THE EDITORIAL

Address,

With advancing times, significant changes and attitudinal shift have been observed in both women’s and society’s thought about women’s equality and emancipation. Women today have been successfully winning all battles and climbing the ladder of success in diversified sectors each day.

Saluting and celebrating the spirit of woman-hood, it gives us immense pleasure to bring to you the March edition of “THE PUMBA GAZETTE” dedicated to the woman of today : ‘T he tender, gentle and a flawless leader.’

In line with this, we bring to you an exclusive interview with Mrs. Roopali Tople (Criterium Inc., Pune) on clinical trials in India.

In view of the advancements in Intra Uterine Contraceptive Devices (IUCD), our students have undertaken a project with the aim to survey the awareness and usage pattern of IUCD in Pune city.

It also includes a section on changing trends in advertisements focusing on women.

We also bring to you one of the 12 part series on various noteworthy CSR initiatives. The article titled ‘Back to Society’, covers the initiative by TATA Chemicals for empowerment of women.

To be abreast with the developments in the industry we have also included a section on BT News, and The PUMBA Gazette’s view point on the same.

A section based on PUMBA and the happenings in and around the same has also been included.

Your Feedback & Suggestions are welcome at

thepumbagazette@gmail.com

“Reading is to the mind what exercise is to the body”

- Joseph Addison

Sincerely Yours,

Chief Editior: Vijendra S. Agarwal, MBA-BT (Sem II)

(THE PUMBA GAZETTE Team)

(The detailed project reports shall be provided on enquiry. Kindly send in your enquiries at thepumbagazette@gmail.com )

Dr.(Capt.) C. M. Chitale, DEAN ,

University Of Pune

CONTENTS •Cover story

--Calculative Contraception

•Articles/Analysis --The Pink Shift

•Back to Society

--OKHAI Initiative by TATA Chemicals.

•BT News

--In support of trials – Truly Asia

•Candid Talk

--An Interview with Mrs. Roopali Tople

•PUMBA News --International Conference on Global meltdown

--PUMBA at BIOASIA Conference 2009

“I am very happy to note that ‘The PUMBA GAZETTE’ Team is dedicating this issue to women.

Women, in general, have to face challenges both at personal and professional levels to prove their mettle.

It is observed that women are sincere and honest to their responsibility and fulfil the job expectations.

In fact, today women work at par with men and have proved to be equal or sometimes even better than the male force.

My best wishes to all working women for their future endeavours.”

Calculative Contraception

SSuurrvveeyy aabboouutt aawwaarreenneessss aanndd uussaaggee ppaatttteerrnn ooff IInnttrraa UUtteerriinnee CCoonnttrraacceeppttiivvee DDeevviiccee ((IIUUCCDD)) iinn PPuunnee cciittyy

In view of the International Women’s Day, a survey was conducted with the aim to study the awareness and usage of IUCDs in Pune city. The target sample included 315 married women in the age group of 18 to 60 from various strata of society. Pune city was divided into six different zones & random sampling procedure was used. 35 Gynaecologists from eminent hospitals in Pune were also interviewed. The survey revealed that most of the women in Pune are aware of IUCDs but fall back on account of its usage.

IUCDs used in India are found to be of three basic types, Copper T (CuT), Multi load and hormone releasing devices. However there are variations of CuT like CuT 380A, CuT 200 etc. The survey was aimed at finding out the devices which are usually recommended by Gynaecologists and preferred by women. Its objective also included finding out the preferences of IUCDs over other measures of contraception like contraceptive pills, condoms (used by partner), surgical procedures & spermicidal creams.

It was found that about 91% women were aware of IUCDs and their functions. The various sources of this awareness were doctors, friends, relatives and media with the major source being doctors (Graph 1).

Contraceptive pills were found to be more popular with women of age group 18-27 years and surgical procedures were preferred in the age group of 38-47 years (Graph 4). However, both IUCDs and contraceptives are popular in age group 28-37 years, IUCDs ranking higher than contraceptive pills (Graph 2).

Among IUCD’s, Multiload was found to be negligibly used by women, the reason being its higher price in comparison to freely available Copper T in government hospitals. However, it is highly recommended by doctors (Graph 3).

