In a landmark step towards enhancing drug safety and quality across the country, a pioneering national initiative - State Health Regulatory Excellence Index (SHRESTH) - aimed at benchmarking and bolstering the performance of state drug regulatory authorities has been launched by the Union Health Ministry.
The transparent data driven index was virtually launched by Union Health Secretary Punya Salila Srivastava in the presence of Dr. Rajeev Singh Raghuvanshi, Drug Controller General of India (DCGI) among others, at an event held in the national capital.
Conceived by the Central Drugs Standard Control Organization (CDSCO), SHRESTH seeks to foster uniformity and efficiency in the regulation of pharmaceutical manufacturing and distribution at the state level, thereby ensuring that stringent quality and safety standards are upheld consistently.
Under this innovative framework, states will be categorised as either Manufacturing States or Primarily Distribution States/Union Territories and ranked accordingly. The index incorporates 27 performance parameters for Manufacturing States spanning five critical domains — Human Resources, Infrastructure, Licensing Activities, Surveillance Activities, and Responsiveness — while Primarily Distribution States will be evaluated on 23 indices.
Speaking on the occasion, Srivastava underscored the imperative of centre-state synergy in regulating India’s vast pharmaceutical sector, describing cooperative federalism as the “only way forward to ensure medicines made in India earn trust not only domestically but globally.” She further noted that SHRESTH will serve as a virtual gap assessment tool enabling states to measure their current regulatory maturity and strive towards certification.
Dr. Raghuvanshi elaborated that states would submit monthly data against predefined metrics to CDSCO, which would be scored and disseminated to all states and UTs, fostering a culture of continuous improvement and accountability.
Representatives from various states lauded SHRESTH as a transformative roadmap rather than a mere scorecard, emphasizing its role in harmonising regulatory processes, promoting technology-driven innovation, and facilitating structured knowledge sharing. They highlighted the importance of uniform implementation of the Drugs and Cosmetics Act and lauded CDSCO’s commitment to sharing success stories from top-performing states to encourage collaboration and learning.
The event was also attended by senior officials including Vijay Nehra and Nikhil Gajraj, Joint Secretaries in the Union Health Ministry, alongside other dignitaries from CDSCO.
With the launch of SHRESTH, India takes a significant stride towards reinforcing its pharmaceutical regulatory landscape, promising safer and more reliable medicines for millions across the nation.
