The Union health ministry is actively contemplating on a proposal from the medical devices industry associations for waiver of brand approval of notified medical devices for the purpose of export.
According to sources, the issue of waiver of brand approval of notified medical devices for export came up for deliberations during the government-industry meeting called by the Union health ministry on December 5, 2015 to discuss pending issues concerning the medical devices industry in the country.
After presentation by medical devices industry associations, it was indicated in the meeting that a way out could be, that for export purposes, a direction under Section 33(P) of Drugs and Cosmetics Act could be issued by the ministry of health and family welfare to all the states/UTs to issue a license to a manufacturer for notified medical device in generic name only.
However, in certain cases, for purposes of export, if it is necessary to do so, and, if the manufacturer requests to register the brand name, the free sale certificate may include brand name also. It was decided that CDSCO will send a formal proposal with full justification after obtaining suggestions from the industry associations.
K.L. Sharma, joint secretary, ministry of health and family welfare; D.N. Sahoo, deputy secretary, ministry of health and family welfare; DCGI Dr. G.N. Singh; and Dr. E.S. Reddy, JDC were present in the meeting as representatives of the government. The meeting is part of the government's pro-active measures in promotion of medical devices industry in India and make the country a hub for manufacturing medical devices to meet not only the domestic but also global requirements of medical devices.
Representatives of industry associations like CII, FICCI, AIMED ASSOCHAM and IDMA participated in the meeting which was held to discuss pending issues concerning the medical devices industry.