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India strengthening clinical trial regulatory capacity, gov says

By Nick Taylor , 10-Apr-2012

India strengthening clinical trial regulatory capacity, gov says

The Indian regulator is adding staff and strengthening infrastructure to enforce its new clinical trial guidelines, a government minister said.

In recent years India has tried to tighten clinical trial regulations to counter claims poor practices are a threat to patient health. The next step is equipping the regulator to enforce the new guidelines.

Shri Ghulam Nabi Azad, the Indian minister of health and family, said: “The manpower and infrastructure of CDSCO (Central Drugs Standard Control Organization) is being strengthened for strict compliance of the provisions of the said rules.”

Azad made the statement in response to questioning in parliament about oversight of clinical trials in India. The questioners wanted to know what clinical trial violations regulators have found and what actions they took in response.

In the past three years 1,743 patients died in trials in India, although few of these were as a direct result of research. Over the same period 2,169 trials were registered. A document shared by Azad shows six investigations, including one from 2008, into alleged violations of clinical trial regulations.

The investigations looked into practices at sponsors and CROs (contract research organisations), both local and global, as well as two doctors and a non-governmental organisation (NGO). Warning letters, temporary clinical trial bans, and suspensions of research licenses were some of the case outcomes.

India has also started making sponsors and CROs pay compensation to the families of some patients who died during clinical trials. The families of 22 patients who died in 2010 have received payments.

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