According to a 2025 market analysis by Bain & Company, India secured the 11th position in global pharmaceutical exports by value in 2023, contributing 3% of the total market share. To ensure the safety, efficacy, and quality of medicines, the Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare have implemented multiple reforms.
Since December 2022, CDSCO and state regulators have conducted risk-based inspections of pharmaceutical manufacturing and testing facilities, evaluating 905 units and initiating 694 enforcement actions, including suspending licenses, halting production, and issuing warnings. These measures have reinforced regulatory compliance and enhanced production standards.
To further tighten oversight, the government revised the Drugs Rules, 1945, through a notification dated December 28, 2023. The updated Schedule M, which outlines Good Manufacturing Practices, came into effect on June 29, 2024, for companies with an annual turnover exceeding $28.68 million. Smaller manufacturers with revenues below this threshold have been granted an extension until December 31, 2025.
In addition, regulatory changes have introduced mandatory barcodes or Quick Response (QR) codes on the packaging of the top 300 drug brands from August 1, 2023, allowing better authentication. A similar requirement was enforced on all active pharmaceutical ingredients from January 18, 2022, ensuring improved tracking and tracing mechanisms. Since 2020, manufacturers and marketers have been held directly accountable for drug quality and regulatory compliance.
Further amendments to the Drugs and Cosmetics Act of 1940 have introduced strict penalties for the production of counterfeit medicines. Special courts have also been established to expedite legal proceedings related to pharmaceutical violations. Additionally, drug manufacturers are now required to submit bioequivalence studies and stability data when applying for production licenses.
To strengthen regulatory enforcement, CDSCO has significantly expanded its workforce over the past decade and has conducted extensive training programs, educating over 35,000 personnel since April 2023. These efforts were highlighted by Union Minister of State for Health & Family Welfare, Ms. Anupriya Patel, in a written response to the Rajya Sabha.
