In an alarming revelation, the Central Drugs Standards Control Organisation (CDSCO) declared over 50 medicines, including popular drugs like Paracetamol and Pan D, as ‘not of standard quality’ (NSQ) in its August 2024 report. This revelation has raised significant safety concerns for millions of consumers who rely on these medicines for common health conditions like fever, acidity, and more. The report sheds light on a broader issue of substandard medications in the market, calling for immediate attention to ensure public health safety.
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What Does the CDSCO Report Reveal?
In its August 2024 report, the CDSCO highlighted that random monthly sampling by state drug officers revealed several widely used medicines, including Paracetamol, Pan D, vitamin D supplements, anti-diabetic pills, and high blood pressure medications as failing to meet quality standards. These products were categorized under the NSQ Alert, signaling they are either substandard or spurious, making them a potential consumer risk.
Some of the key medicines that failed the quality test include:
- Paracetamol (IP 500 mg): A go-to remedy for fever and pain, its failure in quality testing raises serious concerns about its efficacy and safety for consumers.
- Pan D: Used for treating acidity, Pan D was flagged as spurious in tests conducted by a Kolkata drug-testing lab, along with other popular drugs like Clavam 625.
- Vitamin and Mineral Supplements: Popular supplements like Shelcal (calcium and vitamin D3), vitamin C soft gels, and vitamin B complex tablets also failed the quality check, highlighting a worrying trend in essential nutrient-based medications.
- Glimepiride and Telmisartan: Critical drugs used to manage diabetes and high blood pressure, respectively, these failures could have severe consequences for patients who depend on consistent and reliable medications.
Benefits of Complementary and Alternative Medicine
The Companies and Products Under Scrutiny
Several well-known pharmaceutical manufacturers are under scrutiny following the test results. The list includes notable names like Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, Pure & Cure Healthcare, and Meg Lifesciences. These companies produce widely distributed medicines, further escalating concerns about the prevalence of substandard products in the market.
For instance, Metronidazole, a common treatment for stomach infections produced by HAL, also failed quality testing. Similarly, Shelcal, a trusted calcium and vitamin D3 supplement, was flagged for being substandard, a blow to the confidence of consumers seeking these essential nutrients.
NSQ Alerts and Spurious Drugs: A Growing Concern
The CDSCO’s report goes beyond highlighting medicines that failed quality checks. It also uncovered spurious drugs like Pan D and Cepodem XP 50 Dry Suspension, a medication used for treating children’s infections. The drug manufacturers, in some cases, have denied producing these batches, raising suspicions of counterfeit medicines circulating in the market.
In response to these concerns, the central drug regulator has issued two lists—one listing 48 drugs that failed quality tests, and another with 5 drugs in the NSG Alert category. The report includes responses from manufacturers who claim the flagged batches were not produced by them, but are instead counterfeit products.
Public Health at Risk: Implications for Consumers
The failure of such widely used medicines in quality tests highlights the risks to public health. Substandard or spurious drugs could lead to:
- Ineffective Treatment: Patients may not experience relief from their symptoms, resulting in prolonged illness or deterioration of health.
- Adverse Reactions: Consuming unsafe medications could lead to harmful side effects, some of which may be life-threatening.
- Drug Resistance: For medicines like antibiotics, taking substandard doses can contribute to antimicrobial resistance, making future treatments less effective.
CDSCO’s Role in Ensuring Quality Control
The CDSCO has proactively ensured drug safety by conducting random monthly sampling through state drug officers. These inspections help in identifying drugs that are not up to standard and serve as a critical checkpoint to prevent the distribution of harmful medications. In August 2024 alone, the CDSCO also banned over 156 fixed-dose drug combinations across the country, citing “likely risks to humans” as the primary reason. This indicates the regulator’s increasing vigilance in protecting public health.
What Should Consumers Do?
As a consumer, you can take certain precautions to safeguard your health:
- Purchase from Trusted Sources: Always buy medicines from reputable pharmacies and online platforms with proper certifications.
- Check for Recalls and Alerts: Stay updated on alerts issued by the CDSCO and other health authorities regarding the quality of medicines you use.
- Consult Healthcare Providers: If you’re currently using any of the flagged drugs, consult your doctor to explore alternative medications.
Conclusion
The declaration by the CDSCO that Paracetamol, Pan D, and over 50 other drugs are not of standard quality is a serious wake-up call for both the pharmaceutical industry and consumers. With substandard and even spurious drugs posing significant risks to public health, regulatory bodies must intensify efforts to ensure drug safety. Meanwhile, consumers should remain vigilant, informed, and proactive in seeking safe and reliable healthcare solutions.
