The Quarterly Newsletter from the Corporate of Aurous HealthCare - CRO…

Mar 2014 Vol. 01 Ed. 03

Since 2008…Since 2008…

PROPRIETARY OF AUROUS HEALTHCARE R&D INDIA PRIVATE LIMITED

© Aurous HealthCare R&D India Private Limited, 2008, All Rights Reserved

The pioneer Contract Research Organisation (CRO) with focus on Clinical Research

http://auroushealthcare.wordpress.com/dr-vt-sriraam/

From the Desk of MD…

As a medical entrepreneur, I am excited like a child on his birthday that the dawn of another

financial year looms close.

Our AURO-BLOG has been religiously capturing the pulse of the Drug Research Industry and it

thrills me to see the progress we are making towards a more regulated and scientifically advanced world.

The happiness also stems from the very promising activity in the sphere of AYUSH!

The world is travelling back to its ancient roots and the foray of herbal cosmetics with natural

extracts and ingredients, is the most fascinating progress of recent times. AYURVEDA and SIDDHA is

making it’s presence felt with safer, milder herbal medicines and cosmetics. As a doctor from the school of

modern medicine and surgery, it prides me that the most ancient science of our land is being reinvented to

match the standards of modern science and provide the safest and most suitable care to our health.

It is interesting to note that Clinical Studies are no longer feared upon as an experimentation but

are being considered as the medically apt scientific approach to ensuring the safety and efficacy of

your product - even an AYURVEDIC or SIDDHA formulation that has been around for years -

before it reaches the larger public.

With Best Regards, Dr. VT. Sriraam MBBS MD (Pharmacology)

ManagingDirector | Medical director—Aurous HealthCare– CRO

**************************************************************************************************************

Dr. VT. Sriraam MBBS MD (Pharmacology) is the founder– director of Aurous HealthCare - CRO. An alumni of Stanley Medical College, he was honored as ―The Best Doctor” by the Ministry of Health, Maldives at the age of 23. Gaining rich and varied experience at top CRO, Dr. VT. Sriraam founded Aurous HealthCare in 2008. An astute medical entreprenuer, his sharp business sense combined with his rich knowledge and experience in the field of clinical research has pushed Aurous HealthCare from strength to strength. He was recently shortlisted as one of the TOP 9 Innovative Entrepreneurs for CavinKare’s Chinnikrishnan Innovation Award 2013. A man with strengths so varied and unique, Dr. VT.Sriraam is the epitome of the entrepreneurial combination of business brains and clinical-research creatives.

AurouSpeak

#2

Inside…Inside…

AURO Ayur………………...………..…Page 4

POLIO FREE INDIA!!......………..…Page 5

AURO BYTE………………...………..…Page 5

AURO- DAYS………………………..…Page 6

USFDA Commissioner visits……..Page 7

More from AUROBLOG..………..…Page 7

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Send a test mail and receive quarterly updates

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inbox!

mgr.bd@auroushealthcare.com corporate@auroushealthcare.com

Register!Register!

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The following are the major amendments in the Drugs & Cosmetics

Rules - 2013 pertaining to the field of clinical research...

GSR 53(E) - 30-Jan-13 Addition of the above following details in SCHEDULE Y, as a clause

to "Responsibilities of Sponsor", "Responsibilities of Ethics

Committee" and additions of responsibilities and reporting

timelines to Ethics Committee and Licensing Authority as

"Responsibilities of Investigator"

Additions to SCHEDULE Y - APPENDIX V - INFORMED

CONSENT : Statement mentioning medical management and

financial compensation. Addition to informed consent document

that captures the name and contact details of the subject's

nominee.

Addition of Rule 122 DAB - Compensation in case of injury or

death during clinical trial.

7 points were added highlighting important aspects such as free

follow up medical management, subject/nominee may also be

entitled to financial compensation as borne by the sponsor and the

criteria for deciding on the factors of injury and their association

with the clinical trial or the investigational products.

Addition of APPENDIX XII to SCHEDULE Y : Compensation

incase of injury or death during clinical trial. 6 points that outline

the details of handling and reporting a serious adverse event

during a clinical trial.

GSR 63 (E) - 01-Feb-13 Addition of Rule 122 DAC - Permission to conduct clinical

trial.

The points that were added stressed on conduction of clinical

trials in compliance with Schedule Y and Good Clinical Practice

guidelines, the importance of obtaining Ethics Committee approval

and registering the clinical trial with CTRI - Clinical Trial Registry -

India before enrolling the first subject into the trial.

The rule also stresses the submission of annual reports, timely and

apt reporting of serious adverse events to the regulatory

authorities.

GSR 72 (E) - 08-Feb-13 Addition of Rule 122 DD - Registration of Ethics Committee.

