Last Updated on October 12, 2024 by The Health Master
Regulators
Regulators: The Indian pharmaceutical industry is a global leader, and to maintain this position, ensuring the quality and safety of drugs is paramount.
The Central Drugs Standard Control Organisation (CDSCO) is taking a proactive step towards this goal by launching a series of impactful training initiatives for regulators.
Equipping Regulators with Advanced Skills
21 Training Programs in 2024-25:
The CDSCO plans to roll out an extensive program consisting of:
- 9 residential training programs,
- 6 regional programs, and
- 6 national workshops.
These programs aim to equip regulators with advanced skills in crucial areas:
Risk-Based Inspections:
This approach focuses on identifying and prioritizing high-risk areas for more thorough inspections, optimizing resource allocation and ensuring drug safety.
Good Manufacturing Practices (GMPs):
Regulators will be trained to ensure pharmaceutical companies adhere to the latest GMP standards outlined in Schedule M, promoting quality and consistency in drug manufacturing.
New Therapy Adoption:
The program will cover the intricacies of evaluating and regulating new, innovative drug therapies, ensuring patient access to safe and effective treatments.
Industry 4.0 Technologies:
Regulators will learn how to leverage advancements in automation and data analysis for efficient inspections and data-driven regulatory decision-making.
Building on Past Success
This initiative builds upon the success of the 23 training programs conducted in collaboration with the Indian Drugs Manufacturers’ Association (IDMA) last year.
Over 3,200 participants attended in person, with an additional 20,000+ viewers attending virtually.
These programs focused on critical aspects including:
- Risk-based inspections
- Launching prosecutions against non-compliant manufacturers
- Effective implementation of the revised Schedule M
Modernizing Schedule M for a Competitive Future
The revised Schedule M, notified by the Government of India in 2018, aligns India’s GMP standards with those of the World Health Organization (WHO).
This ensures:
Enhanced Drug Quality:
Stricter regulations ensure higher manufacturing standards, leading to safer and more effective drugs for patients.
Boosted Exports:
Compliance with international standards paves the way for increased export opportunities for Indian pharmaceutical companies.
Innovation Promotion:
A robust regulatory framework fosters a climate of innovation in drug development.
Building Trust:
Strong regulations inspire confidence in the quality of drugs manufactured and sold in India.
Implementation Timeline
- Larger Companies (Turnover > Rs. 250 Crore): Required to implement the revised Schedule M within 6 months.
- Medium & Small Enterprises (Turnover < Rs. 250 Crore): Given a timeframe of one year for implementation.
The CDSCO’s training initiatives and the revised Schedule M demonstrate the Indian government’s commitment to maintaining India’s position as a global leader in high-value drug manufacturing and ensuring patient access to safe and effective medications.
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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