| Health under Schedule 7 of the Constitution • State List: 6. Public health and sanitation; hospitals and dispensaries. • Concurrent List: 19. Drugs and poisons, subject to the provisions of entry 59 of List I with respect to opium • Concurrent List: 25. Medical education and universities |
- The Union Health Ministry has banned 156 Fixed Dose Combination (FDC) medicines, including antibiotics, painkillers, and multivitamins, citing health risks.
- FDCs combine two or more active ingredients in a single dosage form.
- Many of these drugs were approved by state authorities without sufficient research or clinical trials to ensure their safety.
- The 2019 clinical trial rules classify FDCs as new drugs, requiring central drug regulator approval.
- The ban aims to prevent the development of drug resistance due to irrational use and curb the misuse of medications.
- An expert committee appointed by the Central Government found no therapeutic justification for the banned FDCs, noting that safer alternatives are available.
- Examples of Banned FDCs: Mefenamic acid + Paracetamol injection, Cetirizine HCl + Paracetamol + Phenylephrine HCl, Levocetirizine + Phenylephrine HCl + Paracetamol.
Dig Deeper: Read about The Drugs & Cosmetics Act, of 1940 and New Drugs and Clinical Trial Rules 2019 in contexts of drugs and cosmetics regulation.
