Union Health Secretary Smt. Punya Salila Srivastava unveiled the State Health Regulatory Excellence Index (SHRESTH), an innovative national initiative by CDSCO designed to benchmark and enhance state drug regulatory systems, with the goal of ensuring the safety, quality, and effectiveness of medicines for every citizen.
Highlights:
- SHRESTH: pioneering index designed to evaluate and enhance state drug regulatory systems.
- Developed by CDSCO to promote uniform standards in drug safety and quality.
- Index includes 27 parameters for manufacturing states and 23 for distribution states.
- Monthly data submission and scoring to track and enhance performance.
- Promotes cooperative Centre–State action and global harmonization.
- Aims to elevate India’s pharmaceutical standards to WHO benchmarks.
The Union Health Ministry has unveiled a landmark initiative to bolster India’s drug regulatory systems with the launch of the State Health Regulatory Excellence Index (SHRESTH). Virtually launched by Union Health Secretary Smt. Punya Salila Srivastava in the presence of Dr. Rajeev Singh Raghuvanshi, Drug Controller General of India, SHRESTH aims to provide a transparent, data-driven framework for evaluating and improving state drug regulatory authorities.
Proposed by the Central Drugs Standard Control Organization (CDSCO), the five-theme index will assess states on parameters such as human resources, infrastructure, licensing activities, surveillance measures, and responsiveness. Manufacturing states will be evaluated on 27 indices, while primarily distribution states/UTs will be assessed on 23. States will submit data monthly, with CDSCO scoring and sharing results to foster healthy competition and knowledge exchange.
Highlighting the index’s importance, Smt. Srivastava emphasized that medicine quality underpins the nation’s health and called for stronger Centre–State collaboration. She noted that SHRESTH serves as a “virtual gap assessment tool” to help states progress toward maturity certification and achieve uniform regulatory excellence.
Drawing attention to India’s WHO ML3 status for vaccines, she stressed that the next goal is elevating medicines to similar global standards, reinforcing India’s standing as the “Pharmacy of the World.” The initiative will also include capacity-building workshops, expansion of the Not of Standard Quality (NSQ) Dashboard, and joint trainings.
Dr. Raghuvanshi explained that the SHRESTH Index is not merely a scorecard but a roadmap, promoting harmonized implementation of the Drugs and Cosmetics Act, innovation in technology, and sharing of best practices. Representatives from states welcomed the initiative, recognizing its potential to standardize processes and enhance drug safety nationwide.
With structured evaluation, cross-learning opportunities, and regular tracking, SHRESTH marks a decisive step toward ensuring that every Indian, regardless of geography, has access to safe, effective, and high-quality medicines.
