NEWS – The Union Health Ministry has launched the State Health Regulatory Excellence Index (SHRESTH) to benchmark and strengthen state drug regulatory systems through a transparent, data-driven framework. Developed by the Central Drugs Standard Control Organization (CDSCO), SHRESTH aims to ensure drug safety, quality, and efficacy across India.

HIGHLIGHTS

Purpose & Significance

• Ensures safety, quality, and efficacy of medicines — a key government commitment.
• Acts as a virtual gap assessment tool for states to evaluate current capacities and progress toward maturity certification.
• Focuses on human resources, infrastructure, and digitization to guarantee safe drugs nationwide.

Structure of SHRESTH Index

• Two categories:
  1. Manufacturing States – 27 indices across Human Resources, Infrastructure, Licensing, Surveillance, and Responsiveness.
  2. Primarily Distribution States/UTs – 23 indices.
• Monthly data submission to CDSCO; scoring and feedback on the 1st of each month.

Expected Benefits

• Targeted improvements in state regulatory systems.
• Harmonization of regulatory processes across India.
• Promotion of best practices, technology innovation, and uniform implementation of the Drugs and Cosmetics Act.

Stakeholder Involvement

• Launch attended virtually by Health Secretaries, Drugs Controllers, and senior officials.
• Emphasis on centre–state collaboration in regulating India’s large pharmaceutical industry.
• States acknowledged SHRESTH as a roadmap, not merely a scorecard.

Future Plans

• Extension of the Not of Standard Quality (NSQ) Dashboard to all states.
• Symposium on Drug Regulatory Systems.
• Expansion of joint trainings, audits, and structured knowledge-sharing platforms.

Global Context

• Builds on India’s WHO ML3 vaccine status with an aim to raise medicine standards to similar global benchmarks.
• Reinforces India’s role as the “Pharmacy of the World” through international harmonization.