Revised Schedule M: CDSCO organizes nationwide Workshops

Dr. Rajiv Singh Raghuvanshi, DCGI, emphasized the importance of these workshops in disseminating critical information related to the Revised Schedule M.

The Health Master

September 15, 2023

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Last Updated on December 31, 2023 by The Health Master

Revised Schedule M

In a proactive move towards enhancing pharmaceutical manufacturing standards in India, the Central Drug Standard Control Organization (CDSCO), under the aegis of the Ministry of Health and Family Welfare, Government of India, has announced a series of regional workshops aimed at disseminating crucial information regarding the Revised Schedule M.

Watch Video: Workshop on revised Schedule M by Dr. S. Eswara Reddy, Joint Drugs Controller, India

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Revised Schedule M: A Synchronized Approach

The Ministry of Health and Family Welfare, Government of India, took a significant step towards Revised Schedule M, a set of Good Manufacturing Practices (GMP) guidelines for the pharmaceutical industry.

The draft notification, published under GSR 999(E) on October 5th, 2018, is currently open for public comments.

Download notification No. GSR 999(E) dated 05-10-2018

This revision aligns Schedule M with the globally recognized WHO-GMP standards, demonstrating India’s commitment to maintaining high-quality pharmaceutical manufacturing practices.

New Guidelines and Timelines:

On August 2, 2023, the Union health ministry allotted a six-month window for small-scale manufacturers and a year-long period for larger units to secure their World Health Organization-Good Manufacturing Practices (WHO-GMP) certification.

Notably, a draft notification was issued as early as 2018, aiming to elevate and align Schedule M with international standards.

This move was catalyzed by observations from ongoing risk-based inspections, prompting the Government to reevaluate the prevailing GMP regulations and Quality Management Systems (QMS) adhered to by pharmaceutical manufacturers.

Key Changes in the Revised Schedule M:

The revised Schedule M mandates a host of requirements covering facilities and their maintenance, personnel, manufacturing, control, and safety testing, as well as storage and transport of materials.

These include, but are not limited to:

Introduction of a pharmaceutical quality system (PQS)
Implementation of quality risk management (QRM)
Initiation of product quality review (PQR)
Validation and qualification of equipment
Management of change controls
Self-inspection protocols
Establishment of a quality audit team
Approval and audit of suppliers
Conducting stability studies under recommended climate conditions
Validation of GMP-related computerized systems
Specific stipulations for the manufacture of hazardous products

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Nationwide Workshop Initiative

To ensure widespread awareness and understanding of the Revised Schedule M, the CDSCO has organized a series of one-day regional workshops across India.

These workshops will serve as a platform for various stakeholders to gain insights into the updated requirements and standards.

The workshops will be conducted in a hybrid mode, allowing participants the flexibility to attend either in person or virtually.

This approach is in line with the current circumstances and aims to facilitate maximum participation.

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Workshop Schedule and Key Figures

The CDSCO has released the tentative schedule for the workshops, which are set to take place in major pharmaceutical hubs across India.

The following locations and dates are included on the schedule:

New Delhi
September 15, 2023

Inauguration:

Dr. Rajeev Singh Raghuvanshi, DCGI
State Licensing Authority
Representatives of Industry associations

Baddi
September 16, 2023

Inauguration:

Dr. Rajeev Singh Raghuvanshi, DCGI
State Licensing Authority
Representatives of Industry associations

Hyderabad
September 16, 2023

Inauguration:

Dr. S. Eswara Reddy, JDCI
Dr. A. Ramkishan
State Licensing Authority
Representatives of Industry associations

Kolkata
September 27, 2023

Inauguration:

Mr. A.K. Pradhan
Mr. Arup Chattergy
State Licensing Authority
Representatives of Industry associations

Mumbai
September 30, 2023

Inauguration:

Dr. S. Eswara Reddy, JDCI
Mr. Jayant Kumar
State Licensing Authority
Representatives of Industry associations

Ahmedabad
September 30, 2023

Inauguration:

Mr. A.K. Pradhan
Dr. Ravikant Sharma
State Licensing Authority
Representatives of Industry associations

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Maximizing Participation: A Collective Endeavor

In a letter addressed to all Drug Manufacturers Associations and Pharmexcil, Dr. Rajiv Singh Raghuvanshi, Drugs Controller General of India (DCGI), emphasized the importance of these workshops in disseminating critical information related to the Revised Schedule M.

He urged all members of the associations to actively participate in the workshops, either in person or virtually.

For Further Information

For any additional information or inquiries, interested parties can contact Dr. S. Eswara Reddy, Joint Drugs Controller India, at 8130885581.

This initiative by CDSCO reflects the Indian government’s dedication to maintaining high-quality pharmaceutical manufacturing practices, ensuring the country’s continued leadership in the global 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.

Watch Video: Workshop on revised Schedule M by Dr. S. Eswara Reddy, Joint Drugs Controller, India