Gujarat FDCA Equips Pharma Industry for Revised Schedule M

Dr. H G Koshia, Commissioner of Gujarat FDCA, emphasized the urgency of this initiative.


Last Updated on June 28, 2024 by The Health Master

Gujarat FDCA

Gujarat FDCA: The Indian pharmaceutical industry is a global powerhouse, but maintaining compliance with international quality standards is crucial for sustained success.

To address this, the Gujarat Food and Drug Control Administration (Gujarat FDCA) has taken a significant step forward.

Extensive Training Programs

2,000 Manufacturers Equipped:

Through a series of training programs across Vadodara, Ahmedabad, and Gandhinagar, the Gujarat FDCA has successfully equipped over 2,000 manufacturers, primarily MSMEs (Micro, Small and Medium Enterprises), to implement the revised Schedule M guidelines.

Collaboration for Knowledge Sharing:

The FDCA partnered with the Indian Drug Manufacturers Association (IDMA) Gujarat Chapter to train 300 manufacturers on effective implementation.

Building a Quality Culture:

The Central Drugs Standard Control Organisation (CDSCO) also conducted workshops in 2023 to promote understanding of the new guidelines.

Importance of Revised Schedule M Compliance

Maintaining Global Credibility:

Dr. H G Koshia, Commissioner of Gujarat FDCA, emphasized the urgency of this initiative. He stated, “Implementing the revised norms is essential to uphold India’s reputation as the ‘Pharmacy of the World.”

This ensures adherence to evolving international regulations for developed and developing markets.

Gujarat: A Leader in Pharmaceutical Manufacturing

Highest Number of WHO-GMP Units:

Gujarat boasts the highest number of WHO-GMP certified units (over 1,081) and USFDA approved units (140) in the country.

MSME Focus:

India has around 10,500 manufacturing units, with 8,500 falling under the MSME category. Notably, 2,000 MSME units hold WHO-GMP certification, highlighting India’s strength in this sector.

CDSCO’s Proactive Approach

The CDSCO has actively supported this initiative by conducting:

  • 23 Training Programs: These programs, held over the past year, covered critical aspects like risk-based inspections, legal actions, adoption of new therapies, and leveraging Industry 4.0 technologies.
  • 1,100 Regulators Trained: These training sessions have effectively enhanced regulatory efficacy and adherence to the revised Schedule M.

Key Provisions of Revised Schedule M

Regulatory experts have highlighted the following key requirements introduced by the revised Schedule M:

  • Batch Record Review: More stringent review processes ensure accurate record-keeping.
  • Stability Studies: Enhanced focus on stability testing guarantees product quality over time.
  • Computerized Systems: Implementation of robust computer systems streamlines data management and analysis.

Benefits of Revised Schedule M

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

  • Compliance with Drug Standards: Stricter regulations ensure the safety and efficacy of manufactured drugs.
  • Export Promotion: Meeting international standards facilitates smoother exports to global markets.
  • Building Trust in Quality: Enhanced quality control builds trust in Indian-manufactured drugs.

Industry-Centric Measures

The pharmaceutical industry has welcomed the revised Schedule M, particularly provisions like:

  • Retesting Expired APIs: This allows for the utilization of safe, previously expired active ingredients after retesting.
  • Annual Product Quality Review (PQR): Regular reviews ensure continuous improvement in product quality.
  • Quality Risk Management (QRM): Proactive risk management helps identify and address potential quality issues.

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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