1,500 MSMEs towards full compliance with Revised Schedule M

Dr. Koshia emphasized the pivotal role of the revised Schedule M guidelines in guaranteeing the quality, safety, and efficacy of pharmaceutical products.

The Health Master

April 1, 2025

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1,500 MSMEs towards full compliance with Revised Schedule M

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Last Updated on April 3, 2025 by The Health Master

Revised Schedule M

Gujarat’s micro, small, and medium enterprises (MSMEs) actively moving towards full compliance with the guidelines of revised Schedule M.

This proactive approach shows a strong commitment of pharma manufacturers to increase the quality of drugs manufactured in the state.

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Key Developments

This development is the result of an initiative taken by the Food and Drug Control Administration, Gujarat (FDCA Gujarat).

According to Dr. H G Koshia, the Commissioner of Gujarat FDCA, approximately 1,500 MSMEs within the state’s pharmaceutical sector are diligently conducting thorough gap analyses and submitting their detailed compliance reports to the Drugs Controller General of India (DCGI).

This signifies a widespread and serious commitment from these smaller players to meet the elevated standards.

The Vision

The FDCA Gujarat’s proactive approach by means of providing a training program is aligned with the vision of the state to implement and enforce the guidelines of revised Schedule M among the pharmaceutical manufacturing units in the state.

This urgency is driven by the increasing global demand for stringent quality assurance in pharmaceuticals.

Click for Guidance documents for industry

Safeguard Public Health

The swift and effective enforcement of Revised Schedule M guidelines gives a double benefit as under:

1. It will significantly enhance the public health protection by means of providing high-quality and safer drugs for the consumers in the state.

2. It will also enhance Gujarat’s standing as a global destination for drug manufacturing, which will attract more international investments and collaboration in the pharmaceutical sector.

Training

The FDCA Gujarat has also started a regular training program for its regulatory officers.

These training sessions started on October 10, 2024, has been specifically designed to enhance strict enforcement of these critical regulations.

The Significance of Revised Schedule M Guidelines

Dr. Koshia emphasized the pivotal role of the revised Schedule M guidelines in guaranteeing the quality, safety, and efficacy of pharmaceutical products.

He stated, “The fast adoption and strict enforcement of the guidelines of Revised Schedule M are very important for maintaining compliance by the industry.”

What the Revised Schedule M Entails

The Revised Schedule M guidelines introduce more stringent requirements across various aspects of pharmaceutical manufacturing.

These guidelines of Revised Schedule M are very important for enhancing the overall quality of drugs manufactured in India and further strengthening the nation’s reputation as a reliable and leading pharmaceutical provider worldwide.

Key areas of focus:

Advanced Infrastructure:

Integration of cutting-edge manufacturing facilities and sophisticated equipment to proactively prevent contamination and consistently maintain high production standards.

Quality Control:

Implementation of robust quality control mechanisms to ensure that every drug meets the required standards before it reaches market.

Enhanced Hygiene:

Implementation of robust cleanliness measures within manufacturing facilities to prevent contamination and cross-contamination, which may occur for the manufacturing of high-quality drugs.

Sustainable Practices:

By adopting high-quality air, water, and waste management systems at par with global environmental standards and promoting sustainable manufacturing practices.

Gujarat’s Path Forward

Gujarat manufactures over 30% of India’s total pharmaceutical output; the prompt implementation of Revised Schedule M by its industry will have a profound impact.

Importance of Innovation

Dr. Koshia further emphasized the importance of innovation in ensuring Revised Schedule M compliance by the industry.

The training programs encourage the adoption and implementation of new techniques in the manufacturing and quality control procedures.

Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.

Click below links for more articles on Revised Schedule M

Schedule M

Gist of 31 Chapters on Schedule M

Revised Schedule M Guidelines: Drug Recall and Ensuring Pharma Quality

Pharmaceutical Quality: Key Amendments in Revised Schedule M

Revised Schedule M: The Role of Pharmaceutical Waste Management

Guidance documents for industry

Key Notes on Revised Schedule M: Compilation

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