Government's expert panel recommends 'first come, first served' policy for registering new drugs

The expert committee that was constituted to look into the report of the parliamentary committee, which had indicted the Central Drugs Standard Control Organisation (CDSCO) for approving drugs without holding clinical trials or establishing their safety, has gone against the recommendations of the house panel.  The Parliamentary committee had recommended priority-based registration of new drugs for trial. But the expert panel has recommended that the government should go by the “first come, first served”  policy for registration of new drugs.

The report of the parliamentary standing committee on health and family welfare that looked into the functioning of CDSCO and approval of drugs was tabled in Parliament last May. The report, while criticising the approval of 31 new drugs between January 2008 and October 2010 without conducting clinical trials on Indian patients, had stressed on priority-based approval of drugs.

House panel recommended approval on priority basis

“Prioritization is the key. For a example, work relating to an application for marketing approval of new drug that will be used by millions and thus have an impact on the well-being of public at large in India for years to come, is far more important and urgent than giving permission to foreign company to conduct clinical trials on an untested new patented monopoly,” the house panel said.

But the three-member expert committee has taken the reverse stand. “A national regulatory body (CDSCO) should not follow the policy of pick and choose. For transparency, the policy of 'first come, first served' would be more desirable,” the experts said. The committee, comprising V M Katoch, director general of Indian Council for Medical Research,  P N Tandon, president of National Brain Research Centre, Department of Biotechnology, Manesar and S S Aggarwal, former director of Sanjay Gandhi Post-graduate Institute of Medical Sciences at Lucknow, was set up on May 10, 2012, two days after the parliamentary standing committee presented its 59th report on the functioning of  CDSCO. The experts were to give their report within two months, but they submitted it in November. The report came to light following an RTI application filed by an activist.

The Indore-based RTI activist, Anand Rai, termed the expert report as biased in favour of the pharma industry. “The expert committee report has proved that medical experts live in awe of industry and are not ready to stand up for patients' interest. It gave a note of approval to the Parliamentary Standing Committee but has come up with little on how to save doctors from the new mafia of drug companies,” he said.

He further said that if the parliament panel report had been implemented in true spirit, it would have ushered in a change for good and only tried, tested, safe and effective medicines would have been made available to Indian citizens.

Another activist working on drug safety, Kalpana Mehata, said that the latest report is nothing but hogwash. She also said that the expert committee has clearly taken side of pharma companies and recommends many committees to look into the issues.

Meanwhile, Union health minister Ghulam Nabi Azad, informed Rajya Sabha on Monday that the report of the expert committee is under consideration of the ministry. He said it in a written reply to a question. Earlier, on March 1, the minister had informed the house that there were 16 deaths in 2012 which can be attributed to clinical drug trials.

 

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