Last Updated on July 24, 2025 by The Health Master
NSQ Drugs
The Indian government is poised to implement stricter regulations against pharmaceutical companies whose drugs are declared as not of standard quality (NSQ drugs).
The Union Health Ministry is currently in discussions with state authorities to finalize a robust framework that mandates immediate action against manufacturers of NSQ drugs.
Immediate License Suspension
A forthcoming notification from the Health Ministry is expected to introduce a stringent penalty: the immediate suspension of product licenses for companies identified by government laboratories as producing “not of standard quality” (NSQ drugs).
This proposed measure is a zero-tolerance policy for drug quality infringements.
Currently, the Central Drugs Standard Control Organisation (CDSCO) is actively discussing the things with various pharmaceutical lobby groups, who have voiced concerns regarding the proposed regulation.
Industry Consultations and Concerns
While the government’s drug technical advisory board (DTAB) on drugs, a key body within the CDSCO, had previously endorsed swift action against manufacturers of NSQ drugs, the implementation process involves crucial consultations.
The board emphasized the importance of suspending product permission immediately upon a drug being declared NSQ drugs, citing public interest.
Reinstatement of licenses would only occur after a thorough root cause analysis (RCA) and the implementation of corrective and preventive actions (CAPA) by the drug manufacturers.
However, pharmaceutical industry associations have raised objections, highlighting the complexities involved in the implementation of the new regulation.
The Federation of Pharma Entrepreneurs (FOPE), for instance, has submitted representations arguing that NSQ drugs instances are often a “global phenomenon” primarily stemming from technical issues rather than deliberate malintent.
Q. What is a “Not of Standard Quality” (NSQ) drug?
A. An NSQ drug refers to a pharmaceutical product that fails to meet the specified quality parameters and standards set by regulatory authorities.
Q. Who declares a drug as NSQ?
A. Government testing laboratories are responsible for testing drug samples and declaring them as NSQ if they fail to meet quality parameters.
Q. What is the proposed new punitive measure for NSQ drugs?
A. The proposed measure is the immediate suspension of product licenses for companies found producing NSQ drugs.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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