New Delhi: 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 was not considered beneficial in relation to the potential risks involved.
The move, the Union Health Ministry said, was to safeguard public health and promote rational use of medicines while ensuring only effective and scientifically validated medicines are available to the public.
FDC drugs are those which 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. The Drugs Technical Advisory Board (DTAB) had constituted an expert committee to examine various drug combinations and identify those that were irrational, therapeutically unjustified or potentially harmful.
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 Ministry said.
It added that these combination drugs were found to lack therapeutic justification and were not considered beneficial with respect to the risks involved.
It further said that the prohibited formulations span a range of therapeutic categories, including certain dermatological preparations, analgesic (painkillers) and antispasmodic (muscle relaxants) 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 the notifications issued under Section 26A of the Drugs and Cosmetics Act, 1940.
The Ministry noted that the action is part of the government’s efforts to promote the rational use of medicines and strengthen patient safety. It recalled that several irrational FDCs had been prohibited in previous years following detailed scientific reviews.
All state drug controllers, regulatory authorities and enforcement agencies have been directed to ensure strict implementation of the notifications.
Manufacturers, importers, distributors and other stakeholders have also been advised to take necessary corrective measures to comply with the law.
