Pharmaceutical Industry in India

India is a big healthcare market and a land of opportunities in pharmaceuticals. One billion strong population in India constitutes the biggest market in the world for pharmaceuticals. As per the Economic Survey of India 2006 – 2007, the output of the Indian pharmaceutical industry is INR 55,000 Crores and the export is over INR 21,000 Crores. India holds fourth position in terms of volume and thirteenth position in terms of value of production in pharmaceuticals. India has a huge untapped potential in the domestic pharmaceuticals market, wherein the production meets only around 70% of the country's demand.

A dual system of regulatory control over drugs – (i) the Central Authority at the national level and (ii) the State Authorities at the state level exists in India at present. The legal frame work in India provides foreign investors freedom of entry, investment, location, choice of technology, import and export and repatriation of capital and dividends. FDI up to 100% is allowed under the automatic route subject to certain conditions. However, Government approval is mandatory for FDI not covered under the automatic route. Drugs and Cosmetics Act, 1940 is the basic sectoral law.

CLG’s Pharmaceutical Industry Practice
 
CLG’s regulatory practice covers a number of industry areas including pharmaceutical drugs, vaccines, medical devices, clinical trial etc. CLG’s  multidisciplinary Pharmaceutical team includes lawyers and technical professionals having considerable experience across virtually all the concerned industry areas. CLG has  assisted clients in obtaining necessary regulatory licenses and statutory approvals particularly with regard to product approval for marketing and manufacturing. A significant part of CLG’s drug law practice is devoted to counseling clients on various issues such as manufacturing, marketing, safety, good Clinical Practice requirements, good Manufacturing Practice Requirements, regulatory strategies and life cycle management, labeling, advertising, import/exports clearances for biological and dual use materials, clinical investigation requirements, product liability, market protection and enforcement issues.
CLG represents interest of many multinational pharmaceutical companies in India in policy and Intellectual Property matters. CLG has to its credit thousands of Patent Applications filed in India for major pharmaceutical companies, apart from prosecuting Trademark, Design, Copyright and other Intellectual Property Rights Applications.