, temperature, antifoam or any special parameter. This fermentor is provided with a PLC-based controller with a touchscreen module attached with PC. It can be operated by software & data as per 21CFR PART 11. The company also offers IQ/PQ/OQ documentations.

Shree Biocare India - Ahmedabad - GujaratTel: 079-4008 4116, 98989 99146, Fax: 079-4008 4116Email: [email protected]

Single rotary tableting machine Shree Bhagwati Pharma Machinery Company offers single rotary tableting machine. This machine is totally enclosed, ie, the top half of the machine (compression zone) with SS hood & acrylic covers, while the lower half of the machine has matt-finish SS covers. This reduces the noise level and to &

fro flow of dust between compression zone foundation. The turret is made of highly ductile SG iron casting. Large paint-free compression zone with plenty of space for ease-of-cleaning & accessibility of components is the main attraction of this machine. Electronic total output counter is provided on the control panel. Its friction plate is provided on cam plate to minimise wear & tear of cam track, which also facilitates its easy replacement.

Shree Bhagwati Pharma Machinery Company - Ahmedabad - GujaratTel: 079-2277 0475, Fax: 079-3041 7645Email: [email protected]



Fluid bed dryerMillennium Industries offers fluid bed dryer, which is suitable for drying granular, crystalline, coarse or similar materials in the pharmaceutical, fine chemicals, food and allied industries. It can be supplied in electrical heating, steam heating or hot water circulation system. The drying time depends on various factors including physical properties of material, moisture content, type of moisture, etc. This dryer is provided with an explosion flap & pressure relief valve, and in case of excess pressure, it is relieved through the explosive vent on the rear/top of unit. Materials that come with this dryer include gaskets, ‘Teflon’, silicon tubes, etc, which are food grade materials. All measuring instruments are calibrated. Further, all the product contact parts are made of SS-316.

Millennium Industries - Hyderabad - Andhra PradeshTel: 040-6529 4801/5924, Fax: 040-2319 6272Email: [email protected]

Controlling and monitoring systemPepperl+Fuchs (India) offers ‘VisuNet GMP’ controlling and monitoring system within GMP environments. This system is tailored to meet specific requirements of pharmaceutical & life science industry. The product portfolio includes simple monitors, remote monitor systems with Ethernet connection to the host PC as well as complete PC systems. It is available with a variety of mechanical mounting options and in a wide range of configurations, like single- & twin-monitor systems. All models are equipped with a 19-inch display, which is also optionally available with touchscreen facility.

It features stainless steel cabinets according to protection rating IP 65. The remote monitors and PCs offer RS232, PS/2, Ethernet, as well as USB interfaces. The overall architecture of the system is designed to prevent the accumulation of dirt and fluids.

Pepperl+Fuchs (India) Pvt Ltd - Bengaluru - KarnatakaTel: 080-2837 8030, 2839 5585, Fax: 080-2837 8031Email: [email protected]



‘V’ blenderChitra Machineries offers ‘V’ blender – a blending machine used for homogeneous mixing and lubrication process of dry powders. Approximately two-third volume of the blender is filled to ensure proper mixing.

It is used in pharmaceutical, food, chemical and cosmetic products, etc. In the ‘V’ blender, the powders come from all sides due to the ‘V’ shape of the product container, and hence the requirement of rpm is medium. All contact parts are made of SS-304/SS-316 or SS-316L or as per customer requirement. Manual rotating facility with hand wheel is provided for inching. Its features include easy loading & unloading, easy cleaning, simple design, minimum maintenance, safe operation, etc.

Chitra Machineries Pvt Ltd - Ahmedabad - GujaratTel: 079-2290 0433, 2929 2650Fax: 079-2289 1666Email: [email protected]



Recorder with printerAce Instruments offers recorder with printer. It records all parameters in a single instrument. This recorder can be attached to pressure transmitters, vacuum transmitters, temperature sensors (RTD Pt-100, all thermocouples), flow transmitters, humidity transmitters and differential pressure transmitters on a single instrument. It monitors all parameters on display & prints the same automatically at front key selected intervals. The printer is a noiseless thermal 24-column strip printer. The instrument is a microcontroller-based instrument with factory fixed universal input. It can take up to eight inputs from different transmitters or sensors. Each channel can be configured for a separate type of input. The instrument is totally programmable with channel enable/disable selection, print interval selection, scan time programming, individual channel calibration from front keys and RS232/RS485 communication port for PC monitoring. The software provided for PC monitoring enables for real-time supervision, historical trend analysis, graphs and report generation in excel sheet. The instrument is available in 1, 2, 3, up to 8 channel configuration.

