State Health Regulatory Excellence Index (SHRESTH), Objectives, Significance, UPSC Notes!

The State Health Regulatory Excellence Index (SHRESTH) is a national initiative launched by the Union Health Ministry to benchmark and improve how states regulate drugs and medical devices in India. Its main goal is to ensure that medicines and medical devices are safe, effective, and of high quality for all citizens. This is especially important for India, known globally as the “pharmacy of the world.” SHRESTH aims to create a uniform, strong regulatory framework across the country by improving human resources, infrastructure, digital systems, and promoting best practices. States are evaluated on criteria like licensing, inspections, and their response to regulatory challenges.

This topic is relevant for GS Paper 2 under Governance, Health Policy, and Government Initiatives in the UPSC Civil Services Examination. 

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What is the State Health Regulatory Excellence Index (SHRESTH)?

The State Health Regulatory Excellence Index, or SHRESTH, is a new system created to measure and rank the performance of drug regulatory authorities in all Indian states and Union Territories. It acts as a scorecard that helps states see how well they are doing. This index was proposed by the Central Drugs Standard Control Organization (CDSCO), which is the main body for regulating drugs and medical devices in India.

The main purpose of SHRESTH is to move from a simple system of checking for problems to a system that actively works to prevent them and improve overall quality. It's a way to assess the current situation in each state and provide a clear roadmap for them to reach a "maturity certification." This certification shows that a state's regulatory system is strong, well-managed, and in line with global best practices. By doing this, SHRESTH aims to create a more reliable and trustworthy system for medicines across the country.

Know more about the National Action Plan for Drug Demand Reduction (NAPDDR)!

Why is SHRESTH Needed?

SHRESTH is needed for several important reasons that affect every person in India.

• India's health system has a "federal structure", meaning both the central government and the state governments play roles in regulating the pharmaceutical industry. This can sometimes lead to different standards or gaps between states. SHRESTH was created to solve this problem by bringing all states onto the same page.
• Without a system like SHRESTH, it can be difficult to ensure that a medicine made in one state is as safe and effective as a medicine made in another. The index acts as a "virtual gap assessment tool", helping states identify weaknesses and figure out what they need to fix. This is crucial for making sure that all medicines sold in India, and those exported from India, meet high and consistent standards.
• SHRESTH also helps to formalize and celebrate the good work that some states are already doing, encouraging others to follow their lead and adopt best practices.
• By creating a unified system, SHRESTH strengthens India's overall reputation as a reliable and high-quality source for pharmaceuticals.

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The main objectives of the State Health Regulatory Excellence Index are focused on improving the drug regulatory system from the ground up.

• To Benchmark and Improve Performance: One of the primary goals is to set a standard (a "benchmark") for all states to follow. The index provides a clear way to measure performance, which in turn helps states understand where they stand and how they can get better. It's not just about giving a score; it's about providing a clear path for improvement.
• To Strengthen Human Resources and Infrastructure: The index aims to encourage states to invest in and improve their human resources and physical infrastructure. This includes making sure there are enough trained staff, that laboratories have the right equipment for testing, and that there are modern facilities for all regulatory work.
• To Promote Digitization: A key objective is to push states towards using more digital tools and systems. This includes digitizing licensing processes, approvals, and inspections. Digital systems make the process faster, more transparent, and easier to track.
• To Ensure Drug Safety and Quality: The most important objective is to guarantee that all medicines are safe, of high quality, and work as they are supposed to. SHRESTH aims to do this by ensuring that all regulatory rules are followed consistently and that bad-quality medicines are quickly identified and removed from the market.
• To Foster Cooperation and Cross-Learning: By ranking states and sharing the results, the index creates a platform for states to learn from each other. States that are doing well can share their "best practices" with others, which helps everyone improve together.

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Criteria for Evaluation of States under SHRESTH

The SHRESTH index uses a detailed set of criteria to evaluate states. These criteria are divided into different themes to get a full picture of each state's regulatory system. To make the evaluation fair, states are placed into one of two categories: "Manufacturing States" (those with significant pharmaceutical production) and "Primarily Distribution States" (those that mainly handle the storage and sale of medicines).

The index for manufacturing states includes 27 different indicators, while for distribution states, it uses 23 indicators. Both sets of indicators are based on five key themes:

• Human Resources: This theme looks at the staff. It evaluates whether the state has enough people to do the work, if they are well-trained, and if they have the right skills and experience.
• Infrastructure: This checks the physical setup of the regulatory body. It looks at the quality of drug testing labs, the availability of modern equipment, and the general facilities that support regulatory work.
• Licensing Activities: This theme focuses on the process of giving out licenses to pharmaceutical companies. It evaluates how efficient and transparent the licensing process is, and how well it is being digitized.
• Surveillance Activities: This is about how well the state monitors the market for unsafe medicines. It checks the number and quality of inspections, how often drug samples are collected and tested, and how the state handles complaints and takes action against those who break the rules.
• Responsiveness: This theme measures how quickly and effectively a state's regulatory body responds to issues. It looks at how fast they can take action on drug recalls, how well they cooperate with the central government, and their ability to address problems that come up.

Know more about the Health Indicators!

The SHRESTH index has several important features that make it a powerful tool for improving health regulation in India.

• A Data-Driven Framework: The index is built on a framework that uses real data and metrics, not just opinions. States are required to submit data on specific points every month, which is then scored to create the rankings. This makes the system transparent and fair.
• Categorization of States: By dividing states into "Manufacturing" and "Primarily Distribution" categories, the index makes sure that the evaluation is relevant to each state's specific situation. This prevents a state with no factories from being judged on criteria that only apply to manufacturing.
• Continuous Improvement: The index is not a one-time audit. It is a continuous process with monthly data submissions and scores. This creates a feedback loop that helps states constantly monitor their performance and work towards ongoing improvement.
• Virtual Gap Assessment Tool: SHRESTH is described as a virtual tool that helps states see their own strengths and weaknesses. It shows them where the "gaps" are between their current system and an ideal system, giving them a clear path to follow.
• Alignment with Global Standards: The index is designed to help states move towards higher, internationally recognized standards for drug regulation. The ultimate goal is to help India's drug regulatory system reach the same high global standard that its vaccine regulatory system has already achieved.

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Significance of the State Health Regulatory Excellence Index (SHRESTH)

The launch of SHRESTH is very significant for India's public health and its role in the global pharmaceutical market.

• First, it is a major step towards protecting public health in India. By ensuring that all medicines are safe and high-quality, the index directly improves the health and well-being of every citizen. It helps to build trust in the medicines that people use every day, no matter where they live in the country.
• Second, it strengthens India's reputation as the "pharmacy of the world." India is a key supplier of affordable medicines to many countries. A strong and consistent regulatory system across all states reinforces this image and builds global trust in "Made in India" drugs. This can lead to more trade and new opportunities for the pharmaceutical industry.
• Third, the index promotes a culture of accountability and collaboration. It encourages states to take ownership of their regulatory systems and work together with the central government and with each other to share best practices. It's a move away from working in silos and towards a more unified and cooperative approach.
• Finally, SHRESTH serves as a roadmap for future growth. By identifying gaps and providing a framework for improvement, it helps states make smart investments in their infrastructure, technology, and human resources. This sets the stage for a stronger, more modern, and more effective drug regulatory system for years to come.

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