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DCC stresses on need for uniform implementation of drug standards nationwide
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Gireesh Babu, New Delhi
November 27 , 2025
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Alarmed by various issues including some states lagging behind in implementation of drugs standards, low conviction rates due to various delays among others, the Drugs Consultative Committee (DCC) has stressed on the need for uniform implementation of standards nationwide.
The Committee, in its meeting held on November 17, observed that concerns are raised regarding effective enforcement of medicine standards nationwide uniformly, owing to various issues.
Stressing on the need for uniform implementation of standards across the country, the Committee recommended that a letter may be written to all states to take proactive steps to address these issues.
"It was further suggested that Government may write a letter to the state governments for providing the necessary infrastructure including the adequate manpower as highlighted under State Health Regulatory Excellence Index (SHRESTH)," said the minutes of the meeting.
The Committee identified that some states are lagging behind in the uniform implementation of prescribed drugs standards, testing facility of laboratories, skilled development of staff and creation of a centralized agency for effective enforcement of drugs standards on national level.
Low conviction rate due to reasons like insufficient investigations, delay in testing results and ineffective prosecution services, and issues related to implementation of rigorous scrutiny of adulteration in imported pharmaceuticals products were also highlighted.
The recommendation is in line with the advice of the Parliamentary Standing Committee on Health and Family Welfare, which in its 163rd report on the Demands for Grants 2025-26 of the Department of Health and Family Welfare, regarding implementation of a comprehensive, nationwide and phased Medicines Regulatory Maturity Enhancement Programme in the lines of World Health Organisation's (WHO) vaccine benchmarking process to ensure a consistently high standard of drug regulation across the country.
The Panel also recommended urgent implementation of a proactive, structured engagement strategy with all states and Union Territories (UTs) well in advance of each fiscal year's budget cycle to enhance the demand for the Strengthening of State Drug Regulatory System (SSDRS) scheme.
"The Committee is of the view that India being the pharmaceutical hub of the world, the same level of benchmarking/capacity building of states/UTs in the field of medicines/drugs is the need of the hour. This requires regulatory capacity building up gradation of the States in medicines/drugs/API/formulations," said the panel headed by Member of Rajya Sabha Prof Ram Gopal Yadav.
In August, the Union health ministry launched SHRESTH, a first-of-its-kind national initiative to benchmark and strengthen state drug regulatory systems through a transparent, data-driven framework.
The initiative, proposed by the Central Drugs Standard Control Organization (CDSCO) is aimed to drive improvements in the performance of state drug regulatory authorities across India, ensuring drug safety and quality standards are consistently met. Under the initiative, states will be divided into two categories – Manufacturing States and Primarily Distribution States/UTs and will be ranked accordingly on the index.
It has 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.
Under the SHRESTH initiative, States are expected to 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.
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