Paracetamol and 53 Other Drugs Fail Quality Tests, Raising Serious Safety Concerns in India

In a shocking revelation, the Central Drugs Standards Control Organisation (CDSCO), India’s apex drug regulatory body, has declared a staggering 53 drugs as “Not of Standard Quality (NSQ) Alert” in its latest monthly drug alert list. This development has sent shockwaves across the nation, as these drugs include widely used and trusted medicines that millions of Indians rely on for their health and well-being.

The list of substandard drugs reads like a who’s who of essential medicines, including:

• Paracetamol tablets, a ubiquitous pain reliever and fever reducer
• Calcium and vitamin D3 supplements like Shelcal, crucial for bone health
• Anti-diabetes drugs such as Glimepiride
• High blood pressure medications including Telmisartan
• Vitamin B complex and vitamin C softgels
• Antacid Pan-D, used to treat acid reflux and heartburn
• Metronidazole, a commonly prescribed antibiotic for stomach infections

These substandard drugs are manufactured by some of the biggest names in the Indian pharmaceutical industry, such as Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, Meg Lifesciences, and Pure & Cure Healthcare.

The CDSCO’s NSQ Alert is based on random monthly sampling conducted by state drug officers across various laboratories. The fact that such a large number of essential medicines have failed these quality tests is a matter of grave concern for the health of the nation.

To make matters worse, a Kolkata drug-testing lab has gone a step further, deeming certain antibiotics like Clavam 625 and Pan D as “spurious” or counterfeit. The same lab also flagged Hetero’s Cepodem XP 50 Dry Suspension, commonly used for severe bacterial infections in children, as substandard.

Paracetamol tablets produced by Karnataka Antibiotics & Pharmaceuticals Ltd were also specifically highlighted for quality issues.

The pharmaceutical companies involved have denied responsibility, claiming the failed batches are “spurious” and not manufactured by them. However, the CDSCO has included these drugs in the list of essential medicines that failed quality checks, leaving little room for doubt.

This development raises serious questions about the efficacy and safety of these drugs. Experts warn that the habit of taking paracetamol without consulting a doctor should be stopped, as the substandard quality of these medicines could lead to adverse health effects.

In a related move, the CDSCO had also banned over 156 fixed-dose drug combinations in August 2024, citing that they were “likely to involve risk to humans”. These included popular fever drugs, painkillers, and allergy tablets.

The NSQ Alert list serves as a wake-up call for both the government and the pharmaceutical industry to take immediate action to ensure the quality and safety of drugs manufactured in India. The health and well-being of millions of Indians depend on it.

As concerned citizens, it is crucial that we stay informed about these developments and exercise caution when consuming medicines. Always consult with a qualified healthcare professional before taking any medication, and be wary of purchasing drugs from unverified sources.

Together, we must demand accountability from the authorities and the pharmaceutical industry to uphold the highest standards of drug quality and safety. The health of our nation depends on it.

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