Do Not Issue Licenses Without New Drug Permission from DCGI, Govt Panel Tells States
New Delhi: In a move to reinforce coordination between central and state drug regulatory bodies, the Drugs Consultative Committee (DCC) has called on State Licensing Authorities (SLAs) to prioritize and implement a series of critical regulatory initiatives launched by the Ministry of Health and Family Welfare and the Central Drugs Standard Control Organisation (CDSCO).
The discussion took place during the 66th DCC meeting held on June 17, 2025, in hybrid mode at CDSCO Headquarters, FDA Bhawan, New Delhi, under the chairmanship of Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI). In his opening remarks, Dr Raghuvanshi “highlighted the need for strengthening of Drug Regulatory System throughout the country and appreciated the support extended by all the States.”
The DCC was apprised that “in recent past, CDSCO has taken a number of steps where cooperation of State Licensing Authorities is required.” A list of priority areas was outlined, highlighting systemic issues that require immediate attention from state regulators. These include:
“Implementation of revised Schedule M.”
“To refrain from issuance of licence without new drug permission from DCGI.”
“Issuance of product licence without having BA/ BE study data for BCS Class II & IV drugs.”
“To take action as recommended during Risk Based Inspection.”
“Uploading and verification of details of manufacturers and their products on online portal as per the requirement of rule 84AB.”
“Implementation of State Drug Regulatory Index.”
“Capacity building of the Government drug testing laboratories.”
“Onboarding on ONDLS.”
“Action against spurious and NSQ drugs.”
The DCC expressed concern over gaps in ONDLS (Online National Drug Licensing System) adoption, noting that “only 16 States/ UTs have on-boarded on ONDLS portal for manufacturing and sale related licenses and other states are yet to on-board.” The Chairman emphasized that ONDLS is critical “for achieving uniformity in the processing of application across the country,” and urged states to accept applications for LVP and Blood Centre licenses exclusively through the ONDLS portal.
The DCC also called for stricter action against firms producing spurious and Not of Standard Quality (NSQ) drugs. “All the States were requested to provide their continued support on the various activities as stated above and also to make proactive approach in taking suitable/ appropriate regulatory action against manufacturer(s) not complying with the requirements and repeatedly manufacturing the NSQ product,” the committee stated.
Further, to enhance central oversight and coordinated enforcement, the committee 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.”
The Chairman also “placed on record its appreciation to all States/ UTs for their cooperation in carrying out more than 1000 Risk Based Inspections (RBI) across the country.”
