Laboratories and clinical investigational sites in India will find it easier to import and export shipments of human biologic samples now that import/export license requirements have been lifted.   In a notice issued on August 4th, India’s Directorate General of Foreign Trade (DGFT)[i] announced it would no longer require import or export licenses for human biological samples. 

The announcement comes as good news to clinical institutions accustomed to waiting up to four months to obtain the necessary licenses. With license requirements removed, laboratories and clinical investigational sites will experience significantly shorter import/export approval times which result in additional flexibility when shipping clinical samples.

Labs must still obtain formal import/export clearance approval by Customs but the days of having to wait months for approval to ship or receive human diagnostic samples are over.

 

Daniel J Bell

VP, Regulatory Compliance & Technical Affairs

15, August 2016


[i] http://www.icmr.nic.in/IHD/DGFT%20notification%204-8-16.pdf