New Delhi: Union Health Secretary, Smt. Punya Salila Srivastava virtually launched the State Health Regulatory Excellence Index (SHRESTH), a first-of-its-kind national initiative to benchmark and strengthen state drug regulatory systems through a transparent, data-driven framework in the presence of Dr Rajeev Singh Raghuvanshi, Drug Controller General of India, here today. The initiative, proposed by the Central Drugs Standard Control Organization (CDSCO) aims to drive improvements in the performance of state drug regulatory authorities across India, ensuring drug safety and quality standards are consistently met.
In a meeting attending virtually by the Health Secretaries/Principal Health Secretaries and the Drugs Controllers from various states and union territories, Union Health Secretary reiterated that the health of all Indian citizens begins with the safety, quality, and efficacy of the medicines they consume and ensuring their quality is a commitment of the Government to every home in India.
In a strong call to action, Smt. Srivastava urged continued centre–state collaboration: “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.”
Union Health Secretary highlighted the crucial role played by States/UTs in ensuring quality manufacturing and distribution in India and the need for recognizing and supporting their best practices and growth. “States have strong regulatory certification. SHRESTH is a virtual gap assessment tool for states to assess their current position and help towards maturity certification”, she added.
Underscoring the crucial role of all stakeholders in ensuring the health of all citizens, Smt. Srivastava emphasized the importance of safeguarding the safety and efficacy of drugs and medical products in the country. She informed that more capacity building workshops and seminars will be organized to strengthen the states’ regulatory processes.
Highlighting India’s achievement of WHO ML3 status for vaccines, she stressed that the next step is to elevate medicines to the same global standard, advancing international harmonization and reinforcing India’s role as the “Pharmacy of the World.”
Several upcoming initiatives were also outlined including the extension of the Not of Standard Quality (NSQ) Dashboard to all states, the proposed symposium on Drugs Regulatory Systems, and the expansion of joint trainings and audits.
Speaking on the occasion, Dr Raghuvanshi highlighted that states will be divided into two categories – Manufacturing States and Primarily Distribution States/UTs and will be ranked accordingly on the index. He stated that SHRESTH will have 27 indices for Manufacturing States across five key themes: Human Resources, Infrastructure, Licensing Activities, Surveillance Activities and Responsiveness and 23 indices for Primarily Distribution States. States will submit the data on predefined metrics to CDSCO which will be collected by 25th of every month and these metrics will be scored on the 1st of next month and shared with all states and UTs.
Sharing their feedback on the index, representatives from states appreciated the launch of the index and highlighted that the index will help harmonize regulatory processes across the country and give impetus to innovation in technology. They also pointed out that SHRESTH is not a score card but a roadmap for states for ensuring safe and effective drugs and medical devices. They also noted that uniform implementation of the Drugs and Cosmetics Act, sharing of best practices and structured knowledge sharing platform will help ensure that all states have a functioning regulatory system.
The SHRESTH Index will enable targeted improvements in human resources, infrastructure, and digitization across states, ensuring drug safety is guaranteed for every Indian, regardless of geography. It will also promote cross-learning of best practices and foster collaborative spirit.
The Index, developed after detailed deliberations with the states, will regularly assess the states on several parameters such as human resources, strength of lab testing capacities, extent of digitisation of various approvals and licenses, rigour of inspection and surveillance activities, and responsiveness towards grievances received from citizens.
CDSCO will facilitate sharing of success stories from top-performing states to drive collaboration and transfer of learnings.
Shri Vijay Nehra, Joint Secretary, Union Health Ministry; Shri Nikhil Gajraj, Joint Secretary, Union Health Ministry and senior officials of the Union Health Ministry and CDSCO were present on the occasion.
