Ranbaxy’s current face-off with the US Food and Drug Administration (FDA) over the quality of its generic drugs is neither a first for it, nor for other Indian pharma firms. But, it may mark a strong step-up in scrutiny on India, given the building up of pressure points in the global generics market.
FDA’s scanning of Ranbaxy’s plants largely relates to allegations that the active pharma ingredients (APIs) used to make some of its generic drugs come from unapproved sources, and to irregularities in its records about the drugs’ bioequivalence (proof that they impact patients in the same way as the original, patented version).
These are valid, critical concerns that drug regulators need to address strictly, as the global market is only set to become increasingly more attractive. Generics provide an equally effective, yet far cheaper treatment. With this class of medicines covering two-thirds of all US prescriptions last year, and with several branded medicines going off patent, competition is only getting hotter in the single largest market for generics.
FDA has been seeking to facilitate speedy entry of generics and also campaigns to allay patients’ fear about their efficacy. It has also been facing harsh public criticism in the US for focusing more on drug approvals than on safety. A recent incident where contaminated ingredients from China for a blood thinner produced in the US, Heparin, were linked to severe drug reactions and several deaths, led to active questioning of FDA’s ability to audit overseas plants that export drugs or ingredients to the US. The body now plans to begin operating in both China and India for monitoring on ground.
India has long been a reputed, leading exporter of generics drugs. But now China, a major exporter of APIs, is also expected to make a strong generics presence in a few years. Indian players already face tough competition from big contenders such as Israel’s Teva and Sandoz, owned by Novartis. So, they can ill afford to lose what is a considerable edge and need to do all it takes to stay ahead. The government also needs to substantially spruce up on quality regulation and monitoring.
Both truth and perception are crucial in the quality game.
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