Ace Instruments - Hyderabad - Andhra PradeshTel: 040-2307 8848, 3290 1226, Fax: 040-2307 8848Email: [email protected]

Rapid mixer granulatorAvon Pharma Machines offers rapid mixer granulator. It is designed to meet the GMP requirements. The contact parts are made of SS-304/316. This granulator comes with specially designed control panel with display system and microprocessor. The bowl, lid mixing agitator and discharge housing are made of stainless steel. All MS parts of the machine are covered with stainless steel. Limit switch is provided on the main lid and discharge valve for safe operation. The features of the granulator are as follows: components of the machine are easily accessible for cleaning, all electrical & pneumatic parts are pre-wired to simplify installation. It is provided with an impeller, which consists of two full and two half solid mixing blades. The specially designed chopper blades are driven at a high speed, which gives fast and even granulation, throughout the whole mass in the product bowl.

Avon Pharma Machines Pvt Ltd - Thane - MaharashtraTel: 0250-245 0638-39, Fax: 0250-245 0640Email: [email protected]



The information published in this section is as per the details furnished by the respective manufacturer/

distributor. In any case, it does not represent the views of Modern Pharmaceuticals

Oscillating granulatorRatnakar Pharma Machinery offers oscillating granulator, which is suitable for wet granulation. It is used in the pharmaceutical, food & allied industries and is provided with sieves, which are easy-to-clean and have quick opening & locking arrangements. A rotor covers the sieves and works on the pendulum motion principle. The

granulator meets cGMP requirement and is available in capacities in the range of 150-250 kg/hr for pharma industrial model, while the laboratory model is available in capacities in the range of 10-45 kg/hr. It is provided with AC frequency drive for changing to the desired speed. The contact parts of the granulator are made of SS-316 and non-contact parts of SS-304.

Ratnakar Pharma Machinery - Ahmedabad - GujaratTel: 079-2289 2614, Mob: 09427031284Email: [email protected]

CentrifugesUnited Engineering Enterprises offers full-lid opening centrifuges, which conform to GMP standards for active pharmaceutical ingredients, herbal extracts, flavours, colours, chemicals and allied process industries. These centrifuges are of four-point suspension type

in a stainless steel construction. The entire body can be lifted & opened hydraulically. Thus, the basket and drain platform are exposed facilitating easy & quick cleaning. The body is hydraulically lowered into the closed position and clamped to the lower portion of the casing by means of quick clamps. These centrifuges are suitable for manufacturing facilities that require frequent product changeover.

These centrifuges are available in various designs depending on cake characteristics and customer requirements, viz, standard top discharge, top discharge with bag lifting arrangement & bottom discharge with/without scrapper. The centrifuges can be offered in vapour-tight construction with nitrogen blanketing for hazardous chemicals. The CIP design with built-in cleaning nozzles ensures no product cross-contamination. These centrifuges are manufactured in batch capacities in the range of 5-600 kg.

United Engineering Enterprises - Mumbai - MaharashtraTel: 022-2308 3990Email: [email protected]

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Access controllerAir shower controllersAnalytical instrumentsAutoclave gasketsAutomatic cream fi lling machineAutomatic overwrapping machine Automatic twin-head power fi lling machineAutomationBlow-fi ll & seal machinesBottle capperBraided hoseCablesCapping machinesCapsule fi ller, encapsulation machineCentrifugesChemical storage cabinetsCM pumpCollating & overwrapping machineColumns & chemistriesConductorConical screw dryersControlling and monitoring systemCordsCorona treater sleevesCounters & power suppliesCR pumpDehumidifi ersDifferential scanning calorimetryDigital panel meterDilatometryDoor interlock systemsDosing pumpDouble-sided rotary pressDrivesDry syrup powder-fi lling linesElectrical (HT & LT)Electrical connectivityEncodersEvolved gas analysisExhaust blowersExhibition - Engineering ExpoExhibition - Healthex 2010Exhibition - India Lab Expo 2010FBD gasketsFermentorFine chemicals Fire alarmFluid bed dryerFogging machineFume extractorsFume hoods-constantFumigation unitsGaskets

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P R O D U C T I N D E X

Product Pg No Product Pg No Product Pg No

Access controller ........................................................57

Air shower controllers..................................................57

Analytical instruments .................................................37

Autoclave gaskets ..........................................................79

Automatic cream filling machine................................33

Automatic overwrapping machine .............................33

Automatic twin-head power filling machine .............33

Automation .............................................................49, 55

Blow-fill & seal machines ..........................................19

Bottle capper .................................................................76

Braided hose..................................................................79

Cables ..........................................................................79

