India considers exempting from local drug trials medicines for life threatening diseases that have been approved abroad

The Indian government is considering exempting some important drugs, which have been approved in clinical trials abroad, from being tested in local clinical trials.

Media reports said that the government had decided to prepare a list of serious and life threatening diseases specifically relevant to India and to consider exempting new drugs for such diseases and ailments from local clinical trials if they have already been approved for marketing in developed countries such as the United States, the United Kingdom, Japan, Canada, and Australia. The move was announced at a recent meeting of the health ministry’s technical committee, which is responsible for clinical trials of experimental drugs.1

Currently, to get approval for marketing in India from the drug controller general of India, all new drugs—including those that are approved for marketing in other countries—must clear local clinical trials on a specified number of patients in India. However, under the current rules, the drug controlling authority can issue a waiver of such local trials in the public interest.

Experts noted that, although the new proposal was a “welcome move,” it remained unclear how well drugs that were approved for marketing in developed countries would meet India’s needs. Gopal Dabade, of the All India Drug Action Network, an India based non-profit group that campaigns for access to essential drugs, said, “India needs medicines for malaria, tuberculosis, kala-azar, etc. These are not public health issues in those countries.

“So, ultimately if this proposal is only for drugs approved in Canada and other developed countries, it will only help big companies to sell their products straight into India without the Indian drug controller’s hindrance,” Dabade told The BMJ. He added, “In general, this is a policy to help drug companies in the US and other developed countries that can straight away market their products into Indian markets. On the other hand, Indian companies may still need to struggle to get drug clearance.”

S Srinivasan, managing trustee of the Vadodara based organisation Low Cost Standard Therapeutics, said, “What is new [here] is the drawing up of a list of life threatening situations.” He told The BMJ, “If it is a life threatening situation and a public health emergency, it makes sense to waive off the requirements for clinical trials. Otherwise it is unnecessary.”

Srinivasan added, “Loopholes and escape hatches in the proposed measure need to be studied and plugged.”