NEW DELHI: In a significant step towards safeguarding public health and promoting the rational use of medicines, the centre has banned the manufacture, sale and distribution of 16 fixed-dose combination (FDC) drugs, saying they lack "therapeutic justification" and their use was not considered beneficial, keeping in mind the potential risks involved.
The decision came following the directions of the Supreme Court, which had mandated a comprehensive review of Fixed Dose Combinations available in the country.
Complying with the apex court directions, the Drugs Technical Advisory Board (DTAB) constituted an Expert Committee to examine various FDCs and identify those that are irrational, lack therapeutic justification, or may pose risks to human health.
FDC drugs are those that contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.
The prohibited FDCs belong to various therapeutic categories, including certain dermatological preparations, analgesic and antispasmodic medicines, and antibiotic-based formulations.
In this regard, the Union Health Ministry issued notifications under Section 26A of the Drugs and Cosmetics Act, 1940, prohibiting the manufacture for sale, sale and distribution for human use of 16 Fixed Dose Combinations (FDCs). The notifications have come into force with immediate effect.
The ministry noted that this action is in line with the government’s continuing efforts to ensure that only safe, effective and scientifically validated medicines are available to the public.
Officials said in previous instances as well, several irrational FDCs were prohibited following detailed scientific review, reinforcing the commitment of the government towards patient safety and evidence-based healthcare.
Accordingly, the manufacture for sale, sale, distribution and supply of the identified 16 FDCs for human use shall stand prohibited with immediate effect across the country, the official added.
The ministry said all state drug controllers, regulatory authorities and enforcement agencies have been directed to ensure strict implementation and compliance with the notifications.
“Manufacturers, importers, distributors and other stakeholders have also been advised to take necessary corrective measures to comply with the provisions of the law,” the ministry added.
The medicine include, acetyl salicylic acid + Ethoheptazine, a pain-relief formulation; aloe extract + Allantoin + Alphatocopherol Acetate +D-Penthenol + Vitamin A; Aloe Extract +Vitamin E + Dimethicone + Glycerine; Aloe Vera +Jojoba Oil +Vitamin E; Aloe vera + Orange oil; Aloe vera + Jojoba oil + Wheat germ oil + Tea tree oil; Aloe vera + Vitamin E + Herbal; Dicyclomine + Paracetamol + Clidinium Bromide, a powerful prescription-only medication used to treat abdominal pain, stomach cramps, and gastrointestinal spasms; Dicyclomine +Paracetamol + Clidinium Bromide + Chlordiazepoxide, used to treat severe abdominal cramps, Irritable Bowel Syndrome (IBS), and associated anxiety or stomach spasms; Gliclazide + Chromium Picolinate, used in the treatment of diabetes and Paracetamol + Lignocaine, a pain relief medication.
Four medicines that treat bacterial infections and were banned include Amoxicillin + Serratiopeptidase+ Lactobacillus Sporogenes and Amoxicillin + Cloxacillin + Lactic acid bacillus + Serratiopeptidase; Amoxicillin + Serratiopeptidase; Cefadroxyl + Probenecid; and Cefuroxime + Serratiopeptidase.