The various contraceptive measures like contraceptive pills, condoms, IUCDs & surgical procedure are advised by doctors. The actual usage pattern among women was found to be as depicted in Graph 2. Women prefer condoms over IUCDs and contraceptive pills.

The majority of doctors interviewed in the survey carried out 5-10 IUCD procedures per month. Among the 35 doctors surveyed, 50% agreed that some complications occur after installation and the rest said otherwise.

Few companies in India manufacture IUCDs (that too, only CopperT). Easy and affordable availability of Multiload will popularize its usage, since doctors recommend it over CopperT due to many aspects.

CONCLUSIONS AND SUGGESTIONS

1. Though a large percentage of women surveyed were aware of the IUCDs, few preferred using them.

2. Women are reluctant to use IUCDs because of the doubts, apprehensions, lack of awareness and proper guidelines regarding its use.

191

19

76

020406080

100120140160180200

Number of women

respondents

Doctors Media Friends &Relatives

Sources

Graph 1: Sources of awareness about IUCDs

Graph 2: Usage of various contraceptive measures among women

19.23%

26.92%

23.08%

17.31%

13.46%

Contraceptive Pills

Condoms

IUCDs

Surgical Procedure

No usage

Graph 3: Recommendations for IUCDs by doctors

38%

3%

11%

48%

CuT

HormoneReleasingCuT 380A

Multiload

0%

20%

40%

60%

80%

100%

Preference

Condoms

Contraceptive

pills

Surgical

procedures

IUCD

Graph 4: Age group wise preferences for various contraceptives

48 & above

38-47

28-37

18-27

3. The government should take more efforts to encourage usage of IUCDs as doctors feel they are safer, convenient and more reliable than the frequent medical termination of pregnancy and the use of emergency contraceptive pills.

4. The media (print media, electronic media, internet, radio, etc.) can be used to create awareness about the usage of IUCDs.

5. More Indian manufacturers can enter the IUCD market, so that this potentially untapped market can be explored.

Compiled by: Anagha Bhavale, Dipti Tayade , Dr. Nishith Tyagi , Snigdha Sinha, Vandita Javali, Vishakha Shinde, MBA-BT (Sem II)

The Pink Shift

It’s said ‘Men are from Mars and Women are from Venus’ and in the advertising world the Martians were the ones thought to be holding the purse strings with a majority of ads targeted towards them. It was assumed that men took all major financial decisions. Women in ads were portrayed as being dependent on men, not making important decisions and as homemakers rather than outside the home. In general, women were often found in ads for home products, baby items, cosmetics, and food items whereas men were seen in ads for products such as automobiles, alcohol, insurance, financial services, and electronic products. Till the end of the 20th century a women reminding her husband to take an insurance policy for ‘himself’ so as to secure the entire family and an advertisement for a bank showing a father taking loan for his daughter’s marriage, were not uncommon!

However, women's role in society has been changing. For example, ads for washing powder were earlier men centric where the woman was supposed to buy the right powder in order to clean her husband’s collar. But the 21st century career oriented woman is depicted in ads which portray a policewoman buying the right detergent so as keep her ‘VARDI’ clean, definitely a 21st century woman!!

Ads for beauty products, especially fairness cream, have always been targeted towards women. However women were portrayed in these ads as male dependent where the entire purpose of being fair was to secure a suitable husband. However, recently the ads have been showing career oriented women who wish to get fair and beautiful in order to pursue a career of their choice.

Women today are also seen as major financial decision makers by advertisement companies. Women have become significant buyers of several products like automobiles, insurance, financial services & electronic devices. In fact, these products are specially designed and marketed for women. ‘They are slim. They are pink. They have got the curves’. This is the promo of HP’s latest notebooks, seeking to become the modern woman’s next fashion accessory.

Evidences also exist that women are now being portrayed in less stereotypical ways in ads. A peppy Priyanka Chopra announced “Why should boys have all the fun!!” Indian advertisers have taken this seriously knowing that now ‘men moisturize and women use power tools.’

Women are now seen as prospective buyers for previously tagged ‘masculine’ products. Today companies have an opportunity to tap the women consumer markets. For example, Venky's Rock, the wine division of Venkateshwara Hatcheries (VH) group, wants to become a niche player in the Indian wine market. The company plans to launch four brands of wine targeting women consumers.

