The latest update on Revised Schedule M, related to Good Manufacturing Practices (GMP) for pharmaceuticals in India, includes an extension for small and medium-sized manufacturers (MSMEs). Initially, the revised standards were to be implemented by June 28, 2024, for large manufacturers, and subsequently, the deadline was extended for MSMEs to December 31, 2025, according to the Ministry of Health and Family Welfare. This extension applies to those who apply for it within three months.
Key Points:
Large Manufacturers:
The revised Schedule M requirements were implemented for large manufacturers on June 28, 2024.
MSMEs:
Small and medium-sized manufacturers (MSMEs) were granted an extension until December 31, 2025, to comply with the updated standards.
Application for Extension:
MSMEs seeking the extension had to submit an application within three months of the notification.
Purpose of Extension:
The extension was granted to provide MSMEs with more time to upgrade their facilities and comply with the revised GMP standards.
Focus on Quality:
The revised Schedule M aims to enhance the quality and safety of pharmaceutical products manufactured in India by strengthening GMP requirements, according to the Economic Times.
Impact:
The changes are expected to improve the overall regulatory system and ensure better quality and safety in pharmaceutical manufacturing.
