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HindustanTimes Sun,13 Jul 2014

Other Columns

Too many experts, not enough credibility
Sanchita Sharma, Hindustan Times
May 13, 2012
First Published: 01:51 IST(13/5/2012)
Last Updated: 11:50 IST(17/5/2012)

Death by hanging was what the then Union Health Minister Sushma Swaraj had suggested as punishment for people who make spurious drugs and knowingly hasten the death of the ill and suffering. "Death penalty is certainly not too great for people who are interested only in profiteering, the result of which is mass murder," said an outraged Swaraj, way back in 2003.

The death penalty may sound a bit over-the-top, but Swaraj was supported by Mashelkar Committee's report on spurious drugs, which recommended stringent non-bailable action. "The penalty for sale and manufacture of spurious drugs that cause grievous hurt or death should be enhanced from life imprisonment to death," the Mashelkar Committee said in its report the same year. The Union health ministry at once promised to crack down on the guilty and everyone went home happy at the thought of having made the world a safer place.

Ironically, the very experts who are responsible for making drugs safe have now been found guilty of colluding with drug manufacturers to illegally fast-track drug approval and give unsafe and ineffective drugs a go ahead.

Seventy-two hours after a Parliamentary committee accused India's drug regulator of "irregularities in approval process of new drugs that can potentially have adverse effect on the lives of people," the Union Ministry of Health went and did the expected: constituted an expert committee to "examine" the irregularities and recommend action.

So, a new set of experts handpicked by the government are investigating why another set of experts appointed by the same government toed drug manufacturers' line with no thought being given to patients whose interests it's their job to protect.

The three-member Committee will submit its report within two months.

Reviews of randomly selected drugs by the Parliamentary Standing Committee on Health and Family Welfare this week heightened fears that many drugs available in the Indian market are not safe or effective to treat the condition they are being prescribed for. The Central Drugs Standard Control Organisation (CDSCO) - which is responsible for the licensing, marketing and testing of drugs - has approved 2,167 drugs between Jan 2001 and Nov 30, 2010, approving one drug each month without safety trials.

The pharmaceutical stakes are huge. The pharma industry has grown 15% in India, from US $11.4 billion in 2010 to US $13 billion in 2011, and is expected to grow by 15.7%, shows industry-tracking IMS Prognosis Report 2011. In comparison, the global pharma market growth is 5-7%.

The Parliamentary Committee report also shows that India has become a dumping ground for drugs which developed countries have banned or have no use for. One in three medicines approved by India's drug regulator over the past decade do not have permission to be sold in major developed countries such as the US, Canada, EU, Britain or Australia. None of the drugs surveyed had any special or specific relevance to the medical needs of people in India.

Describing this as a "gross violations" of the law, the report said CDSCO prioritised the interests of drug manufacturers over those of the patients. "There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts," says the report.

"It is difficult to believe these irregularities on the part of CDSCO were merely due to oversight or unintentional... Hence all the cases listed above and cases similar to these should be investigated and responsibility fixed and action taken against erring officials whether currently in service or retired," recommends the report.

Going by the ministry's past record of punishing offenders, I don't expect any surprises. This is one report I won't wait for with bated breath.


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