A trend towards polarizing is seen in the media now-a-days. One of the best examples is seen in the banking and insurance sector. The ads till the late 90s generally showed a worried father taking loan for daughter’s marriage. (The motto then being money for ‘Beti ki shaddi’).

On the other hand, an HDFC ad in 2008 shows a daughter gifting a cheque to her father for buying a new car and the father saying “Beti badi ho gayi hai!”

The ad of Priety Zinta shows a successful established woman who declines a marriage proposal on the basis that “the boy does not own a landline.” This clearly reflects the changing position of women in the society and in the advertisers’ minds.

So it is for sure that advertisers have established women as strong & independent buyers and family decision influencers!

So much so that ads have to scream “Men are back!” Sorry boys the Venusians have taken over!!!

References:

1. Men and Women in Indian Magazine

Advertisements: A Preliminary Report: Mallika Das

2. L J Busy and G Leichty, Feminism and advertising in traditional and non-traditional women's magazines 1950s-1980s, Journalism Quarterly, 70(2), 1993.

Compiled by: Ankita Barve, Dhruva Deshpande, MBA-BT (Sem II)

Back to Society: OKHAI Initiative By

TATA Chemicals

“You are not truly independent until and unless you are financially independent”.

"Financial security" or “Financial Independence” is considered to be the top most priority for empowerment of Indian rural women. Most of the women in rural areas are financially dependent on their partners. There is a need for women empowerment at the grass root level which will help them to take the financial responsibility of herself and her children.

Tata Chemicals Ltd. (TCL) has truly realized the need for women empowerment at rural level and has been facilitating them with various initiatives for the development of self, family and society. TCL has, with the help of Sir Dorab Tata Trust, Okhamandal Sewa Trust, Tata-Chem Golden Jubilee Foundation, and Tata Chemicals Society for Rural Development (TCSRD), made a marked improvement over the years in its efforts to make the people of Okhamandal, a taluka in Saurashtra region, self reliant in every way.

One such initiative to empower the women of this region is ‘OKHAI’. For this initiative, Okhai trust was registered under the name ‘Okhai center for Empowerment.’ The objectives of this trust are--

• To provide employment to local women.

• To focus on overall development of women.

In this initiative handicraft skills of women are nurtured and promoted. The women work on embroidery, pattern designing, patch work and stitching. The product portfolio offered by them include apparels (kurta, kurti), home furnishings (bed sheet, cushion and pillow covers, coffee and simple table clothes, wall piece, curtains) and accessories (mobile covers, picnic bags, sling and potli purses, zola bags, tea coasters)

The programme has a highly organized channel for distribution of raw material and collection of finished goods. Based on urgency of the work, amount of the work and skills demanded, Mandals or Self Help Groups are formed within the villages. Each group has its own ‘Pramukh’ (head) and ‘Co-Pramukh’ (co-head) who handles activities of bank, work distribution, primary quality check and all records.

Every group has its account in the bank in the name of their head or their group. Records of each woman and their bill book are maintained by this group. TCSRD had allotted a fund of Rs. 8.5 lakhs for the year 2007-2008.

Presently 450 women are working in Okhai out of which 250 are permanent, and 200 are temporary. Okhai presently covers 13 villages (Arambada society, Udyognagar, Bhimrana, Okha, Poshitra, Mulvel, Padli, Rajbra, Dwarka, Bardia, Makanpur, Vernala and Batia) which consist of 36 Mandals. The women here are also trained by institutes like NIFT & AVPT Government College, Ahmedabad. Okhai has won many consignments like ‘SASHA Handicraft’, Tajkhajana in the Goa resort, ‘Option shop’, Rajkot ‘Neemranaz’ (Delhi) and Home Expression (Bangalore). It conducts exhibitions at various branches of TCL, Tech Mahindra, TATA Chemicals, TATA Power, TATA teleservices, TATA-SKY, Oracles & Reliance (Jamnagar). Okhai has come a long way in the last year. The first outlet of Okhai has been inaugurated in the ‘Himalaya’ mall, Ahmedabad. This initiative has made a great impact on the social life of women. It has developed a sense of ownership and belongingness in them. They are empowered & feel confident about their work at Okhai. They are now recognized through the exhibitions conducted to display their finest of the works. This initiative is another feather in the cap of the company.

