CDSCO underscores stringent compliance to Revised Schedule M

The government recognizes the importance of a smooth transition to the revised Schedule M

May 28, 2024

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Last Updated on June 12, 2024 by The Health Master

Revised Schedule M

The Indian pharmaceutical industry, a global leader in affordable medicines, is undergoing a significant transformation to ensure even higher quality standards with respect to Revised Schedule M.

The government’s focus is on strict compliance with the revised Schedule M, a regulation outlining Good Manufacturing Practices (GMP) for pharmaceutical manufacturing units in India.

This comprehensive rewrite dives deeper into the impact of the revised Schedule M and the government’s initiatives to support its implementation.

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Quality and Competition

Dr. S Eswara Reddy, Joint Drugs Controller India at CDSCO, emphasized that the revised Schedule M can not only strengthen the quality of Indian pharmaceuticals but also boost their competitiveness in the global market.

He made these remarks at a recent Product Process Knowledge workshop held in Bengaluru by CDSCO, KDPMA, and IDMA.

Why is Revised Schedule M Important?

Maintaining high-quality pharmaceutical manufacturing is crucial for several reasons:

Patient Safety:

High-quality medicines ensure patients receive effective and safe treatments, minimizing the risk of adverse reactions.

Global Reputation:

Strict adherence to GMP strengthens the reputation of Indian pharmaceuticals in the international market, boosting exports and trust.

Pharma Industry Competitiveness:

A robust quality framework positions Indian pharma companies to compete effectively in the global market, attracting investments and partnerships.

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Government Support for Seamless Implementation

The government recognizes the importance of a smooth transition to the revised Schedule M.

Here’s how they’re supporting the pharma industry:

Year-Long Training Programs:

CDSCO (Central Drugs Standard Control Organization) is conducting nationwide training workshops throughout the year.

These programs educate pharmaceutical companies on the revised regulations, ensuring a thorough understanding of the requirements.

Deadline-Based Compliance:

The government has set deadlines for compliance based on company size.

Large companies with annual sales exceeding Rs. 250 crore need to comply by June 27, 2024, while MSMEs (Micro, Small & Medium Enterprises) have until the year-end.

Focus on Quality Systems:

The revised Schedule M emphasizes the implementation of Pharmaceutical Quality Systems (PQS) and Product Quality Review (PQR).

These weren’t previously mandatory, but now play a central role in ensuring consistent quality throughout the manufacturing process.

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Building a Culture of Quality

The revised Schedule M goes beyond just regulations. It aims to foster a culture of quality within the Indian pharma industry.

This involves:

Eliminating NSQ Medicines:

The revised Schedule M aims to bring down the percentage of Not-of-Standard Quality (NSQ) medicines from 5% to zero. This will significantly improve patient safety and ensure consistent product quality.

Formulation Development Facilities:

The regulation emphasizes the importance of dedicated formulation development facilities, especially for MSMEs.

These facilities enable close monitoring of quality practices during all product development stages.

Companies that lack the resources can partner with Third-Party Manufacturers (TPMs) compliant with the revised Schedule M.

Empowering Employees:

Training workshops not only educate management but also equip employees across all departments with the knowledge necessary to maintain high-quality standards.

This fosters a culture where quality becomes an integral part of everyday operations.

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The Road Ahead: Enhanced Quality, Stronger Pharma Industry

With the revised Schedule M and government support initiatives, the Indian pharmaceutical industry is poised for a positive transformation.

By prioritizing quality, this transformation will lead to:

Improved Public Health:

Patients will benefit from consistently high-quality medicines, ensuring their health and safety.

Sustainable Business Growth:

Companies that embrace quality will build stronger reputations and experience higher customer trust, leading to sustainable growth.

Global Competitiveness:

Indian pharmaceuticals will be well-positioned to compete on a global scale, attracting investments and partnerships.

The revised Schedule M marks a significant step towards a stronger, more patient-centric Indian pharmaceutical industry.

By working hand-in-hand, the government and the industry can ensure that India remains a global leader in the supply of high-quality and affordable medicines.

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.