India, ranking 11th globally in pharmaceutical exports by value in 2023, is taking significant strides to enhance the quality, safety, and efficacy of its medicines. This comes as a 2025 Bain & Company report reveals India accounts for 3% of total global pharmaceutical exports. This press release was issued on March 11, 2025.
The Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare have implemented a series of measures to bolster regulatory compliance and manufacturing standards.
Key Initiatives and Regulatory Actions
Risk-Based Inspections
Since December 2022, CDSCO, in collaboration with state regulators, has conducted risk-based inspections of 905 drug manufacturing and testing units.
These inspections have resulted in 694 actions, including production stoppages, license suspensions, and warning notices, leading to improvements in manufacturing practices.
Revised Schedule M (Good Manufacturing Practices)
The Drugs Rules, 1945, have been amended to revise Schedule M, establishing stricter Good Manufacturing Practices.
Effective from June 29, 2024, for manufacturers with a turnover exceeding ₹250 crore, and until December 31, 2025, for those with lower turnovers.
Barcode/QR Code Implementation
Packaging labels of the top 300 drug formulation brands and Schedule H2 drugs are now required to feature barcodes or QR codes for authentication, effective from August 1, 2023.
QR Codes for Active Pharmaceutical Ingredients (APIs)
APIs manufactured or imported into India must bear QR codes for tracking and tracing, including essential information like batch number and expiry date, since 2022.
Since March 1, 2021, drug marketers share responsibility with manufacturers for drug quality and regulatory compliance.
Amendments to the Drugs and Cosmetics Act, 1940, have introduced stricter penalties for manufacturing spurious and adulterated drugs, with certain offenses made cognizable and non-bailable.
State and Union Territory governments have established special courts for the speedy disposal of drug-related cases.
Research and Training
Applicants for manufacturing licenses must submit bioequivalence study results for oral dosage forms of certain drugs.
Applicants must provide evidence of stability and excipient safety before obtaining manufacturing licenses.
The number of sanctioned posts in CDSCO has significantly increased. Regular training and workshops on Good Manufacturing Practices are provided to CDSCO and state regulatory officials, with over 35,000 persons trained since April 2023.
The Central regulator coordinates activities of State Drug Control Organisations and provides expert advice through the Drugs Consultative Committee.
