Union Health Ministry Launches SHRESTH – State Health Regulatory Excellence Index

IN NEWS: Union Health Ministry Launches SHRESTH – State Health Regulatory Excellence Index

Analysis

1. Launch and Objective
   • The Union Health Ministry launched SHRESTH (State Health Regulatory Excellence Index) on 12 August 2025, marking a first-of-its-kind national initiative to strengthen state drug regulatory systems.
   • The index aims to benchmark and enhance state-level drug regulation through a transparent, data-driven framework developed by the Central Drugs Standard Control Organization (CDSCO).
2. Purpose and Vision
   • The initiative seeks to ensure the safety, quality, and efficacy of medicines across India — a key component of the Government’s commitment to public health.
   • It is designed as a virtual gap assessment tool, enabling states to evaluate their current systems and progress towards maturity certification in regulatory performance.
3. Structure of the Index
   • States and Union Territories will be divided into two categories:
     • Manufacturing States
     • Primarily Distribution States/UTs
   • Manufacturing States will be assessed on 27 indices across five key themes:
     1. Human Resources
     2. Infrastructure
     3. Licensing Activities
     4. Surveillance Activities
     5. Responsiveness
   • Distribution States/UTs will be evaluated on 23 indices.
4. Data Collection and Evaluation Process
   • States will submit monthly data to CDSCO by the 25th of each month.
   • Data will be scored on the 1st of the following month, and results will be shared with all States and UTs.
   • The process ensures continuous monitoring, accountability, and evidence-based decision-making.
5. Expected Outcomes
   • Targeted improvementsin:
     • Human resources
     • Regulatory infrastructure
     • Digitization of processes
   • Strengthened inspection and surveillance systems, and better grievance responsiveness.
   • Enhanced state-level performance tracking and harmonization of regulatory practices nationwide.
6. Stakeholder Feedback
   • State representatives welcomed SHRESTH, emphasizing that it is not a scorecard but a roadmap for improving drug and medical device regulation.
   • It is expected to foster uniform implementation of the Drugs and Cosmetics Act, promote knowledge sharing, and enable structured collaboration across jurisdictions.
7. Broader Health Governance Context
   • The initiative builds on India’s achievement of WHO ML3 (Maturity Level 3) certification for vaccines.
   • The next milestone, as highlighted by the Union Health Secretary, is to elevate the regulation of medicines to global standards, strengthening India’s position as the “Pharmacy of the World.”
8. Associated Initiatives and Future Plans
   • Extension of the NSQ (Not of Standard Quality) Dashboard to all States.
   • A national symposium on Drug Regulatory Systems.
   • Expansion of joint trainings, audits, and capacity-building workshops.
   • CDSCO to facilitate cross-learning by sharing success stories of top-performing States.
9. Key Remarks
   • Union Health Secretary Smt. Punya Salila Srivastava stressed that ensuring medicine quality is the Government’s commitment to every household in India.
   • She called for continued Centre–State collaboration within India’s federal pharmaceutical regulatory structure.
   • Dr. Rajeev Singh Raghuvanshi, Drug Controller General of India, emphasized the role of SHRESTH in harmonizing regulatory efficiency and strengthening national drug safety assurance.

Static / Background Information

• CDSCO (Central Drugs Standard Control Organization):
  The national regulatory authority under the Ministry of Health and Family Welfare, responsible for approval of drugs, clinical trials, and oversight of drug manufacturing and distribution.
• Drugs and Cosmetics Act, 1940:
  Governs the import, manufacture, distribution, and sale of drugs and cosmetics in India to ensure quality, safety, and efficacy.
• WHO Maturity Level 3 Certification:
  Indicates that a regulatory authority is functioning well and stable, with a consistent system to ensure product quality — achieved by India’s vaccine sector in 2024.
• SHRESTH Index:
  Acronym for State Health Regulatory Excellence Index, a digital framework for performance benchmarking, gap analysis, and capacity building among State and UT drug regulators.

Updated – 12 Aug 2025 ; 7:13 PM | PIB Delhi

Source: PIB