Capping machines ..........................................................9

Capsule filler, encapsulation machine ........................75

Centrifuges ....................................................................83

Chemical storage cabinets............................................79

CM pump........................................................................7

Collating & overwrapping machine ............................33

Columns & chemistries ................................................37

Conductor ...............................................................49, 55

Conical screw dryers.......................................................5

Controlling and monitoring system............................78

Cords .............................................................................79

Corona treater sleeves ..................................................79

Counters & power supplies............... Front inside cover

CR pump.........................................................................7

Dehumidifiers.............................................................75

Differential scanning calorimetry..................................6

Digital panel meter .......................................................17

Dilatometry .....................................................................6

Door interlock systems.................................................57

Dosing pump ..................................................................7

Double-sided rotary press............................................12

Drives................................................... Back inside cover

Dry syrup powder-filling lines.......................................9

Electrical (HT & LT)...................................................57

Electrical connectivity ............................................49, 55

Encoders ............................................. Front inside cover

Evolved gas analysis........................................................6

Exhaust blowers ............................................................79

Exhibition - Engineering Expo...............................13,31

Exhibition - Healthex 2010..........................................10

Exhibition - India Lab Expo 2010...............................76

FBD gaskets ................................................................79

Fermentor......................................................................77

Fine chemicals .............................................................11

Fire alarm ......................................................................57

Fluid bed dryer .............................................................78

Fogging machine...........................................................55

Fume extractors ............................................................79

Fume hoods-constant...................................................79

Fumigation units ..........................................................55

Gaskets ........................................................................79

Geared box ....................................................................21

Geared motor................................................................21

GMP heat exchangers.....................................................5

GMP reactors ..................................................................5

Heart valve frames .....................................................25

HPLC .............................................................................37

Hydro MPC pump .........................................................7

Hydrogenator/autoclaves ...............................................5

Induction seals/wads............................................49, 55

Industrial control & sensing devices .....Front inside cover

Industrial pumps for aggressive fluids ........................61

Inflatable gaskets...........................................................79

Informatics ....................................................................37

Injectable container solutions........................................8

Injectable powder-filling machines ...............................9

In-line filling and stoppering machine .......................74

Inspection systems........................................................29

Institute of pharmaceutical education & research.....23

Invertor/variable frequency drives ... Front inside cover

Lab extruder................................................................74

Laboratory benches/cabinets........................................79

Level controllers................................. Front inside cover

Liquid-filling lines ..........................................................9

Liquid-filling machines ..................................................9

Measuring & monitoring relays ....Front inside cover

Medical refrigerator......................................................76

Motion controls ................................. Front inside cover

NB pump.......................................................................7

NK pump ........................................................................7

O rings.........................................................................79

Oil seals .........................................................................79

Oscillating granulator...................................................83

Packaging machines .....................................................9

Packaging solutions ................................................49, 55

Packaging test equipments.....................................49, 55

Paperless recorder.........................................................17

Pass box interlock systems...........................................57

Peristaltic pumps ..........................................................77

Photoelectric sensors ......................... Front inside cover

Process controllers........................................................17

Process heat exchangers .................................................5

Process reactors...............................................................5

Profiles ...........................................................................79

Programmable logic controllers ....... Front inside cover

Programmable terminals................... Front inside cover

Proximity sensors .............................. Front inside cover

Pumps............................................................................61

Rapid endotoxin detection system............................75

Rapid mixer granulator................................................80

Recorder with printer...................................................80

RFID ................................................... Front inside cover

Rotary multihead screw-capping unit.........................33

Rotary tablet press ........................................................12

Rotary vacuum dryers ....................................................5

Rotating electrical connectors ...............................49, 55

Rotocone dryers..............................................................5

Safety light curtains ........................Front inside cover

Safety monitors/controls ..............................................79

Sections..........................................................................79

Self-adhesive tapes ........................................................79

SEZ developers.........................................Front gate fold

Sheets .............................................................................79

Silicone carbide heat exchangers ...................................5

Silicone rubber sleeves ................................................79

Silicone transparent platinum cured tubings .............79

Simultaneous thermal analysis ......................................6

Single rotary tableting machine...................................77

Solder paste .............................................................49, 55

Spherical paddle chopper dryers ...................................5

Sponges..........................................................................79

Squares...........................................................................79

Sterilisation-in-place (SIP) system ..............................74

Sticker (self-adhesive) labelling machines ....................9

Stoppering machine......................................................74

Strips ..............................................................................79

Switching relays ................................. Front inside cover

Tablet bottle-packing lines ..........................................9

Tablet press machine....................................................12

Tableting machine ......................................... Back cover

TC gaskets .....................................................................79

