ABSTRACT

This chapter presents an analysis of the strategic presence of Indian pharmaceutical firms in the global generics market. It draws on a comprehensive study of product registrations and filings in several countries as well as export and import data. The pharmaceutical sector is the undisputed champion among Indian industries and a major global producer and exporter of generic medicines. Generics can be legally launched upon final expiration of all pending intellectual property rights. India is currently one of the top countries in terms of number of regulatory approvals granted by the Food and Drugs Administration (FDA) for generics. India is strong in drug registrations in developing countries, and is also rapidly expanding exports of generics to major regulated markets. The strong presence of Indian firms in many developing countries with growing populations, large installed production capacities, and forthcoming patent expiries provide a base for sustaining India as a major generics producer and exporter.