The union health ministry has constituted an expert committee to guide the drugs controller general of India (DCGI) in matters related to regulation of biotech products. Apart from formulating guidelines and SOPs on the functioning of new drug advisory committees (NDACs), the expert panel will also advise CDSCO for changes in Drugs & Cosmetics Rules, 1945 pertaining to regulation of biotech products.

The expert panel is mandated to formulate policy, guidelines and SOPs for approval of new and subsequent recombinant drugs 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; specific circumstances, if any, under which local clinical trial can be abbreviated, relaxed or omitted; types of local clinical trial, its design, sample size, sites and their distribution, inclusion of ethnic, etc. in the local clinical trials of biotech products; and requirements of post-marketing (phase IV) trial to assess safety of new drugs in post-marketing scenario.

The committee will also formulate policy, guidelines and SOPs for approval of clinical trials including global clinical trials of new drug substances discovered abroad and bioavailability and bioequivalence study for export for special emphasis on monitoring the functioning of ethics committees; accreditation of clinical trial sites and investigators; clinical trial inspections; and participation of state authorities in monitoring the clinical trials.

The panel will also 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.

Besides, the panel will formulate policy and procedures for identification of experts for advising CDSCO in its various matters. It will also constitute sub-groups for consultation and preparation of operating guidelines on safety, efficacy and quality for industry as well as regulator. It will also identify training needs of CDSCO in view of emerging challenges of regulation of biotech products.

Prof Anurag Singh Rathore, professor, Department of Chemical Engineering, IIT Delhi is the chairman of the expert committee.

Prof YK Gupta, professor and head, department of pharmacology, AIIMS, New Delhi; Dr Chandiswar Nath, ex-head, department of toxicology, CDRI, Lucknow; Dr Girish Sahni, director, Institute of Microbial Technology, Chandigarh; Dr Amulya Kumar Panda, scientist, product development cell, National Institute of Immunology, New Delhi; and Prof GK Suraish Kumar, department of biotechnology, IIT Madras, Chennai are the other members of the six-member committee.