Pharma Progress: Extended Deadline for GMP Compliance

The Health Ministry has extended the deadline by 12 months for small and medium pharma companies to comply with revised good manufacturing practices (GMP) under Schedule M of the Drugs and Cosmetics Act. The change aims to help MSMEs upgrade facilities and meet global standards, especially WHO certifications.

In a significant move to aid the pharmaceutical industry, the Health Ministry announced a 12-month extension for small and medium-sized pharma companies to comply with the revised good manufacturing practices (GMP) as outlined in Schedule M of the Drugs and Cosmetics Act. This decision comes as MSMEs expressed the need for additional time to upgrade their production facilities.

India, a leading exporter of medicines to low and middle-income countries, requires its manufacturers to meet WHO GMP standards. Currently, about 2,000 of the nation's MSME pharma units hold this certification. The Ministry emphasized that aligning GMP standards with global benchmarks is essential for ensuring product quality and safety.

The Central Drugs Standard Control Organization (CDSCO) has taken proactive steps to facilitate awareness across the nation. With 36,855 participants attending sessions on the revised requirements, the response has been overwhelmingly positive, indicating a collective effort towards international compliance.

(With inputs from agencies.)