The draft Drugs and Cosmetics (Amendment) Bill, 2015, released by the Union health ministry recently, proposes to make the Drugs Technical Advisory Board (DTAB) a notified authority.

The Bill proposes to amend Section 5 of the Act to insert the words “by notification, constitute a Board to be called the Drugs Technical Advisory Board”.

Director General of Health Services (DGHS) will be the ex officio chairperson of the Board, which is the highest such body in the Union health ministry on technical matters, and the Drugs Controller General of India (DCGI) will be the ex officio member secretary of the Board.  

Other members of the Board include one Director of the Central Drugs Laboratory to be nominated by the Central Government, ex officio; one expert to be nominated by the Department of Animal Husbandry and Dairy; three experts to be nominated by rotation by the Central Government from amongst persons who are in charge of drugs control in the State Government; one expert, to be nominated by the Executive Committee of the Pharmacy Council of India, from amongst teachers in pharmaceutical sciences; and one expert, to be nominated by the authority established for regulating the medical education, from amongst teachers in medicine or therapeutics.

Besides, there will be two persons in the Board to be nominated by the Central Government from the pharmaceutical industry; one pharmacologist to be nominated by the Department of Health Research; one person to be nominated by the Central Council of the Indian Medical Association; one expert to be nominated by the Central Council of the Indian Pharmaceutical Association; and two Government Analysts to be nominated by rotation by the Central Government.

There will be more members, they include the Director of the National Institute of Biologicals, ex officio; the Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission, ex officio; one expert to be nominated by the Department of Pharmaceuticals; one expert to be nominated by the Department of Bio-technology; one expert to be nominated by the Central Government from the medical institutions involved in the conduct of clinical trials; and one person to be nominated by Union Ministry dealing with Consumer Affairs from amongst consumer associations.

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 and also provided further that a member nominated under sub-section (1) 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.