Government Bans Production and Sale of 35 Unapproved Fixed-Dose Combination Drugs

New Delhi (The Uttam Hindu): The Central Drugs Standard Control Organisation (CDSCO) has directed state and Union Territory drug controllers to halt the manufacture, sale, and distribution of 35 unapproved fixed-dose combination (FDC) drugs. These FDCs, which include painkillers, nutrition supplements and anti-diabetics, pose a serious risk to public health and safety due to lack of prior evaluation of safety and efficacy.

Key Concerns

Safety Risks: Unapproved FDCs can lead to adverse drug reactions, drug interactions, and other health hazards due to absence of scientific validation.

Lack of Uniform Enforcement: Manufacturers claim licenses were granted by regional authorities, highlighting inconsistent enforcement of national drug standards.

Regulatory Action: CDSCO has asked state and UT drug controllers to review their approval process for FDCs and ensure strict compliance with the Drugs and Cosmetics Act 1940 and rules.

Background

The CDSCO's directive follows repeated concerns raised since 2013 about FDC drugs being licensed without due approval from the Drugs Controller General of India (DCGI). A recent letter was issued in February this year, emphasizing the need for strict compliance. The regulator's move aims to protect public health by ensuring regulatory compliance across the nation.¹ ²

Impact

The CDSCO's action underscores the importance of rigorous evaluation and approval processes for FDCs to safeguard patient safety. By halting the production and distribution of unapproved FDCs, the regulator seeks to prevent potential health hazards and promote adherence to national drug standards.