GMP Compliance Deadline For Pharma MSMEs Extended To December 2025

New Delhi, Jan 6 (KNN) In a significant move aimed at supporting small and medium-sized pharmaceutical enterprises, the Health Ministry announced on Saturday that companies with an annual turnover below Rs 250 crore will receive an additional 12 months to comply with the revised Good Manufacturing Practices (GMP) outlined in Schedule M of the Drugs and Cosmetics Act.

These companies now have until December 31, 2025, to upgrade their facilities and meet the enhanced standards.

The extension comes in response to requests from pharmaceutical MSMEs, which constitute the backbone of India's medicine production.

Out of 10,500 manufacturing units nationwide, around 8,500 fall under the MSME category, with only about 2,000 currently holding WHO GMP certification.

The revised Schedule M, notified in December 2023, aligns India's GMP standards with global benchmarks to ensure the production of high-quality, globally acceptable drugs.

The government initially set a six-month compliance period for large manufacturers and a 12-month period for MSMEs following the notification in January 2024.

However, after industry representations highlighted challenges such as financial constraints and time requirements for upgradation, the ministry granted the extension.

To facilitate the transition, the Central Drugs Standard Control Organisation (CDSCO) has conducted 15 awareness sessions nationwide, attracting over 36,000 participants from the pharmaceutical sector.

These sessions emphasised the technical requirements and importance of the revised GMP, which focuses on improving materials, methods, personnel, and facility management in drug manufacturing.

Manufacturers are required to register their upgradation plans with CDSCO within three months, followed by audits to assess progress.

Facilities failing to implement changes may face action. Initial inspections of 800 units and 252 public labs indicate a promising trend of compliance among MSMEs.

The ministry’s statement highlighted, "There is awareness and sensitisation throughout the industry, and many units have already initiated the upgradation process. This ensures the production of safe, efficacious, and quality pharmaceuticals, bolstering India's position as a global leader in medicine exports to low and middle-income countries."

With this extension, the government aims to balance the industry's financial realities with the need for global-quality standards in drug manufacturing.

(KNN Bureau)