New Delhi, August 13, 2025: The Union Health Ministry has launched the State Health Regulatory Excellence Index (SHRESTH), a national framework aimed at benchmarking and improving the performance of state drug regulatory authorities through a transparent, data-driven approach. The initiative, proposed by the Central Drugs Standard Control Organization (CDSCO), seeks to ensure consistent drug safety and quality standards across the country.
Union Health Secretary Smt. Punya Salila Srivastava formally launched the index in the presence of Dr. Rajeev Singh Raghuvanshi, Drug Controller General of India, during a virtual meeting attended by Health Secretaries, Principal Health Secretaries, and Drugs Controllers from various states and union territories.
“The health of all Indian citizens begins with the safety, quality, and efficacy of the medicines they consume and ensuring their quality is a commitment of the Government to every home in India,” Smt. Srivastava said, calling for continued centre–state collaboration. “Our federal structure is designed to regulate a complex and globally significant pharmaceutical industry. The only way forward is cooperative action — to ensure medicines made in India are trusted everywhere, starting with every citizen in India.”
She noted that SHRESTH will serve as a “virtual gap assessment tool for states to assess their current position and help towards maturity certification,” and emphasized the importance of recognizing best practices and strengthening state-level regulatory systems. More capacity-building workshops and seminars will be organized to support states in this effort, she added.
Highlighting India’s attainment of WHO ML3 status for vaccines, Smt. Srivastava said the next goal is to bring medicines to the same global standard, reinforcing the country’s role as the “Pharmacy of the World.” Upcoming measures include expanding the Not of Standard Quality (NSQ) Dashboard to all states, holding a symposium on Drugs Regulatory Systems, and increasing joint training and audits.
Dr. Raghuvanshi explained that states will be classified as Manufacturing States or Primarily Distribution States/UTs and ranked separately. “SHRESTH will have 27 indices for Manufacturing States across five key themes — Human Resources, Infrastructure, Licensing Activities, Surveillance Activities, and Responsiveness — and 23 indices for Primarily Distribution States. States will submit data on predefined metrics by the 25th of each month, with scoring on the 1st of the following month, which will then be shared with all states and UTs,” he said.
State representatives welcomed the index, noting it will harmonize regulatory processes nationwide and encourage innovation. They emphasized that SHRESTH is “not a score card but a roadmap” for ensuring safe and effective drugs and medical devices, and that sharing best practices along with uniform implementation of the Drugs and Cosmetics Act will strengthen the regulatory system.
The SHRESTH Index will guide targeted improvements in human resources, infrastructure, and digitization, promote cross-learning, and ensure drug safety for all citizens regardless of location. CDSCO will facilitate the exchange of success stories from top-performing states to promote collaboration and knowledge transfer.
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