Meeting Title: LSW Round Table Meeting with Dr. Ranjit Roy Chaudhury
Meeting Called by: LSW LifeScienceWorld
Purpose of the Meeting: To revive Clinical Trial Operations in India
Meeting Date: November 5, 2014
Venue: The Orchid, Mumbai
Chair: Prof. Dr. Ranjit Roy Chaudhury, Adviser to Minister of Health, Govt. of India
Note Taker: Dr. Milind Antani, Advisory Board Member, LSW and Partner, Nishith Desai
Associates
Dr. Shailesh Ayyangar, Managing Director, Sanofi India
Jitendra Tyagi, Managing Director, Bristol - Myers Squibb
Dr. Murtaza Khorakiwala, Managing Director, Wockhardt
Aman Bajaaj, Managing Director, Takeda Pharma
Dr. Santosh Jha, Director-Medical & Regulatory, Takeda
Sudharshan Jain, Managing Director, Abbott Healthcare.
Dr.Arun Mishra, Director-Regulatory Affairs, Abbott India
Dr. Chandrashekhar Potkar,Director-Medical & Regulatory Affairs, Pfizer
Dr. Suresh Menon, CSO, Novartis
Jeroze J Dalal, Head-Clinical Operations, India & Pakistan, Gsk
Dr. Anish Desai, Director-Medical Affairs, Johnson & Johnson
Nandita Chopra, India Representative, NIH, USA
Dr. Milind Antani, Partner, Nishith Desai Associates
D G Shah, Secretary-General, Indian Pharmaceutical Alliance
Dr. Rashmi Hegde, Director- Medical Affairs, Abbott
Dr. Veena Jagutse, Director-Development Operations, Amgen
Sankar Iyer, Editor & Managing Partner, Lsw Lifescienceworld
6 points of the policy pertaining to Clinical Trials
Centre which will carry out clinical trials will be accredited
Principal Investigator will be accredited
Ethics Committee will be accredited
Industry’s views, future plans and suggestions to the government with regards to the revival of clinical trials as before and on other core issues pertaining to the pharma industry, and what industry can expect from the government.
Following recommendations were put forth:
1. To form a committee representing industry, government and NGO to discuss and handle various issues
2. To have clarity in the language of notifications/office orders and to give clarification that the regulations notified are applicable to prospective trials and not ongoing trials
3. New Drug Advisory Committee (NDAC)
a. To have only one layer of committee approval
b. NDAC must act very fast and ethically
c. Proper training program for NDAC members
d. Regular evaluation of performance of NDAC members should be done
e. There should be clarity on the process of functioning of the committee
f. An experience industry expert should be involved in the committee
g. All the minutes of meeting should be published on website
h. Committee must have an able leader, should give adequate time in the meeting and decisions in meeting must be communicated immediately
i. Composition of committee needs to change
j. Professional project management training should be done
k. High level committee should be formed regarding formation
4. To create a platform at government level to connect with all the stake holders
5. While finalizing the notifications/office order, DCGI office should invite industry representative to sit with them as many a times outcome of meeting is not interpreted correctly
6. Correspondence regarding invitation to be committee should happen from office of ministers and properly as it is an honor
7. To study and compare global practices and implement
8. In reporting of SAE, language should change from “occurrence” to “awareness”
9. To issue clarification on post marketing surveillance and phase 4 clinical trials
10. to tacked medical device issues and expedite pending bills
1. To provide relevant examples of issues they have faced so that proper representation can be made before the minister
2. To provide global practices and what best can / should be implemented in India
3. To discuss and provide guidance on Project Management expertise
4. To give composition of NDAC
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