SHRESTH Index Strengthening State Drug Regulation in India

Launch of SHRESTH Index

SHRESTH Index Strengthening State Drug Regulation in India: On 12 August 2025, the Union Health Ministry introduced the State Health Regulatory Excellence Index (SHRESTH) to enhance drug regulatory systems across India. This first-of-its-kind framework benchmarks states through transparent, data-driven assessments, ensuring safe and effective medicines reach citizens nationwide.
Static GK fact: India is the world’s third-largest producer of pharmaceuticals by volume.

Need for a Standard Framework

India, known as the “Pharmacy of the World”, has a vast pharmaceutical network supplying affordable drugs globally. However, state-level regulatory capacity has varied greatly, creating a need for harmonized oversight. With States/UTs managing manufacturing licenses, quality checks, and distribution, a national benchmark became essential.
Static GK fact: India achieved WHO ML3 status in vaccine regulation in 2020, a global recognition of regulatory maturity.

Structure and Purpose of SHRESTH

SHRESTH acts as a virtual gap assessment tool for states to measure and improve performance. It evaluates:

• Human resources and training
• Infrastructure adequacy
• Licensing efficiency
• Surveillance systems
• Responsiveness to public health risks

Categories of Assessment

The Central Drugs Standard Control Organization (CDSCO) manages SHRESTH. States are divided into:

• Manufacturing States – rated on 27 indices under five themes.
• Distribution-focused States/UTs – rated on 23 indices under similar parameters.
  Static GK Tip: CDSCO functions under the Ministry of Health and Family Welfare and is India’s national regulatory authority for drugs and cosmetics.

Data Submission and Ranking

States must submit monthly data by the 25th. Rankings are prepared on the 1st of the next month and shared openly. This transparent ranking mechanism is aimed at fostering competition and best practice exchange.

Public Health Significance

Union Health Secretary Punya Salila Srivastava stated that medicine quality is the first line of defense in public health. The index ensures uniform application of the Drugs and Cosmetics Act, boosts public trust, and aligns Indian drug standards with global expectations.

Linked Initiatives

Alongside SHRESTH, the ministry is:

• Expanding the Not of Standard Quality (NSQ) Dashboard to all states.
• Hosting a National Symposium on regulatory systems.
• Conducting joint audits and trainings for state officials.
• Running capacity-building workshops for global standard alignment.

Static Usthadian Current Affairs Table

SHRESTH Index Strengthening State Drug Regulation in India: