CDSCO Directs States and UTs to Halt Sale and Production of 35 Unapproved Fixed-Dose Combination Drugs
In a significant step aimed at strengthening the safety and quality oversight of pharmaceutical products in the country, India’s apex drug regulatory authority — the Central Drugs Standard Control Organisation (CDSCO) — has issued clear directives to all state and Union Territory (UT) drug controllers, instructing them to immediately stop the manufacturing, sale, and distribution of 35 fixed-dose combination (FDC) drugs that were found to have been approved and marketed without the necessary evaluation of safety and efficacy.
These 35 FDCs — which span categories like pain management, nutritional supplements, and anti-diabetic medications — were reportedly licensed at the state level for commercial production and sale without first obtaining mandatory clearances from the Central Drugs Standard Control Organisation.
According to the CDSCO, such approvals were granted without adequate scientific validation, raising serious concerns over potential risks to public health.
Fixed-dose combination drugs are pharmaceutical formulations that include two or more active pharmaceutical ingredients (APIs) combined in specific, pre-determined ratios to provide therapeutic benefits.
While FDCs are often created to improve patient compliance, simplify treatment regimens, or enhance efficacy, these combinations also carry the risk of adverse reactions, drug-to-drug interactions, and other safety concerns, especially when not subjected to rigorous clinical evaluation.
The CDSCO’s latest directive, issued on April 11, follows the discovery that some state and UT drug licensing authorities had, over time, granted manufacturing permissions for such FDCs despite the absence of required central regulatory clearance.
The Drugs Controller General of India (DCGI), Dr. Rajeev Raghuvanshi, highlighted these concerns in his official communication to state regulators, calling attention to repeated warnings sent by the CDSCO dating back to as early as January 2013.
In that 2013 letter, the DCGI had already cautioned state authorities about the unchecked granting of manufacturing licenses for FDCs that fell under the regulatory category of “New Drugs” — which, under the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials (NDCT) Rules, 2019, require prior approval from the central regulator before they can be licensed at the state level.
Despite these longstanding directives, the DCGI noted that the same concern has resurfaced repeatedly over the years. Multiple follow-up letters were sent to state licensing bodies urging them to rectify this lapse and adhere strictly to the provisions outlined in the Drugs and Cosmetics Act and associated rules.
The latest reminder, before the April 11 directive, was sent in February 2024.
In his communication, Dr. Raghuvanshi expressed deep concern over the continued existence of such FDCs in the market, underscoring that the lack of central evaluation has created a scenario where unverified drugs have been made available to the public, posing significant health risks.
He emphasized that the scientific assessment of safety, efficacy, and therapeutic justification is critical for all FDCs, particularly those classified as New Drugs, and that bypassing this process undermines the integrity of the country’s pharmaceutical regulatory framework.
Further, the letter noted that when manufacturers were confronted with show-cause notices regarding these unapproved FDCs, many of them responded by stating that the licenses had been legitimately granted by their respective state authorities, and that they had not knowingly violated any rules.
This situation, the CDSCO noted, has created inconsistency in the enforcement of the NDCT Rules, as the lack of uniform interpretation and application of regulations across different states has allowed unapproved products to enter the market.
In light of these findings, the CDSCO has formally instructed all state and UT drug controllers to undertake a thorough review of their approval processes, specifically about fixed-dose combinations, and to align their practices fully with the central rules and legal requirements outlined under the Drugs and Cosmetics Act, 1940 and the NDCT Rules, 2019.
Additionally, the letter appended an official list of the 35 unapproved FDCs that were previously licensed for manufacturing, sale, and distribution by state or Union Territory licensing authorities, without the requisite evaluation and clearance from the central regulator.
The CDSCO also noted that in several cases, the manufacturing licenses for these products were later either revoked by the relevant State Licensing Authorities (SLAs) or voluntarily surrendered by the manufacturers after the regulatory non-compliance was flagged through show-cause notices.
The CDSCO’s move underscores its commitment to patient safety and the need for stringent oversight in the pharmaceutical supply chain, while also highlighting the importance of collaboration and consistent enforcement between central and state-level regulators to ensure that only scientifically validated medicines are made available to Indian consumers.
