DCC asks SLAs to implement various regulatory decisions of CDSCO with priority for uniformity
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Gireesh Babu, New Delhi
July 01 , 2025
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The Drugs Consultative Committee (DCC), the advisory committee that advises the Central and State Governments on matters that require uniform implementation across the country, has recommended to the State Licensing Authorities (SLAs) to cooperate with the Central drug regulator on implementation of various regulatory decisions with priority for uniformity.
The Central Drugs Standard Control Organisation (CDSCO) has taken several steps in the recent past including implementation of revised Schedule M manufacturing standards, insisting on permission of central drug regulator prior to approval of new drugs by the SLAs, issuance of product license without having BA/BE study data for certain Class II and IV drugs, and taking action as recommended during the Risk Based Inspections (RBIs).
The other regulatory decisions by the CDSCO in the recent past include implementation of State Drug Regulatory Index, uploading and verification of details of manufacturers and their products on online portal as per the requirement of Rule 84AB, capacity building of government drug testing laboratories, onboarding of Online National Drugs Licensing System (ONDLS), and action against spurious and Not of Standard Quality (NSQ) drugs.
The DCC, listing these initiatives, discussed that states should accord priority for these issues to ensure uniformity and compliance.
"It was also recommended that the States while taking such regulatory action shall also keep CDSCO informed for taking better regulatory decisions in order to further strengthen the drug regulatory system in the country," said the minutes of the latest meeting of the DCC held on June 17, 2025.
The Committee was apprised that only 16 States and Union Territories have on-boarded on ONDLS portal for manufacturing and sale related licenses and other states are yet to on-board.
Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), the Chairman of the DCC, apprised about the importance of on boarding on ONDLS for achieving uniformity in the processing of application across the country. He requested all the members to obtain applications for LVP and Blood Centre through ONLDS portal only.
During the meeting, he also placed on record its appreciation to all states/UTs for their cooperation in carrying out more than 1,000 RBI across the country.
All the states were requested to provide their continued support on the various activities as stated above and also to make a proactive approach in taking suitable and appropriate regulatory action against manufacturers not complying with the requirements and repeatedly manufacturing the NSQ product, added the minutes of the meeting.
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