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The government has set up a separate advisory board that will look into issues in the medical devices sector.
This will be on the lines of the Drugs Technical Advisory Board (DTAB), which looks into issues in the pharmaceuticals sector. This body will make recommendations to the health ministry for amendments to medical devices regulations.
Sources say that the body has been created because there was no set up with technical expertise for framing regulations for devices.
Rajiv Nath, forum coordinator for AIMED, a lobby group of domestic device manufacturers, said, “While this move is positive, it makes no sense having the drug regulator chair the meeting. Drug controller only needs to implement rules and not make the rules.” This committee has representatives from the industry – domestic as well as multinationals. Even those from a few other regulators like atomic energy watchdog and other government departments are part of this committee on medical devices. The government is working on trade margin rationalisation of drugs and devices. It went in full-swing to cap margins of coronary stents as well as orthopaedic knee implants.
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