A detailed account of the composition, conduct and registration of

the Ethics Committees in India, which would help the CDSCO, keep

a vigilant check on the ethical aspect of the clinical trials

conducted in India and the specific bodies approving the same. Continued on page 6...

Recent Amendments in Recent Amendments in

Drugs & Cosmetics Rules, 2013. Drugs & Cosmetics Rules, 2013.

AurouSpeak

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AURO Ayur…AURO Ayur…

Madana...

Scientific name: dried fruit

of Xeromphis spinosa

Sanskrit : Madani

Assamese : Maen

Bengali : Mayanaphal

English : Emetic nut

Gujrati : Mindhol

Hindi : Manphal

Kannada : Mangarikkai, Karigidda

Malayalam : Malankara; Marathi : Ghalphala

Tamil : Marukarrai; Telugu : Monga Kaya; Urdu : Mainphal

Medicinal uses:

Main use is that as an emetic agent.

In smaller doses it is a nauseant, expectorant and diaphoretic.

In smaller doses for the teething problems of infants.

Also credited with antihelminthic properties.

Applied externally for rheumatic pain.

Ayurvedic Properties and Action:.

Rasa: Madura, Tikta

Guna: Laghu, Rukha.

Virya: Usna

Vipaka: Katu

Karma: Vamana, Lekhana

Dose: 1-2g of the drug in powder form. Ref : The Ayurvedic Pharmacopeia of India - Part I - Volume I

Contact : Contact : mgr.bd@auroushealthcare.com +91mgr.bd@auroushealthcare.com +91--98409091559840909155

We also offer Clinical Trial Rescue Services to help mend strained Sponsor—CRO relationships, issue analysis at Clinical Trial Site,

Medical monitoring services and independent quality audit services.

AuroQuiz answers: 1.B 2.B. 3A. 4A. 5A. www.auroushealthcare.com

D A PRASANNA ELECTED AS ACRO

INDIA’S NEW CHAIRMAN… The Association of Contract

Research Organizations

(ACRO) India has

unanimously elected D A

Prasanna, founder and

chairman Ecron Acunova, as

the chairman of the

Association.

He took over from Apurva

Shah, group managing director, Veeda Clinical

Research Pvt. Ltd.

Speaking on the appointment, D A Prasanna

said that clinical research in India has contributed

to bringing vaccines, drugs, devices to needy

patients at affordable prices. From neglected

diseases like kala azar to tropical disease like

malaria, Indian clinical research has alleviated

suffering. India has made a name in the world in

lowering healthcare costs through generics and

building a reputation in development of biotech

drugs and medical devices. ACRO India’s priority is

to promote safe conduct of clinical research without

impeding the development of much needed drugs

for Indian patients and to make Indian research

data useful to market drugs across the world. Source: PharmaBiz...

AurouSpeak

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AURO Byte… AURO Byte…

BLAST: Basic Local Alignment Search ToolBLAST: Basic Local Alignment Search Tool

www.ncbi.nlm.nih.gov/BLAST/

The Basic Local Alignment Search Tool (BLAST) finds regions of local similarity between

sequences. The program compares nucleotide or protein sequences to sequence databases and

calculates the statistical significance of matches. BLAST can be used to infer functional and

evolutionary relationships between sequences as well as help identify members of gene

families. A BLAST search enables a researcher to compare a query sequence with a library or database of sequences, and identify library

sequences that resemble the query sequence above a certain threshold. The BLAST program was designed by Stephen Altschul,

Warren Gish, Webb Miller, Eugene Myers, and David J. Lipman at the National Institute of Health in 1990.

www.auroushealthcare.com

WHO DECLARES INDIA POLIO FREE… India was once recognized as the world’s

epicentre of polio. But there has not been a

single recorded case of polio in India since 13

Jan 2011. All pending laboratory investigations

have returned negative, in the coming weeks India

will officially be deemed to have stopped

indigenous transmission of wild poliovirus.

“India’s success is arguably its greatest

public health achievement and has provided a

global opportunity to push for the end of polio,”

said WHO Director-General Margaret Chan.

“The Global Polio Eradication Initiative is in full

emergency mode and focused on using this

momentum to close this crippling disease down.

Stopping polio in India required creativity, perseverance and professionalism – many of the innovations in polio

eradication were sparked by the challenges in India. The lessons from India must now be adapted and implemented

through emergency actions to finish polio everywhere.”

The key to India’s remarkable progress in the fight against polio according to UNICEF Executive Director

Anthony Lake, has been the strong leadership of the Government of India and state governments, which launched a

comprehensive polio eradication programme that has enabled sustained high immunization coverage in states like Uttar

Pradesh and Bihar with high rates of poverty, high population density and poor sanitation and infrastructure, conditions

in which disease like polio can thrive.

