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New Ipr Regime and Challenges of the Small Pharma Industry
1. Introduction
Pharmaceutical SSI units in India account for nearly 50 percent of total drug production in the country and they cater to the rural medicine demand by supplying low cost medicines. In the earlier patent regime, small firms have been facilitated by various favorable policies like exemption from the Drug Price Control Order (DPCO) and drug policy parameters, reservation of drugs for exclusive production in small scale sector etc. which were instrumental for the prosperity of the small Pharmaceutical firms. The situation in the new patent regime is however not that encouraging for small Pharmaceutical firms. Moreover two major policy initiatives in 2005 - to mandate good manufacturing practices (GMP), i.e., compliance to schedule M, for all pharmaceutical units and excise exemption to industrial units located in the hill states of North India - affected the fortunes of these players. With the migration of manufacturing units into the excise free zones the products manufactured at these locations are far cheaper than those manufactured by the SSI units located in the non-excise free zones. As a result, more than 5000 SSI units, which invested over Rs 75 - 90 billion, are on the brink of closure and the life of more than nine lakh workers and their families dependent on these units are under question.1.1 Sequence of eventsi. In 2002, State FDA's had forced all units to comply with the new Schedule-M requirements. Schedule M represents a set of regulations as per the ...See the full content of this document
(Copyright 2011)
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