Even after three months of the submission of the report by the Dr PN Tandon-headed expert committee on introduction of drugs without clinical trials in India, the Union health ministry is yet to implement its recommendations as the ministry is still studying the report.

According to sources, the report of the expert committee has been submitted to the government in November last year and the same is under the active consideration of the ministry. The committee is learnt to have recommended several structural changes in the way the new drugs are approved by the Central Drugs Standard Control Organisation (CDSCO). After examining the report in detail, the ministry will place the report before Parliament, sources said.

Dr Tandon-headed panel was constituted by the union health ministry in May last year in the wake of Parliamentary Standing Committee's striking criticism of the functioning of the CDSCO. In its 59th Report, the committee, headed by Brajesh Pathak, had raised various issues of irregularities particularly in the area of approval of new drugs without clinical trials in the country. The report had also pointed to a collusive nexus between drug manufacturers, officials of CDSCO and medical experts in granting approvals to new drugs and said drugs banned, discarded or withdrawn in developed countries are in circulation in India.

The ministry constituted the three-member committee to examine the issues raised by the Parliamentary Committee. Dr V M Katoch and Dr S S Aggarwal were the other two members of the panel which was mandated,  inter alia, to examine the validity of the scientific and statutory basis adopted for approval of new drugs without phase-III clinical trials on Indian population.

At present, new drugs are approved by the CDSCO based on non-clinical data, clinical data of safety and efficacy of drug, regulatory status in other countries etc. as per the Guidelines and requirements specified in Rule 122A, 122B, 122D and schedule-Y of the Drugs and Cosmetics Rules, 1945. However, as per Rule 122 A (2) and Rule 122 B (3), the requirement of clinical trial may not be necessary if the drug is of such a nature that the Licensing Authority may, in public interest, decide to grant permission to import/manufacture the new drug on the basis of data available from other countries.

Further, as per clause 1 (3) of Schedule Y, for drugs indicated in life threatening/ serious diseases or diseases of special relevance to the Indian health scenario, clinical data requirements may be abbreviated, deferred or omitted, as deemed appropriate by the Licensing Authority. For grant of permission to import/ manufacture of the Fixed Dose Combinations (FDC), the requirements are prescribed under Appendix-VI of Schedule-Y. As per these requirements, clinical trial on Indian patients is required in certain category of FDCs.