Govt bans 16 drug combinations:Includes skin, cosmetic products; says health risks outweigh benefits

The central government has banned the manufacture, distribution, sale and supply of 16 Fixed-Dose Combination (FDC) drugs across the country, citing concerns that the risks associated with these medicines outweigh their benefits. In a notification issued under Section 26A of the Drugs and Cosmetics Act, 1940, the Union Health Ministry said the affected drug combinations were found to have no proven therapeutic value and could potentially harm patients. The ministry said the move is aimed at strengthening public safety and promoting the rational use of medicines by ensuring that only scientifically validated and effective drugs remain available in the market. Decision based on expert review According to the Health Ministry, the decision follows a scientific review of FDC drugs conducted in line with directives from the Supreme Court. For the review, the Drugs Technical Advisory Board (DTAB) constituted an expert committee to examine various drug combinations currently available in the market. The committee concluded that several combinations were scientifically irrational, therapeutically unnecessary and potentially unsafe for patients. Based on these findings, the government decided to prohibit 16 such drug combinations with immediate effect. States Directed to Ensure Compliance The ministry has directed drug controllers, regulatory authorities and enforcement agencies in all states and Union Territories to strictly implement the ban. Drug manufacturers, importers, distributors and other stakeholders have also been instructed to take necessary steps to comply with the government order and ensure that the banned products are withdrawn from circulation. The Health Ministry noted that several irrational FDC drugs had been banned in the past as well after undergoing scientific evaluation. What are fixed-dose combination drugs? Fixed-Dose Combination (FDC) drugs are medicines that contain two or more active pharmaceutical ingredients (APIs) combined in a fixed ratio within a single tablet, capsule, injection or syrup. Such combinations are often prescribed to simplify treatment, reduce the number of medicines a patient has to take and improve adherence to therapy. They are commonly used in the treatment of conditions such as tuberculosis, HIV, hypertension and diabetes. However, health experts caution that not all combinations are scientifically justified. If medicines are combined without adequate research or clear medical necessity, patients may be exposed to unnecessary drugs, increasing the risk of adverse side effects and drug interactions. In some cases, irrational combinations can also reduce treatment effectiveness and make it difficult for doctors to determine which ingredient is responsible for a particular side effect or complication. The ministry said the latest action is part of its ongoing efforts to ensure that medicines available to the public meet scientific standards of safety, efficacy and therapeutic value. ​