Latest news with #StateHealthRegulatoryExcellenceIndex
The Print
15 hours ago
- Health
- The Print
Health Ministry launches SHRESTH index to strengthen state drug regulatory systems
The initiative, proposed by the Central Drugs Standard Control Organisation (CDSCO), aims to improve the performance of state drug regulatory authorities, ensuring that drug safety and quality standards are consistently met, the ministry said in a statement. The index was launched on Tuesday by Union Health Secretary Punya Salila Srivastava virtually in the presence of Drug Controller General of India Dr Rajeev Singh Raghuvanshi. New Delhi, Aug 13 (PTI) The Union Health Ministry has launched the State Health Regulatory Excellence Index, a first-of-its-kind national initiative to benchmark and strengthen state drug regulatory systems through a transparent and data-driven framework. In a meeting attended virtually by the health secretaries, principal health secretaries and the drugs controllers from states and Union Territories, Srivastava reiterated that the health of all citizens begins with the safety, quality, and efficacy of the medicines they consume. Ensuring their quality is the government's commitment, she said. '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,' the Union health secretary said. Srivastava highlighted the crucial role played by states and Union Territories in ensuring quality manufacturing and distribution in India and the need for recognising and supporting their best practices and growth. 'States have strong regulatory certification. State Health Regulatory Excellence Index (SHRESTH) is a virtual gap assessment tool for states to assess their current position and help towards maturity certification,' she added. Highlighting India's achievement of WHO ML3 status for vaccines, Srivastava stressed the next step is to elevate medicines to the same global standard, advancing international harmonisation 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 Drug Regulatory Systems, and the expansion of joint training and audits. Speaking on the occasion, Dr Raghuvanshi highlighted that states will be divided into two categories — manufacturing and primarily distribution — and will be ranked accordingly on the SHRESTH index. 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 the 25th day of every month, and these metrics will be scored on the first day of next month and shared with all states and Union Territories, Dr Raghuvanshi said. PTI PLB NSD NSD This report is auto-generated from PTI news service. ThePrint holds no responsibility for its content.
Mint
2 days ago
- Health
- Mint
Shresth: New national index to boost drug safety across India
New Delhi: The Union health ministry has launched the State Health Regulatory Excellence Index (Shresth) to benchmark and strengthen the systems that regulate drugs in states through a transparent, data-driven framework. The health of all citizens begins with the safety, quality, and effectiveness of the medicines they take, and ensuring their quality is a commitment of the government to every person in India, said Punya Salila Srivastava, Union health secretary in on Tuesday. The Shresth initiative, proposed by the Central Drugs Standard Control Organization (CDSCO), aims to improve the performance of state drug regulatory authorities nationwide, guaranteeing that drug safety and quality standards are consistently met. During a virtual meeting with health secretaries and drug controllers from various states and Union territories, Srivastava described Shresth as a virtual tool for states to assess their current position and work toward a "maturity certification". She emphasized the crucial role played by states and Union territories in ensuring quality manufacturing and distribution in India and the need to recognize and support their best practices. The new index will enable targeted improvements in human resources, infrastructure, and digitization across states, ensuring drug safety is guaranteed for every Indian, regardless of where they live. The states will be divided into two categories: 'manufacturing states' and primarily distribution states/UTs', and will be ranked accordingly. Manufacturing states will be evaluated on 27 indices across five key areas: human resources, infrastructure, licensing activities, surveillance activities, and responsiveness. Primarily distribution states will be evaluated on 23 indices. The data for the predefined metrics will be submitted by states to the CDSCO by the 25th of each month, with the scores being calculated and shared with all states and union territories on the 1st of the following month. Dr. Rajeev Singh Raghuvanshi, the Drug Controller General of India, said this index will help to harmonize regulatory processes across the country. It will also promote cross-learning of best practices and a collaborative spirit among states. The CDSCO will facilitate the sharing of success stories from top-performing states to encourage collaboration and the transfer of knowledge. Representatives from the states pointed out that Shresth is not just a scorecard but a roadmap for states to ensure safe and effective drugs and medical devices. They also noted that a uniform implementation of the Drugs and Cosmetics Act, along with the sharing of best practices and a structured knowledge-sharing platform, will help ensure that all states have a functional regulatory system. Srivastava also highlighted India's achievement of WHO maturity level-3 status for vaccines, stressing that the next step is to elevate medicines to the same global standard, reinforcing India's role as the 'pharmacy of the world'. Mint on 9 February reported that about the government's plan on developing drug regulatory index.
