Indian clinical trial rules counter-productive, says ASSOCHAM

The Associated Chambers of Commerce and Industry of India (ASSOCHAM ) has expressed concern at the setback to clinical trials for new pharmaceutical drugs in the country and has called for several changes in the Drugs and Cosmetics Amendment Rules (DCAR) to meet industry concerns about these trials.

In its study on the Indian Pharmaceutical Industry (IPI), the chamber pointed out that “few clinical trials have been approved” in calendar year 2013 after the Supreme Court’s interim order on this subject. As against 55 global clinical trials in 2012, only 17 were approved last year. With India having 16% of the world population and 20% of the global disease burden, only 1.5% of the global clinical trials were being conducted in the country.

Allaying much of the myths against these trials, the Chamber stressed the need to create awareness among various groups at all levels about the need and importance of clinical trials among the Indian population groups to enable foreign drug discoveries to be applied in our conditions.