State Health Regulatory Excellence Index
The Union Health Ministry launched the State Health Regulatory Excellence Index (SHRESTH) in 2025. This new initiative benchmarks state drug regulatory systems to ensure the safety and quality of medicines across India. The index uses a transparent and data-driven framework to promote uniform regulatory standards. It marks step towards strengthening drug regulation in the country.
Purpose
- SHRESTH is introduced by the Central Drugs Standard Control Organization (CDSCO).
- It aims to improve the performance of state drug regulatory authorities.
- The focus is on drug safety, quality, and efficacy.
- The initiative supports India’s commitment to providing safe medicines to every home.
- It also aligns with India’s global role as the Pharmacy of the World.
Framework and Categories
States and Union Territories are divided into two groups:
- Manufacturing States and Primarily Distribution States. Manufacturing States are evaluated on 27 indices across five themes
- Human Resources, Infrastructure, Licensing Activities, Surveillance Activities, and Responsiveness. Distribution States are assessed on 23 indices.
- Data is submitted monthly to CDSCO for scoring and feedback.
Key Themes and Metrics
The index covers critical aspects of drug regulation. These include the strength of human resources, quality of infrastructure, licensing efficiency, surveillance rigor, and grievance responsiveness. Digitisation of approvals and lab testing capabilities are also assessed. This ensures a comprehensive view of each state’s regulatory maturity.
Role of Centre-State Collaboration
The initiative stresses cooperative federalism. The regulatory excellence requires joint efforts. States are encouraged to share best practices and innovate. The index acts as a gap assessment tool, helping states improve and achieve maturity certification.
Capacity Building and Future Plans
Capacity building workshops and seminars will support states in strengthening regulatory processes. The NSQ (Not of Standard Quality) Dashboard will be expanded nationwide. A symposium on Drug Regulatory Systems and joint trainings are planned. These steps aim to harmonise drug regulation across India.
Benefits and Impact
SHRESTH promotes uniform implementation of the Drugs and Cosmetics Act. It encourages cross-learning and collaboration among states. The index is not a scorecard but a roadmap for progress. It will improve human resources, infrastructure, and digitisation. Ultimately, it guarantees drug safety for all Indian citizens regardless of location.
Stakeholder Engagement
The launch included participation from Health Secretaries and Drug Controllers from various states. Representatives appreciated the index’s role in harmonising regulatory processes. CDSCO will share success stories from top-performing states. This will encourage knowledge transfer and innovation in regulation.
| Related | |
|---|---|
