Last Updated on August 27, 2024 by The Health Master
Revised Schedule M
India’s pharma industry is facing a pressing deadline to implement revised Schedule M of the Drugs and Cosmetics Rules.
The industry is seeking a two-year extension to ensure the survival of small and medium-sized enterprises (SMEs).
Schedule M: A New Set of Standards
Revised Schedule M outlines the good manufacturing practices (GMP) that pharma companies must adhere to.
These practices include measures like prompt product recalls for defective items.
The revised Schedule M, notified in January 2024, introduces stricter standards aimed at improving the quality and safety of pharmaceutical products.
Industry Concerns and Requests
Pharma industry associations, including Laghu Udyog Bharati (LUB) and the Federation of Pharma Entrepreneurs (FOPE), have written to the health minister, Dr. J P Nadda, urging him to postpone the December 2024 deadline for revised Schedule M implementation.
They cite a lack of resources and the challenges faced by SMEs in meeting the new requirements as reasons for the extension.
Key Concerns Raised by the Industry:
- Financial Burden: SMEs are struggling to invest the significant amounts required to upgrade their facilities to comply with revised Schedule M.
- Time Constraints: The industry believes that the current deadline is too short to implement the necessary changes, especially for smaller units.
- Equipment Procurement: Procuring and installing new equipment takes time, and the industry needs more lead time to complete these tasks.
Industry Representatives Seek Dialogue
Laghu Udyog Bharati (LUB) representatives plan to meet with the health minister to discuss their concerns and advocate for an extension.
Rajesh Gupta, the all-India head of pharma at LUB, emphasizes the need for more time to upgrade infrastructure and ensure compliance with the revised Schedule M.
The Road Ahead
As the deadline for revised Schedule M implementation approaches, the pharma industry is grappling with the challenges posed by the new regulations.
The industry’s request for an extension is a reflection of the difficulties faced by SMEs in meeting these standards.
It remains to be seen whether the government will grant the industry’s request and provide additional time for compliance.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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