Apparently browbeaten by the Supreme Court of India for the alleged lapses in regulating clinical trials in India, the union health ministry has constituted two - tier panel - an apex committee and a technical committee, consisting of senior ministry officials and experts, for supervising clinical trials on new chemical entities in the country.

Dr V M Katoch, secretary, Department of Health Research, and director general, ICMR; Dr Jagdish Prasad, Director General of Health Services and  Dr A K Panda, joint secretary, Ministry of Health & Family Welfare (MoHFW) are the members of the three-member apex committee.

The Apex Committee will meet every month to take stock of new approvals. Secretary (Health & Family Welfare) will take the assistance of technical committee to supervise and monitor the conduct of the clinical trials in the country.

Besides, the ministry has formed a 16-member technical committee under the chairmanship of Dr Jagdish Prasad, Director General of Health Services.  Other members of the technical committee include Dr Ranjith Roy Choudhury, Dr Ashok Kumar Das, Dr Vinod Raina, Dr Sanjay Tyagi, Dr Jaspal Sharma, Dr Nikhil Tandon, Dr Kamlakar Tripathi, Dr Shashank Parulekar, Dr Debasis Bas, Dr P K Dalal, Dr Rajutitus Chacko, Dr S N Gaur, Dr B L Sherwal and Dr Nandini Kumar.

The Technical Committee will meet every month to oversee the conduct of clinical trials in the country and give its recommendation to the Apex Committee for taking further appropriate action. The list of clinical trials along with title and objective of the study, name of the applicant and other details, permitted by the DCG(I) shall be submitted to the Technical Committee on monthly basis for the said purpose.

The ministry constituted these committees on the directive of the Supreme Court. The Apex Court had directed the ministry in January this year that until further orders clinical trials on new chemical entities in the country should be conducted strictly in accordance with the procedures prescribed in the Schedule Y of the Drugs and Cosmetics (D&C) Act, 1940 under the direct supervision of secretary, Ministry of Health & Family Welfare.