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Context:
The Union Ministry of Health & Family Welfare, through the Central Drugs Standard Control Organization (CDSCO), has launched SHRESTH – the State Health Regulatory Excellence Index, India’s first national framework to benchmark and strengthen state drug regulatory systems via transparent, data-driven evaluation.
Key Highlights:
- What is SHRESTH?
- A virtual gap assessment tool to evaluate, rank, and improve state/UT drug regulatory authorities.
- Ensures medicine safety, quality, and efficacy in line with WHO standards.
- Objectives
- Benchmark state drug regulatory systems.
- Target improvements in human resources, infrastructure, and digitisation.
- Enhance public trust in medicines made and distributed in India.
- Evaluation Criteria
- Manufacturing States: 27 indicators under 5 themes – Human Resources, Infrastructure, Licensing, Surveillance, Responsiveness.
- Distribution States/UTs: 23 indicators under the same themes.
- Monthly: States submit data to CDSCO → scored → feedback loop.
- Key Features
- Two-tier categorisation: Manufacturing States & Distribution States/UTs.
- Continuous improvement via monthly rankings and updates.
- WHO-aligned to move towards ML3-equivalent global standards.
- Cross-learning platform for sharing success stories.
- Regulatory harmonisation for uniform Drugs & Cosmetics Act enforcement across India.
