India’s pharmaceutical exports achieved an impressive 11th place globally in terms of value in 2023, accounting for 3% of total pharmaceutical exports, according to a 2025 market analysis by Bain and Company. The Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare have introduced various measures to ensure the quality, safety, and efficacy of medicines.
To enhance regulatory compliance, CDSCO initiated risk-based inspections of drug manufacturing and testing firms in December 2022, in collaboration with state regulators. Out of 905 units inspected, 694 actions have been taken, including orders to halt production or testing, license suspensions or cancellations, and issuance of warnings or show cause notices. These inspections have led to corrective actions and improvements in the regulatory framework.
The Central Government amended the Drugs Rules, 1945 to revise Schedule M, effective from June 2024 for manufacturers with a turnover exceeding ₹250 crore. Smaller manufacturers have until December 2025 to comply. Additionally, the rules now require top 300 drug formulation brands to have barcodes or QR codes on packaging labels for authentication, effective from August 2023.
In January 2022, the rules were amended to mandate QR codes on every active pharmaceutical ingredient (bulk drug) manufactured or imported in India, facilitating tracking and tracing. These codes include essential details such as product identification code, batch number, manufacturing date, and expiry date.
An amendment in February 2020 made both manufacturers and marketers responsible for drug quality and regulatory compliance. The Drugs and Cosmetics Act, 1940, was also amended in 2008 to introduce stringent penalties for manufacturing spurious and adulterated drugs, making certain offenses cognizable and non-bailable. Special courts have been established in states and union territories for speedy disposal of such cases.
To ensure drug efficacy, applicants for manufacturing licenses must submit bioequivalence study results for oral dosage forms of certain drugs. They must also provide evidence of stability and excipient safety. The number of sanctioned posts in CDSCO has increased significantly over the last decade. The Central regulator coordinates state drug control activities through the Drugs Consultative Committee, and provides training on Good Manufacturing Practices, with over 35,000 individuals trained since April 2023.
This information was shared by Union Minister of State for Chemicals and Fertilizers, Anupriya Patel, in a written reply to the Rajya Sabha.
