Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

The Drugs Technical Advisory Board (DTAB) in India has recommended for amendment of Drug Rules for suspension of Product License of drugs declared Not of Standard Quality (NSQ) by a Government Testing Laboratory.  In its 92nd meeting held on 24 April 2025, the DTAB deliberated the issue at length and the board noted that once a drug is declared NSQ, the license of such product shall be suspended immediately in public interest. Product license suspension shall be revoked only after submission of root cause analysis, satisfactory corrective and preventive action (CAPA) by manufacturer and implementation of the CAPAs.

The Drugs Technical Advisory Board (DTAB) is the highest statutory body in India that advises the Government on technical matters related to drugs and cosmetics. Constituted under the Drugs and Cosmetics Act, 1940, DTAB role is to advise the Central and State Governments on technical matters in the administration of the Drugs and Cosmetics Act. The Director General of Health Services (DCHS) is the Chairman of the board which has as its members Drugs Controller General of India (DCGI), Directors of Central Drug Laboratories, Director of IVRI, President of Medical Council of India, President of Pharmacy Council of India, State drug controllers, technical experts and representatives if ICMR, IMA, IPA.

NSQ Drugs:

Central and State Drug authorities in India routinely pick samples of drug products from point of sale and distribution points and analyse at government laboratories as part of continuous regulatory surveillance. The CDSCO (Central Drugs Standards & Control Organisation) publish the list of Not of Standard Quality (NSQ) drugs every month on the CDSCO portal.

Minutes of the 92nd Meeting of DTAB, India (April 2025)

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