New Delhi, April 16 -- India's top drugs regulatory authority has instructed state and union territory drug controllers to immediately stop the manufacture, sale, and distribution of 35 unapproved fixed-dose combination (FDC) drugs, citing serious public health concerns.
The Central Drugs Standard Control Organisation (CDSCO) issued the directive on April 11 after discovering that numerous FDC medications, including painkillers, nutritional supplements, and anti-diabetic formulations, had been licensed without proper safety and efficacy evaluations.
"It has come to the notice of this directorate that certain FDC drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy as per the provision of NDCT Rules 2019 under the Drugs and Cosmetics Act 1940. This poses a serious risk to public health and safety," wrote Drugs Controller General of India (DCGI) Dr Rajeev Raghuvanshi in the communication. Fixed-dose combination drugs contain two or more active pharmaceutical ingredients combined in specific ratios within a single dosage form. While these formulations can offer advantages like improved patient compliance and potentially enhanced therapeutic effects, they require thorough evaluation before approval.
The regulatory body highlighted a longstanding issue dating back to January 2013, when the DCGI's office first raised concerns about state licensing authorities granting manufacturing permissions for FDCs that qualify as "New Drugs" without obtaining mandatory central approval. Despite multiple communications addressing this problem over the years, including the most recent one in February 2025, compliance issues have persisted. Dr. Raghuvanshi's letter pointed out that the approval of such unapproved combinations "compromises patient safety and may lead to adverse drug reactions, drug interactions, and other health hazards due to the absence of scientific validation."
When regulators issued show-cause notices to manufacturers of these unapproved combinations, the companies defended themselves by claiming they had received proper licenses from respective state drug authorities and had not violated any regulations. This response revealed inconsistent enforcement of drug safety provisions across different states.
"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," the letter stated.
To address these concerns, the CDSCO has not only ordered an immediate halt to the problematic drugs but also directed all state and union territory drug controllers to thoroughly review their approval processes for combination drugs and ensure strict compliance with the Drugs and Cosmetics Act 1940 and its associated rules.
The regulatory notice included a comprehensive list of 35 unapproved FDCs that had previously received licences from state or union territory authorities without CDSCO evaluation. These licences were later either cancelled by state licensing authorities or voluntarily surrendered by manufacturers following the issuance of show cause notices.
Published by HT Digital Content Services with permission from Millennium Post.