India’s Pharmaceutical Industry: A Snapshot of Growth

India has firmly established itself as a global player in the pharmaceutical sector, ranking 11th globally in terms of export value in 2023, according to a secondary market research analysis by Bain & Company. The country accounted for an impressive 3% of the total pharmaceutical exports globally.

The Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare have been instrumental in driving these improvements. Since December 2022, CDSCO, in collaboration with state regulators, has carried out risk-based inspections of drug manufacturing and testing facilities. These inspections, which have covered 905 units and led to 694 enforcement actions—including production stoppages, license suspensions, and warnings—have been critical in ensuring adherence to regulatory standards. These efforts are helping to improve manufacturing practices across the country.

Change in Drug Safety Rule

In a move to further strengthen drug safety, the Indian government amended the Drugs Rules, 1945, in late 2023. The revision of Schedule M, which relates to Good Manufacturing Practices (GMP) and requirements for pharmaceutical production facilities, took effect on June 29, 2024, for manufacturers with a turnover exceeding ₹250 crore (approximately US$ 28.68 million). Manufacturers with a turnover of up to ₹250 crore have been given an extension until December 31, 2025, to comply with these updated requirements.

As of August 1, 2023, packaging labels for the top 300 drug brands must now include barcodes or Quick Response (QR) codes to aid in product authentication. Similarly, all active pharmaceutical ingredients (APIs) are required to carry QR codes for tracking and tracing, with the rule coming into effect on January 18, 2022.

Conclusion

India’s pharmaceutical industry is not only growing in terms of global exports but is also taking substantial steps to ensure that the drugs it manufactures are of the highest quality. With increased regulatory measures, modernised rules, and a focus on accountability, the future of India’s pharmaceutical sector looks both promising and secure, solidifying its position as a key player in the global pharmaceutical landscape.

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