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Policy for drug approval and clinical trials



A government policy for the approval of medicines, as well as clinical trials conducted in India is in the offing. The move is expected to strengthen regulation on the pharmaceutical industry and ensure patient safety in the country.

Ranjit Roy Chaudhury, advisor in the health ministry, will head the committee constituted by The Union Ministry of Health and Family Welfare to formulate a policy “for approval of new drugs, clinical trials and banning of drugs”.

The repeated slamming by the Supreme Court and Parliament’s Standing Committee on health and family welfare, comes as a booster drive to initiate the process. In its report submitted last year, the Parliamentary Standing Committee had pointed out that 33 new medicines were approved between January 2008 and October 2010 without conducting clinical trials on Indian patients.


The report observed that there is no scientific evidence to show that these 33 drugs are really effective and safe when administered to Indian patients. Recently, in the mounting numbers of deaths during clinical trials, the SC also cracked the whip on the government, asking it to keep a tab on these trials and compensate the victims.

Besides the committee formed to formulate the policy on drug approvals and clinical trials, the health ministry has also formed a separate committee to consider the formulation of a policy on fixed dose combination.

The formation of both these committees was notified by the Drugs Controller General of India (DCGI), G N Singh, last week. “There are various issues flagged by the Parliamentary Standing Committee, civil society and the SC. The policy will address those issues,” Singh said. He added the government wants to fast-track the formation of the policy and therefore, the committees are expected to submit their recommendations within two to three months.

Currently, there are no specific norms and guidelines for approval of clinical trials. Though the regulator approves medicines and clinical trials based on the provisions of the Drugs and Cosmetics Act, it is solely at the discretion of the DCGI to approve or reject applications. “The policy will ensure that powers of the DCGI are not misused and the rules laid in the Act are properly implemented,” another senior official in the health ministry said.

According to Singh, the policy will bring in place “standard operating procedures” for implementation of rules and guidelines which help ensure transparency and accountability of companies as well as the regulator. Apart from other things, the committee will consider laying provisions as part of the policy to allow waiver to companies from conducting clinical trials in specific cases where some essential medicines are immediately required to be introduced in the country.

According to data from DCGI office, till August 2012, as many as 272 deaths were registered during clinical trials conducted in India, as against a total of 438 and 667 deaths in all of 2011 and 2010 respectively.

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