Abstract

Small firms dominate the Indian pharmaceutical industry with significant contribution to the national drug production and employment. They had played an important role in enhancing domestic technological capabilities in drugs production and have been instrumental in keeping drugs prices affordable for the Indian populace in remote rural areas. This rise of small firms in this sector has been facilitated by a set of strategic government polices implemented in the past decades like adoption of a process patent regime, relaxation granted from price control and industrial licensing requirement, reservation of items for exclusive production and preference in government procurement, etc. Since 1990s the regulatory regime for small firms underwent dramatic changes with withdrawal of most of the favoruable policies and implementation of regulations like a long‐term product patent regime, withdrawal of exemption from price controls, implementation of good manufacturing practices, etc. These new policies have a number of implications for the survival and growth of small pharmaceutical firms today.

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