Under Section 26A of the Drugs and Cosmetics Act, 1940, the Union Health Ministry in June 2026 banned 16 Fixed Dose Combination (FDC) drugs following a review by the Drugs Technical Advisory Board (DTAB). The advisory board’s expert committee declared these formulations irrational, meaning they lacked scientific justification, offered no therapeutic benefits, and posed potential health risks to patients.

Fixed Dose Combinations (FDCs) are a cornerstone in the treatment of Tuberculosis (TB) under the World Health Organization’s DOTS (Directly Observed Treatment, Short-course) strategy. By combining multiple anti-TB drugs like Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol into a single daily tablet, FDCs dramatically reduce the number of pills a patient needs to swallow, preventing partial compliance and the development of drug-resistant TB strains.

Irrational FDCs pose several clinical risks: (1) Difficulty in dose titration: If a doctor needs to adjust the dose of only one drug, they are forced to increase the dose of both, leading to potential toxicity. (2) Masking of side effects: If a patient develops an allergic reaction, it is difficult to identify which specific drug caused it. (3) Reduced effectiveness: Combining drugs without scientific backing can lead to chemical interactions that make the individual components less effective.

Antimicrobial Resistance (AMR) is a global health crisis, and India is one of the worst-affected countries. The widespread and unregulated use of Fixed Dose Combinations (FDCs) containing antibiotics, often prescribed for viral infections where they are useless, accelerates the survival of resistant bacteria. This renders standard life-saving antibiotics ineffective, making common infections treatable only with stronger, more expensive, and highly toxic last-resort drugs.

The Drugs Technical Advisory Board (DTAB) is the highest statutory advisory body in India on technical matters related to drug regulations. Established under the Drugs and Cosmetics Act, 1940, it functions under the Central Drugs Standard Control Organization (CDSCO). The board consists of ex-officio, nominated, and elected members, and is chaired by the Director General of Health Services (DGHS). Its recommendations are critical for policy formulation, drug approvals, and banning irrational medicines in India.

India’s drug regulation follows a dual system: the central agency (CDSCO) approves ‘New Drugs’ (including FDCs), while State Licensing Authorities (SLAs) issue manufacturing licenses. However, a major enforcement gap arises when SLAs issue licenses for FDCs without obtaining prior CDSCO clearance. This lack of coordination has led to thousands of unscientific or banned drug cocktails circulating in the market, highlighting the need for centralized oversight and uniform enforcement.

The Pharmacovigilance Programme of India (PvPI) was launched in July 2010 by the Ministry of Health and Family Welfare to monitor and analyze Adverse Drug Reactions (ADRs) in the country. It is coordinated by the Indian Pharmacopoeia Commission (IPC), Ghaziabad. PvPI serves as a crucial regulatory support system for the CDSCO, collecting safety data from hospitals nationwide to ensure that the clinical benefits of marketed medicines outweigh their risks.