Why paracetamol, antiacid, and other common Indian drugs have failed quality tests

In a shocking revelation, India’s top drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has flagged over 50 commonly used medications, including household names like Paracetamol and antacid Pan D, for failing to meet safety and quality standards.

These are not obscure drugs, but essentials found in millions of homes across the country. From vitamins and calcium D3 supplements to antiacid Pan-D and diabetes and blood pressure medications have been listed as “not of standard quality” by the CDSCO.

These findings, released in a recent alert, have sparked significant worry among consumers and healthcare professionals alike. Here’s what we know about the situation

Which medicines have been flagged?

Several well-known medications have been flagged by CDSCO, following random monthly testing by state drug officers. CDSCO is the sole authority that grants no-objection certificates to pharmaceutical companies that manufacture drugs that are unapproved, new, or banned for the sole purpose of exports in India.

The alert issued in August revealed over 50 popular drugs failing to meet quality standards, spanning pain relievers, antibiotics, and supplements from major pharmaceutical manufacturers.

Among the flagged medications are Paracetamol 500 mg tablets, the anti-diabetic drug Glimepiride, and high blood pressure medication Telma H (Telmisartan 40 mg). Acid reflux treatment Pan D and calcium supplements Shelcal C and D3 were also on the list.

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Additionally, the widely prescribed antibiotic Metronidazole, produced by Hindustan Antibiotics Limited, and Shelcal, distributed by Torrent Pharmaceuticals but produced by Pure & Cure Healthcare in Uttarakhand, did not meet quality standards.

A Kolkata-based lab found that antibiotics Clavam 625 and Pan D, produced by Alkem Health Science, were substandard. This same lab also flagged Cepodem XP 50 dry suspension, used for treating bacterial infections in children, from Hetero as failing tests.

Further concerns were raised over Paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd. Additionally, Sun Pharma’s Ursocol 300, a drug for dissolving gallstones, was labeled “spurious,” and several batches of Telmisartan, manufactured by Life Max Cancer Lab, failed to pass quality checks.

Interestingly, a non-sterile gauze roll also made it onto the flagged list.

Bhaskara Vilasam Vaidyasala’s Haridrakhandam has also come under scanner as it failed the test ‘pH’ as per API or the Ayurvedic Pharmacopoeia of India. Yogaraja Guggulu from the same firm has also failed the quality test, reported The Times of India.

#UPDATE | The Central Drugs Standard Control Organization (CDSCO) has issued an alert regarding 59 medicines that were found to be substandard during tests conducted in August.

The list includes commonly used medications such as Pan-D, #Paracetamol , antibiotics, blood pressure… pic.twitter.com/GJ76VC8ab9

— PB-SHABD (@PBSHABD) September 26, 2024

This come after the the regulator previously banned 156 fixed-dose drug combinations in August, raising concerns about drug safety in India. These included popular fever medications, painkillers, and allergy tablets, commonly used for cold, fever, and pain relief.

Pharma companies deny involvement

Several pharmaceutical companies have denied responsibility for producing the drugs that were flagged in the CDSCO’s quality tests. The drug regulator shared two lists: one featuring 48 drugs and a second with 5 additional medications.

In the reply column, many manufacturers claimed, “The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufacturer by them and that it is a spurious drug. The product is purported to be spurious, however, the same is subjected to outcome of investigation."

Companies like Sun Pharma and Glenmark have echoed similar denials. Sun Pharma, which had three drugs—Pulmosil (for erectile dysfunction), Pantocid (for acid reflux), and Ursocol 300—fail the tests, stated they were not responsible for the production of the flagged batches. Likewise, Glenmark rejected claims that their hypertension drug Telma H (Telmisartan) was part of the substandard findings.

Additionally, Macleods Pharma faced allegations over its arthritis medication Defcort 6, which was flagged as failing quality tests. The pharmaceutical companies maintain their stance that the drugs in question were either counterfeit or spurious, as investigations continue.

Monitoring drug quality alerts from regulatory bodies is vital for safeguarding public health. These alerts help identify harmful or ineffective drugs, reducing risks of adverse reactions, treatment failures, and serious health complications. Staying informed can ensure patient safety and maintain trust in the healthcare system.

With input from agencies