“India’s achievement is proof positive that we can eradicate polio even in the most challenging environments –

in fact, it is only by targeting these areas that we can defeat this evil disease,” Mr Lake said. “We have the ability to protect

every last person, especially

children, from this entirely prevent-

able disease – and because we can,

we must finish the job of eradicating

polio globally, once and for all.”

Th e G l o ba l P ol io

Eradication Initiative (GPEI) is

spearheaded by national govern-

ments, WHO, Rotary International,

the US Centers for Disease Control

and Prevention (CDC) and UNICEF.

AurouSpeak

#6

Universal Ethics Committee: Universal Ethics Committee: The Ethics Committee Division of The Ethics Committee Division of Aurous HealthCare Aurous HealthCare -- CRO…CRO…

Universal Ethics Committee (UEC), is a unit of Aurous HealthCare (CRO) that is registered with

CDSCO-DCGI holding registration number ECR/125/Indt/TN/2013 ECR/125/Indt/TN/2013 & OHRP (Office of Human Rights Pro-

tection, Unites States) - IRB00008683. UEC has been serving the Clinical Research fraternity since 2012 by provid-

ing guidance for conduct and ethical clearance for clinical trial projects. Equipped with a GCP and

Schedule Y compliant Expert member team, UEC contributes to the conduct of justified human (clinical) trials. We

also review and approve PMS studies...

Contact : universalethicscommittee@gmail.com or via +91Contact : universalethicscommittee@gmail.com or via +91--98409091559840909155

AURO Days…AURO Days…

APRIL:APRIL:

7 : World Health Day

17 : World Hemophilia Day

25 : World Malaria Day

MAY:MAY:

6 : World Asthma Day.

8 : World Red Cross Day.

12 : International Nurses Day.

17 : World Hypertension Day

JUNEJUNE

14 : World Blood

Donation Day

Check Your GCP Knowledge…Check Your GCP Knowledge…

1. What are the absolute minimum requirements for essential documents at site before Investigational Product can be sent to clinical trial site? A. Clinical Trial Agreement & CV of Investigator B. Clinical Trial Agreement & Ethics Committee Approval C. Clinical Trial Agreement & Singed Protocol.

2. According to ICH GCP when should a sponsor provide an audit certificate? A. Always B. When audit is successful. C. When required by law or regulation.

3. ICH GCP states that a Sponsor Audit is independent and separate from which of the following? A. Routine Monitoring & Regulatory Audit. B. Site Close out Visit C. Investigator’s Meeting. D. Section 4.8.1 Answers on Page 7

www.auroushealthcare.com

Recent Amendments in Drugs & Cosmetics Rules, 2013. Recent Amendments in Drugs & Cosmetics Rules, 2013. Continued from page 3.

GSR 364 (E) - 07-Jun-13 Additions to SCHEDULE Y - APPENDIX V - INFORMED CONSENT : Statement mandating the audio video recording of

the informed consent process, statement attesting to possibility of failure of investigational product for its intended

therapeutic use and clearly defined statement that the use of placebo in a placebo-controlled trial will not have any

therapeutic effect.

GSR 588 (E) - 30-Aug-13

New Label format for Schedule H1 - Drug Warning - with Rx symbol and red border.

GSR 702 (E) - 24-Oct-13 Addition to SCHEDULE Y - APPENDIX IB- Data to submitted along with the application to conduct a clinical trial or im-

port or manufacture of a PHYTOPHARMACEUTICAL DRUG in the country.

Definition : "Phytopharmaceutical drug includes processed or unprocessed standardised materials derived from plants

or parts thereof or combination of part of plants or extracts or fractions thereof in a dosage form for internal or external

use of human beings or animals and intended to use for diagnosis, treatment, mitigation or prevention of any disease r

disorder in human beings or animals,but does not include administration by parenteral route."

A two part detailed description of the data that is required to be submitted for the application to conduct a clinical trial

on a phytopharmaceutical drug unless, it has already been marketed for the said indication for more than 5 years.

GSR 703 (E) - 24-Oct-13

Addition of clauses to Schedule C, which mentioned about the educational qualification of the personnel involved in

manufacturing and testing of medical devices.

Addition of rule 109-A: Labeling of Medical Devices. - 15 points that cover the aspects that are mandated in the label-

ing of a medical device during manufacturing and clinical testing.

Addition of rule 109-B: Exemption of certain labeling requirements for medical devices for export from India -

Labels on packages or container of devices for export shall be adopted to meet specific requirement.

AurouSpeak

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AURO Quiz… AURO Quiz… Osteoporosis . . .Osteoporosis . . .

