Last Updated on December 31, 2023 by The Health Master
Chintan Shivir Highlights
The Union Health Minister, Mansukh Mandaviya, has emphasised the crucial importance of ensuring that medicines and medical devices produced in India are of the highest quality.
Speaking at the ‘Drugs: Quality Regulations and Enforcement‘ conclave in Hyderabad, Mandaviya said that both the Centre and states should work together to establish robust regulatory systems to achieve India’s vision of being known as the world’s most respected and recognised drugs regulator.
Introduction
- India is a major producer of pharmaceuticals in the world
- Concerns about the quality of some of India’s medicines and medical devices
- Need for a more robust regulatory system to ensure safety and efficacy
The ‘Drugs: Quality Regulations and Enforcement’ Conclave
- Two-day brainstorming conclave in Hyderabad
- Health secretaries and drug regulators from various states and union territories participated
- Aimed to build a robust, resilient, transparent, accountable and citizen-friendly drugs regulatory framework
Also read: ‘Chintan Shivir’ to be held with focus on Drug Quality Regulation and Enforcement
Moving to Quality-Generic Production
- Need to move from generic to quality-generic drugs and medical devices production
- Ensuring high-quality products for both domestic and export markets
- Focus on establishing robust regulatory systems that meet the needs of research and development, innovation, organisation strengthening and capacity enhancement
Quality by Design Approach to Manufacturing
- Importance of a quality by design approach to manufacturing
- Building quality into the design of the product
- Ensuring that the product is consistently of high quality for patient safety and confidence in the healthcare system
Technology’s Role in Regulatory Systems
- Role of technology in facilitating and enabling uniformity, transparency and accountability in the regulatory system
- Uniform portal with a national database with integrated legacy systems discussed
- Ensuring that the regulatory system is accessible and easy to use for all stakeholders
India’s Vision
- India’s vision is to be known as the world’s most respected and recognised drugs regulator
- The Centre and states need to work together to establish a regulatory system that is inclusive, holistic, and comprehensive
- System should set the vision and meet the requirements of the next 25 years on the three levels of policy, priorities, and implementation
Key points:
- The two-day brainstorming conclave aimed to build a robust, resilient, transparent, accountable and citizen-friendly drugs regulatory framework.
- The regulatory system should meet the needs of research and development, innovation, organisation strengthening and capacity enhancement, and “quality by design” should be the motto.
- India needs to move from generic to quality-generic drugs and medical devices production to achieve its vision.
- Discussions at the conclave highlighted the importance of making the country’s drug regulatory systems transparent, predictable, and verifiable through principles of uniform standards.
- Technology can play the role of a facilitator and enabler for uniformity, transparency and accountability.
- The need for a uniform portal with a national database with integrated legacy systems was also discussed.
Conclusion
- Implementation of recommendations is crucial to ensure safety and efficacy of drugs and medical devices produced in India
- India’s ambition to become the world’s most respected and recognised drugs regulator requires a concerted effort from all stakeholders
- The ‘Drugs: Quality Regulations and Enforcement‘ conclave was a significant step in building a regulatory framework that ensures the quality, availability and accessibility of high-quality drugs and medical devices across the country.
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