India's Active Pharmaceutical Ingredients (API) segment has established strong presence in world market and moving ahead with investments in R&D, expansion and new approvals from US and European authorities for their Drug Master Files (DMFs).
Both listed and unlisted Indian pharma companies filed 404 number of DMFs with US FDA in 2011 and the submission of DMFs continued in the first quarter of 2012 also. During the first quarter, these companies filed 97 DMFs. The Indian pharma companies filed total 311 DMFs with US FDA during 2010 and 271 DMFs in 2009.
Hetro Group, based in Hyderabad, consisting of Hetero Drugs Ltd and Hetero Labs Ltd, submitted 42 DMFs in US followed by Dr Reddy's Laboratories with 20 DMFs, Alembic Pharmaceuticals 17 DMFs and Emcure Pharmaceuticals Ltd 14 DMFs, Jubilant Life Sciences Ltd and Mylan Laboratories Ltd (formerly known as Matrix Laboratories Ltd) filed 11 DMFs each and Cadila Healthcare Ltd and Lupin filed 10 DMFs during 2011.
Other pharma majors like Macleods Pharmaceuticals submitted 9 DMFs with US FDA in 2011. Apotex Pharmachem India Pvt Ltd, Orchid Chemicals Ltd, Parabolic Drugs also filed 8 DMFs each followed by Symbiotec Pharmalab Ltd and Ipca Laboratories with 7 DMFs each.
With investments in R&D and focus on quality as well as cost, Indian companies have been able to maintain their position in the international market. These API players are well ahead of other countries in filing of DMFs in US and Certificates of Suitability (CoS) in Europe. India ranks third in the world with producing about 500 different APIs and largest number of US FDA approved plants outside US.
The R&D expenditure of 30 leading Indian pharmaceutical companies increased by 18.7 per cent to Rs.3,770 crore during 2010-11 from Rs.3,177 crore in the previous year with significant higher product filings with regulated authorities in US, Europe, Japan and emerging markets.
The cost-cutting measures adopted by US and highly regulated countries in healthcare segment pushed the demands for low cost generics. Further, several blockbuster brands lost market exclusivity during last couple of years and more are losing in coming years. This assisted the overall growth in API operations and Indian players have grabbed this opportunity successfully. The multinational pharma players adopted cost cutting measures to maintain profit margins. Sourcing bulk drugs from cost competitive destinations is one such strategic shift during last few years. Such a shift has provided India with immense opportunity for growth leveraging its existing capabilities.
Indian players have been able to meet the domestic demand and exporting huge quantities to several emerging pharma markets as well as regulated markets. With number of international standard facilities, talent pool, CRAMS opportunities and backup of R&D activities, India has emerged as major hub for API sourcing.
DMFs filed by Indian companies in 2011