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SHRESTH – State Health Regulatory Excellence Index

13 Aug 2025 GS 3 Reports & Indexes
SHRESTH – State Health Regulatory Excellence Index Click to view full image

1. Overview

  • Launched by: Union Health Ministry (12 Aug 2025)

  • Proposed by: Central Drugs Standard Control Organization (CDSCO)

  • Nature: First-of-its-kind national benchmarking initiative for state drug regulatory systems.

  • Purpose:

    • Strengthen & harmonize drug regulation across states

    • Ensure safety, quality, and efficacy of medicines for all citizens

    • Provide transparent, data-driven evaluation

    • Act as a roadmap, not just a scorecard

2. Key Features

  • Virtual Gap Assessment Tool → Helps states assess current status & move toward maturity certification.

  • Two Categories for Ranking:

    1. Manufacturing States – 27 indices under 5 themes:

      • Human Resources

      • Infrastructure

      • Licensing Activities

      • Surveillance Activities

      • Responsiveness

    2. Primarily Distribution States/UTs – 23 indices under similar themes.

  • Data Collection:

    • States submit metrics to CDSCO by 25th of each month

    • Scoring done on 1st of next month

    • Results shared with all States/UTs

3. Expected Benefits

  • Improved Human Resources, Infrastructure, Digitization in regulatory systems

  • Uniform Implementation of the Drugs & Cosmetics Act

  • Promotion of cross-learning & sharing of best practices

  • Boost to drug safety, ensuring Indian medicines are trusted domestically & globally

  • Support for India’s goal to match WHO ML3 status (already achieved for vaccines) in medicines

4. Additional Initiatives Announced

  • Extension of Not of Standard Quality (NSQ) Dashboard to all states

  • Symposium on Drug Regulatory Systems

  • Expansion of joint trainings & audits

  • Capacity-building workshops & seminars for states


Central Drugs Standard Control Organisation (CDSCO) 

Overview

  • National regulatory body for cosmetics, pharmaceuticals, and medical devices in India.

  • Equivalent to:

    • US Food and Drug Administration (FDA)

    • EU European Medicines Agency (EMA)

Current Development

  • Govt. plans to bring all medical devices (including implants and contraceptives) under CDSCO review.

Organisational Structure

  • Drug Controller General of India (DCGI) – Head of CDSCO.

    • Under: Ministry of Health & Family Welfare.

    • Advised by:

      1. Drug Technical Advisory Board (DTAB)

      2. Drug Consultative Committee (DCC)

Functions

  • Pre-licensing and post-licensing inspections.

  • Post-market surveillance of drugs and devices.

  • Drug/device recalls when required.

  • Ensures safety, efficacy, and quality standards.

Import or manufacture for sale of drugs including vaccines are regulated under 
  • Drugs and Cosmetics Act, 1940 and 
  • Drugs & cosmetics Rules, 1945 and 
  • New Drugs and Clinical Trials Rules, 2019.

  • CDSCO (Central Drugs Standard Control Organization) registration is mandatory for selling medical devices in India, encompassing both manufacturing and import. 

  • CDSCO (Central Drugs Standard Control Organization) license is mandatory for selling Class C and Class D medical devices in India, effective October 1, 2023. This includes both manufacturing and import licenses. 

Zonal Offices

  • Spread across India – handle regional licensing and inspection duties.

  • CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.

Role of Manufacturers

  • Foreign manufacturers must appoint an Authorised Indian Representative (AIR) for dealings with CDSCO.




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