CDSCO Reports Risk-Based Inspections of Pharmaceutical Manufacturing Units

The Ministry of Health and Family Welfare has provided information to the Rajya Sabha regarding inspections and regulatory action concerning pharmaceutical manufacturing units.

Key points include:

1. Drug manufacturing, sale and distribution are regulated under the Drugs & Cosmetics Act, 1940 and the Drugs Rules, 1945.
2. Manufacturing premises are periodically inspected to verify compliance with Good Manufacturing Practices (GMP) prescribed under Schedule M.
3. CDSCO, together with State Drugs Controllers, has conducted risk-based inspections of more than 1,040 premises since December 2022.
4. More than 950 actions have been taken based on inspection findings, including show cause notices, stop production orders, suspensions, licence or product licence cancellations and warning letters.
5. More than 1,100 cough syrup manufacturers have undergone intensive audits in coordination with State authorities.
6. Increased market surveillance and sampling of syrup formulations has also been undertaken.
7. State Licensing Authorities are empowered to take further action, including prosecution where appropriate.