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Indias pharmaceutical industry caters to about 30% of the world’s generic requirements. Despite its tremendous volume, it has been facing difficult times recently, with the WHO stance on counterfeit drugs, as well as seizure of Indian generic shipments in the EU.
There is some good news now on the turf with the introduction of Bipartisan Biogenerics Consensus Bill: Promoting Innovation and Access to Life-Saving Medicine Act in US which shall open up the US markets to biogenerics. It is proposed by Rep. Henry A. Waxman who is also credited with an existing legislation on pharma generics to his name. (Hatch-Waxman Act) The Bill intends to authorize FDA to approve generic biotech drugs and provide a regulatory set up for the same. This would help Indian companies to launch their biological generics in US by 2010.
The patent protection for blockbuster first-generation biotherapeutics developed in the West has begun to expire, throwing them open for generic exploitation. While continued high demand, high prices, and applicability in previously untreatable conditions are behind the success of branded biologics, the absence of generic competition has meant that the growth has gone unchallenged.
A quite interesting explanation of the potential changes in store for the “generic” pharmaceutical industry, and the importance of generic drug manufacturing to India (which is a leader in this area, partly do to patent laws that have favored generic drug manufacturers).
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