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May 11, 2012, 08.34 AM IST | Source: CNBC-TV18

Par Committee digs hole in drug approval procedure

The Indian drug industry has received a rude shock. The Parliamentary Committee report on the central drug regulator points out serious lapses in procedure for granting drug marketing approvals, and accuses the organisation of being hand-in-glove with private parties, reports Archana Shukla of CNBC-TV18.

The Indian drug industry has received a rude shock. The Parliamentary Committee report on the central drug regulator points out serious lapses in procedure for granting drug marketing approvals, and accuses the organisation of being hand-in-glove with private parties, reports Archana Shukla of CNBC-TV18.

Parliamentary proceedings have thrown the Indian pharma industry for a loop. The Parliamentary Committee report on the The Central Drug Regulator contains some scathing criticism mainly regarding the manner in which drugs were granted marketing approvals.

The report, without pulling punches, accuses the drug regulator of colluding with private players when it came to approvals. The report follows an in-depth investigation of 42 randomly selected drugs from a list of 2,167 drugs approved between 2000 and 2010. It says, "Between January 2008 and October 2012, 33 drugs were approved without the mandatory clinical trials. Some of the clinical trial data submitted in the period were not performed on the mandatory trial size or patient groups. There have been cases of gross violation of the laws of the land by the CDSCO."

Only eight of 42 drugs in the list had proper follow-ups of side effects in Indian patients by doctors and manufacturers. The report also says CDSCO needs to re-examine marketing approvals for drugs like analgesic Analgin, which have been withdrawn from most other markets.

But here's the shocker: The report says it has, "adequate documentary evidence to conclude that many opinions were actually written by invisible hands drug manufacturers and experts merely obliged by putting their signatures."

So, it argues that there is a collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts. However, some players whose name has made it into the report, refute the allegations.

Yusuf K Hamied, CMD, Cipla, said, "Two of Cipla's drugs have been named (in the report). One thing I can assure that Cipla has followed all the laws and regulations laid down in the Drugs and Cosmetics Act for grant of licences to produce products and that there has been no violations."
 
Apart from the lack of proper coordination, and a lack of physical infrastructure, the report also blames chronic staff shortage for the regulator's inefficiencies. It also says that with a mission to propagate and facilitate the drugs industry, CDSCO has failed to uphold the interests of the most important stakeholder, the Indian consumer.

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