NEW DELHI, 20 Jun: The Centre has prohibited the manufacture, sale, and distribution of 16 fixed-dose combination (FDC) drugs, saying they lack therapeutic justification and their continued use is not considered beneficial in relation to the potential risks involved. This move aims to safeguard public health and promote the rational use of medicines, ensuring that only effective and scientifically validated medicines are available to the public. FDC drugs contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.
The decision follows a review of FDCs undertaken in compliance with the Supreme Court’s directions, where the Drugs Technical Advisory Board (DTAB) constituted an expert committee to examine various drug combinations and identify those that were irrational, therapeutically unjustified, or potentially harmful. The ministry stated that the manufacture, sale, distribution, and supply of the identified 16 FDCs for human use shall stand prohibited with immediate effect across the country. The prohibited formulations span a range of therapeutic categories, including dermatological preparations, analgesic and antispasmodic medicines, and antibiotic-based combinations.
Among the banned formulations are combinations such as acetyl salicylic acid with ethoheptazine; dicyclomine, paracetamol, and clidinium bromide; dicyclomine, paracetamol, clidinium bromide, and chlordiazepoxide; gliclazide with chromium picolinate; and paracetamol with lignocaine. Several antibiotic-based combinations have also been prohibited, including amoxicillin with serratiopeptidase; amoxicillin with serratiopeptidase and lactobacillus sporogenes; amoxicillin with cloxacillin, lactic acid bacillus, and serratiopeptidase; cefadroxyl with probenecid; and cefuroxime with serratiopeptidase. The banned list additionally includes several dermatological and skincare formulations containing combinations of aloe vera or aloe extract with ingredients such as Vitamin E, jojoba oil, orange oil, wheat germ oil, tea tree oil, allantoin, and D-Panthenol.
The ministry banned the FDC in notifications issued under Section 26A of the Drugs and Cosmetics Act, 1940, as part of the government’s efforts to promote the rational use of medicines and strengthen patient safety. All state drug controllers, regulatory authorities, and enforcement agencies have been directed to ensure strict implementation of the notifications, and manufacturers, importers, distributors, and other stakeholders have been advised to take necessary corrective measures to comply with the law. (Source: Arunachal Times, PTI)
