Authorized Generics: Indeed Path for Betterment of Indian Pharmaceutical Industry

Kushal Shah, Rachana Yeligar

Abstract: The present study focuses on the scenario of the Indian Pharmaceutical Industry with Authorized generics (Anti-generic strategies) and its effect on consumer’s affordability to medicine. This study identifies benefits of Authorized generics for Indian Pharmaceutical Industry and also effect of price, quality and trust towards customers and consumers. Indian Pharmaceutical Industry is mainly focused on only generic drugs instead of development of new drug. In this scenario, if our pharmaceutical industry absorbs this new strategy, it will make healthy relation with big player of the industry and will create fame in international market, like in India Dr Reddy’s Lab first launched the authorized generic version of Merck’s billion dollar drug Zocor (Simavastatin) & gained R 300-400 crores last quarter in 2006. Authorized generics contributed high profit margin so the major Indian companies - Ranbaxy, Sun Pharm, Zydus Cadila etc. - are attracting towards the practice of authorized generic. This is quite way to enter in new market by tying with the MNC by the major Indian companies. Authorized generics compete with generics during 180 day exclusivity period and lowers generic drug price and provide benefit to consumers. Authorized generics drugs has been providing brand quality product at generic price, sometime even lower than that of first ANDA filer. Authorized generics promote competition and force to generic companies to ply consumer affordable medicine. Authorized generic agreements provide benefits to both innovator and especially generic drug company. By this agreements generic company acquiring good manufacturing experience, gaining first mover advantage in generic market, expanding their product line and most important they have brand quality product which is an additional income source, such as royalty on sales made by its generic agreement. Thus, Anti-generic strategies will create indeed benefits for Indian Pharmaceutical Companies and also for consumers.
Authorized generic (AG) drugs are brand name drugs packaged and sold by an innovator drug company as generics, under its own New Drug Approvals, through either the innovator’s generic subsidiary or an independent generic drug company. An ‘authorized generic’ is a pharmaceutical product that is marketed by or on behalf of a brand-name drug company, but is sold under a generic name. Authorized generics are thus similar to "private label" products, which are manufactured by one firm but sold under the brand of another. Current interest in authorized generics is largely due to a shift in corporate strategies that has been traced to the early 1990’s. Until that time, many entrants in the pharmaceutical industry engaged exclusively either in selling brand-name firms began to market authorized generics shortly before parents on their products were due to expire. Among such products were due to expire.



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