Gujarat FDCA and IDMA Join Forces for GMP Compliance Training

Dr. H.G. Koshia, Commissioner of Gujarat FDCA, emphasizes the urgency of GMP compliance.

May 20, 2024

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Last Updated on May 28, 2024 by The Health Master

Gujarat FDCA

To compliance with international quality standard, the Gujarat Food and Drug Control Administration (Gujarat FDCA) and the Indian Drug Manufacturers Association (IDMA) Gujarat Chapter have launched a significant training program.

This initiative targets 300 Gujarat-based pharmaceutical manufacturers, focusing on the effective implementation of the Revised Schedule M Guidelines.

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Why is this Training Initiative Important?

Maintaining Credibility as the “Pharmacy of the World”:

Dr. H.G. Koshia, Commissioner of Gujarat FDCA, emphasizes the urgency of this program.

He highlights the need to equip manufacturers with the knowledge to implement the revised norms.

This ensures India upholds its reputation as a reliable source of high-quality pharmaceuticals.

Meeting Evolving International Regulations:

The Central Drugs Standard Control Organisation (CDSCO) has actively conducted training programs for regulators.

This collaborative effort between FDCA and IDMA ensures manufacturers stay updated on the changing international regulatory landscape, enabling them to cater to both developing and developed markets.

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What are the Revised Schedule M Guidelines?

The revised Schedule M, notified in October 2018, aims to achieve three key objectives:

Ensuring Drug Quality:

The guidelines establish stricter standards for drug manufacturing, promoting better quality control measures.

Promoting Pharmaceutical Exports:

By adhering to these guidelines, Indian manufacturers can ensure their products meet international standards, facilitating smoother exports.

Building Trust in Indian Pharmaceuticals:

The emphasis on quality strengthens trust in Indian-made drugs, both domestically and internationally.

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Key Requirements and Deadlines

The Union Health Ministry has mandated stricter compliance deadlines based on company size:

Large Pharmaceutical Companies (Turnover > Rs. 250 Crore): Must achieve WHO-GMP certification within six months.
Medium and Small-Scale Enterprises: Have a 12-month window for compliance.

A More Comprehensive Approach to Quality Assurance

The revised norms redefine “Good Manufacturing Practices” (GMP) as “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products.”

This broader term reflects a more holistic approach to quality assurance, encompassing all aspects of the production process.

Strengthening India’s Pharmaceutical Leadership

Dr. Koshia concludes by expressing optimism about the initiative’s impact.

He believes this collaboration will significantly enhance the quality and credibility of India’s pharmaceutical exports, solidifying the nation’s position as a global leader in the industry.

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