It will also suggest ways to improve grant of statutory approvals for drugs and functioning of the CDSCO
Close on the heels of a parliamentary standing committee report exposing malfunctioning in the drugs control department, the Union health ministry has formed a three-member committee to look into the charges.
The three-member committee will submit a report within two months after examining the grounds for approval of the new drugs. These drugs were released in the market by Central Drugs Standard Control Organisation (CDSCO) without conducting the necessary clinical trials. It will also suggest ways to improve grant of statutory approvals for drugs and functioning of the CDSCO.
The team comprises V M Katoch, secretary of Indian Council of Medical Research, P N Tandon, president of National Brain Research Centre, Department of Biotechnology in Manesar and S S Aggarwal, former director of Sanjay Gandhi Postgraduate Institute of Medical Sciences in Lucknow.
The Parliamentary Standing Committee on Health and Family Welfare, in its report tabled in the Parliament on May 8, accused the department of favouring drug manufacturers over patients’ interest by approving the marketing of drugs without companies complying with standard procedures like conducting clinical trials in India. (See Parliament committee indicts drugs regulatory authority)
Meanwhile, health minister Ghulam Nabi Azad announced in the Lok Sabha on May 11, that 12 new drug advisory committees and six medical advisory committees will be constituted to evaluate clinical trials proposals. He said these committees will strengthen regulation and monitoring of clinical drug trials in the country.
A draft notification has also been issued for including a new rule in the Drugs & Cosmetics Rules of 1945 that will provide medical treatment and financial compensation to the trial subjects in case of trial related injury or death.
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