Summary:
India’s pharmaceutical industry secured the 11th position globally in export value in 2023, contributing 3% of total global pharmaceutical exports, according to a 2025 secondary market research report by Bain & Company. To strengthen drug quality, safety and efficacy, the Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare have introduced several regulatory measures. From December 2022 onward, CDSCO, alongside state regulators, carried out risk-based inspections of 905 drug manufacturing and testing facilities, resulting in 694 enforcement actions, including production halts, license suspensions and official warnings. These initiatives have greatly improved regulatory compliance and elevated manufacturing standards. On December 28, 2023, the government amended the Drugs Rules, 1945, updating Schedule M to align with Good Manufacturing Practices (GMP). The revised regulations came into effect on June 29, 2024, for manufacturers with a turnover exceeding ₹250 crore (US$28.68 million), while companies with a lower turnover were granted an extension until December 31, 2025.
Additional amendments mandated QR codes on the packaging of the top 300 drug brands from August 1, 2023 and required QR codes on all active pharmaceutical ingredients from January 18, 2022, for improved traceability. A 2020 amendment placed greater responsibility on manufacturers and marketers for ensuring drug quality and regulatory compliance, reinforcing accountability across the pharmaceutical sector. Revisions to the Drugs and Cosmetics Act of 1940 introduced stricter penalties for producing spurious drugs, alongside the establishment of special courts to expedite case resolution. To further strengthen quality control, the government mandated bioequivalence studies and the submission of stability data as prerequisites for obtaining drug manufacturing licenses. Over the past decade, the Central Drugs Standard Control Organization (CDSCO) has seen a significant rise in sanctioned posts, while ongoing training initiatives have equipped more than 35,000 personnel since April 2023. This update was shared by Union Minister of State for Health & Family Welfare, Ms. Anupriya Patel, in a written response to the Rajya Sabha.
Source: IBEF
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