The India Brand Equity Foundation (IBEF) has compiled findings and released an overview of the current generics market in India. According to its findings, the Indian market has seen an increase manufacturing innovation and development technologies as a result of generics production.
IBEF maintains that during the past three years, pharma exports (largely generics) have grown 22% (CAGR), accounting for more than $13 billion in annual sales. Also, according to IBEF, 40% of ANDAs received by the FDA in 2012 were from India. India currently has more than 3000 DMFs registered with U.S. FDA and is now positioned to start producing more patented products. IBEF maintains that there are 546 U.S. FDA-approved company sites, 23 companies holding 1,100 authorizations with UK's MHRA, and 166 companies with CEPs (Certificates of Suitability) from EDQM.
Furthermore the Indian Government has committed a major multi-billion dollar initiative with 50% public funding through a public-private partnership model to support innovation. In addition, the Government has created tax incentives to the pharmaceutical sector and a weighted tax deduction of 150% for any R&D expenditures, as well as introduced 19 dedicated Special Economic Zones to help stimulate pharma sector investment across the country.
So far this year, India’s Dr. Reddy’s, Lupin Labs, Sun Pharma, Ranbaxy and Cipla have invested more than $500 million in R&D, with plans to increase innovation in manufacturing processes that will ultimately lead to lower production costs.
Rajeev Kher, Additional Secretary, Department of Commerce, Ministry of Commerce and Industry, Government of India, remarked, “India, termed as the Pharmacy of the World, has a basket of wide spectrum of generics that are second to none in terms of quality. The industry is on the track to expand its reach to newer markets, which makes it equally critical for the Indian pharmaceutical industry to keep its focus on quality, affordability and accessibility of medical solutions for the global pharma market. The country’s success in generics manufacturing is helping to keep our industry at the forefront of innovation and over the next few years we are lending our support to the R&D effort across the country so that we are leading in generics production and even developing new drugs out of India.”