Minutes of Meeting Council Meeting on Drug & Pharmaceutical September 17, 2013

New Delhi November 19,2013: Dr. Om S Tyagi, Senior Director, ASSOCHAM extended welcome to the Chair Mr. Bahskar V Iyer, Co- Chairman Mr. Umang Chaturvedi and members of the Council.

Chairman Mr. Bhaskar Iyer and Co- Chairman Mr. Umang Chaturvedi also greeted the member’s followed by Dr. Om. S Tyagi, Senior Director, ASSOCHAM reading out the Minutes of Meeting for last Council Meeting on August 13, 2013, with a request to add/delete substance(s) of the minutes

As per decision in the previous council meeting, Mr Shri Anirban Roy Chowdhary, Senior Director, Global Clinical Trial Operations, MSD Pharmaceutical Pvt. Ltd shared status paper prepared on the Clinical Trial.

There was suggestion that since report of Dr Ranjit Rai Choudhary on Clinical Trial is up loaded on the website, it will make logical to contrast both ASSOCHAM status report with Dr Choudhary report to submit memorandum on the points which are not covered in later’s Report.

Members were unanimously in favor of maintaining a sustained pressure on the Government particularly on the Ministry of Health and Family Welfare concerning reform in drug regulation and clinical trial.

The areas of focus in clinical trials include, bioethics, strengthening regulations, provision for strong ancillary care, compensation and site inspection for clinical trials. Post marketing surveillance of clinical trials, role of New Drug Advisory Committee (NDAC), etc.

Members suggested that clinical trials should come under the “Patient Safety Umbrella”. This will bring industry’s perspective and government’s point of view on the same platform.

Further, members suggested Mr. Anirban Roy Chowdhary to prepare a fresh set of recommendations to be submitted to DGHS and Ministry of Health & Family Welfare, GOI.

The Second position paper was presented by Shri Amitabh Baxi, Director, Abbott on Fixed Dose Combination (FDC)

Members were concerned about the government policy on FDC furthermore; legal procedures and compliances are the foremost areas of worry. Members were concerned about the impact of government policy on small companies in pharmaceutical sector. However, it was clarified that Form 44; do not adhere to provide all the information.

Next agenda for discussion was selection of a topic for conducting seminar. There were suggestions likeAccess to Healthcare, Counterfeiting, Adherence and Compliances, CSR Corporate Social Responsibility, Drug exports, PPP model etc

Members were in opinion that topic should be such that it appeal to multi-stakeholders.

Access to Healthcare may be cover specific sessions on healthcare in future years, generic drugs, quality of drugs especially during transition from pint of manufacturing to consumption, counterfeit drugs, affordability, new innovations in healthcare, use of technology, traditional healthcare system, innovative healthcare models including public private partnership (PPP) in healthcare, Supply Chain Management, State Government initiatives etc.

Meeting concluded on the following points:

· Group headed by Mr Anirban Roy Chowdhary to revise their status paper on clinical trials in light of the developments after Dr Ranjit Rai Chaudhary’s report

· Mr Amitabh Baxi to update the council on FDC in next meeting by proposing possible follow up

· Involvement of more industry relevant people in council meetings. All members agreed to forward names of the relevant people especially Delhi based

· Inviting people from other associations for frequent significant discussions.

· ASSOCHAM secretariat to work on the date of the event on access to healthcare

ATTENDEE’S PRESENT:

Mr. A. S. Sarna, Cadila Healthcare Ltd,

Dr. A K Prasad, Former University Prof & HOD, Delhi University,

Mr Amitabh Baxi, Director Government Affairs Abbott Healthcare Pvt Ltd,

Mr. Anirban Roy Chowdhury, Senior Director, Global Clinical Trial Operations, India, MSD Pharmaceuticals Pvt. Ltd. (Merck & Co),

Mr. Z. H. Charna, Director, Independent Consultant, Ex- OPPI Director.

Mr. Abhinav Srivastava, Manager – Corporate Affairs, Ranbaxy Laboratories Ltd,

Mr. Venkataraman C. V, Director- Corporate Services, Lupin Limited

Arun Sachedva, Senior Manger- Regulatory Affair, Lupin Limited

Mr. Kuldeep Wakhloo, Lupin Pharma,

Mr. Rajan Narain, Advocate on Record, Supreme Court, Global Legal Associate

Mr. Prateek Goel, Senior Manager, Deloitte

Mr. V. K Agarwal, Mc Coy Overseas

Ms. Vandana Jain, Mc Coy Overseas

Mr. Umesh Sanghi

Mr. V. K Singh, Director Healthcare Asaia, Simpler Healthcare India

Mr. Amrish Tiwari, Senior Associate, K & S Partner

Ms. Archana Pandey, Director- Business Development, Max India Limited

Mr. Shrikant Gaur, Executive Vice President & Head, Life Science, Yes Bank

Dr. V.K Singh, Adjunct Research Professor, Ivey

Dr. Ravi Kaushik, Associate Operations Manager, Excel Life Sciences

Dr. Aparjita Singh Rathod, Director Regulatory Affairs (Research) Taj Pharmaceutical

Ms. Vidhi Rathee, Senior Correspondent, India Medical Times

Mr. Rajiv Sehgal, Vice President- Marketing, Care World TV

Mr. Anil Seth, Director- Clinical Research, Eli Lilly

Mr. D. K Singh, Senior Vice President, Cadila Healthcare Limited

Dr. Deepali Mittal, Head, Clinical Research & Pharmacovigilance, LG Life Sciences India Pvt. Ltd.   CCI Newswire