India Launches SHRESTH Index to Strengthen State Drug Regulatory Systems

In a landmark step toward bolstering India’s drug regulatory framework, Union Health Secretary Smt. Punya Salila Srivastava on Tuesday virtually launched the State Health Regulatory Excellence Index (SHRESTH) — the first national initiative of its kind to benchmark and strengthen state drug regulatory systems. The initiative, developed by the Central Drugs Standard Control Organization (CDSCO), will assess and guide improvements in the performance of state drug regulatory authorities through a transparent, data-driven model.

The virtual launch was attended by Health Secretaries, Principal Health Secretaries, and Drug Controllers from states and union territories, alongside Dr. Rajeev Singh Raghuvanshi, Drug Controller General of India. Senior officials from the Union Health Ministry, including Shri Vijay Nehra and Shri Nikhil Gajraj, also joined the event.

Strengthening Trust in Indian Medicines

Reiterating the government’s commitment to ensuring drug safety and quality, Smt. Srivastava stated,

“The health of all Indian citizens begins with the safety, quality, and efficacy of the medicines they consume. Ensuring this quality is our commitment to every home in India.”

She emphasised that India’s federal structure is uniquely positioned to regulate a globally significant pharmaceutical industry, but achieving consistent standards across states demands cooperative action between the Centre and states. The ultimate aim, she said, is to ensure medicines made in India are trusted worldwide, beginning with domestic trust and safety.

SHRESTH as a Tool for Continuous Improvement

Explaining the framework, Smt. Srivastava described SHRESTH as a “virtual gap assessment tool” designed to help states identify their current standing and move towards regulatory maturity certification. The Index will not merely rank states but provide a roadmap for strengthening their systems.

The Health Secretary stressed the role of capacity building in achieving these goals, announcing upcoming workshops, seminars, and training programmes to support states. She also highlighted India’s achievement of WHO ML3 status for vaccines, noting that the next target is elevating medicines to similar global standards.

Index Structure and Methodology

Dr. Raghuvanshi outlined the operational details, noting that states will be divided into two categories:

1. Manufacturing States – evaluated on 27 indices across five themes: Human Resources, Infrastructure, Licensing Activities, Surveillance Activities, and Responsiveness.

2. Primarily Distribution States/UTs – evaluated on 23 indices.

States will submit data on predefined metrics to CDSCO by the 25th of each month, with scores generated on the 1st of the following month. Results will be shared with all states and UTs to encourage healthy competition and improvement.

Industry and State Reactions

Representatives from several states welcomed the initiative, stating that SHRESTH will harmonise regulatory processes nationwide, promote technological innovation, and facilitate uniform implementation of the Drugs and Cosmetics Act. They stressed that the index is a guidance tool, not just a scorecard, and will help states cross-learn from each other’s best practices.

They also called for a structured knowledge-sharing platform and more collaborative efforts to ensure functional and efficient drug regulatory systems across India.

Driving Uniform Standards and Innovation

The SHRESTH Index will assess parameters such as:

• Adequacy of human resources in regulatory agencies

• Laboratory testing capacities and infrastructure

• Degree of digitisation in licensing and approvals

• Rigour of inspection and surveillance operations

• Responsiveness to public grievances

CDSCO will regularly share success stories from top-performing states, encouraging replication of effective models across the country. The ultimate objective is to ensure safe, effective, and quality-assured medicines for every citizen, regardless of geography.

This new benchmarking system is expected to further India’s reputation as the “Pharmacy of the World”, reinforcing both domestic and global confidence in the country’s pharmaceutical products.