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LATEST NEWS UPDATES | Committee on drugs calls for 20 sub-panels-Vidya Krishnan

Committee on drugs calls for 20 sub-panels-Vidya Krishnan

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published Published on Mar 5, 2013   modified Modified on Mar 5, 2013
-Live Mint

An investigation found DCGI cleared drugs without conducting mandatory clinical trials

After five rounds of consultations in six months, a committee tasked with making recommendations on cleaning up India’s drugs-approval process and ending the cosy relationship between doctors, pharmaceutical companies and government officials had no suggestions to offer by way of a crackdown. It has, instead, suggested setting up 20 sub-committees.

The report submitted to the health ministry in November is now in public domain following a right to information application.

Experts said it doesn’t appear to address the concerns raised by a parliamentary panel earlier last year that found “sufficient evidence” to establish a nexus involving medical experts, drug firms and Central Drugs Standard Control Organization (CDSCO) officials.

The panel had suggested that the health ministry restructure the drug approval process in the country.

“The worst thing the committee has done is not to take any stand on any matter,” said Kalpana Mehta, health activist and a petitioner in the Supreme Court on the HPV vaccine trial on tribal girls in Khammam district of Andhra Pradesh.
 
A parliamentary committee investigation found in May that the Drugs Controller General of India (DCGI) had been approving one new drug a month on an average, without conducting mandatory clinical trials or seeking expert medical opinion.

The 18-month investigation into the functioning of the CDSCO, headed by the DCGI, revealed that an “overwhelming” majority of the drugs in India were being approved “on the basis of personal prescriptions and without any scientific evidence”.

The panel concluded that “there is adequate documentary evidence to show that (expert) opinions are written by the invisible hands of drug manufacturers and experts merely oblige by putting their signatures”.

The panel had picked 42 drugs randomly from the market and asked DCGI and the health ministry to furnish approval papers.

The panel, which had found evidence of wrongdoing, forwarded a list of medical experts who had colluded with drug companies, suggesting that action be taken against them.

This prompted the health ministry to set up the three-member committee comprising V.M. Katoch, director-general of the Indian Council of Medical Research (ICMR), P.N. Tandon, founder chairman of the National Brain Research Centre society and S.S. Agarwal, former director of the Sanjay Gandhi Postgraduate Institute of Medical Sciences.

“We have tried to address all the concerns raised by the parliamentary panel. People can comment on our recommendations when the health ministry asks them to,” said Katoch. “We cannot give judgements on every matter.”

The Katoch committee report makes no mention of action against doctors cited in the parliamentary panel findings. It recommends the setting up of committees for drug approval processes, fixed dosed combinations, defining DCGI’s powers and responsibilities, writing a mission statement for CDSCO and for structural and functional reorganization of CDSCO.

“It has not even fixed desired qualifications for the drugs controller but has asked for formation of committees and consultants in every matter raised unequivocally by the parliamentary panel,” Mehta said.

“Meanwhile, no drugs have been banned, no consumer information has been made available and no errant person or company has even been charge-sheeted.”

Live Mint, 4 March, 2013, http://www.livemint.com/Politics/nsTtEPStU6q1S7gEH5Fj5N/Panel-on-drugs-calls-for-20-subpanels.html


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