The Union Health Ministry has unveiled SHRESTH – the State Health Regulatory Excellence Index, a groundbreaking national initiative designed to benchmark and enhance the capacity of state drug regulatory systems through a transparent, data-driven approach. This marks the first such comprehensive effort in India to systematically assess and upgrade state-level regulatory mechanisms, ensuring uniform standards for drug safety and quality across the country.
Developed by the Central Drugs Standard Control Organization (CDSCO), SHRESTH serves as a virtual gap assessment tool to evaluate the performance of state drug regulators and guide them toward maturity certification. By pinpointing strengths and identifying areas needing improvement, the framework aims to bring regulatory processes closer to global best practices.
The assessment is structured around key functional areas crucial for effective drug regulation:
- Human Resources – Adequacy, training, and technical expertise of regulatory staff.
- Infrastructure – Availability of modern laboratories, equipment, and facilities.
- Licensing Mechanisms – Efficiency, transparency, and compliance in granting manufacturing and distribution licenses.
- Surveillance & Monitoring – Strength of pharmacovigilance and market surveillance systems.
- Responsiveness – Speed and effectiveness in addressing complaints, recalls, and public health alerts.
A notable feature of SHRESTH is its categorization of states into two main segments based on their primary focus — Manufacturing-focused (states with significant pharmaceutical production) and Distribution-focused (states primarily involved in storage, transportation, and retail distribution). This classification ensures that the evaluation is relevant to each state’s operational realities and market role.
The system mandates monthly data submissions from states, enabling continuous performance tracking and iterative improvement. Over time, the states will be able to monitor their own progress, benchmark against peers, and implement targeted reforms to bridge identified gaps.
Health Ministry officials emphasized that SHRESTH is not just an audit mechanism but a capacity-building tool. By offering structured guidance and measurable indicators, it will empower state regulators to move toward maturity certification — a process that aligns with the World Health Organization’s Global Benchmarking Tool for regulatory systems.
The ultimate aim of SHRESTH is to guarantee the safety, efficacy, and quality of medicines available in India, thereby protecting public health and boosting trust in the pharmaceutical sector. This initiative is particularly significant given India’s reputation as the “Pharmacy of the World”, supplying affordable, high-quality medicines to over 200 countries. Ensuring consistent regulatory excellence across states will further strengthen India’s global leadership in pharmaceuticals.
The Health Ministry also noted that SHRESTH will foster a culture of transparency and accountability, encouraging states to adopt a proactive approach toward compliance and innovation. By harmonizing standards and fostering collaboration between central and state regulators, the initiative is expected to create a robust, future-ready drug regulatory ecosystem in India.
With SHRESTH, India takes a decisive step toward a uniform, high-performing regulatory landscape, reinforcing its commitment to public health and global pharmaceutical leadership.
