Pharmaceuticals & Clinical Trials

Pharmaceuticals & Clinical Trials

Our firm regularly advises clients on various Indian laws regulating pharmaceutical business and clinical trials in India.

India plays an important role in global pharmaceutical industry. The Indian pharmaceutical market is the third largest in the world in terms of volume. India is the largest provider of generic drugs globally and the branded generics constitute nearly 70 to 80 per cent of the market.

Indian government is all set to amend the existing FDI policy in the pharmaceutical sector to promote manufacturing of medical devices in India and attract more FDI in the drugs and pharmaceuticals sector. Further, the government has a vision of making India a global leader in end-to-end drug manufacture, and is taking significant measures, such as the approval time for new facilities has been reduced to enhance investments, introduction of mechanisms such as the Drug Price Control Order and the National Pharmaceutical Pricing Authority to deal with the affordability and availability of drugs in India, and so on.

This increased spending and growth focussed policy measures will open up greater possibilities for industry participants. All these developments are leading to significant changes in the structure and organization of healthcare services for many providers and related businesses.

Our team of lawyers, by virtue of their sectoral knowledge and experience and capabilities in related legal disciplines, consistently advise the clients on virtually all aspects of the pharmaceutical industry including corporate, finance, tax, anti-trust, restructuring, intellectual property, biotechnology, clinical trials, enforcement actions, etc.

We offer practical and solution-oriented advice to the clients and also assist in regulatory compliances at both the central and state levels, which are complex as well as crucial in this industry.