Compiled by: Ameya Budukh, Birendra Choubey, Nivedita Singh Shweta Sharma, MBA-BT (Sem II)

Special Thanks to: Mr. Omkar Rokade (TATA Chemicals Ltd.)

In Support of Trials - Truly Asia

Malaysia, till recently a tourist destination, has now a lot more to boast about. It is all set to become a new clinical trial hub, facilitated by the Malaysian government’s keenness to build a knowledge infrastructure through scientific collaboration and promotion of research.The country has time and again lived up to its reputation in delivering results, owing to its low cost advantage & its modern medical infrastructure with efficient logistics for trial supplies and biological samples. The country also possesses a large and diverse multi-ethnic population, along with Good Clinical Practice (GCP) certified and English-literate medical professionals in various therapeutic areas.

Some of the government’s strategies include marketing Malaysia as a preferable clinical trial destination, strengthening governance and ethical oversight & the required human capital. It also focuses on developing research supporting infrastructure, facilitating access to Malaysian investigators, strengthening collaboration and partnerships as well as establishing a sound legal framework. This is backed by the Clinical Research Centre (CRC), an arm of the Ministry of Health (MoH).

The MoH is working closely with the Association of Clinical Research Professionals (ACRP) in human capacity building to overcome the shortage of highly trained clinical research professionals. Furthermore, the government sets up fast timelines for ethical review and regulatory approval and ensures strict adherence to international regulatory regime such as compliance with GCP guidelines and Intellectual Property Rights (IPR) protection. Malaysia's most notable feature is its comprehensive integrated network of government healthcare facilities and partner private hospitals, which is achieved through the CRC. It also aims at improving the quality and ethical clinical research through a comprehensive range of services which include phase II to IV clinical trials, disease management, clinical databases & patient registries and medical research registration. With its growing network of centers nationwide, CRC acts as a one-stop-centre that provides a single point of contact to access all Ministry of Health (MoH) hospitals and clinics. Moreover, it is actively seeking Memorandum of Understandings (MoUs) with several private hospitals and academic institutions to set up similar centers.

Also the information regarding the ongoing clinical trials can be obtained from National Medical Research Register (NMRR), which is a web-based integrated system simplifying research application. Through this, one can easily track and obtain information about the number of clinical trials that are conducted in Malaysian government hospitals. This also enables transparency and provides information for the public & researchers and facilitates the research review process.

On the other hand, looking at the Indian scenario, in the past few years India has become one of the top locations for outsourced clinical trials, largely because of the reduced cost of conducting trials. But the attraction of India goes beyond simple cost considerations because India is more of a federation of distinct ethnic groups than a homogenous nation. Also it is becoming more difficult to conduct trials in the West, as people are becoming more risk averse and less willing to

trust experimental treatments. Secondly, it is the cost factor that counts. Trials can be conducted in India at a fraction ofthe price of that of in the US. Trials for standard drugs in the US cost more than $150m, a figure that can be reduced by around 60 percent by shipping them to the sub–Continent. Added features also include faster patient recruitment & the amendment of schedule Y of the Drugs & Cosmetics Act in the year 2005.

The pace for drug trials in the country is so fast that the Clinical Data Interchange Standards Consortium (CDISC), USA, a non-profit organization committed to the development of clinical research organizations' standards the world over, is looking at setting up its chapter in India.

Global consultancy McKinsey & Co estimates that by 2010, global pharmaceutical majors would spend around $1-1.5 billion just for drug trials in the country. However business in India seems to have been affected adversely owing to recent happenings.

Unethical clinical trials in the country have raised issues since the controversial drug trials of letrozole, streptokinase and nordihydroguairetic acid. The Times (London) reported that as many as 49 infants have died during clinical trials at the government-owned All-India Institute of Medical Sciences (AIIMS). But, ethics is also an important part of medical research, till recently being neglected in India. According to a survey conducted by the Indian Council of Medical Research (ICMR), Ethics Committees (ECs) are functioning in over 200 institutions. However, there is no accreditation of these ECs. Besides, some ECs have an irregular schedule of meetings, lack standard operating procedures, and do not have a composition in line with GCP guidelines. This led to severe opposition and strong pressure on the government to take action.

