The Director General of Foreign Trade (DGFT) has notified that the human biological samples imported into India for commercial purposes should be permitted by the customs authorities without prior approvals from any government agency. The importer of the human biological samples has to comply with the norms set for the save transfer and disposal of the biological samples.
Earlier, the importer had to submit an application to the Indian Council of Medical Research (ICMR) for the import of human biological samples and the ICMR has been advised to set up a committee consisting of experts from relevant fields for deciding each proposal on a case-by-case basis and to furnish their views to the Government for consideration.
For this purpose, the DGFT has inserted import and export policy for the transfer of human biological samples for commercial purposes under general notes 17 to schedule 1 import policy of Indian Trade Classification (Harmonised System) [ITC (HS)] 2012 and general notes 4 to schedule -2 Export policy of ITC (HS) 2012.
In the notification the DGFT said that the import of human biological samples by the Indian diagnostic laboratories or Indian clinical research centres for lab analysis or R&D testing or export of these material to foreign laboratories should be permitted by customs authorities at the port of entry or exit without prior approvals from any government agency, provided the concerned Indian company or 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 or exported as per the related norms or regulations set by WHO/DGFT or ministry of environment, forest and climate change, government of India, to the customs authorities at the port of entry or exit along with the details of such samples.