New Delhi : The Central Government has banned the manufacture, sale and distribution of 16 ‘Fixed Dose Combination’ (FDC) medicines. The government says there is no ‘medical justification’ for the use of these drugs and their ongoing benefits outweigh potential risks. The Union Health Ministry said the move was taken to protect public health, promote rational use of medicines and ensure that only effective and scientifically proven medicines are available to the public.
FDC drugs contain two or more active pharmaceutical ingredients (APIs) mixed in a specific proportion. The decision was taken after a review of FDC medicines as per the directions of the Supreme Court. The Drug Technical Advisory Board (DTAB) constituted an expert committee to examine various drug combinations and identify those combinations which are irrational, lack medical support or are potentially harmful.
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Contraindicated drugs include certain drugs used to treat skin diseases, pain relievers, antiepileptics, and antibiotic-based mixtures. Prohibited drug combinations include acetylsalicylic acid with etoheptazine, dicyclomine, paracetamol, and clidinium bromide, dicyclomine, paracetamol, clidinium bromide, and chlordiazepoxide, gliclazide with chromium picolinate, and paracetamol with lignocaine.
Antibiotic-based mixtures are also banned
Many antibiotic-based formulations have also been banned. These include amoxicillin plus serratiopeptidase, amoxicillin, serratiopeptidase, and Lactobacillus sporogenes, amoxicillin, cloxacillin, lactic acid bacillus, and serratiopeptidase, probenecid plus cefadroxil, and serratiopeptidase plus cefuroxime. The banned list also includes many dermatology products containing ingredients such as vitamin E, jojoba oil, orange oil, wheat bran oil, tea tree oil, allantoin and d-panthenol along with aloe vera or aloe extract.
The ministry said this is part of the government’s efforts to promote prudent use of medicines and strengthen patient safety. Many unviable FDC drugs were also banned in previous years after thorough scientific review. All state drug controllers, regulatory authorities and enforcement agencies have been directed to ensure strict compliance of the notification. Related entities are also required to comply with the law, including manufacturers, importers, distributors and others. Corrective measures were advised.
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