In order to make their policy guidelines more representative and broad-based, the two expert panels - constituted by the union health ministry to formulate policy guidelines and SOPs for approval of new drugs, clinical trials, banning of drugs and FDCs - haves asked the members of civil societies and the industry to submit their suggestions to the committees.

“In order to have broad-based inputs on the issues involved, and as desired by the chairmen of the committee, it is requested that the members of civil societies, non-governmental organisations, pharma industry, sponsors, CROs, investigators, and all others concerned with the clinical trials, new drug development and marketing may forward their suggestions for the consideration of these committees by April 7, 2013 to the chairmen of the said committees,” Drug Controller General of India (DCGI) Dr GN Singh in his official notice said.

Earlier, the union health ministry in early February this year had constituted two expert panels. The first committee, headed by Professor Ranjit Roy Chaudhury, was formed to formulate policy guidelines and SOPs for approval of new drugs including biologicals with special emphasis on: to plan a transparent, equitable system of clinical evaluation of new drugs; requirements of local clinical trial on Indian population for drugs
approved in other countries; etc.

The committee has to also formulate policy guidelines and SOPs for approval of clinical trials including global clinical trials of new drug substances discovered abroad and bioavailabilily and bioequivalence study for export. Besides, this committee has to formulate policy guidelines and procedures for examination of issues related to continued marketing of drugs not only due to safety or other reasons but also due to launch/ availability of safer and more efficacious alternative drugs in the country.

The other committee, headed by Prof C K Kokate, was constituted to formulate policy guidelines and SOPs for approval of FDCs with special emphasis on requirements of clinical trial on Indian population;  types of local clinical trial, its design, sample size, sites and their distribution etc in the clinical trial; requirements of Post Marketing (Phase IV) trial to assess safely of Fixed Dose Combinations (FDCs) in Post Marketing scenario; and to formulate guidelines and SOPs on the functioning of New Drug Advisory Committees (NDACs) in respect of FDCs.

The ministry constituted these committees in the background of the adverse observations and recommendations of the Department Related Parliamentary Standing Committee on Health & Family Welfare as contained in its 59th Report on the functioning of the Central Drugs Standard Control Organisation (CDSCO).