Last Updated on March 17, 2025 by The Health Master
NSQ Drug
The Drugs Consultative Committee (DCC), has proposed new guidelines related to the spurious and Not of Standard Quality Drug (NSQ drug) to streamline the drug regulation across India.
This significant move comes as a response that some new advanced testing parameters and updated pharmacopoeias should be more stringent regulatory frameworks.
Upgrading Testing Standards
As per DCC, the current guidelines are lagging, and new advancements are needed in drug testing.
As pharmacopoeias are regularly updated, i.e., inclusion of the latest and crucial parameters like impurity profiling, existing protocols struggle to keep pace.
This gap creates a significant loophole, allowing spurious and NSQ Drug to come out in the market.
Why Impurity Profiling?
Ensures the safety and purity of drugs.
Detects harmful byproducts during manufacturing the drugs.
Protects consumers and patients from toxic substances.
The 65th DCC meeting, held recently on 20-12-2024, highlighted the urgency of this matter.
Read or download: 65th DCC held on 20-12-2024
Must read: Drug Consultative Committee (DCC): Minutes of meetings
“After a detailed deliberation, the DCC agreed with the proposal for the update of new guidelines and recommended that the existing guidelines may be circulated to all the members of the DCC for their comments/suggestions for the update,” stated the minutes of the meeting.
Enhanced Penalties and Legal Amendments
The DCC is also recommended for stricter legal measures to combat the manufacture and sale of spurious drugs.
Recognizing the need for a more robust deterrent, the committee has recommended that the Central Drugs Standard Control Organisation (CDSCO) establish an expert committee to amend the Drugs and Cosmetics Act, 1940.
This amendment will focus on increasing penalties for those found guilty of manufacturing or distributing spurious drugs.
Key Focus Areas for Legal Amendments
- Substantial increase in fines for offenders.
- Longer imprisonment terms for serious violations.
- Streamlined procedures for prosecuting counterfeit drug manufacturers.
To ensure a holistic approach, the expert committee will give feedback after obtaining it from State Licensing Authorities (SLAs) to develop a robust system against drug counterfeiting.
This collaborative approach, as emphasized by the DCC, is critical for effective implementation of the amended laws.
Expert Collaboration
The DCC’s commitment to a thorough and effective regulatory system is evident in its emphasis on expert collaboration.
The expert committee tasked with amending the Drugs and Cosmetics Act will be empowered to co-opt additional experts as needed.
This flexibility ensures that the committee can draw on a wide range of knowledge and experience.
“After detailed discussions, it was recommended that the expert committee may also seek comments from the SLAs, regarding the NSQ drugs so that the issue is addressed more effectively and that the report of the committee may be placed before the DCC for further deliberation and consideration,” the DCC minutes reveal.
Q. What are spurious drugs?
A. Spurious drugs are counterfeit drugs that falsely represent the identity or source of the genuine product. They may contain incorrect ingredients, no active ingredients, or harmful substances.
Q. What are NSQ drugs?
A. NSQ Drugs are Not of Standard Quality drugs. They do not meet the quality standards that are set for them.
Q. Why is upgrading drug testing guidelines important?
A. Upgrading guidelines ensures that drug testing keeps pace with advancements in pharmaceutical science, safeguarding public health.
Q. How does impurity profiling help?
A. Impurity profiling helps to identify and quantify the impurities present in a drug, ensuring its safety and efficacy.
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.
Karnataka’s new NSQ Drug Recall Policy
Himachal Pradesh cracks down on NSQ Drugs Manufacturers
Pakistan: Pharma Company Faces Imprisonment and Fines for NSQ Drug
DCC: Insights from the Drugs Consultative Committee on NSQ Drugs
Govt invites Pharma MedTech companies for funding: Apply now
Strengthen State Drug Testing Laboratories: DCGI
USFDA issues Warning Letter to Granules India over these Deficiencies
CM Haryana Honors FDA Haryana Team
CDSCO approval granted for Durvalumab for Limited-Stage SCLC in India
USFDA issues warning letter to Dexcom for 2 facilities
DCA Telangana cracks down on distributors for Storage Violations
USFDA issued Form 483 to Alembic Pharma with 1 observation
NPPA fixed retail price of 53 formulations: March 2025
DCC agrees with proposal to amend Rule 89 for better clarity
