The Indian Pharma Industry under the Product Patent Regime
Details
BSTR169
25
YES
700
Not Applicable
Pharmaceuticals & Biotech
India
Regulatory Environment
Abstract
The Indian pharma industry has been consistently charting high growth rate in the 1990s and 2000s. The industry which was controlled by the government in the 1970s and 1980s to ensure that medicines were sold at affordable prices, has slowly been liberalised in the 1990s and 2000s. The note explains India's evolution as a pharma supplier to the world, and how India moved into a product patent regime from a process patent regime, in order to comply with its international obligations as part of the WTO agreement on TRIPS. The note explains the role played by the government in facilitating the growth of the industry, the regulatory regime that existed in India prior to liberalisation, the export orientation of the industry, the major pharma players in the country, and issues affecting the industry etc. The note ends with an optimistic outlook stating that the Indian pharma industry will soon be an R&D hub for multinationals in custom research and clinical trials and the industry has the potential to tap the growing generics market in Europe and the US.
Learning Objectives
The case is structured to achieve the following Learning Objectives:
- Effect of multilateral trade agreements on an industry.
- Moving up the value chain.
- Role of government in facilitating the growth of an industry.
Keywords
Indian Pharma Industry, Product patent, Process Patent, DPCO, FERA, Small Scale Industry, TRIPS, The Indian Patent Act, World Trade Organization, Exclusive Marketing Rights (EMR), Union Budget 2005-06, Wockhardt Ltd., Value Added Tax (VAT), Ranbaxy Laboratories Ltd., Dr. Reddy's Laboratories Limited