The Drugs Technical Advisory Board (DTAB) is a statutory body established under Section 5 of the Drugs and Cosmetics Act, 1940. It is the highest body in India for advising the Central and State Governments on technical matters related to the administration of the Act.
The DTAB was created as part of the comprehensive regulatory framework established by the Drugs and Cosmetics Act, 1940, which came into force on April 1, 1947, to regulate the import, manufacture, distribution, and sale of drugs and cosmetics. Its purpose is to provide expert technical advice to ensure the safety, efficacy, and quality of medicines.
The Board functions by making policy decisions on technical aspects of the Act and the Drugs and Cosmetics Rules, 1945, and forwarding its recommendations to the Ministry of Health and Family Welfare for final approval. It is composed of ex-officio, nominated, and elected members, with a total strength of 18 members, and the Director General of Health Services serves as its ex-officio Chairman.
The DTAB is an integral part of the Central Drugs Standard Control Organization (CDSCO). It connects to the Drugs Consultative Committee (DCC), which advises the DTAB on securing uniform enforcement of the Act across India. An informed reader should also know about the separate Ayurvedic and Unani Drugs Technical Advisory Board constituted under Section 33C of the Act.
Recently, the DTAB has been active in recommending significant changes, such as bringing all antibiotics under the definition of "new drug" in the New Drugs and Clinical Trial (NDCT) Rules, 2019, to combat antimicrobial resistance. It also recently recommended restricting the use of certain Fixed Dose Combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride in children below four years of age, a decision implemented under Section 26A of the Act.