Centre Bans 16 Irrational Drug Combinations to Safeguard Public Health
New Delhi, June 20 (TNT): In a significant move to safeguard public health and promote the rational use of medicines, the Ministry of Health and Family Welfare has prohibited the manufacture, sale and distribution of 16 Fixed Dose Combinations (FDCs) for human use with immediate effect.
The decision was notified under Section 26A of the Drugs and Cosmetics Act, 1940, following a comprehensive scientific review undertaken in compliance with directions of the Supreme Court.
According to the Ministry, the Drugs Technical Advisory Board (DTAB) had constituted an Expert Committee to examine various Fixed Dose Combinations available in the country and identify formulations that were irrational, lacked therapeutic justification or posed potential risks to human health.
Based on the committee’s recommendations, the Government concluded that the continued use of the identified 16 FDCs was not justified in view of the potential health risks and absence of proven therapeutic benefits.
The banned formulations belong to several therapeutic categories, including dermatological preparations, analgesic and antispasmodic medicines, and antibiotic-based combinations.
The Ministry said the action forms part of the Government’s ongoing efforts to ensure that only safe, effective and scientifically validated medicines remain available to the public.
It noted that several irrational FDCs had been prohibited in the past as well following detailed scientific assessments.
With the notifications coming into force immediately, the manufacture for sale, sale, distribution and supply of the identified FDCs for human use stand prohibited across the country.
All State Drug Controllers, regulatory authorities and enforcement agencies have been directed to ensure strict implementation of the ban.
Manufacturers, importers, distributors and other stakeholders have also been advised to take necessary corrective measures to comply with the law.
Among the prohibited combinations are Acetyl Salicylic Acid with Ethoheptazine; Dicyclomine with Paracetamol and Clidinium Bromide; Dicyclomine, Paracetamol, Clidinium Bromide and Chlordiazepoxide; Gliclazide with Chromium Picolinate; Paracetamol with Lignocaine; and several antibiotic combinations containing Amoxicillin, Cefadroxyl and Cefuroxime along with Serratiopeptidase and other ingredients.
TNT KS
