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NEW DELHI — In a continued effort to tighten the reins on pharmaceutical quality, India’s apex drug regulatory body, the Central Drugs Standard Control Organisation (CDSCO), has flagged 167 drug samples as “Not of Standard Quality” (NSQ) in its latest monthly alert for December 2025.
The report, released Wednesday, highlights the results of routine surveillance conducted by both central and state laboratories. While the findings underscore the challenges of maintaining rigorous manufacturing standards across a massive pharmaceutical landscape, officials emphasize that these targeted alerts are a sign of a “responsive regulatory system” designed to purge sub-par medicine from the supply chain.
Breaking Down the Numbers: NSQ vs. Spurious Drugs
The December alert is the result of nationwide sampling where regulators test various batches of medicines currently available in the market. The findings are categorized into two primary areas of concern: quality failure and outright counterfeiting.
1. Not of Standard Quality (NSQ) Samples
Out of the thousands of samples tested, 167 failed to meet specified quality parameters.
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Central Drugs Laboratories: Identified 74 NSQ samples.
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State Drugs Testing Laboratories: Identified 93 NSQ samples.
A drug is labeled NSQ when it fails in one or more laboratory parameters, such as “dissolution” (how quickly the pill breaks down in the body), “assay” (the actual amount of the active ingredient), or “sterility.”
2. Spurious (Counterfeit) Drugs
More concerning than quality lapses is the identification of seven samples flagged as “spurious.” Unlike NSQ drugs, which are made by licensed manufacturers but fail a test, spurious drugs are essentially fakes.
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Origin: Samples were traced back to the North Zone (Ghaziabad), FDA Ahmedabad, Bihar, and Maharashtra.
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The Violation: These products were produced by unauthorized manufacturers using the brand names of reputable companies.
“These are not manufacturing errors; these are criminal acts of mislabeling,” says Dr. Arvinder Singh, a public health policy consultant. “The CDSCO is currently investigating these cases to trace the supply chain and take legal action under the Drugs and Cosmetics Act.”
Why Do Drugs Fail Quality Tests?
To the average consumer, “Not of Standard Quality” can sound alarming. However, in the regulatory world, it covers a broad spectrum of issues.
Common reasons for an NSQ label include:
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Dissolution Issues: The tablet does not dissolve within the required timeframe, meaning the body cannot absorb the medicine.
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Description Failures: The color, shape, or coating of the medicine does not match its registered specifications.
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Potency (Assay): The drug may contain 85% of the active ingredient when the law requires 95-105%.
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Impurity Levels: The presence of degradation products beyond the permissible limit, often caused by poor storage or heat exposure.
“It is important to understand that an NSQ report applies specifically to the batch number tested,” explains a senior official at the CDSCO. “It does not mean that every version of that medicine from every pharmacy is unsafe. It is a surgical strike on a specific lot to ensure it is withdrawn.”
Expert Perspective: The Balance of Safety and Access
While the number of failures might seem high, independent experts suggest that increased reporting is actually a positive indicator of transparency.
“For years, the ‘pharmacy of the world’ was criticized for a lack of transparency in its domestic market,” says Dr. S. Chatterjee, an Internal Medicine specialist. “Monthly alerts allow hospital procurement departments and retail pharmacists to immediately check their inventory against the NSQ list. It creates a feedback loop that forces manufacturers to improve their Good Manufacturing Practices (GMP).”
However, some patient advocacy groups argue that more needs to be done regarding “spurious” drugs. “While 167 NSQ samples are a regulatory matter, the seven spurious samples represent a direct threat to patient life,” says a representative from a New Delhi-based health NGO. “We need faster prosecution for those hijacking established brand names.”
What This Means for Consumers
For patients currently taking medication, the CDSCO alert serves as a reminder to be vigilant but not to panic.
How to Stay Safe:
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Check the Batch: If you are concerned about a specific medication, you can cross-reference the batch number on your strip with the NSQ list available on the CDSCO official portal.
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Look for Physical Discrepancies: If your usual medication looks different in color, texture, or breaks apart too easily, consult your pharmacist.
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Buy from Reputable Sources: Spurious drugs often enter the market through “gray market” wholesalers. Buying from licensed, established pharmacies reduces this risk significantly.
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Do Not Stop Medication Abruptly: If you find your medicine is on the list, do not simply stop taking it—especially for chronic conditions like hypertension or diabetes. Instead, take the pack to your doctor or pharmacist and request a replacement from a different, passing batch.
Public Health Implications
India’s pharmaceutical industry is valued at over $50 billion, and ensuring the integrity of this sector is vital for both domestic health and international reputation. The December data shows a slight decrease in total NSQ samples compared to some previous months—a trend regulators hope will continue as new, stricter “Revised Schedule M” GMP guidelines are implemented across the country.
The collaboration between state and central authorities is crucial. Because health is a state subject in India, the CDSCO acts as the central coordinator, but the heavy lifting of inspections and factory shutdowns often falls to state-level FDA officers.
Limitations of the Monthly Alert
While the monthly list is a vital tool, it has limitations:
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Lag Time: The December alert covers tests concluded in that month, but the drugs may have been in the market for weeks prior.
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Storage Factors: Sometimes a drug fails a test not because it was made poorly, but because it was stored in a warehouse without proper temperature control, leading to chemical degradation.
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Scope: The samples tested represent only a fraction of the millions of batches produced in India each month.
The Path Forward
The CDSCO has signaled that it will continue to move toward a more “risk-based” inspection model, targeting facilities with a history of NSQ reports. As India moves toward more digital tracking of drug batches (QR codes on active pharmaceutical ingredients and formulations), the ability to recall sub-standard medicines in real-time is expected to improve.
Would you like me to help you find the specific list of brand names and batch numbers included in the December NSQ report?
References
- https://tennews.in/cdsco-labs-flag-167-drug-samples-as-not-of-standard-quality-in-december/
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.
