Indian pharmaceutical exports ranked 11th globally in value terms in the year 2023 and accounted for 3% of the total pharmaceutical exports

As per a secondary market research analysis by Bain & Company in 2025, India's pharmaceutical exports ranked 11th globally in value terms in 2023, accounting for 3% of total pharmaceutical exports. The Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare have implemented several measures to enhance medicines' quality, safety, and efficacy. Since December 2022, CDSCO, in collaboration with State regulators, has conducted risk-based inspections of drug manufacturing and testing firms, inspecting 905 units and initiating 694 enforcement actions, including production stoppages, license suspensions, and warnings. These inspections have strengthened regulatory compliance and improved manufacturing practices. Additionally, through a notification dated December 28, 2023, the government amended the Drugs Rules, 1945, revising Schedule M concerning Good Manufacturing Practices and requirements for pharmaceutical production facilities. The revised schedule became effective on June 29, 2024, for manufacturers with a turnover exceeding Rs. 250 crore (US$ 28.68 million), while those with a turnover up to Rs. 250 crore (US$ 28.68 million) have been granted an extension until December 31, 2025. 

Further amendments to the Drugs Rules, 1945, include mandatory barcodes or Quick Response (QR) codes on packaging labels of the top 300 drug brands from August 1, 2023, for authentication. Similarly, from January 18, 2022, all active pharmaceutical ingredients must carry a QR code for tracking and tracing. A 2020 amendment mandates manufacturers and marketers responsible for drug quality and regulatory compliance to enforce accountability. Additionally, amendments to the Drugs and Cosmetics Act of 1940 introduced stringent penalties for spurious drug manufacturing, while special courts were established for faster case resolution. The government has also mandated bioequivalence studies and stability data submission for drug manufacturing licenses. CDSCO’s sanctioned posts have increased significantly in the past decade, and regular training sessions have been conducted, training over 35,000 personnel since April 2023. This information was provided by Union Minister of State for Health & Family Welfare, Ms. Anupriya Patel, in a written reply to the Rajya Sabha.

Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.