India Extends Deadline for GMP Compliance in Pharma

On 4th January 2025, the Union Health Ministry extended the deadline for implementing revised Good Manufacturing Practices (GMP) under Schedule M of the Drugs and Cosmetics Act by 12 months to aid the pharmaceutical industry.

Key Points

Revised Standards: Schedule M outlines GMP for pharmaceutical manufacturing, including requirements for premises, plants, and equipment to improve product quality.
Extension Details: Pharmaceutical units must now comply by December 31, 2025, with large manufacturers and MSMEs receiving different timelines.
Global Standards Alignment: The revisions aim to align India’s manufacturing practices with World Health Organization (WHO) standards for globally acceptable drug quality.
Challenges Cited: MSMEs requested an extension citing financial constraints and time required to implement facility upgrades.
CDSCO Involvement: Units must register with the Central Drugs Standard Control Organisation (CDSCO) and share upgradation plans within three months, followed by facility audits.
Industry Scope: India has 10,500 pharma manufacturing units, of which 8,500 are MSMEs; only 2,000 MSME units currently meet WHO GMP certification standards.
Financial Support: The Department of Pharmaceuticals introduced the Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS) to help MSMEs upgrade their facilities.
Progress Observed: CDSCO has inspected over 800 manufacturing units, with notable progress in GMP implementation and heightened awareness among MSMEs.