Drug Trials, Ethical Violation and Feeble Regulations in India

By siliconindia   |   Tuesday, 07 February 2012, 01:29 IST   |    3 Comments
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In a case of ethical violation in Indore last year a formal complaint was filed with the state and national human rights commissions, and the government regulator, the Drug Controller General of India (DCGI). As a result of the complaints, the state's Economic Offences division investigated practices at Maharaja Yeshwant Rao Public Hospital in Indore where it discovered 73 clinical trials being undertaken in 3300 patients, including 1833 children. It resulted in adverse effects and even death in a total of 81 patients, including 18 children, though there was no official conclusion that those cases were directly linked to the trials.

The investigation demonstrated that volunteers did not give informed consent because the fine details of the trials were in English. Activists also alleged that doctors undertaking many trials were also members of supposedly independent ethics committees. It was also seen that patients were also not offered insurance or compensation in case of serious adverse effects.

In another enquiry in Madhya Pradesh, 12 government doctors were fined $100 each (Rs 5000) for improper procedures in other trials. Activists were furious over the small penalties, especially compared to large sums drug makers pay doctors to cover costs of trials. For instance, six doctors at Maharaja Yeshwant Rao Hospital received about $1·02 million (Rs 5·1 crore) from drug makers to undertake the 73 trials in question.