State Health Regulatory Excellence Index (SHRESTH)

The Union Health Secretary recently launched the State Health Regulatory Excellence Index (SHRESTH), a groundbreaking initiative aimed at enhancing the performance of state drug regulatory systems in India.

About SHRESTH

• First-of-its-kind: SHRESTH is a national initiative designed to benchmark and strengthen state drug regulatory authorities through a transparent and data-driven framework.

• The initiative has been proposed by the Central Drugs Standard Control Organization (CDSCO) and focuses on ensuring drug safety and maintaining quality standards across the country.

Key Features of SHRESTH

1. Evaluation Framework: The index evaluates state regulatory systems based on 27 indices for Manufacturing States and 23 indices for Primarily Distribution States. These indices cover five key themes:

   • Human Resources

   • Infrastructure

   • Licensing Activities

   • Surveillance Activities

   • Responsiveness

   Data Collection & Scoring:

   • States are required to submit data on predefined metrics to the CDSCO by the 25th of every month.

   • The data will be scored by the 1st of the next month and shared with all states and UTs to foster transparency and competition.

   Virtual Gap Assessment: SHRESTH functions as a virtual gap assessment tool, helping states assess their current position and guiding them toward maturity certification in terms of regulatory excellence.

Significance of SHRESTH

• Targeted Improvements: The initiative aims to bring about targeted improvements in human resources, infrastructure, and digitization across states.

• Ensuring Drug Safety: Ultimately, SHRESTH ensures that drug safety is guaranteed for all Indians, regardless of geography, making sure the drugs they consume meet consistent safety and quality standards.

This initiative is a significant step towards improving the drug regulatory ecosystem in India, promoting better governance and accountability within the healthcare sector.