The generic drugs sector is consistently fortifying its position as a vital cornerstone within India's burgeoning economy. As the world's foremost provider of generic pharmaceuticals, this industry accounts for 40% of the United States' demand for generics, with Indian enterprises securing 304 Abbreviated New Drug Application approvals from the US Food and Drug Administration (USFDA) in 2017. Additionally, this sector boasts widespread international exports and maintains substantial influence across all extensively-regulated advanced markets.
In contrast to India's chemical, petrochemical, oil & gas, and mining industries, the pharmaceutical realm is notably fragmented, housing an excess of 10,000 companies. This fragmentation is a reflection of the market's considerable scale and the collaborative dynamics of the pharmaceutical ecosystem over numerous years. Daara B. Patel, Secretary General of the Indian Drug Manufacturing Association (IDMA), emphasized the transformation of many former SMEs into expansive national corporations, a source of pride. Regular coordination with the government is employed to bolster the growth of the SME sector. Presently, more than 2,000 plants hold WHO GMP approval, and an anticipated 1,000 additional SMEs are poised to achieve WHO-GMP compliance within the next 3 to 4 years, further augmenting the industry's potency. Notably, Indian firms constituted 35-40% of the worldwide USFDA's 971 approvals in the year 2018.