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In a significant move to safeguard public health, India’s apex drug regulatory body, the Central Drugs Standard Control Organisation (CDSCO), has flagged 60 batches of medicines and medical devices as “Not of Standard Quality” (NSQ). The alert, issued in February 2026 following routine surveillance, includes widely used treatments such as paracetamol (analgesic), cefixime (antibiotic), and telmisartan (anti-hypertensive).
The findings emerged from rigorous testing across several Central and Regional Drug Testing Laboratories. While the alert underscores the robustness of India’s regulatory oversight, it also highlights critical gaps in batch-to-batch consistency for both life-saving injectables and common household medications. For healthcare providers and consumers alike, the report serves as a vital reminder to verify batch numbers before dispensing or consuming these specific products.
Understanding “Not of Standard Quality” (NSQ)
Under the Drugs and Cosmetics Act of 1940, a medication is labeled NSQ if it fails to meet the stringent criteria established by the Indian Pharmacopoeia (IP) or the manufacturer’s own registered specifications.
It is important for the public to distinguish between “NSQ” and “spurious” drugs. While spurious drugs are often deliberate counterfeits, an NSQ designation typically means a specific batch failed laboratory tests for:
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Active ingredient strength (Assay): Having too much or too little of the drug.
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Dissolution: How well a tablet breaks down in the body to be absorbed.
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Sterility: The absence of bacteria or fungi, especially critical for injectables.
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Physical attributes: Issues with appearance, moisture content, or particulate matter.
The CDSCO publishes these lists monthly to ensure that pharmacies and hospitals can immediately halt the distribution of affected batches.
Key Products and Nature of Failures
The February 2026 list includes several household names, raising concerns about the reliability of high-volume generics.
Oral Medications
Commonly prescribed drugs for pain and infection were among the most frequently flagged. For instance, batches of Paracetamol 500 mg from Zenith Drugs and Pinnacle Life Sciences failed dissolution tests.
“If a tablet fails a dissolution test, it means the drug may not release properly in the patient’s digestive system,” explains a senior pharmacologist familiar with the audits. “This can lead to delayed relief or, in some cases, the medication passing through the system without being absorbed at all.”
Similarly, Cefixime oral suspension from Lark Laboratories and Telmisartan 40 mg tablets from Signature Phytochemical Industries failed assay or dissolution tests. For a patient managing hypertension with Telmisartan, an under-potent batch could lead to dangerous spikes in blood pressure.
Injectables and Medical Devices
The alert also highlighted high-risk failures in sterile products. Amikacin Sulphate injections failed sterility testing, while Ceftriaxone injections were flagged for bacterial endotoxins or particulate matter.
Furthermore, medical devices were not immune; the Silky Gold Foley balloon catheter and certain single-use hypodermic needles failed sterility and endotoxin tests. Contamination in these products poses an immediate risk of sepsis or severe inflammatory reactions when introduced into the bloodstream or body cavities.
Public Health Implications
The primary risk to the general public is not a systemic failure of all medicines, but the hidden danger of “suboptimal dosing.” When an antibiotic like Cefixime is under-potent, it doesn’t just fail to clear an infection; it contributes to the broader crisis of antimicrobial resistance (AMR) by exposing bacteria to non-lethal doses of the drug.
For chronic conditions, the impact is more subtle. A patient taking a flagged batch of Telmisartan might experience unexplained headaches or fatigue due to uncontrolled blood pressure, unaware that the medication itself is the variable.
“In a mature generics market like India, routine surveillance is the only way to catch these inconsistencies,” says the pharmacologist. “Monthly NSQ lists help regulators identify which manufacturers need tighter Good Manufacturing Practice (GMP) audits.”
Guidance for Patients and Clinicians
The CDSCO emphasizes that these alerts are batch-specific. An NSQ report does not mean all Paracetamol or Telmisartan is unsafe—only the specific batches listed in the February report should be avoided.
For Healthcare Professionals:
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Verify Batch Numbers: Cross-reference inventory against the CDSCO NSQ archive, especially for high-volume injectables and anticoagulants.
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Monitor Clinical Response: If a patient shows an unusual lack of response to a standard treatment, consider it a potential quality issue and report it to pharmacovigilance authorities.
For Patients:
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Check Your Strips: Look at the back of your medicine foil for the batch number, manufacturing date, and expiry. Compare these with the official CDSCO list.
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Storage Matters: Ensure medicines are kept in a cool, dry place. Heat and humidity can degrade even high-quality batches, worsening issues like poor dissolution.
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Consult Your Pharmacist: If you discover you have a flagged batch, return it to the pharmacy and consult your doctor for a replacement from a verified batch.
Limitations and Industry Perspective
While the NSQ list is a vital safety tool, experts note that it represents a sample of only roughly 1% to 3% of the total drugs in the market. A single failed batch does not necessarily indicate a failure of the manufacturer’s entire portfolio.
Industry representatives often point to the immense pressure of high-volume, low-cost generic production and the complexities of global supply chains as challenges in maintaining 100% consistency. However, public health advocates argue that in categories like antibiotics and cardiovascular drugs, there is zero room for error.
The recurring appearance of common drugs on these lists has sparked calls for more modern notification systems, such as SMS alerts for retail pharmacists, to ensure that flagged medicines are removed from shelves within hours, rather than days.
Medical Disclaimer
Medical Disclaimer: This article is for informational purposes only and should not be considered medical advice. Always consult with qualified healthcare professionals before making any health-related decisions or changes to your treatment plan. The information presented here is based on current research and expert opinions, which may evolve as new evidence emerges.
References
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Medical Dialogues. “NSQ Drug Alert: 60 Batches Including Paracetamol, Cefixime, Telmisartan Fail CDSCO Quality Tests in February.” Medical Dialogues, 24 March 2026. [Link]
