In another bid to give momentum to research and clinical trials in the country, the centre eased regulations governing the import and export of human biological samples for commercial purposes. The Directorate General of Foreign Trade issued a notification, August 4, saying that the import and export of such samples “should be permitted by Customs authorities at the port of entry / exit without prior approvals (import licence / export permit) from any other Government agency.”
As long as “the concerned Indian company/agency submits an undertaking that they are following and will follow all the applicable rules, regulations and procedures for safe transfer and disposal of the biological samples being imported/exported as per the related norms/regulations” to the Customs authority at the port of entry or exit, any other approval is no longer required. Prior to this change, such a company or agency had to submit an application to the Indian Council of Medical Research, which then made decisions case-by-case.
In 2011, ICMR had formed a committee of experts, chaired by the director general of the Council, to scrutinise and, only then, clear every sample going in and out of India. Among the documents that had to be submitted to the committee was a copy of the informed consent of the individual patient agreeing to their sample being used for a particular study.
The debate over the ethics of the commercial use of the biological samples has been around for over a decade now. A November 2002 article from the British Medical Journal notes the objection raised by Indian scientists to a genetic study done by British and German scientists on people from coastal Kerala. The article says the concern was that India’s diverse genetic information could be mined for commercial purposes without regulations.
This notification comes on the heels of two circulars issued by the Central Drugs Standard Control Organisation that also made getting approvals for and the logistics of clinical trials and research easier for companies. All three steps have been taken at the same time as the ICMR bringing out its draft National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, which set standards for ethical practices and consent, and safeguard participants.
One circular removed the cap of three trials per investigator. The other says that trial sites no longer need to have at least 50 beds. Both circulars hand over the decision making powers to the ethics committee presiding over each trial. It was also felt that since India has too few principal investigators, restricting them to only three trials at a time was not feasible.