2 days ago
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.
