In a sweeping move to ensure drug safety and compliance, the Central Drugs Standard Control Organisation (CDSCO) has directed all state and Union territory drug controllers to immediately halt the manufacture, sale, and distribution of 35 unapproved fixed-dose combination (FDC) drugs. These combinations include commonly used painkillers, nutritional supplements, and anti-diabetic medications.
FDCs are pharmaceutical products that combine two or more active ingredients in fixed proportions, designed to offer therapeutic convenience or enhanced efficacy. However, such combinations require rigorous assessment of safety and efficacy before being cleared for market use.
Licensing Without Evaluation Raises Alarm
According to an April 11 communication from Drugs Controller General of India (DCGI) Dr. Rajeev Raghuvanshi, the CDSCO has found that some state licensing authorities had issued manufacturing licenses for these FDCs without obtaining prior approval from the central regulator. This, the DCGI noted, violates the New Drugs and Clinical Trials (NDCT) Rules, 2019, under the Drugs and Cosmetics Act, 1940.
The DCGI emphasised that this practice undermines public health and poses potential risks, including adverse drug reactions and unpredictable drug interactions. The CDSCO reiterated its concern that such approvals bypass the required scientific validation, compromising patient safety.
Inconsistent Enforcement and Regulatory Gaps
The issue of unapproved FDCs is not new. Since as early as 2013, the CDSCO has issued multiple notices highlighting the risks and urging state regulators to align with central protocols. Despite this, many state drug controllers continued to grant licenses without proper evaluation.
Manufacturers who received show cause notices argued that they had only followed approvals granted by their respective state authorities and had not breached any regulations knowingly. This has highlighted a major gap in uniform enforcement of national drug safety rules across the country.
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The letter from CDSCO has now made it mandatory for state authorities to review their licensing processes and enforce strict adherence to NDCT provisions. The 35 banned FDCs, which were earlier either cancelled by the authorities or voluntarily withdrawn by manufacturers, serve as a reference point for compliance going forward.
Looking Ahead
The move is part of the central regulator’s ongoing campaign to tighten control over drug approvals and bring consistency across the Indian pharmaceutical landscape. Experts believe that while this action helps restore regulatory discipline, it also signals the need for a more integrated digital approval system to bridge the gap between state and central oversight.