1. What is the other common name for osteoporosis?

A. Bone Disease B. Silent Disease

C. Silent Death D. Bone Death

2. What is the most common fracture observed with

osteoporosis?

A. Vertebrae B. Hip

C. Leg D. Hand

3. What is the stage of disease before Osteoporosis

called?

A. Osteopenia B. OsteoFracture

C. Osteodepletion D. OsteoCalcium Loss

4. What is the gold standard test for Osteoporosis?

A. BMD-DEXA scan B. Bone Xray

C. Treadmil Test D. Fracture test

5. What is the daily requirement of Calcium in mg/day

for an adult?

A. 1200mg B. 2000mg

C. 3000mg D. 3200mg

Next Edition: How well do you know Next Edition: How well do you know AYURVEDA??AYURVEDA?? Answers on Page 4

Check Your GCP Knowledge 1.B 2.C 3. A

Aurous HealthCare Aurous HealthCare -- Pioneer in Clinical Studies on Pioneer in Clinical Studies on HerbaceuticalsHerbaceuticals & & Cosmeceuticals:Cosmeceuticals:

①① Cost Effective Research!Cost Effective Research!

② Customised Clinical Trial Design!② Customised Clinical Trial Design!

③ ③ World Health Organisation World Health Organisation

&& ICMR Listing for YOUR company!ICMR Listing for YOUR company!

④ Specialised Medical Writing!④ Specialised Medical Writing!

⑤ Internationally Accepted Reports!⑤ Internationally Accepted Reports!

⑥ End to End Study & Regulatory Aid!⑥ End to End Study & Regulatory Aid!

Contact : mgr.bd@auroushealthcare.com or +91Contact : mgr.bd@auroushealthcare.com or +91--98409091559840909155

www.auroushealthcare.com

USFDA COMMISSIONER MARGARET HAMBURG VISITED INDIA…

USFDA Commissioner Dr. Margaret A Hamburg, visited India to hold discussions

with her Indian counterparts and industry leaders on maintaining high-quality standards in

producing drugs. During her trip, she addressed the World Spice Congress in Cochin and

visited spice and seafood processing plants. Between the dates of February 10 and 18 this

year, she also visited Delhi and Mumbai to strengthen cooperation between the FDA and its

Indian regulatory counterparts.

Dr. Hamburg also met with the officials of Marine Products development Authority

in Delhi and Cochin. The USFDA have recently brought in the Food Safety Modernisation Act

(FSMA), which has considerably changed the whole approach of FDA by putting more onus

on food importers to the country. Her visit also held a background of concerns regarding the quality of medicine, spices

and seafood being exported from India to the US. The visit by Dr.Hamburg was an official one which served to further

strengthen the ties with USFDA with respect to drug research in India. Source: Times of India...

More from AUROMore from AURO--BLOG...BLOG...

Steps taken by CDSCO to strengthen clinical trials.

CDSCO to focus on strengthening Pharmacovigilance in 2014.

CDSCO approved must be sought for BA-BE bioanalytical lab

facility.

Rule 96 of D&C Act to be amended to make vaccine based

products as “new drugs”.

Schedule M to be made on par with WHO-GMP very soon.

CDSCO and UDFDA sign letter of intent.

ICMR finalized guidelines on “STEM CELL RESEARCH”.

ICMR published CODE OF CONDUCT GUIDELINES FOR LIFE

SCIENCE RESEARCH SCIENTISTS”.

GLOBAL AYURVEDA FESTIVAL at Cochin a HUGE SUCCESS! -

Dignitaries and eminents from the national and international

scenario took part in the glorious 5 day event!

Details of these posts and more on Details of these posts and more on

www . auroushealthcare . wordpress . comwww . auroushealthcare . wordpress . com

AUROUS HEALTHCARE RESEARCH AND DEVELOPMENT INDIA PRIVATE LIMITED

(Formerly Auroville HealthCare R & D India Pvt Ltd.)

#180/109, Rangarajapuram Main Road, Kodambakkam, Chennai-600024.

Phone: +91-44 23720600, +91-44 32472446 • Mobile: +91 9551050612 Fax: +91-4423720600

contact@auroushealthcare.com mgr.bd@auroushealthcare.com www.auroushealthcare.com

THE PIONEER THE PIONEER CONTRACT RESEARCH ORCONTRACT RESEARCH ORGANISATION (CRO) GANISATION (CRO) WITH FOCUS ON CLINICAL RESEARCHWITH FOCUS ON CLINICAL RESEARCH

www. auroushealthcare . wordpress auroushealthcare . wordpress .com The Quarterly Newsletter from AHC The Quarterly Newsletter from AHC -- CROCRO

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