SHRESTH: India’s First State Health Regulatory Excellence Index

On 12 August 2025, the Union Health Ministry unveiled SHRESTH – the State Health Regulatory Excellence Index, marking a significant milestone in India’s public health governance. This first-of-its-kind national initiative is designed to benchmark and strengthen state drug regulatory systems through a transparent, data-driven framework.

The program reflects India’s growing emphasis on medicine quality, safety, and efficacy, reaffirming the government’s commitment to ensuring that every Indian—regardless of location—receives safe and effective medicines.

Background: Why SHRESTH Was Needed

India’s pharmaceutical sector is one of the largest in the world, often referred to as the “Pharmacy of the World” for its role in supplying affordable drugs globally.

However, regulatory capacity at the state level has varied significantly. With States/UTs playing a frontline role in manufacturing oversight, licensing, and distribution, the need for standardized evaluation and harmonized practices became urgent.

Past successes, like India’s WHO ML3 status for vaccines, have set the stage for similar advancements in drug regulation.

What is SHRESTH?

SHRESTH stands for State Health Regulatory Excellence Index and functions as a virtual gap assessment tool for states.

It will,

• Benchmark performance of state drug regulatory authorities.
• Identify gaps in human resources, infrastructure, licensing, surveillance, and responsiveness.
• Guide states towards maturity certification in line with global standards.

Framework & Implementation

The Central Drugs Standard Control Organization (CDSCO) will oversee SHRESTH.

States will be divided into two categories,

Manufacturing States – evaluated on 27 indices under five themes,

• Human Resources
• Infrastructure
• Licensing Activities
• Surveillance Activities
• Responsiveness

Primarily Distribution States/UTs – evaluated on 23 indices across similar parameters.

Data Submission & Ranking Process,

• States submit data by the 25th of every month.
• Metrics are scored on the 1st of the next month.
• Rankings shared with all States/UTs for transparency.

Significance for Public Health

Union Health Secretary Smt. Punya Salila Srivastava emphasized that medicine quality is the first line of public health defense. SHRESTH aims to ensure that medicines manufactured in India are trusted worldwide, beginning with citizens at home.

The index will,

• Strengthen regulatory systems.
• Enhance consumer trust in medicines.
• Ensure uniform implementation of the Drugs and Cosmetics Act.
• Encourage best practice sharing between states.

Additional Initiatives Linked to SHRESTH

Alongside SHRESTH, the ministry announced,

• Expansion of the Not of Standard Quality (NSQ) Dashboard to all states.
• A National Symposium on Drugs Regulatory Systems.
• Joint trainings and audits for regulatory staff.
• Capacity-building workshops to align state systems with international standards.