New Delhi, July 25: The Central government has banned the manufacture, sale and distribution of 16 fixed dose combination medicines, citing concerns over public health and the lack of scientific evidence supporting their use.
The government informed Parliament on Friday that the decision was based on the final report of the Drugs Technical Advisory Board sub committee and an expert committee constituted in 2021.
According to the Centre, these fixed dose combination medicines lack scientific and therapeutic justification. It also said safer alternatives are already available, making the continued use of these products unnecessary.
The banned medicines include antibiotic combinations such as amoxicillin with serratiopeptidase with or without lactobacillus or cloxacillin, cefuroxime with serratiopeptidase, and cefadroxil with probenecid.
The list also includes pain relief and gastrointestinal drug combinations such as dicyclomine with paracetamol and clidinium bromide with or without chlordiazepoxide, acetylsalicylic acid with etopheptazine, and paracetamol with lignocaine.
In addition, the Centre prohibited the manufacture of certain skin care combination products and the type 2 diabetes combination drug gliclazide with chromium picolinate, stating that these products do not comply with regulatory requirements.
The banned products also include several cosmetic and herbal combinations containing ingredients such as aloe vera, jojoba oil, tea tree oil, vitamin A, vitamin E, allantoin, dimethicone, glycerin, orange oil and other herbal extracts.
The government has directed pharmacies and wholesalers to stop selling the banned medicines immediately. It warned that strict legal action would be taken against those violating the provisions of the Drugs and Cosmetics Act.
The Centre also advised doctors not to prescribe the banned fixed dose combination medicines to patients.
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