Union Health Ministry Rolls out SHRESTH for Drug Safety Oversight

The SHRESTH Index is expected to drive improvements in human resources, infrastructure, and digitization across states, guaranteeing drug safety for every Indian regardless of geography.

The Union Health Ministry has launched the State Health Regulatory Excellence Index (SHRESTH), a national initiative aimed at benchmarking and strengthening state drug regulatory systems through a transparent, data-driven framework.

Union Health Secretary Punya Salila Srivastava, who virtually launched the initiative in the presence of Drug Controller General of India Dr Rajeev Singh Raghuvanshi, said the health of all citizens begins with the safety, quality, and efficacy of medicines.

“Ensuring their quality is a commitment of the Government to every home in India,” she stated.

In a meeting attended by Health Secretaries, Principal Health Secretaries, and Drugs Controllers from states and union territories, Srivastava emphasized the need for cooperative action.

“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 said.

Highlighting the role of states and union territories in ensuring quality manufacturing and distribution, Srivastava described SHRESTH as “a virtual gap assessment tool for states to assess their current position and help towards maturity certification.” She added that capacity-building workshops and seminars will be organized to further strengthen state regulatory processes.

She also noted India’s WHO ML3 status for vaccines and stressed the importance of elevating medicines to the same global standard. Upcoming initiatives include extending the Not of Standard Quality (NSQ) Dashboard to all states, hosting a symposium on drug regulatory systems, and expanding joint trainings and audits.

Explaining the framework, Dr Raghuvanshi said states will be divided into two categories – Manufacturing States and Primarily Distribution States/UTs – and ranked accordingly. SHRESTH will have 27 indices across five key themes for Manufacturing States and 23 indices for Distribution States. Data will be submitted monthly to CDSCO, scored, and shared with all states and UTs.

Representatives from states welcomed the index, noting it will harmonize regulatory processes, foster knowledge-sharing, and serve as a roadmap rather than a scorecard. They emphasized that it will help ensure safe and effective drugs and medical devices across the country.

The SHRESTH Index is expected to drive improvements in human resources, infrastructure, and digitization across states, guaranteeing drug safety for every Indian regardless of geography. CDSCO will also facilitate sharing success stories from top-performing states to encourage collaboration and learning.

The launch was attended by senior officials including Shri Vijay Nehra, Joint Secretary, Union Health Ministry, and Shri Nikhil Gajraj, Joint Secretary, Union Health Ministry, along with officials from CDSCO.

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