Establishment and Legal Basis
Established under Section 33C of the Drugs and Cosmetics Act, 1940.
Serves as the highest statutory advisory body specifically for ASU medicines.
Composition of ASU-DTAB
Director General of Health Services (Chairperson)
Drugs Controller General (India)
Director of Central Drug Research Institute (CDRI), Lucknow
Director of Central Council for Research in Ayurvedic Sciences (CCRAS)
Director of Central Council for Research in Unani Medicine (CCRUM)
Director of Central Council for Research in Siddha (CCRS)
Experts from pharmacognosy, pharmaceutical science, and toxicology
Representatives from the Ministry of AYUSH and State AYUSH regulatory authorities.
Functions
Advisory Role – Provides technical guidance on the safety, efficacy, and quality of ASU drugs.
Standards Setting – Recommends pharmacopoeial standards, quality control measures, and testing methods for raw materials and finished ASU products.
Policy Recommendations – Suggests amendments to the regulatory framework (Rules and Schedules) under the Drugs and Cosmetics Act for improved oversight of ASU drug manufacture, labeling, and distribution.
Good Manufacturing Practices (GMP) Compliance – Ensures alignment with GMP for maintaining the quality of ASU drugs.
