Friday, February 7, 2014

Drug Trials in India: The Pendulum Swings?

In India, 2013 began with allegations that an American NGO (Programme for Appropriate Technology, or PATH) had conducted illegal trials of cervical cancer vaccines on tribal girls. A subsequent Supreme Court filing named major firms including GlaxoSmithKline and MSD pharmaceuticals in the scandal. In September, that court gave the government a month to come up with regulations to curb industry practices which one judge said were "heaven for clinical trials" but were "proving hell for India." Meanwhile, the court banned all new trials. Pharmaceutical firms immediately threatened to leave India. The central government's response was the Drugs and Cosmetic (Amendment) Bill 2013, which included (on and after page 11 in the linked document) much sharper governmental regulation of drug trials, including sponsor liability for all harms caused to subjects by trials, including not only necessary medical care but also damage awards. The new rules required videotaping of subjects' consent, and required that agreements between subjects and companies be filed with India's Drugs Controller-General.  

Now, with industry having dropped the number of trials going on in India by more than half, many are wondering whether the government is regretting its fairly hard-line stance of last year. Speaking after the inauguration of a new Baxter global research center in Syngene, Union Health Minister Ghulam Nabi Azad said,
“The industry has complained that the regulations are too stringent, but there have also been complaints by parliamentarians, NGOs and others that they are too lax, which the Supreme Court had taken note of....We are happy with the current balance between the different interests, but industry also needs to be happy....
Pointing out the decline in the number of trials, he added: "While we are interested in the matter of patient safety, we also want to make sure that innovation is not hampered.”

Many in the press seem to be taking this as a sign that the law will be relaxed. Stay tuned!

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