INDIA MOVES QUICKLY TO REGULATE ORGAN PRESERVATION SOLUTION

On April 2nd, the Ministry of Health and Family Welfare published a special notification requiring organ preservation solution to be registered as a drug with immediate effect and no grace period.

In order to import and sell organ preservation solution in India, products must now have in place a Registration Certificate (Form 41) and then an Import License (Form 10) as per the Drugs and Cosmetics Rules, 1945. The Review time for each application is approximately 6 to 9 months and 4 to 6 weeks respectively.

Previously organ preservation solution was considered a non-Notified medical device in India. Multiple No Objection Certifcates (NOC) were issued between 2010 and 2018 clarifying the non-Notified status of specific organ preservation solution devices.

Then at the February 12, 2018 Drugs Technical Advisory Board (DTAB) meeting, organ preservative solution was slated for Notification as one of the first medical devices to be newly regulated under the Medical Device Rules, 2017. At that time, it was expected to require an Import License (Form MD 15) to import and sell organ preservative solution in India by early 2019.

This Notification announcement (available here) represents a departure from the anticipated process to add devices to those that require registration in India. Manufacturers of currently non-Notified devices should be vigilant about pending registration requirements.

Contact Asia Actual with any questions or requests for support to register your devices in India.