The Second Market Environment
The Second Market Environment
Learning by Proving in Global Regulatory Harmonization
This chapter examines the second market environment for India's pharmaceutical industry which was driven by efforts to harmonize the local market with international regulations. It explains how Indian firms were compelled by harmonization-driven global regulation to meet external standards and improve processing capabilities and describes the Certified Good Manufacturing Process (cGMP) facilities, generic drugs and vaccine processes. This chapter also considers how the local industry was affected by the introduction of the Hatch-Waxman Act to promote generic drugs, the Trade in Intellectual Properties (TRIPS) Agreement, and the World Health Organization's (WHO) procurement of vaccines.
Keywords: pharmaceutical industry, market environment, India, international regulations, cGMP facilities, generic drugs, vaccines, Hatch-Waxman Act, TRIPS, World Health Organization
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