The Government has established a national registry to scrutinize trials in order to ensure compliance with ethical guidelines. The ICMR has also planned to review and audit the functioning of ECs and to introduce a national accreditation system for them. India can also implement some of the steps taken by the Malaysian government feasible here like introducing a web based integrating system and also consider other features to promote trials in India. The other aspects of regulatory revisions such as adoption of Good Clinical Practices (GCP) guidelines, removal of import duty on clinical trial samples, elimination of restrictions on concurrent trials, anticipated patent law changes have shown India's seriousness about becoming a hub of global clinical trials.

Compiled by: Ashish Mishra, Queeny Bubna, MBA-BT (Sem II)

“Behind every successful woman there is a MAN!”

Mrs. Rupali Tople, PUMBA MBA-BT (2004) alumna, has played a key role in setting up of Criterium Inc., a US based Contract Research Organisation. She was the first employee of the company in India. The PUMBA Gazette interview team caught up with one of our own woman achievers. A glimpse of the conversation:

1. Can you brief us about your company?

Criterium Inc is a Full Service Contract Research Organization, with its headquarters located in New York, USA. It was founded by our President and Founder Mr. John Hudak way back in 1991 in New Jersey, USA.

Our Business model is to connect our network of staff, contractors, partners, Investigative sites, and Patients using technology. We not only sell technology; we also sell efficient processes with a staff to back them up.

We are a result driven Service Company that provides high Quality project management services organized around patient enrolment and real time data acquisition.

Our global reach enables 24/7 operations.

2. Why was Pune chosen as a location for setting up the branch?

Pune is a growing city, especially for clinical research, has good talent, good network of hospitals, good connectivity to places across the country.

Besides, Pune has been a dream place to work for many young aspirants who have been working in different corners of our country.

It’s a ‘welcome back to their home’ town!

3. A gender bias is usually observed in India. Did you as a woman face any difficulties while setting up the organization?

No, not at all!! Gender biasing for me is a history. In our organization we have strong policies supported by a very good culture and work environment.

4. Which countries do you consider as a potential hub for clinical research?

Apart from India, countries like Singapore, China, Malaysia, are the potential hub for Clinical research in the coming days.

5. The Malaysian government is promoting clinical research in full swing in Malaysia. What according to you should the Government of India do in order to promote clinical research in India?

India is not far behind. As you can see, today we have all the top CRO’s, and also a good number of pharmaceutical companies based in India. This would not have happened without the government’s support.

However, I do feel a strong requirement for learning and simplifying certain processes like approval timelines, as compared to the other nations.

But on the other hand, we have an added benefit of faster patient recruitment.

Certain recent changes in regulatory affairs encourage clinical trials in India. In 2005, schedule Y of the Drugs and cosmetics Act was amended. Earlier foreign drugs trials could be conducted only at one phase below the highest phase of testing abroad.

Now parallel global clinical trials are possible in India. Permission is granted for concomitant phase II and Phase III trials.

6. India faces cost competition from China, Brazil, Russia and Mexico. What is your take on it?

Due to globalization, world has become a smaller place, and today is the time for “Survival of the fittest”.

I truly believe in Warren Buffet’s advice statement for 2009-

“Hard work-All hard work brings a profit, but mere talks lead only to poverty.”

Hard work, dedication, determination, quality of work and wise spending are the keys to success and beat the competition as well.

7. The U.S. administration has taken an unfavourable approach towards outsourcing in the life science sector. U.S. is a big source for the Indian clinical research market. What is your opinion on this decision?

Decisions like these are taken at a national level in the best interest of the citizens, hence I totally respect it. We are a country of potential and intellectual citizens, who have proved their mettle in difficult times in the past and we will continue to do so in future as well.

8. It has been observed that the Life Sciences sector has not been hit hard by the recession. Please comment.

Although health care and pharmaceutical industries have been traditionally viewed as recession proof, the present upheaval in global financial markets has had and will continue to have a considerable impact on this sector. The discovery and development of new drugs remains an important resource & capital intensive enterprise, hence challenging financial environment will force players to review their priorities, rationalize ongoing initiatives, and explore alternative models.

