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.”
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