Stay with the evidence: On the ban on Fixed Dose Combination drugs

The character of science leans to openness: to new evidence and emerging facts. Its ability to be agile to pivot and shift to newer guidelines is therefore absolutely crucial. The Health Ministry’s recent ban on 16 Fixed Dose Combination (FDC) drugs comes on the evidence that these drug combinations lack therapeutic justification, are ‘deemed irrational or unsafe’ and might pose risks to patients. The drugs include dermatological drugs, analgesics and antispasmodics, and antibiotic-based formulations. An FDC is a drug containing two or more active pharmacological ingredients, combined in a fixed ratio in a single dosage. These were meant to improve treatment compliance in chronic conditions (such as Tuberculosis) by reducing the pill burden and, sometimes, by improved therapeutic effectiveness. However, irrational combinations, besides being ineffective, can also be counter-productive and harmful. As per the latest order, all State Drug Controllers, regulatory authorities, and enforcement agencies are to ensure strict implementation and compliance with the recent notification. Instructions must also be sent to manufacturers, importers, distributors, and even individual pharmacies, to stop stocking and selling the banned FDCs.