Indian Pharma Industry Gears Up to comply Revised Schedule M

This will enable the industry to adapt to market demands while adhering to the stricter regulations of the revised Schedule M.


Last Updated on May 27, 2024 by The Health Master

Revised Schedule M

The Indian pharmaceutical industry, a global leader in affordable medicines, is undergoing a significant shift towards stricter quality control measures and to comply revised schedule M.

This move, spearheaded by the Central Drugs Standard Control Organization (CDSCO) in collaboration with pharma industry associations like IDMA (Indian Drug Manufacturers’ Association) and KDPMA (Karnataka Drugs and Pharmaceutical Manufacturers’ Association), aims to guarantee consistent product quality for patient safety.

Revised Schedule M

The revised Schedule M, a regulatory framework outlining Good Manufacturing Practices (GMP) for pharmaceuticals in India, comes into full effect in June 2024 for large companies and by year-end for MSMEs (Micro, Small and Medium Enterprises).

This revised version emphasizes the concept of “Quality by Design” (QbD), where quality is built into the product from the very beginning.

Challenges and Solutions

Maintaining consistent product quality can be a challenge, especially in a rapidly evolving market.

To address this, CDSCO, IDMA, and KDPMA advocate for a robust justification system for any production process changes.

This will enable the pharma industry to adapt to market demands while adhering to the stricter regulations of the revised Schedule M.

A Day-Long Workshop to Empower the Pharma Industry

Recognizing the need for pharma industry education, a day-long workshop is scheduled for May 25th, 2024, in Bengaluru.

This workshop will delve into crucial aspects of the revised Schedule M, focusing on:

  • Quality Risk Management (QRM): Identifying and mitigating potential risks that could impact product quality.
  • Product Quality Review (PQR) Reports: Evaluating how changes in the production process might affect product quality.
  • Preventing Out-of-Specification (OOS) and Out-of-Trend (OOT) Issues: Implementing systems to avoid deviations from quality standards that could jeopardize patient safety.

Importance of Documentation and Record-Keeping

The workshop will highlight the importance of meticulous documentation.

For example, any changes in equipment, machinery, or ingredients used in the production process must be thoroughly documented with justifications.

This comprehensive record-keeping will aid in identifying the root cause of any quality issues that may arise in the future.

Building Quality from the Ground Up

As highlighted by S M Mudda, Chairman, Regulatory Affairs Committee, IDMA, the revised Schedule M emphasizes building quality into the product from the initial stages of development.

This requires in-depth knowledge of both the product itself and the manufacturing processes involved.

The workshop will address this by focusing on:

  • Product Design: Acquiring comprehensive knowledge of the product during the formulation development phase.
  • Technology Transfer: Implementing a robust process for transferring this knowledge effectively when scaling up production for commercialization.

Scientific Knowledge and Sound Practices

Harish K Jain, President, Federation of Pharmaceutical Entrepreneurs (FOPE), emphasizes that the success of the pharmaceutical industry hinges on delivering safe, effective, and high-quality products to patients.

This objective can only be achieved through a combination of factors:

  • State-of-the-Art Facilities: Investing in well-equipped facilities for development, manufacturing, and testing of pharmaceuticals.
  • Scientific Expertise: Possessing a deep understanding of the product and the manufacturing processes involved.
  • High-Quality Starting Materials: Using raw materials that meet stringent physical, chemical, and microbiological specifications.
  • Validated Manufacturing Processes & Analytical Methods: Implementing robust and validated processes to ensure consistent batch-to-batch quality with minimal deviations.

By advocating for these practices, CDSCO, IDMA, and KDPMA are working together to elevate the Indian pharmaceutical industry to a new level of quality and patient safety.

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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