Last Updated on July 21, 2024 by The Health Master
Revised Schedule M
Large Pharmaceutical Companies in Focus: The Tamil Nadu drug control department is gearing up for inspections starting next week to ensure compliance with the Revised Schedule M guidelines for Good Manufacturing Practices (GMP) in pharmaceutical manufacturing.
This follows the July 5th, 2024 deadline for large pharma companies with an annual turnover exceeding Rs. 250 crore.
Phased Implementation Based on Turnover
The Revised Schedule M, implemented by the Central Government on January 6, 2024, mandates a phased rollout based on company size.
Small and Medium Enterprises (SMEs) with a turnover below Rs. 250 crore have a 12-month grace period, while larger companies had a stricter six-month deadline.
Inspections and Stakeholder Meeting Planned
M. Sridhar, Drug Controller and Joint Director of the Tamil Nadu department, confirmed the upcoming inspections.
He clarified that these will be conducted solely by state authorities and won’t involve the Central Drugs Standard Control Organization (CDSCO).
Zero Tolerance for Non-Compliance
Sridhar emphasized the Central Government’s strict stance on implementation.
While there’s no possibility of extending the deadline, a decision on potential grace periods (30-45 days) might be taken after a stakeholder meeting scheduled for the last week of July.
All Assistant Drug Control (ADC) offices have been instructed to expedite inspections.
Industry Response
Industry leaders from both large and small companies acknowledged their commitment to adhering to the Revised Schedule M.
However, representatives from the MSME sector requested additional support and guidance from the department.
Large Companies
J. Jayaseelan, chairman of the Tamil Nadu chapter of the Indian Drug Manufacturers’ Association (TN IDMA), representing large companies, confirmed their full compliance with the new regulations.
MSMEs
M. Varadarajan, president of the MSME pharma units, highlighted the ongoing implementation efforts by smaller companies.
He emphasized their need for additional time and requested departmental assistance.
Varadarajan assured that all units are financially capable of making the necessary changes and denied reports of potential shutdowns due to financial constraints.
Key Changes Introduced by Revised Schedule M
The Revised Schedule M mandates several crucial improvements in pharmaceutical manufacturing practices:
- Implementation of a Pharmaceutical Quality System (PQS): Ensures a comprehensive and systematic approach to quality management.
- Quality Risk Management (QRM): Proactive identification and mitigation of potential quality risks throughout the manufacturing process.
- Product Quality Review (PQR): Regular assessment of product quality data to identify and address any trends or issues.
- Qualification and Validation of Equipment: Verification of equipment performance and suitability for its intended use.
- Computerized Storage System: Implementation of robust electronic record-keeping for all drug products.
These revisions aim to enhance quality control and public safety within the Indian pharmaceutical industry.
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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