Indian Companies Dominate Competitive Generic Approvals by FDA
(Thursday, July 14, 2022)
FDA approved drugs that have none or few generic versions are designated as Competitive Generics with special incentives to developers under a law passed in 2017 aimed to avoid monopolies that lead to price gouging. Manufacturers based in India dominate the development of competitive generis with almost 55% of all such generics developed by Indian companies. Its not surprising as manufacturers in India are overwhelmingly dominant source of all generic drugs available in the US with more than 60% of all generic drugs being manufactured in that country. Several drugs approved decades ago may still serve critical needs for patients either because no other treatments exist or they offer a cheaper treatment option, that is, till the sole manufacturer of the drug decides to hike the price owing to the monopoly. Although such sole-sourced drugs have existed for decades, they came to the front of the everyday discussions when Turin Pharma led by Martin Shkreli bought an older drug and hiked the price more than 5000% overnight owing to the monopoly. Having single source for such generics much after no patent or market exclusivity exists, creates not only opportunity for an unfair monopoly but high risk to the supply chain. Hence the incentive for creating such generics. The main reason India-based manufacturers are a natural source for Competitive Generics is the presence of immense talent supported by more than three decades of experience in India for developing generic drugs. Indian manufacturers are also able to set up quality manufacturing facilities and reliable supply chains. Although there have been some highly publicized cases of non-compliance in India, overall the manufacturing sites in India have maintained high quality, reliable supply chain, as reported by the FDA. The companies developing Competitive Generics are those with extensive experience with developing and marketing generic drugs. Of the 89 competitive generics developed by Indian companies, 15 were developed by Amneal Pharma and 10 by Dr. Reddy’s, both among the top 10 India-based generic manufacturers. Although, there are obvious concerns with the dependence on one country for supply of critical medicines and the fact that this dependence extends to competitive generics may scare some planners but such concerns would be unfounded based on experience with such suppliers.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC