The Union Health Ministry on 12 August 2025 virtually launched the State Health Regulatory Excellence Index (SHRESTH) — a first-of-its-kind national framework to benchmark and strengthen state drug regulatory systems through transparent, data-driven evaluation. The initiative, led by Union Health Secretary Smt. Punya Salila Srivastava in the presence of Dr. Rajeev Singh Raghuvanshi, Drug Controller General of India, has been developed by the Central Drugs Standard Control Organization (CDSCO) with the goal of enforcing consistent drug quality and safety across all states and Union Territories.
Health Secretaries, Principal Health Secretaries, and Drugs Controllers from various states/UTs attended the launch virtually.
“Drug Quality is the Foundation of Citizen Health”
In her address, Smt. Srivastava stressed that the safety, quality, and efficacy of medicines is the starting point of public health:
“Ensuring medicine quality is a commitment of the Government to every home in India. Our federal structure is built to regulate a complex and globally significant pharmaceutical industry — the only way forward is cooperative action.”
She highlighted the role of state regulatory bodies in monitoring quality manufacturing and distribution, calling SHRESTH a “virtual gap assessment tool” that will help states measure their current status and work towards maturity certification. Workshops, seminars, and capacity-building initiatives will be organised to further strengthen state regulatory processes.
Learning from Global Success and Raising Standards
Pointing to India’s achievement of WHO ML3 status for vaccines, the Union Health Secretary said the next step is to bring Indian medicines to the same global benchmark — advancing international harmonisation and reinforcing India’s reputation as the “Pharmacy of the World”.
Upcoming initiatives include:
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Expansion of the Not of Standard Quality (NSQ) Dashboard to all states.
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A national symposium on drug regulatory systems.
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Joint audits, inspections, and training programmes for officials.
SHRESTH Index Framework and Ranking Criteria
Dr. Raghuvanshi announced that states will be classified into:
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Manufacturing States — evaluated across 27 indices under five key themes: Human Resources, Infrastructure, Licensing Activities, Surveillance Activities, and Responsiveness.
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Primarily Distribution States/UTs — evaluated on 23 indices across similar parameters.
Data on predefined metrics will be uploaded by states to CDSCO by the 25th of every month, scored on the 1st of the next month, and shared with all stakeholders for transparency and cross-learning.
State Feedback and Unified Regulatory Vision
State representatives welcomed the initiative, noting that the SHRESTH Index will:
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Harmonise regulatory processes nationwide.
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Encourage adoption of best practices and technology innovation.
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Provide a roadmap rather than a one-time scorecard for continuous improvement.
Uniform implementation of the Drugs and Cosmetics Act, structured knowledge sharing, and regular cross-state collaboration were identified as key enablers.
Driving Targeted Improvements for All Indians
The SHRESTH Index aims to drive improvements in:
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Human resource capacity
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Infrastructure
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Digitisation of processes
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Surveillance and inspection rigor
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Citizen grievance responsiveness
Top-performing states’ success stories will be documented and shared by the CDSCO to promote collaborative growth and replication of effective models.
Conclusion: A Transparent Roadmap to Drug Safety Excellence
The launch of SHRESTH represents a transformative step in India’s public health governance — one that consolidates federal and state-level efforts to ensure medicines are safe, effective, and accessible for every Indian, regardless of geography. By aligning policy, data-driven assessment, and cooperative governance, SHRESTH is set to strengthen India’s drug regulatory ecosystem and fortify its global leadership in pharmaceuticals.
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Source: PIB
