Substandard Drugs to Face Immediate License Suspension Under DTAB's New Recommendation
New Delhi: In a significant move to tighten quality control and safeguard public health, the Drugs Technical Advisory Board (DTAB) has recommended amending the Drugs and Cosmetics Rules to mandate immediate suspension of product licenses for drugs declared Not of Standard Quality (NSQ) by government laboratories.
The matter was discussed during the 92nd DTAB meeting held on April 24, 2025. “The Board was apprised about the issue,” the meeting minutes noted, adding that DTAB acknowledged the need for swift action against substandard drugs in the interest of public safety.
According to the minutes;
“the board noted that it is very important that once a drug is declared NSQ, the license of such product shall be suspended immediately in public interest unless a satisfactory corrective action and preventive action (CAPA) is submitted by such manufacturers.”
Currently, regulatory timelines and procedural delays can allow NSQ drugs to remain in circulation longer than desirable, posing risks to patients. The proposed amendment aims to close this gap by giving regulators the power to act promptly on lab findings.
Following detailed deliberation, DTAB recommended a rule change stipulating that the suspension of a drug license should only be revoked after a thorough root cause analysis and the successful implementation of corresponding CAPA. The minutes read;
"DTAB recommended for the appropriate amendment in the Drug Rules in this regard and the suspension product license should be revoked only after route cause analysis and corresponding CAPA has been implemented."
The recommendation marks a stricter stance by the apex drug advisory body to hold manufacturers accountable and ensure that substandard drugs do not reach or stay in the market without adequate corrective measures.
This move is expected to empower state and central regulators to act decisively against NSQ products and could serve as a deterrent for non-compliance in pharmaceutical manufacturing.
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