State Health Regulatory Excellence Index (SHRESTH)

Prelims - Current events of national and international importance | Government policies and interventions.

Why in News?

Recently, the Union Health Ministry launched SHRESTH to strengthen the drug regulatory system.

It is a first-of-its-kind national initiative to evaluate and improve state drug regulatory authorities, ensuring drug safety and quality standards are consistently met.
It is a virtual gap assessment tool for states to assess their current position and help towards maturity certification.
Need – To guarantee the safety, quality, and effectiveness of medicines for every citizen.
To reinforce state-level drug regulatory systems that play a vital role in managing India’s vast and complex pharmaceutical sector.
Proposed by – Central drugs standard control organizations (CDSCO).
Objective – To drive improvements in the performance of state drug regulatory authorities across India.
To ensure drug safety and quality standards.
To enable improvements in human resources, infrastructure and digitization across states.
2 categories of ranking
- Manufacturing states.
- Primary Distribution States/UTs.

Themes – Manufacturing States across 5 key themes.
- Human Resources, Infrastructure, Licensing Activities, Surveillance activities and Responsiveness.
Ranking Methodology – It has 27 indices in manufacturing states and 23 indices in primarily distribution states.
Significance – Emphasizing the role of stakeholders in ensuring the health of all citizens and safeguarding the efficacy of drugs and medical products.
Acts as a roadmap for states to assess and improve their regulatory maturity and harmonization of regulatory systems across the country.

Other Upcoming Initiatives

Capacity building workshops and seminars	Organized to strengthen the states regulatory processes.
Not of Standard Quality (NSQ)	Dashboard to all states to monitor
Symposium on Drugs Regulatory Systems	Discuss and enhance states drug regulatory systems.
Expansion of joint trainings and audits.	Coordinate training sessions and joint audits involving multiple states.

Quick facts

Central Drugs Standard Control Organization (CDSCO)

The CDSCO is a National Regulatory Authority (NRA) under directorate general of health service, Ministry of Health & Family welfare.
It envisages uniform implementation of the provisions of the Act & Rules made there under for ensuring the safety, rights and wellbeing of the patients by regulating the drugs and cosmetics.

Reference

PIB| SHRESTH Drug Regulator System