Tempurature controllers .............Front inside cover, 17

Thermal conductivity .....................................................6

Thermogravimetric analysis...........................................6

Three parameter display ..............................................57

Timers................................................. Front inside cover

Transparent tubings .....................................................79

Turnkey projects.............................................................5

Twin-screw elements ....................................................25

Twin-screw co-rotating extruders ...............................25

Twin-screw extruders ...................................................25

Ultrasonic flowmeter .................................................17

ULV fogging machine ..................................................55

UPLC .............................................................................37

‘V’ blender...................................................................79

Vacuum technology......................................................77

Validation of packs..................................................49,55

Valves.............................................................................79

Ventilators .....................................................................79

Vision sensors .................................... Front inside cover

Walk-in models ..........................................................79

Washing and air jet cleaning machines ........................9

Wet glue-labelling machine ...........................................9

COMPLETE ENGINEERING UNDER ONE ROOF @www.engg-expo.com

Advertiser’s Name & Contact Details Pg No Advertiser’s Name & Contact Details Pg No Advertiser’s Name & Contact Details Pg No


A DV E R T I S E R S ’ L I S T

Our consistent advertisers

Arctic India Sales 75

T: +91-11-23906777

E: [email protected]

W: www.bryair.com

Autopack Machines Private Limited 33

T: +91-22-43054800


W: www.autopackmachines.com

Bangalore International Exhibition Ltd 10

T: +91-80-65833234


Bonfiglioli Transmissions (Pvt) Ltd BIC

T: +91-44-24781035


W: www.bonfiglioliindia.com

Brothers Pharmamach (India) Pvt Ltd 9

T: +91-79-40213213


W: www.brothers.co.in

Cadmach Machinery Co Pvt Ltd 12

T: +91-79-25841491


W: www.cadmach.com

Charles River 75

T: +91-80-25588175


W: www.criver.com

Dipesh Engineering Works 5

T: +91-22-26743719


W: www.dipeshengg.com

Eltech Services Pvt Ltd 57

T: +91-40-27759895


W: www.eltechservices.com

Engineering Expo 13, 31

T: +91-9920401226


W: www.engg-expo.com

Fluid Energy Controls Inc 61

T: +91-44-42083536


W: www.fecindia.com

Gordhandas Desai Pvt Ltd 79

T: +91-265-2340795


W: www.gdpl.com

Grundfos Pumps India Pvt Ltd 7

T: +91-44-24966800


W: www.grundfos.in

International Marketing Services 77

T: +91-80-23310124


IPER Pune Pvt Ltd 23

T: +91-20-25468006


W: www.pharmadiplomas.com

J B Sez Pvt Ltd FGF

T: +91-22-66210000


W: www.jbsez.com

LMT (India) Pvt Ltd BC

T: +91-9867168123


W: www.fette-compacting.com

Netzsch Technologies India Pvt Ltd 6

T: +91-44-42965111


W: www.netzsch.com

Omron Automation Pvt Ltd FIC

T: +91-80-40726400


W: www.omron-ap.com

Premium Transmission Ltd 21

T: +91-20-27488886

W: www.premiumtransmission.com

Procon Technologies Pvt Ltd 17

T: +91-79-27492566


W: www.procon.co.in

Progressive Engineering 49, 55

T: +91-22-32944289


W: www.progressiveengineers.net

Radiant Enterprise 55

T: +91-79-66615344


W: www.fogstarindia.com

Ravel Hiteks Pvt Ltd 77

T: +9144-24961004


W: www.ravelhiteks.com

Salesworth India Pvt Ltd(Rommelag) 19

T: +91-80-25274495


W: www.rommelag.com

Salesworth India Pvt Ltd(Seidenader) 29

T: +91-80-25274495


W: www.seidenader.de

SD (India) Corporation 76

T: +91-11-27604500


W: www.indialabexpo.com

Sigma Aldrich Chemicals Pvt Ltd 11

T: +91-80-66219400


W: www.safcpharma.com

Smart Logistics 84

T: +91-22-30034650


Sreelakshmi Traders 79

T: +91-44-24343343


W: www.sreelakshmitraders.com

Steer Engineering Pvt Ltd 25

T: +91-80-23723309


W: www.steerworld.com

Suresh Enterprises 79

T: +91-2762-224814


W: www.sevitsil.com

Waters (India) Private Limited 37

T: +91-80-28371900


W: www.waters.com

West Pharmaceutical Packaging India 8

T: +91-40-40021790


W: www.westpharma.com

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Modern Pharmaceuticals September 2010

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Transcript of Modern Pharmaceuticals September 2010