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Drug safety norms being severely compromised

CNN-IBN
May 14, 2012 at 08:43am IST

Mumbai: A Parliamentary committee has uncovered a nexus between doctors, government bodies and pharmacy companies to approve new drugs without the mandatory clinical trials.

The doctors from top hospitals wrote to the country's Drug Controller General, to allow new drugs to be marketed, without clinical trials - a shocking lapse, highlighted in this Parliamentary standing committee report.

Drug expert CM Gulati said, "All of them are compromised. We've got the evidence from the committee that doctors have written identical letters, three doctors have written a letter to the Director General of India requesting to violate the laws and approve a particular drug without clinical trial."

Drug expert Vikas Dandekar said, "Unapproved drugs have been allowed to be marketed in India, questionable combinations have been allowed to be marketed in India, so all of these will have to be probed very closely. And this will definitely blow up into a big issue."

The report has scrutinised more than 40 drugs. No data was available for three of the drugs. But of the other 39, 28 per cent did not undergo Phase III clinical trials in India. 10 per cent got approval on the basis of inadequate clinical trials and 33 per cent of these are not permitted for sale in the US, Canada, UK and Australia.

Shockingly, the report has named doctors from top institutes like CMC Vellore, PGI Chandigarh, and even AIIMS.

Spokesperson AIIMS YK Gupta said, "Doctors have done so in their individual capacities, this is not the opinion of AIIMS."

While Mumbai's Lilavati Hospital has refused to comment, PGI Chandigarh responded to CNN-IBN - defending its stand and said, "We stand by the advice given in response to the query. Doing repetitive trials of internationally marketed drugs released world over is not routinely justified unless there exists some solid ground of differences."

CNN-IBN has contacted pharma companies named in the report. CIPLA said, "We have followed the procedure. As per the law, it is not mandatory to carry out Phase III trials in India for each and every new drug. Both the drugs in question are marketed in a number of countries internationally and have been proven to be life saving. We deny that there has been any collusion with the DCGI."

The Health Minister has promised action.

Union Health Minister Ghulam Nabi Azad said, "Not true there have been no clinical trials. But we have ordered steps to be taken and a report in two months."

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