SHRESTH – State Health Regulatory Excellence Index

IN NEWS: SHRESTH – State Health Regulatory Excellence Index

Introduction

The Union Health Ministry has launched SHRESTH (State Health Regulatory Excellence Index) as a first-of-its-kind national initiative to benchmark and strengthen state drug regulatory systems through a transparent, data-driven framework. Proposed by the Central Drugs Standard Control Organization, the index aims to ensure uniform drug safety, quality, and efficacy across India by enhancing the performance of state regulatory authorities.

ANALYSIS

1. Background and Rationale

The initiative emerges from the need to ensure that drug safety is consistent across all states, given India’s position as the “Pharmacy of the World.” The Union Health Secretary emphasized that citizens’ health begins with safe and effective medicines, making regulatory strengthening a national priority.SHRESTH reflects a shift from fragmented oversight to a coordinated, measurable, and accountable regulatory framework across states.

2. Key Features of SHRESTH

• Virtual Gap Assessment Tool: Helps states evaluate their current regulatory capacity and move towards maturity certification.
• Data-driven Ranking: States/UTs submit monthly data to CDSCO (by 25th), with scoring on the 1st of every month.
• Two Categories of States:

• Indices Framework:
  • 27 indicators for Manufacturing States
  • 23 indicators for Distribution States
• Five Key Themes (Manufacturing States):
  • Human Resources
  • Infrastructure
  • Licensing Activities
  • Surveillance Activities
  • Responsiveness

3. Institutional Mechanism

The index is implemented under the aegis of CDSCO, with Centre–State collaboration being central. States’ performance will be continuously monitored, encouraging cooperative federalism and competitive benchmarking.

4. Associated Initiatives

• Expansion of Not of Standard Quality (NSQ) Dashboard
• Proposed symposium on Drug Regulatory Systems
• Increased capacity-building workshops and joint audits
• Strengthening digitization of approvals and licensing systems

5. Significance and Implications

• Improved Drug Safety: Ensures uniform quality of medicines nationwide
• Capacity Enhancement: Targets improvements in HR, infrastructure, and digitization
• Regulatory Harmonization: Aligns diverse state systems into a cohesive framework
• Global Credibility: Builds on India’s WHO ML3 certification for vaccines, aiming similar standards for medicines
• Citizen-centric Governance: Guarantees safe medicines regardless of geography

Importantly, SHRESTH is not merely a ranking tool but a roadmap, enabling evidence-based policy interventions and fostering best-practice sharing among states.

STATIC PART

Central Drugs Standard Control Organization (CDSCO)

• Established: 1961 (under Drugs and Cosmetics Act framework)
• Headquarters: New Delhi
• Head: Drug Controller General of India (DCGI)
• Functions:
  • Approval of new drugs and clinical trials
  • Regulation of drug standards and quality
  • Coordination with State Drug Control Organizations
  • Ensuring safety, efficacy, and quality of pharmaceuticals

Conclusion

SHRESTH represents a transformative governance reform in India’s public health ecosystem. By integrating technology, transparency, and cooperative federalism, it strengthens regulatory capacity and ensures that drug safety becomes a guaranteed right for every citizen, while reinforcing India’s global pharmaceutical leadership.

Updated - 12 August 2025 ; 7:13 PM | PIB

News Source: Press Information Bureau , All India Radio News