The Central Drugs Standard Control Organization (CDSCO), in collaboration with state regulators, has implemented a series of stringent regulatory and enforcement measures to prevent the entry of substandard, adulterated, or spurious drugs into the market. Union Minister of State for Health and Family Welfare provided this information in a written reply in the Rajya Sabha on August 12, 2025.
Since December 2022, a risk-based inspection drive has been underway to assess the regulatory compliance of drug manufacturing and testing firms. So far,
905 units have been inspected, leading to 694 enforcement actions, including Stop Production Orders, license suspensions or cancellations, and warning letters, depending on the severity of non-compliance. This initiative has provided crucial insights into manufacturing practices and has led to a noticeable improvement in the regulatory framework.
To ensure drug authenticity and traceability, the government has mandated the use of QR codes on drug packaging.
- An amendment to the Drugs Rules, 1945, came into force on August 1, 2023, requiring manufacturers of the top 300 drug brands to print or affix a Quick Response (QR) code on their primary or secondary packaging.
- A separate amendment from January 18, 2022, mandates that every API manufactured or imported into India must bear a QR code on its label. This code must store minimum particulars like a unique product identification code, batch number, manufacturing date, and expiry date to facilitate tracking and tracing.
Quality Monitoring and Regulatory Upgrades
The government has introduced several measures to enhance drug quality and streamline regulatory processes.
- Details of drug samples that fail quality checks are publicly uploaded on the CDSCO website as part of a monthly Drug Alert system.
- An online portal, SUGAM Labs, has been operational since September 2023 to integrate the workflow of CDSCO’s drug testing labs. It automates the testing process for drugs, vaccines, cosmetics, and medical devices, allowing for easy tracking of testing status.
- The Drugs Rules, 1945, were amended on December 28, 2023, to revise Schedule M, which pertains to Good Manufacturing Practices (GMP). This revised standard became effective for manufacturers with a turnover of more than ₹250 crore on June 29, 2024.
- In February 2024, CDSCO published guidelines for the sampling of drugs, cosmetics, and medical devices by drug inspectors to ensure a uniform and structured approach to surveillance.
Additional steps include providing stringent penalties for manufacturing spurious and adulterated drugs under the Drugs & Cosmetics (Amendment) Act 2008, setting up special courts for speedy trials, and increasing the number of sanctioned posts in CDSCO. Joint inspections by central and state drugs inspectors and mandatory submission of bioequivalence study results for certain drugs have also been implemented.
The Central government continues to coordinate with State Drug Control Organizations and provides regular training and workshops to officials. In the last two fiscal years (2023-24 and 2024-25), over 43,000 persons have been trained.