In a move aimed to boost the export of medical devices from the country, the country’s top drug regulator body has extended the validity of mandatory free sale certificate for notified gadgets from current two years to till the expiry of manufacturing licence.
The move is in keeping with the demand from the country’s medical devise
players engaged in export which rued that the cap on validity was adversely affecting their business.
Earlier the Drug Controller General of India (DCGI) had extended the validity to five years as was decided in a meeting late last year. But now it has been allowed till the validity of the manufacturing license, said a senior official from the Health Ministry.
During the meeting Kl Sharma, Joint Secretary in the Ministry talked in details about the steps being taken by the Government for promotion of medical devices industry in India and to make the country a hub for manufacturing medical devices to meet not only the domestic but also global requirements of medical devices.
The DCGI has recently issued a directive to the concerned departments in this matter. As the Associations (representing the medical gadgets sector) and DCGI agreed, a circular may be issued to all State licensing Authorities by Drugs Controller General (India) for extending the validity from of Free Sale Certificate from 2 years to till the validity of manufacturing license held by the firm, said the directives.
The manufactures have been asked to pay a fee of Rs 5,000 per application for obtaining the Free Sale Certificate from the State licensing Authority, the directive adds.
The official said the associations representating the industry had been raising concerns that the country was losing a considerable amount of export opportunity due to non-availability of free sale certificate for medical devices that have not been notified as drugs by the Health Ministry. “This is so as many importing countries require the certificate to be issued by the Ministry. Associations had requested that the certificate issued by Director General of Foreign Trade (DGFT) could be endorsed by the Ministry,” said the official.
The Associations has also sought inclusion of brand name of the medical equipments that are exported in the free sale certificate.