SHRESTH: State Health Regulatory Excellence Index

Recently, Ministry of Health and Family Welfare launched the State Health Regulatory Excellence Index (SHRESTH), a first-of-its-kind national initiative to benchmark and strengthen state drug regulatory systems through a transparent, data-driven framework

About SHRESTH – State Health Regulatory Excellence Index

• SHRESTH  is a virtual gap assessment tool to evaluate, rank, and improve state drug regulatory authorities, ensuring medicine safety, quality, and efficacy.
• Implementing Agency: Central Drugs Standard Control Organization (CDSCO)
• Aim: Ensure safety, quality, and efficacy of medicines through a transparent, data-driven framework.

Objectives & Purpose

• Benchmark performance of State Drug Regulatory Authorities.
• Identify gaps via a virtual gap assessment tool; guide states towards maturity certification.
• Ensure uniform standards across manufacturing & distribution states.
• Promote global trust in Indian medicines; align with Pharmacy of the World vision.
• Build on WHO ML3 status for vaccines, extend similar standards to medicines.

Structure of the Index

• State Categories:
  • Manufacturing States – 27 indices across 5 themes:
    • Human Resources
    • Infrastructure
    • Licensing Activities
    • Surveillance Activities
    • Responsiveness
  • Primarily Distribution States/UTs – 23 indices.
• Data Collection:
  • States submit predefined metrics to CDSCO by 25th each month.
  • Scoring done on the 1st of next month; shared with states/UTs.

Significance

• Drug Safety Assurance: Equal quality standards for all citizens, regardless of geography.
• Federal Cooperation: Centre–state collaboration to regulate India’s vast pharma sector.
• Innovation Push: Encourages tech adoption in regulatory systems.
• Global Competitiveness: Supports India’s export credibility in pharma products.

About CDSCO

• CDSCO is India’s National Regulatory Authority (NRA) under the Directorate General of Health Services, Ministry of Health & Family Welfare.
• Headquarters: New Delhi. 
• Key Responsibilities of CDSCO
  • Safety and Quality: Ensures transparency, accountability, and uniformity in services to maintain the safety, effectiveness, and quality of medical products.
  • Approval of New Drugs: Approves new drugs and oversees clinical trials.
  • Standards for Drugs: Establishes standards for drugs and controls the quality of imported drugs.
• Collaboration with State Regulators
  • Licensing: Along with state authorities, CDSCO grants licenses for critical drugs like blood products, vaccines, IV fluids, and sera.
  • Expert Advice: Provides guidance to ensure uniform enforcement of the Drugs and Cosmetics Act across the country.

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