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.

This is not the first time that the Health Ministry is cracking down on FDCs. A detailed scientific review is undertaken before these decisions to ban FDCs are taken. In March 2016, the government banned a whopping number of over 330 FDC drugs, on the ground that they were irrational, with immediate effect. While FDCs offer the advantage of a reduction in the number of pills, of certain benefit to certain categories of patients, there are some innate issues as well: patients might need different titrations of doses, impossible with FDCs; patients might develop allergies, but it will not be clear what particular pharmaceutical ingredient they are reacting to. It is also clear that all patients may not actually need all the drugs in the combination, exposing them to unnecessary side effects. A further potential harm exists with FDCs of antibiotics: In 2016, 19% of the 330 FDCs banned were antibiotics; There is enough evidence to show that irrational antibiotic FDC drug usage leads to or exacerbates the growing antimicrobial resistance problem in the country. While the government has taken a positive step with banning these FDCs, its work has just begun. In many instances in the past, stocks of banned drugs were still being sold in pharmacies, because the message had not percolated down. While staying solidly on the side of evidence-based medicine, the government must also activate its monitoring and supervision arm in order to ensure that the benefits from the ban reach the last mile.