Norms for human bio samples trade unveiled by DGFT
The Directorate General of Foreign Trade has laid down the conditions for import and export of human biological samples for commercial purposes recently.
August 12, 2016: As per the policy, "export and import should be permitted by "customs authorities at the port of entry/exit without prior approvals (import licence/export permit) from any other government agency, provided 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 samples".
The norms are a major relief for biotech companies, CROs, research centers as the earlier licensing process required a great deal of paper work. Every sample needed to be authorized by the Indian Council of Medical Research (ICMR) committee which met every three months, hence the lag in the review process. As per the new notification, an organization would need to give a self certification to the customs authority that the companies would be following applicable rules, regulations, and procedures for safe transfer and disposal of the biological samples.