The draft Drugs and Cosmetics (Amendment) Bill, 2015, released by the Union Health Ministry recently, proposes to constitute a Medical Devices Technical Advisory Board to advise the Central government and state governments on technical matters pertaining to medical devices, arising out of administration of the amended Drugs and Cosmetics Act, and to carry out other functions assigned to it by or under the Act.
The Director General, Indian Council of Medical Research, will be the ex officio chairperson of the Board and the Drugs Controller General of India will be the ex officio member secretary.
Other members of the Board include one expert each, having qualifications and experience in the field of medical devices, from the Department of Science and Technology; the Department of Atomic Energy; the Department of Electronic and Information Technology; the Central Government testing laboratories responsible for testing of medical devices; the Department of Pharmaceuticals; the Bureau of Indian Standard; the Defence Research and Development Organisation; and one expert to be nominated by the Indian Pharmacopoeial Commission or any other standards setting body as may be constituted by or with approval of the Central Government.
Besides, there will be one expert from the field of biomedical technology from recognised technical educational institutions, to be nominated by the Central Government; one expert from the field of biomaterial or polymer technology from recognised technical educational institutions, to be nominated by the Central Government; one person to be nominated by Union Ministry dealing with Consumer Affairs from amongst consumer associations; one pharmacologist to be nominated by the Central Government from recognised medical or research institute in the field of medical devices; one expert to be nominated by the Central Government from recognised medical or research institute from amongst person involved in conduct of clinical trials; four experts to be nominated by the Central Government from the medical device industry including in-vitro diagnostics industry.
The nominated members of the Board shall hold office for a period of three years but shall be eligible for re-nomination, provided that no member shall be eligible for nomination for more than two consecutive terms. Provided further that a member nominated under sub-section by virtue of his holding an office in the government shall hold office on Board so long as he holds the appointment of the office by virtue of which he was nominated to the Board.
The procedure for conduct of business of the Board shall be such as may be prescribed. The Board may constitute sub-committees and may appoint to such sub-committees, persons who are not members of the Board for such periods not exceeding three years, as it may decide, for the consideration of particular matters.