As many as 26 new drug molecules, including non-biologicals and biological, had been approved by the Central Drug Standard Control Organisation (CDSCO) without clinical trials in the country since 2010, the Union health ministry has revealed.
Maximum number of 13 new drug molecules were approved during 2010 while three were approved in 2011. Another eight new drugs went to the market without clinical trials during 2012. This year upto July, two new drugs were approved, Union Health Minister Ghulam Nabi Azad told the Lok Sabha on Tuesday.
“Twenty three cases of new Fixed Dose Combinations (FDCs) considered as new drugs were also found to be licensed by State Licensing Authorities (SLAs) without approval of the Drugs Controller General (India). SLAs in all these cases were asked to take action under the Drugs and Cosmetics Act, 1940,” the Minister said.
“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 trials 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,” he said.
“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 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,” according to the Minister.