The Union Health Ministry has prohibited the manufacture, sale and distribution of 16 fixed-dose combination (FDC) drugs for human use with immediate effect, citing lack of therapeutic justification and potential risk to patients, according to gazette notifications issued by the Department of Health and Family Welfare on June 11 and published on June 15.
The action was taken under Section 26A of the Drugs and Cosmetics Act, 1940, following a multi-year regulatory review.
Which drugs are banned?
The list includes:
- Acetyl Salicylic Acid + Ethoheptazine
- Aloe Vera + Jojoba Oil + Wheat Germ Oil + Tea Tree Oil
- Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes
- Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide
- Amoxicillin + Serratiopeptidase
- Aloe Extract + Allantoin + Alpha Tocopherol Acetate + D-Penthenol + Vitamin A
- Aloe Extract + Vitamin E + Dimethicone + Glycerine
- Aloe Vera + Jojoba Oil + Vitamin E
- Aloe Vera + Orange Oil
- Aloe Vera + Vitamin E + Herbal
- Dicyclomine + Paracetamol + Clidinium Bromide
- Paracetamol + Lignocaine
- Gliclazide + Chromium Picolinate
- Amoxicillin + Cloxacillin + Lactic Acid Bacillus + Serratiopeptidase
- Cefadroxyl + Probenecid
- Cefuroxime + Serratiopeptidase
Background of the decision
An expert panel examined the FDCs in 2021 and found that available data and peer-reviewed scientific evidence did not support the rationality of these combinations.
For the Amoxicillin-Serratiopeptidase based combinations (including with Lactobacillus Sporogenes and with Cloxacillin), the committee found the pairing pharmacodynamically irrelevant, stating there was no sound clinical evidence for concurrent use of the antibiotic and the enzyme, and that the combination did not follow standard therapeutic guidelines. The same reasoning was applied to Cefuroxime + Serratiopeptidase.
For the Dicyclomine-based combinations, the committee noted that Dicyclomine already has potent anti-cholinergic and smooth-muscle relaxant properties, making its combination with another anti-cholinergic agent such as Clidinium Bromide unjustified.
For Gliclazide + Chromium Picolinate, used in Type 2 diabetes management, the committee said neither national nor international standard treatment guidelines recommend the use of Chromium Picolinate.
For Cefadroxyl + Probenecid, the committee found no pharmacokinetic data to justify adding Probenecid for dose titration, and said further studies would be needed to determine appropriate dosing, which it did not recommend pursuing.
For several Aloe-based topical formulations, the committee additionally noted that the products were not defined as well as characterized and lacked scientific support.
Process leading to the ban
The Drugs Technical Advisory Board (DTAB) examined the Expert Committee's findings and agreed in principle, directing its Sub-Committee to examine all such irrational FDCs in detail. The Sub-Committee gave manufacturers and stakeholders an opportunity to submit data through public notices before submitting its final report on December 28, 2024, recommending prohibition in the larger public interest. The DTAB accepted this recommendation, after which the Central Government concluded a ban was necessary and expedient in the public interest.
The bans take effect immediately, barring manufacturers from legally producing, selling, or distributing these combinations for human use in India.
