New Delhi, February 7, 2025: The Union Health Ministry has intensified efforts to curb spurious and poor-quality drugs, with the CDSCO and State Drugs Controllers conducting over 500 risk-based inspections since December 2022. These inspections, based on reported quality issues, have led to over 400 regulatory actions, including license suspensions, production halts, and show cause notices. Government data confirms the detection of 531 substandard drugs in the last six months.
To strengthen drug quality standards, the government has revised Schedule M of the Drugs Rules, 1945, enforcing stricter Good Manufacturing Practices (GMP) from June 2024 for large manufacturers, while smaller firms have until December 2025 to comply. Additionally, QR codes are now mandatory on Active Pharmaceutical Ingredients (APIs) for better tracking and monitoring.
