Indian pharmaceutical companies were in for a shock in March when the government announced a ban on the sale and manufacture of 344 fixed dose combinations (FDCs) in the country. The decision sealed the fate of medicines worth `3,000 crore, including some popular drugs like Pfizer's Corex cough syrup and P&G's Vicks Action 500 Extra, and compelled the industry to seek judicial interventions.
From the industry point of view, the decision was abrupt, as none of the procedural stakeholder consultations that normally precede such announcements, happened in this case. The apex medicine regulator - the office of the Drugs Controller General of India (DGCI), has an entirely opposite view. The agency says that it had acted upon the recommendations of an expert committee that looked threadbare into the rationality of such medicines and conducted several stakeholder consultations, before banning the "irrational" FDCs.
Indian drug firms have been excelling in the art of combining different types of medicines in a single tablet, syrup or injectable form for decades now. Companies promote these as an instant solution to tackle all possible causes of a disease symptom. It allows the drug companies to increase the price of each pill, even though it may result in the patient taking medicines that are completely unnecessary. Experts say that consumption of such irrational medicines causes adverse side effects and may even result in antibiotic resistance.
Over the past two years, the health ministry has developed proper criteria to decide the rationality of FDCs that should be allowed to be manufactured and marketed in the country. But that can only prevent future problems, as India is already flooded with FDCs. Experts suggest that every second drug prescribed in India is an FDC, as against one in eight drugs globally. While there are only 200 rational FDCs approved globally, there is no consolidated list of FDCs sold in India. The main reason for proliferation of FDCs was the lack of regulation. Initially, licences for such combinations used to be given indiscriminately by the state drug regulatory authorities. Later, DCGI became the sole authority to approve FDCs. But by then, thousands of FDCs, including the ones that have been banned now, were already in the market. Even the decision of DCGI is not beyond doubt, as a report of the Parliamentary Committee on Health in May 2012 had accused the central drug regulator of having a pro-industry bias by clearing doubtful FDCs.
Several high courts of the country are currently seized of the matter, and some companies have even managed to get a stay on the decision to ban some of their fast moving products. A favourable verdict may protect the industry's commercial interests, but will not guarantee an unbridled future for FDCs.