Measure to boost clinical trials in India backfires

Some US and Canadian companies stop clinical trials in India following an amendment to the rules that they say could lead to ‘unreasonable claims’ by patients

Several US and Canadian companies have stopped clinical trials in India following an amendment to the rules that they say could lead to ‘unreasonable claims’ by patients. The new rules, brought in by the Directorate General of Drugs Control in India, make it mandatory for companies and educational institutions to meet all medical expenses of those who volunteer for clinical trials.

The regulator has decreed that if the trial fails to show the claimed therapeutic effect on the participant, there is no need financially to compensate her/him. However, the patient should get free treatment for all side-effects caused by the usage of the potential drug. The measure was meant to boost clinical trials in India, but has set alarm bells ringing among both foreign and domestic multinational drug companies.

A McKinsey report prepared for the USA India Chamber of Commerce identified India’s clinical trial policies as one of the biggest hurdles to the country’s booming pharma sector. Similar views were expressed by industry experts at a recent US-India Bio-Pharma and Health Care Summit 2013 in Boston, stating that the current policy and environment is not conducive to clinical trials in India.

A trial to test anticlotting drug Rivaroxaban was sponsored by Bayer. In earlier trials, India was included, but the company withdrew from the country after the new regulations were announced. More clinical trials could face a similar fate soon.

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