Govt Reconstitutes DTAB, AIOCD Protests Exclusion from Drug Regulatory Body

This reconstitution supersedes the previous notification (S.O. 4326(E)) dated October 18, 2021, while maintaining the validity of actions taken before its repeal.

The Drugs Technical Advisory Board (DTAB) serves as the highest statutory body on technical matters related to drugs, cosmetics, and medical devices in India. It advises the government on regulations, safety protocols, and amendments to drug laws to ensure public health and safety. The restructuring aligns with the government's commitment to strengthening pharmaceutical governance and ensuring efficient regulatory oversight.

Composition of the Newly Constituted DTAB

The newly reconstituted Drugs Technical Advisory Board (DTAB) comprises 18 members, including ex-officio members, nominated members, and elected representatives from medical and pharmaceutical institutions. The Director General of Health Services, New Delhi, will serve as the Chairman of the board.

Key Members of the Board

The following officials and experts have been appointed to the board as per Section 5 of the Drugs and Cosmetics Act, 1940:

Ex-Officio Members:

Drugs Controller General of India (DCGI), New Delhi

Director, Central Drugs Laboratory, Kolkata

Director, Central Research Institute, Kasauli

Director, Indian Veterinary Research Institute, Bareilly, Uttar Pradesh

Chairman, National Medical Commission (NMC), India

President, Pharmacy Council of India

Director, Central Drugs Research Institute, Lucknow

Nominated Members:

Director, Food and Drug Administration, Goa

State Drugs Controller, Himachal Pradesh

Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance

Government Analysts from Drug Control Laboratories in Andhra Pradesh and Uttar Pradesh

Elected Members:

Dr. Atul Kumar Nasa, Member, Pharmacy Council of India

Dr. Vijay Oza, Post Graduate Medical Education Board, NMC

Dr. Jerin Jose Cherian, Scientist-E, Indian Council of Medical Research

Dr. Bhavesh Vyas, Assistant Professor, Pharmacology, Narendra Modi Medical College, Ahmedabad

Dr. R.N. Gupta, National President, Indian Pharmaceutical Association

Additionally, the Drugs Controller (India) will function as the Member-Secretary of the board, facilitating operations and regulatory decision-making.

With experts from various pharmaceutical, medical, and scientific institutions, the board will provide evidence-based recommendations to the government on matters related to drug manufacturing, clinical trials, safety, and pricing regulations. The inclusion of state-level regulatory authorities, research institutes, and industry representatives ensures that the board's decisions are well-rounded, considering both scientific advancements and public healthcare needs.

With this reconstitution, the DTAB is expected to actively participate in reviewing new drug approvals, amendments to the Drugs and Cosmetics Act, and policies on drug safety monitoring.

AIOCD’s Strong Opposition to Exclusion

However, the All India Organisation of Chemists and Druggists (AIOCD) has strongly opposed its exclusion from the reconstituted DTAB. AIOCD President J.S. Shinde and General Secretary Rajiv Singhal raised concerns over the lack of representation for over 12.40 lakh chemists and druggists who play a crucial role in India’s pharmaceutical supply chain.

AIOCD emphasized that its participation in DTAB is essential for ensuring practical and inclusive decision-making on drug regulations, supply chain management, and medicine accessibility.

"The organization has consistently provided valuable insights, recommendations, and policy suggestions to the government on critical pharmaceutical trade issues because it is only main biggest stakeholders’ Association," Rajiv Singhal said.

"Despite being a key stakeholder in the pharmaceutical supply chain, AIOCD’s exclusion from DTAB is a serious concern. The absence of representation means that the voice of retail and wholesale pharmacists who form the backbone of last-mile medicine delivery is not being adequately considered in policymaking," he added.

"This inclusion is essential for maintaining transparency, safeguarding the interests of lakhs of chemists, and strengthening India’s pharmaceutical distribution network," Singhal further expressed.

AIOCD urged the Ministry of Health & Family Welfare to reconsider this decision and ensure fair representation in DTAB.

"The organization remains hopeful that the government will address this concern at the earliest, ensuring that policies governing the sector are made with comprehensive stakeholder participation," AIOCD said in a statement.