'Steps in place to monitor drug trials'

Under attack over the functioning of the Central Drugs Standard Control Organisation (CDSCO), the Ministry of Health and Family Welfare today claimed to have “already taken several steps” to plug the loopholes in the system.

Reacting to a standing committee report on the functioning of CDSCO, tabled in Parliament yesterday, the ministry said it was examining the observations. “After receipt of inputs from CDSCO on the report and thorough its scrutiny, appropriate action would be taken by the ministry wherever required,” the statement said.

The ministry had already “initiated several steps to strengthen the CDSCO and streamline its functioning”, it added.

The committee, headed by Brajesh Pathak of the Samajwadi Party, said 31 new drugs were approved from January 2008 to October 2010 without conducting clinical trials on Indian patients. “Thus, there is no scientific evidence to show these 33 drugs are really effective and safe in Indian patients.”

On why new drugs were being approved without clinical trials, ministry officials had given “public interest” as their reply to the committee. The ministry stated the Drugs and Cosmetic Rules did not prescribe specific situations, under which clinical trial exemption could be granted due to public interest.

The panel also pointed out that most of the ills in the system of drug regulation in India were mainly due to CDSCO’s “skewed priorities and perceptions”. For decades, the organisation had been facilitating drugs industry, due to which the interest of the biggest stakeholder — consumer — has never been ensured.

The panel has also raised concern over CDSCO being severely under-staffed and the long duration of time taken to complete recruitment. Of the 327 sanctioned posts, only 124 are occupied.