Last Updated on November 28, 2024 by The Health Master
Revised Schedule M
Indian pharmaceutical industry is poised for a significant transformation as the revised Schedule M of the Drugs and Cosmetics Rules (1945) is set to be fully implemented by January 1, 2025.
Speaking on the sidelines of the OPPI Annual Summit, Dr. Rajeev Raghuvanshi, Drug Controller General India, highlighted the critical importance of Schedule M in ensuring the quality and safety of pharmaceutical products.
He explained how Schedule M is a cornerstone of the regulatory value chain.
This regulatory overhaul aims to enhance Good Manufacturing Practices (GMP) standards, ensuring the production of high-quality and safe medications.
Key Changes and Implications
The revised Schedule M introduces stricter guidelines for pharmaceutical manufacturers, covering a wide range of areas, including:
- Infrastructure: Upgraded facilities to meet new standards.
- Systems and Procedures: Enhanced quality management systems and operational procedures.
- Manpower: Increased emphasis on skilled personnel and training.
Impact on Drugmakers
The implementation of the revised Schedule M will have a substantial impact on pharmaceutical companies, particularly those with a turnover of ₹250 crore or more.
These companies were required to comply with the new norms by July 2024, while smaller companies had an extended deadline of December 2024.
However, the Federation of Pharma Entrepreneurs (FOPE) had sought a two-year extension for smaller drugmakers to adapt to the stringent regulations.
While the final decision on this request is awaited, it is clear that the industry is undergoing a period of significant change.
Addressing Quality Concerns
The Drug Controller General of India (DCGI) has taken proactive measures to strengthen the regulatory framework.
These include:
- Mandatory Testing: All cough syrup batches intended for export must now undergo mandatory testing.
- Systemic Improvements: Enhanced regulatory oversight and inspections.
A New Era for Indian Pharma
The revised Schedule M is expected to elevate the standards of pharmaceutical manufacturing in India.
By adhering to these stringent norms, Indian drugmakers can position themselves as global leaders in the industry.
Companies that fail to comply with the regulations risk facing severe consequences, including regulatory actions and potential market bans.
As the deadline for full implementation approaches, the pharmaceutical industry is gearing up to embrace this new era of quality and safety.
By staying informed about the latest regulatory developments and proactively implementing the necessary changes, Indian pharmaceutical companies can ensure their continued success in the global market.
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What is Schedule M?
Schedule M is a set of guidelines governing Good Manufacturing Practices (GMP) in the pharmaceutical industry.
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When will the revised Schedule M be fully implemented?
The revised Schedule M will be fully implemented by January 1, 2025.
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How will the revised Schedule M impact drugmakers?
Drugmakers will need to upgrade their infrastructure, systems, procedures, and manpower to comply with the new standards.
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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