New Delhi, June 20 (IANS). Taking a major decision, the Union Ministry of Health and Family Welfare has immediately banned the manufacturing, sale and distribution of 16 medicines (FDCs). The Ministry issued a notification in this regard under Section 26A of the Drugs and Cosmetics Act, 1940. The order said that these notifications have come into effect with immediate effect.
This decision has been taken following the directions of the Supreme Court, which ordered a review of the Fixed Dose Combination (FDC) medicines available in the country. Following these instructions, the ‘Drugs Technical Advisory Board’ (DTAB) formed an expert committee. Its objective was to examine individual FDC drugs to identify those that may be unscientific, medically inappropriate, or risky to human health.
The ministry said in a statement that based on scientific assessment and recommendations of the expert committee, the government has taken action against 16 drugs (FDCs) that were not found to have therapeutic justification and whose continued use was not considered beneficial in the context of potential risks.
The restricted FDACs relate to different therapeutic categories, including certain dermatological drugs, pain relievers and anticonvulsants, and antibiotic-based drugs.
The ministry said that this action is in line with the government’s continuous efforts to ensure that only safe, effective and scientifically proven medicines are made available to the public. In the past too, many drugs (FDCs) have been banned after detailed scientific review, further strengthening the government’s commitment towards patient safety and evidence-based healthcare.
The statement further said, “Accordingly, the manufacture (for sale), sale, distribution and supply of 16 FDCs will be banned with immediate effect across the country. All state drug controllers, regulatory authorities and enforcement agencies have been directed to ensure strict compliance and implementation of these notifications.”
The Ministry has also advised drug manufacturers, importers, distributors and other stakeholders to take necessary corrective measures to comply with the provisions of the law.
–IANS
DCH/
