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New Delhi, India – April 17, 2025: India’s top drug regulatory body, the Central Drugs Standard Control Organisation (CDSCO), has issued an urgent directive ordering an immediate halt to the manufacturing, sale, and distribution of 35 specific Fixed Dose Combination (FDC) drugs, often referred to as “cocktail” medicines. The order, communicated to all state and Union Territory drug controllers, cites serious risks to public health and safety due to the lack of proper approval for these combinations.
In a letter dated April 16th, the Drugs Controller General of India (DCGI), Rajeev Singh Raghuvanshi, stated, “it has come to the notice of this Directorate that certain Fixed Dose Combination drugs have been licensed for manufacture, sale and distribution without prior evaluation of safety and efficacy as per provision of NDCT Rules 2019, under the Drugs and Cosmetics Act 1940. This poses a serious risk to public health and safety.”
The directive highlights a critical gap in regulatory enforcement. While the CDSCO requires evaluation of safety and efficacy before approving FDCs under the New Drugs and Clinical Trials (NDCT) Rules 2019, it was discovered that several state and UT Licensing Authorities had granted licenses for these 35 combinations without this mandatory central assessment.
Manufacturers reportedly defended their actions, stating they held licenses granted by respective state authorities and had not violated rules. The DCGI’s letter noted this discrepancy, stating, “This has resulted in a lack of Uniform enforcement of the provision of NDCT Rules 2019 under the Drugs and Cosmetics Act, 1940, across the country.”
Fixed Dose Combinations combine two or more active pharmaceutical ingredients in a single dosage form. Examples cited include painkiller combinations like Nefopam Hydrochloride (30mg) + Paracetamol (325mg) tablets, and antibiotic combinations such as Cefixime (200mg) + Ofloxacin (200mg) + Lactic acid bacillus (60 million spores) tablets, along with various supplements and fertility combinations.
The CDSCO has instructed all State and UT Drug Controllers to:
- Ensure that the 35 listed FDCs, and any other unapproved FDCs, are not manufactured, sold, or distributed within their jurisdictions.
- Investigate the matter thoroughly.
- Take necessary action against violators as per the provisions of the NDCT Rules, 2019.
This move underscores the CDSCO’s focus on ensuring that medicines available in the Indian market are rigorously evaluated for safety and effectiveness, thereby safeguarding patient health.
Disclaimer: This news article is based on information reported by ANI (Asian News International) on April 16th regarding a directive issued by the CDSCO. While compiled with care, readers are advised to refer to official communications from the CDSCO or relevant health authorities for complete and updated details.
