Indian government bans 16 fixed-dose drugs for irrational combinations
What's the story
In a major public health move, the Indian government has banned 16 fixed-dose drug combinations (FDCs), including antibiotics and topical formulations. The decision was taken after an extensive review by experts who found these combinations to be irrational and lacking therapeutic justification. The aim is to eliminate questionable drugs from the market and ensure only proven treatments are available for patient safety and wellness.
Legal action
Ban invoked under Drugs and Cosmetics Act
The government has invoked Section 26A of the Drugs and Cosmetics Act, 1940, to impose the ban. The decision comes after a multi-year review process by an Expert Committee, the Drugs Technical Advisory Board (DTAB), and a DTAB Sub-Committee. These bodies jointly found these combinations to be lacking therapeutic justification. The review process started in 2021, and peer-reviewed scientific evidence did not support any of the combinations' rationality.
Antibiotic ban
Popular combinations banned
Among the banned combinations are popular ones like Amoxicillin and Serratiopeptidase, which was prohibited as there is no clinical evidence supporting their combined use. The same reason was given for banning Amoxicillin and Serratiopeptidase, a two-ingredient version of the same irrational pairing. Another combination, Cefuroxime and Serratiopeptidase, was also banned on similar grounds.
Other bans
Irrational combinations that were prohibited
The combination of Dicyclomine, Paracetamol, Clidinium Bromide, and Chlordiazepoxide was also banned as it was found to be irrational. Dicyclomine already has potent anticholinergic and smooth muscle relaxant properties, making the addition of another anticholinergic agent therapeutically unjustified. Topical combinations such as Aloe Extract with Allantoin and Alphatocopherol Acetate were also prohibited due to a lack of therapeutic justification.
Regulatory concerns
Expert committee recommendations
The expert committee also criticized some formulations for being poorly defined and inadequately characterized, making them problematic from a regulatory standpoint. The combination of Paracetamol and Lignocaine was banned due to a lack of therapeutic justification and potential risks associated with the pairing. Gliclazide with Chromium Picolinate was prohibited as neither national nor international standard treatment guidelines recommend its use in diabetes care.