Measures Against Adulterated Drug Sales

Comprehensive Summary of Measures Taken to Prevent Sale of Adulterated Drugs in India

The Central Drugs Standard Control Organization (CDSCO) in collaboration with the Ministry of Health and Family Welfare has undertaken significant initiatives to combat the issue of adulterated and spurious drugs in India. The following measures have been implemented to enhance drug quality, ensure regulatory compliance, and strengthen the framework for drug safety monitoring:

• Risk-Based Inspections: Since December 2022, CDSCO and state regulators have conducted inspections of 905 drug manufacturing units, resulting in 694 enforcement actions including Stop Production Orders, servicing Stop Testing Orders, and license cancellations. These actions were taken in response to non-compliance with regulatory standards.

• Amendments to Drugs Rules: Key amendments to the Drugs Rules, 1945 have been put into effect:

  • Barcodes and QR Codes: Effective from August 1, 2023, manufacturers of the 300 most prominent drug formulations must incorporate barcodes or Quick Response Codes on packaging. This measure aims to facilitate authentication and traceability of drugs.
  • Active Pharmaceutical Ingredients (APIs): From January 18, 2022, all APIs must also display QR Codes, detailing critical data such as unique product identification codes, batch numbers, manufacturing, and expiry dates.

• Public Monitoring and Alerts: CDSCO has introduced public monthly Drug Alerts for transparency about quality issues. Drug samples failing quality checks are published on their website to inform consumers, and firms are mandated to recall these products immediately.

• Updated Manufacturing Guidelines: As of December 28, 2023, the Drugs Rules were revised concerning Good Manufacturing Practices under a newly updated Schedule M, which takes effect on June 29, 2024. Manufacturers with a turnover exceeding Rs. 250 crores are bound to comply. Those under this threshold have a conditional extension to December 31, 2025, provided they submit an upgrade plan.

• Drug Sampling Guidelines: CDSCO published guidelines in February 2024 that systematic methodologies for drug inspectors for sampling drugs to ensure quality. These guidelines emphasize risk-based sample selection covering diverse locales, including rural areas.

• Integration of Drug Testing Labs: An online portal, SUGAM Labs, launched in September 2023, aims to automate and manage the workflow of drug testing, ensuring compliance with quality specifications.

• Enhanced Penalties and Special Courts: The Drugs and Cosmetics Act, 1940 was amended to establish stringent penalties for offenses related to adulterated and spurious drugs. Special courts in States and Union Territories have been established to expedite cases under this Act.

• Ongoing Training Programs: The CDSCO has significantly increased the number of sanctioned posts and conducts regular training for its officials and state regulatory agencies on Good Manufacturing Practices. Training figures indicate that 22,854 individuals were trained in FY 2023-24 and 20,551 in FY 2024-25.

• Joint Inspections for Manufacturing Licenses: The amendment to the Drugs and Cosmetics Rules mandates that all manufacturing establishments be jointly inspected by state and central Drugs Inspectors prior to the issuance of a manufacturing license.

• Certificate Requirements for License Issuance: Amendments stipulate that applicants must submit biosafety data and evidence for the stability of excipients to relevant licensing authorities before the grant of licenses.

• Coordination with State Authorities: The central government coordinates the activities of State Drug Control Organizations and engages in regular meetings with State Drugs Controllers to ensure uniformity in the administration of drug regulations.

These comprehensive measures aim to bolster the drug regulatory framework in India, ensuring consumer safety and enhancing the integrity of drug manufacturing practices.

Key Points:

• Risk-based inspections of 905 drug units; 694 actions taken.
• Mandatory integration of barcodes and QR codes in drug packaging since August 2023.
• Monthly public alerts on drug quality issues published by CDSCO.
• Enhanced Good Manufacturing Practices effective for larger manufacturers by June 2024.
• Structured drug sampling methodology introduced in February 2024.
• Special courts established for swift prosecution of drug-related offenses.
• Training for CDSCO and state officials significantly increased over the past two fiscal years.
• Joint inspections mandated for manufacturing license grants.
• Regulatory coordination between central and state authorities reinforced.