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State Health Regulatory Excellence Index (SHRESTH)
Context: The Union Health Ministry has launched the State Health Regulatory Excellence Index (SHRESTH) proposed by the Central Drugs Standard Control Organisation (CDSCO), this initiative aims to ensure that drug safety, quality, and efficacy are upheld uniformly across India, in line with the nation’s role as the “Pharmacy of the World.”
What is SHRESTH?
SHRESTH (State Health Regulatory Excellence Index) is a virtual, data-driven benchmarking tool designed to evaluate and improve the maturity of State and Union Territory drug regulatory authorities.
- It assesses states on human resources, infrastructure, licensing, surveillance, and responsiveness.
- States are divided into Manufacturing States (27 indices) and Primarily Distribution States/UTs (23 indices).
- Data will be submitted monthly by states to CDSCO and scored to monitor progress.
How will it track the progress of state drug regulatory systems?
- Monthly Data Submission: States submit predefined metrics by the 25th of each month.
- Centralised Scoring: CDSCO scores them on the 1st of the following month.
- Parameters: Lab testing capacity, digitalisation of approvals, inspection rigour, grievance responsiveness.
- Feedback Loop: Performance results shared with all states to encourage improvements.
Why is such an index important?
- India’s pharmaceutical industry is globally significant but regulated under a federal structure with varied capacity across states.
- Ensures uniform implementation of the Drugs and Cosmetics Act.
- Facilitates cross-learning and harmonisation of regulatory processes.
- Helps meet global benchmarks like WHO standards for medicines (already achieved for vaccines).
How will it bolster the quality drug ecosystem in India?
- Strengthens State Capacities: Targets HR gaps, infrastructure upgrades, and digitisation.
- Promotes Accountability: Transparent scoring drives performance improvement.
- Improves Public Health: Ensures citizens nationwide have access to safe and effective medicines.
- Supports Export Credibility: Enhances trust in Indian pharmaceuticals globally.
- Encourages Innovation: Streamlined processes enable faster adoption of new technologies.
