Delhi: The Centre has banned the manufacture, sale and distribution of 16 fixed-dose combination (FDC) drugs with immediate effect, citing concerns that the formulations pose risks to public health and lack scientific justification. The decision was notified by the Union Health Ministry following recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB), according to HT.
According to the notification, the government concluded that the combinations were “irrational” and did not have any therapeutic justification. Authorities said the use of these drug combinations was likely to pose a risk to human health, prompting the prohibition under the provisions of the Drugs and Cosmetics Act.
The banned formulations include Acetyl Salicylic Acid with Ethoheptazine; Dicyclomine, Paracetamol and Clidinium Bromide; Dicyclomine, Paracetamol, Clidinium Bromide and Chlordiazepoxide; and Gliclazide with Chromium Picolinate.
Several antibiotic-based combinations have also been prohibited, including Amoxicillin with Serratiopeptidase, Amoxicillin with Serratiopeptidase and Lactobacillus Sporogenes, Amoxicillin with Cloxacillin, Lactic Acid Bacillus and Serratiopeptidase, and Cefuroxime with Serratiopeptidase.
The banned list additionally includes several dermatological and skincare formulations containing combinations of Aloe Vera or Aloe Extract with ingredients such as Jojoba Oil, Orange Oil, Wheat Germ Oil, Tea Tree Oil, Allantoin and D-Panthenol.
The move follows a regulatory review that examined the scientific basis of the drugs and found that the combinations failed to demonstrate clear therapeutic benefits. Health authorities said the ban is aimed at ensuring that only safe, effective and rationally formulated medicines remain available in the market.
The latest action is part of a broader crackdown on irrational fixed-dose combinations in India. In recent years, regulators have repeatedly prohibited several such formulations after expert panels flagged concerns over patient safety, adverse reactions and the absence of adequate clinical evidence supporting their use.
The prohibition takes effect immediately, requiring manufacturers, distributors and retailers to halt the production and sale of the 16 identified combinations across the country.
