The State Health Regulatory Excellence Index (SHRESTH), launched by the Union Health Ministry in 2025, marks a significant step towards strengthening India’s drug regulatory framework. This innovative initiative benchmarks state drug regulatory systems to ensure the safety, quality, and efficacy of medicines across the country. Designed as a transparent and data-driven framework, SHRESTH aims to promote uniform regulatory standards and reinforce India’s global reputation as the “Pharmacy of the World.”
Purpose of the State Health Regulatory Excellence Index
Introduced by the Central Drugs Standard Control Organization (CDSCO), the State Health Regulatory Excellence Index is a visionary effort to enhance the performance of state drug regulatory authorities. The initiative primarily focuses on drug safety, quality, and efficacy, ensuring that every Indian household has access to safe medicines. By standardising regulatory practices, SHRESTH aligns with the government’s broader vision of a robust, accountable, and modern pharmaceutical ecosystem.
The index is also a reflection of India’s commitment to global health standards. With increasing pharmaceutical exports, the country’s ability to maintain high-quality regulatory oversight is crucial. SHRESTH not only benchmarks state performance but also provides actionable insights for continual improvement.
Framework and Categories
Under the State Health Regulatory Excellence Index, states and Union Territories are categorised into two groups:
- Manufacturing States – These are assessed across 27 indices covering five key themes: Human Resources, Infrastructure, Licensing Activities, Surveillance Activities, and Responsiveness.
- Primarily Distribution States – Evaluated on 23 indices, these states focus on ensuring drug safety during distribution.
Data is submitted monthly to the CDSCO, allowing real-time scoring and feedback. This approach enables states to monitor progress and take corrective action promptly.
Key Themes and Metrics
The index covers critical dimensions of drug regulation. Key aspects include the strength and competency of human resources, quality of regulatory infrastructure, efficiency in licensing procedures, rigour in surveillance activities, and responsiveness to grievances. Additional metrics such as digitisation of approvals and lab testing capabilities offer a comprehensive view of each state’s regulatory maturity.
By incorporating these metrics, the State Health Regulatory Excellence Index ensures that regulatory improvements are measurable, targeted, and aligned with national and international standards.
Role of Centre-State Collaboration
A unique feature of SHRESTH is its emphasis on cooperative federalism. Effective drug regulation requires seamless collaboration between the Centre and the states. The index encourages states to share best practices, foster innovation, and collectively raise regulatory standards. Acting as a gap assessment tool, SHRESTH helps states identify weaknesses and achieve maturity certification, thereby ensuring that regulatory excellence becomes a nationwide goal rather than an isolated achievement.
Capacity Building and Future Plans
To support states in achieving regulatory maturity, the initiative will include capacity-building workshops, seminars, and joint training programs. The Not of Standard Quality (NSQ) Dashboard will be expanded nationwide, providing a comprehensive platform for monitoring drug quality. Furthermore, a symposium on Drug Regulatory Systems will encourage discussion, knowledge sharing, and innovation in regulatory practices.
Benefits and Impact
The State Health Regulatory Excellence Index promotes uniform implementation of the Drugs and Cosmetics Act while facilitating cross-learning among states. Far from being a mere scorecard, SHRESTH acts as a roadmap for progress, helping improve human resources, infrastructure, and digitisation. The ultimate impact is a safer pharmaceutical environment for all citizens, regardless of location.
Stakeholder Engagement
The launch of SHRESTH saw participation from Health Secretaries and Drug Controllers from across India. Representatives appreciated the index’s potential to harmonise regulatory processes, and CDSCO plans to highlight success stories from top-performing states. This knowledge transfer will encourage continuous improvement and innovation, ensuring that India’s regulatory standards remain world-class.
In conclusion, the State Health Regulatory Excellence Index represents a transformative step for India’s pharmaceutical governance. By combining data-driven evaluation with collaborative strategies, SHRESTH promises not only safer medicines but also a modern, transparent, and accountable drug regulatory system that can serve as a model for the world.
