Last Updated on August 20, 2025 by The Health Master
NSQ drug
In an important decision to enhance patient safety and drug quality, the Food and Drugs Administration Karnataka (FDA Karnataka) has drastically reduced the time of “Not-of-Standard Quality” (NSQ) drug recall from the market.
This deceptive action by FDA Karnataka, reducing the NSQ drug recall time from 30 days to just 3 days, is a direct response to eliminate the NSQ drugs from the state.
The decision leads to a zero-tolerance approach to unsafe drugs and holds manufacturers and distributors accountable for their NSQ drugs.
The FDA Karnataka has been on high alert, with its enforcement wing conducting surprise inspections and collecting random drug samples in the state.
These continuous checks recently led to the discovery of 59 samples that failed to meet mandatory standards, giving the urgent need for a faster drug recall process.
A Wave of Enforcement Actions and Public Warnings
This heightened scrutiny is not just about identifying faulty drugs; it’s about swift and decisive action.
In the recent past month, the FDA Karnataka has taken important steps, filing 29 court cases against pharmaceutical companies for serious violations of the Drugs and Cosmetics Act 1940 & Rules framed thereunder.
These enforcement actions target a wide range of products, from common over-the-counter medications to critical drugs for chronic conditions.
The Karnataka government is also actively alerting the public and healthcare professionals.
Various warnings have been issued to retail medical stores, wholesalers, and hospitals, urging them to immediately send back these NSQ drugs to the dealers from whom they have acquired these NSQ drugs.
Patients are also continuously advised to be vigilant and not purchase these drugs.
Medical practitioners are also being urged to ensure they do not prescribe these NSQ drugs.
Understanding the risk due to NSQ Drugs
Not-of-Standard Quality drug (NSQ drug) is a serious concern with public health.
These are the drugs that do not meet the mandatory quality standards set by regulatory authorities.
This includes:
Purity issue: The drug contains various contaminants or impurities.
Strength issue: The active ingredient in the drug is either too high or too low, affecting the therapeutic effect of the drug.
Dissolution issue: The tablet or capsule doesn’t dissolve in the body within the prescribed time, preventing the drug from being absorbed effectively in the body.
Labeling issue: The labeling of the drug or information is not correct or misleading.
The above-said issues can directly impact the safety and efficacy of the drug, leading to adverse effects on the health of the people.
This is why organizations like the Central Drugs Standard Control Organization (CDSCO) regularly publish lists of NSQ drugs, to keep healthcare providers and consumers informed.
High-Profile NSQ Drugs Recalled
The drugs identified as NSQ are not limited to one specific category but span a broad spectrum of therapeutic areas.
Companies from across the country, not just Karnataka, are facing action.
The recalled drugs include popular formulations used for:
Pain and Fever: Panoxen (diclofenac sodium and paracetamol)
Diabetes and Hypertension: Glimepiride & Metformin, Telmisartan
Infections: Cefixime, Ofloxacin, and Ornidazole
Gastric Issues: Pantoprazole, Esomeprazole
Chronic Conditions: Rosuvastatin (for cholesterol), Sodium Valproate
Other Critical Formulations: Povidone iodine solution, Methylcobalamin, Vitamin B complex, and various injections like sodium chloride and adrenaline bitartrate.
Health and Family Welfare Minister Gundu Rao confirmed that during a recent crackdown, his department recalled substandard drugs worth Rs. 40 lakh in July 2025 alone.
Beyond NSQ:
The FDA Karnataka is continuing surveillance efforts to target illegal activities within the pharmaceutical industry.
This includes issuing show-cause notices to 231 medical stores for selling drugs, such as sleeping pills and antibiotics, without obtaining a valid prescription.
This proactive and quick response from the FDA Karnataka sets a new benchmark for the safety and efficacy of the drug safety, protecting people of the region.
Q: What are NSQ drugs?
A: NSQ means “Not-of-Standard Quality.” These are the drugs that do not meet the mandatory quality standards required for the purity, strength, and efficacy of the drugs.
Q: How can I ensure the purchase of safe drugs?
A: To ensure the purchase of safe drugs , always buy the drugs from a licensed medical store. Check for proper labelling/packaging, seals, and a date of expiry.
NSQ Drug: Route cause analysis and CAPA
NSQ Drugs: Pharma companies may lose licenses
42 Companies banned over supply of NSQ drugs: Rajasthan
Himachal: 1471 NSQ drugs in past 2 years: Minister
NSQ Drug: New Guidelines Proposed
FDA Haryana secures Convictions in Landmark Drug Cases
A New Era for Haryana’s Pharma Industry: Lalit Kr Goel
NPPA fixed retail price of 37 formulations: August 2025
NPPA fixed Ceiling price of 4 scheduled formulations: August 2025
Drug Imports: New Online System for Dual Use NOC launched
FSSAI: Food Labelling and Display – Chapter-20
USFDA inspection: At Torrent Pharma with zero observations at Vizag
Govt. appoints Adnl. DGHS as the Compounding Authority
