Revised Schedule M Implementation Extended for Small and Medium Pharma Manufacturers in India
The Ministry of Health & Family Welfare has announced a conditional extension for the implementation of revised Schedule M (Good Manufacturing Practices provision) for small and medium pharmaceutical manufacturers in India. This extension applies to manufacturers with a turnover of Rs. 250 crores or less and will extend the deadline to December 31, 2024.
The revised Schedule M requirements, notified by the Government of India on December 28, 2023, upgraded the "good manufacturing practices" to "good manufacturing practices and requirements of plan and equipment for pharmaceutical products." This upgrade aimed to enhance the quality and safety of pharmaceutical products manufactured in India.
Initially, manufacturers were divided into two categories based on their turnover. Large manufacturers with a turnover exceeding Rs. 250 crores were given a six-month timeline for compliance, while small and medium manufacturers with a turnover of Rs. 250 crores or less were given a 12-month timeline. The revised Schedule M requirements have been implemented for large manufacturers since June 28, 2024.
However, small and medium-sized manufacturers advocated for a longer timeline to comply with the new regulations. They cited the need for additional time to build infrastructure, train staff, and arrange funding. In response to these concerns, the Ministry has granted a three-month extension starting February 11, 2024, for small and medium-sized firms to submit their Form A upgrade plan to the Central License Approving Authority. Manufacturers who submit their plans within this timeframe will have their implementation timeline extended until December 31, 2024.
The revised Schedule M requirements are a positive step towards ensuring the quality and safety of pharmaceutical products in India. The new regulations are expected to strengthen the domestic position of Indian pharma companies and enhance their global competitiveness.
6 Comments
Habibi
Supporting small manufacturers with extra time is a clear sign of a forward-thinking regulatory framework that prioritizes both safety and growth.
Africa
An extension like this is practical and progressive—it's all about long-term benefits for our healthcare and industry standards.
Muchacha
I applaud this thoughtful approach; small firms now have a fair chance to upgrade their processes without being rushed.
ytkonos
At a time when public safety should be paramount, extending the compliance deadline might do more harm than good.
lettlelenok
I appreciate the balanced approach—ensuring both compliance and support for smaller manufacturers to thrive.
Raphael
This shows that the government values quality and safety, but at the same time understands the limitations of smaller firms.