In an unprecedented move to protect public health, Indian drug regulators have ordered an immediate halt to the manufacturing and sale of 35 potentially dangerous combination medications that were approved without proper safety evaluation.
In a strongly-worded directive issued on April 11, Dr Rajeev Singh Raghuvanshi, India's Drug Controller General, ordered all state and union territory drug authorities to immediately ban the manufacturing, sale, and distribution of 35 fixed-dose combination (FDC) drugs that never received proper safety and efficacy evaluations.
The sweeping crackdown targets a wide range of popular medications, including pain relievers, diabetes treatments, supplements, and antibiotics that combine multiple active ingredients in fixed ratios. Among the banned combinations are medications containing Sertraline with Clonazepam, various diabetes treatments combining Metformin with other drugs, and several antibiotic combinations.
"This poses a serious risk to public health and safety," Dr. Raghuvanshi warned in his directive, emphasizing that these unapproved combinations could lead to dangerous adverse reactions, unexpected drug interactions, and other health hazards due to the lack of scientific validation.
The regulatory failure highlights a troubling disconnect between central and state authorities. Despite multiple warnings from the Central Drugs Standard Control Organization (CDSCO) dating back to January 2013, certain state drug licensing authorities continued approving these combinations without the mandatory central clearance required for "New Drugs" under India's pharmaceutical regulations.
When confronted with show-cause notices, manufacturers defended themselves by claiming they had obtained proper licenses from state authorities and had not violated any rules. This defense exposed a critical lack of uniform enforcement across India's complex regulatory framework.
The current enforcement action follows years of regulatory cat-and-mouse, with CDSCO repeatedly warning state authorities about these unapproved combinations. The most recent warning before this ban was issued just two months ago in February 2025, suggesting growing frustration with continued non-compliance.
The banned list includes several popular combinations that patients may currently be taking, such as Pregabalin with Nortriptyline and Vitamin D3, combinations of antidepressants with anti-anxiety medications, and various antibiotic cocktails containing Cefixime.
Dr Raghuvanshi's directive makes it clear this is not merely a paperwork issue, but a matter of patient safety. State authorities have been instructed to conduct thorough investigations and take action against violators under the New Drugs and Clinical Trials Rules of 2019 and the Drugs and Cosmetics Act of 1940.
For patients currently taking these medications, the abrupt ban raises concerns about treatment continuity. Healthcare professionals are likely to face challenging conversations with patients as they transition to alternative, approved treatments in the coming weeks.
This regulatory crackdown represents a significant moment in India's ongoing efforts to strengthen its pharmaceutical oversight and ensure that every medication available to Indian citizens meets rigorous safety and efficacy standards.
Source: CDSCO communication issued April 11, 2025, File No. 4-01/2023-DC (Misc. 3)
