Indian Drug Regulatory and Pharma Embroiled in Scandal Over Approvals

Indian Drug Regulatory and Pharma Embroiled in Scandal Over Approvals

May 9th, 2012 // 5:59 pm @


A scandal is unfolding in India where a report by a parliamentary committee has found that the Drug Controller General has approved, on average, one new drug each month between 2008 and 2010 without conducting mandatory clinical trials or seeking expert medical opinions. As a result, the committee asked the health ministry to withdraw authority given to the Central Drugs Standard Control Organization, which is overseen by the DCGI, to grant approvals to drugmakerss.

The panel chose 42 drugs available in the Indian market and asked DCGI and the health ministry to provide approval documents and found that an “overwhelming” majority of the drugs were approved without any scientific evidence, LiveMint writes. The report concludes “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.”

“For decades, it has been according primacy to the propagation and facilitation of the drugs industry…,” the report noted, adding that there was “sufficient evidence” to establish collusion between CDSO officials, drugmakers and medical experts. “We will give the health ministry time to take action on officials and pharmaceutical companies involved,” Sanjay Jaiswal, a member of the parliamentary panel, tells LiveMint.

Of 42 drug approvals reviewed, 11 were endorsed without phase-III clinical trials for safety and efficacy testing. The other 33 approvals, including drugs made by Cipla, UCB, Lundbeck Novartis and GlaxoSmithKline, were approved without any testing. And 25 drugs were approved without seeking the opinion of medically-qualified experts, according to The Times of India.

“In a country where seven lakh (700,000) doctors of modern medicine are in practice, such a miniscule number of opinions are hardly adequate to get diverse views and come to a well considered rational decision apart from the possibility of manipulation by interested parties,” the panel wrote, according to the Times of India. “As against this, to review just the dose of popular pain-killer paracetamol, the US FDA constituted a panel of 37.”

Moreover, 13 of the drugs were banned in developing countries and one drug, nimesulide, was banned globally for prescription to children in 2005, LiveMint writes. Those approved without trials included Cubicin, an anti-infective sold by Novartis; the Alimta cancer med sold by Eli Lilly and the Isentress HIV med sold by Merck. In each case, the panel determined there was sufficient time to conduct testing. Manufacturing licenses for some drugs may be revoked.

“This is an extraordinary report and we are already consulting our lawyers to file this document in the Supreme Court as supporting material in our case,” Anand Rai, who has petitioned the Indian Supreme Court concerning unethical clinical trials (see this), tells LiveMint. “This gives us hope that our demand for a complete restructuring of the system will take place and Indians will not be used as guinea pigs.”

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