Export rule eased for medical device makers

The government has decided to increase the validity of free sale certificates required by domestic medical device manufacturers for exports. Now, these will expire only alongside the manufacturing licence.

Free sale certificates valid for two years are issued to medical device manufacturers by state licensing authorities. To export medical devices, manufacturers need to register with the foreign country and obtain its regulatory approval. These authorities generally ask for a free sale certificate to allow imports.

Under the provisions of the Drugs and Cosmetics Act, 1940, only 15 medical devices that are classified as drugs are regulated for import, manufacture and marketing in the country. The notification on free sale certificate validity will apply to these 15 devices only.

"In order to bring uniformity in its implementation, you (all state drug regulators) are requested to grant free sale certificates to manufacturers located under your jurisdiction with the validity of their manufacturing licence to promote exports," said GN Singh, Drugs Controller General of India (DCGI), in his letter to state regulators.

According to Rajiv Nath, secretary, Association of Indian Medical Device Industry (AIMED), medical device exports decreased from $1.2 billion in 2014 to $1.1 billion in 2015.

"Extension of validity of the free sale certificate has been a longstanding request to promote exports. The validity period of two years used to restrict registration in overseas countries. It also added to re-registration costs of overseas importers," he added.

Around 95 per cent of medical devices manufactured and sold in India remain unregulated. For medical devices not covered as drugs under the Drugs and Cosmetics Act, the certificates are issued by the Directorate General of Foreign Trade (DGFT).

"Many countries, especially in south and central America, are not satisfied with this certification. Their authorities desire the certificates be issued by the health ministry or our drug regulatory authority," Nath said.

A proposal was made by the AIMED to the Union health ministry to endorse the DGFT certificate. The health ministry is yet to take a decision on the issue.

KEY TAKEAWAYS

• Free sale certificates required for exports will now expire only alongside the manufacturing licence
   
• Free sale certificates valid for two years are issued to medical device manufacturers by state licensing authorities
   
• The notification on free sale certificate validity will apply to 15 devices classified as drugs
   
• For medical devices not covered as drugs the certificates are issued by Directorate General of Foreign Trade