Indian authorities have banned up to 156 combination drugs commonly used as painkillers, multivitamins, antibiotics, and for treating fever and cold, among other purposes. In a gazette notification issued on August 21, India's central government stated that the use of 'fixed-dose combination' drugs containing Amylase, Protease, Glucoamylase, Pectinase, Alpha Galactosidase, Lactase, Beta-Gluconase, Cellulase, Lipase, Bromelain, Xylanase, Hemicellulase, Malt diastase, Invertase, Papain could pose risks to human health, especially since safer alternatives exist. Following the recommendations of the Drugs Technical Advisory Board, the government has prohibited the production, sale, and distribution of these drugs nationwide with immediate effect. This decision was made after an expert committee reviewed the issue and deemed the administration of such fixed-dose combination drugs as 'irrational'. The Drugs Technical Advisory Board also evaluated the FDC and stated, 'There is no therapeutic justification for the ingredients in this FDC. The FDC may involve risk to human beings. Therefore, in the larger public interest, it is necessary to prohibit the manufacture, sale, or distribution of this FDC under section 26 A of the Drugs and Cosmetics Act 1940.' The notification also mentioned that the ban includes drugs used for hair treatments, skincare, and antiparasitic and anti-allergic medications. Fixed-dose combination (FDC) drugs are those that combine two or more medicines in a single pill, also known as cocktail drugs. The Indian Pharmaceutical Alliance (IPA) supports the government's decision. Sudarshan Jain, secretary-general of the IPA, told ANI, 'This has been an ongoing issue for many years, and a committee reviewed the entire matter... This is the right step in the interest of patients, considering all aspects.' He further added, 'They have provided an opportunity for companies to present data supporting their products, ensuring that only the right products continue. If there is no data to support a product, companies must withdraw it.'
Text: Lara Palmer
23.08.2024
Central Government Prohibits Manufacture and Sale of Fixed-Dose Combination Drugs