9. How does your company plan to deal with the recession?

We have strong employee retention policies and strategies developed to take care of cost outs with no or minimal impact to our employees.

Positive aspect of recession is that it brings out the best in you and your organization as well.

10. Do you consider entrepreneurship to be the need of the hour in this recession period?

Yes, entrepreneurship is the need of the hour. Any small business started with good foundation can reap good benefits in long run.

In today’s fast growing world one cannot depend on the single source of income.

11. What is your secret of maintaining a balance between your work and family?

Work and family play equal importance in one’s life. Maintaining the right balance always helps.

I generally plan my work, and my day, be it official or personal. This helps me prioritize my responsibilities and duties and I can cater to each task effectively and in timely manner.

Also, I have a very strong support from my family and especially my husband who equally understands me and respects my style of work. In fact I would proudly love to say that ‘behind every successful woman there is a MAN!’

Compiled by: The PUMBA Gazette Interview Team.

PUMBA NEWS

1) PUMBA in association with CSIR-IPR Chair, University of Pune, had organized an International Conference on Global Meltdown - Opportunities and Challenges on 20th and 21st March, 2009 at PUMBA. The economic crisis faced by the world economy today has forced both- the government and corporate authorities that are responsible for governance to take a hard look at the way they have been handling the issues faced by the world. Thus the Conference proposed to focus on these issues in order to reinvent the whole gamut of things, which would lead to a paradigm shift and bring the economy back on track and ensure sustainable business environment. Academic scholars, practicing professionals and management students participated in the event and shared their thoughts on the various themes through their research papers. Close to 500 abstracts were received, out of which around 250 were shortlisted for final presentations.

Dr. Narendra Jadhav (Hon’ble Vice Chancellor, University of Pune) was the Chief Patron of the Conference and Dr. (Capt.) C.M. Chitale (Prof. & Dean, PUMBA and CSIR-IPR Chair Professor), Dr. Pandit Vidyasagar (Director-BCUD) and Dr. M. L. Jadhav (Registrar) were the Patrons. Dr. B. V. Sangvikar (Prof. & Head, PUMBA) was at the Conference Chair. The inaugural function at the IUCCA Auditorium started with the lighting of the lamp by Dr. Narendra Jadhav and the other dignitaries present. Dr. Narendra Jadhav released the conference proceedings of the selected papers which were compiled in the abstract book followed by addresses made by the dignitaries who gave their valuable inputs on the current economic situation in the world economy.

The first day of the conference ended with a melodious ghazal program. The paper presentations by the delegates and students continued on the second day of the conference. The Valedictory Session in the afternoon saw a number of eminent guests making their presence felt. The Chief Guest for the session was Dr. Ganesh Natrajan (Chairman NASSCOM, CMD, Zensar Technologies), the guest of Honor, Dr. P.C. Shejwalkar (Professor Emeritus), Dr. (Capt.) C. M. Chitale, Dean, Faculty of Management, Dr. B.V. Sangvikar, Head of the Department and Dr. Praful Pawar (Conference Secretary). The winners of the Student Research Paper Contest were awarded prizes and certificates by the guests.

2) The BIOASIA 2009 organized by the Federation of Asian Biotech Associations (FABA) from February 2-4 2009 at Hyderabad International Convention Centre (HICC), was an excellent platform for the students of first semester of MBA Biotechnology to become aware of the current biotech scenario both at the domestic and the global front. This Global Bio Business Forum attracted both scientists and business leaders from all over the world covering 18 countries. Discussions were held on the current economic meltdown and its impact on the sector. The panel discussions were mainly focused on:-

1. Innovative solutions to funding challenges. 2. Partnerships in drug discovery in Asian countries. 3. Business drivers leading to collaborations in licensing. 4. Oncology & Monoclonal Antibodies. 5. Vaccines- India’s Strength. 6. Service sectors. 7. Nanotechnology & CADD approaches for drug

discovery. 8. Stem cell research scenario in India. 9. Manpower challenges in Biotechnology.

There was also an exhibition of various companies from all over the world all the three days. This conference provided a direct interaction between students and people from corporate world.