Prelims - Current events of national and international importance | Government policies and interventions.
Why in News?
Recently, the Union Health Ministry launched SHRESTH to strengthen the drug regulatory system.
- It is a first-of-its-kind national initiative to evaluate and improve state drug regulatory authorities, ensuring drug safety and quality standards are consistently met.
- It is a virtual gap assessment tool for states to assess their current position and help towards maturity certification.
- Need – To guarantee the safety, quality, and effectiveness of medicines for every citizen.
- To reinforce state-level drug regulatory systems that play a vital role in managing India’s vast and complex pharmaceutical sector.
- Proposed by – Central drugs standard control organizations (CDSCO).
- Objective – To drive improvements in the performance of state drug regulatory authorities across India.
- To ensure drug safety and quality standards.
- To enable improvements in human resources, infrastructure and digitization across states.
- 2 categories of ranking
- Manufacturing states.
- Primary Distribution States/UTs.
- Themes – Manufacturing States across 5 key themes.
- Human Resources, Infrastructure, Licensing Activities, Surveillance activities and Responsiveness.
- Ranking Methodology – It has 27 indices in manufacturing states and 23 indices in primarily distribution states.
- Significance – Emphasizing the role of stakeholders in ensuring the health of all citizens and safeguarding the efficacy of drugs and medical products.
- Acts as a roadmap for states to assess and improve their regulatory maturity and harmonization of regulatory systems across the country.
Other Upcoming Initiatives
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Capacity building workshops and seminars
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Organized to strengthen the states regulatory processes.
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Not of Standard Quality (NSQ)
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Dashboard to all states to monitor
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Symposium on Drugs Regulatory Systems
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Discuss and enhance states drug regulatory systems.
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Expansion of joint trainings and audits.
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Coordinate training sessions and joint audits involving multiple states.
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Quick facts
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Central Drugs Standard Control Organization (CDSCO)
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- The CDSCO is a National Regulatory Authority (NRA) under directorate general of health service, Ministry of Health & Family welfare.
- It envisages uniform implementation of the provisions of the Act & Rules made there under for ensuring the safety, rights and wellbeing of the patients by regulating the drugs and cosmetics.
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Reference
PIB| SHRESTH Drug Regulator System
