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Indian Supreme Court seeks more oversight of DCGI’s clinical trial approvals

By Zachary Brennan+

03-Oct-2013
Last updated the 03-Oct-2013 at 10:40 GMT

The Indian Supreme Court asks for more info on recent clinical trial approvals
The Indian Supreme Court asks for more info on recent clinical trial approvals

India’s Supreme Court has called for all of the data supporting the approval of 162 clinical trials between July and August of this year by the Drug Controller General of India.

The hearing that led to the subsequent orders was brought about by a petition filed by NGO Swasthya Adhikar Manch, which argued that there was a discrepancy between the number of clinical trial deaths claimed by the Ministry of Health and Family Welfare and the number of actual deaths.

The NGO said that clinical trials contributed to the deaths of 2,644 patients, though only 80 deaths were attributed to clinical trials by the Ministry. Similarly, out of 11,972 SAEs (serious adverse events), according to the NGO, 506 were attributed to clinical trials.

In addition to the call for more data, the top court also called on the Indian Ministry of Health and Family Welfare to implement suggestions provided by state governments, NGOs and others on ways to strengthen the clinical trial oversight in India.

Sanjay Parikh, counsel for Swasthya Adhikar Manch, said that the cause of the clinical trial deaths was because new chemical entities and new molecular entities “are being tested on Indian citizens without following the regulations and taking necessary precautions taking advantage of poverty and tardy implementation including corruption.”

The lawyer also said the clinical trials are not beneficial to India and should not be allowed. The case was originally filed in February 2012.

HPV Trials

The Supreme Court issued notice on an intervening application filed by Swasthya Adhikar Manch based on a parliamentary report that called for action to be taken against entities approving HPV vaccine trials .

Swasthya claims the HPV vaccine was given to 14,091 girls in Khammam district of Andhra Pradesh and 10,686 girls in Vadodra, Gujarat. These girls were between age group of 10-14, of which 7 girls died due to these illegal vaccine trials.

The Court said it appreciated the notice that Indian citizens “are being exploited by multinational drug companies and without proper regulatory framework clinical trials.”

The next top court hearing is scheduled in two weeks.

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