India’s top drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has flagged over 50 widely used medications, including common drugs like Paracetamol and the antacid Pan D, for failing to meet safety and quality standards. These findings, released in a recent alert, have raised significant concerns among both consumers and healthcare professionals.
Common Household Drugs Under Scrutiny
The flagged drugs are not obscure or rarely used; they are common household medications. CDSCO’s report identified a range of medications, including vitamins, calcium supplements, pain relievers, and diabetes and blood pressure drugs, as “not of standard quality.” These medications are used by millions of people in India, making the findings particularly alarming.
Among the drugs listed are Paracetamol 500 mg tablets, Glimepiride (an anti-diabetic drug), Telma H (a blood pressure medication), and Pan D, which is widely used for acid reflux. Other commonly prescribed medications such as the antibiotic Metronidazole, calcium supplements Shelcal C and D3, and the gallstone treatment Ursocol 300 were also flagged.
The CDSCO report is based on random testing conducted by state drug officers, part of their monthly monitoring efforts. This scrutiny has revealed a worrying pattern of substandard drugs, even from some of India’s largest pharmaceutical companies.
Substandard Drugs and Their Manufacturers
Many of the flagged medications were produced by well-known pharmaceutical companies. For instance, Clavam 625 and Pan D, both produced by Alkem Health Science, were found to be substandard by a Kolkata-based lab. Additionally, Cepodem XP 50, used for treating bacterial infections in children, was another drug that failed quality tests.
Shelcal, which is widely prescribed for calcium deficiency, was found to be below standards. This product is distributed by Torrent Pharmaceuticals but manufactured by Pure & Cure Healthcare in Uttarakhand. Furthermore, Karnataka Antibiotics & Pharmaceuticals Ltd produced the Paracetamol tablets that failed the tests, raising further concerns about the widespread use of these drugs.
Additionally, Sun Pharma’s Ursocol 300 was labeled “spurious” by the regulator, along with several batches of Telmisartan, a medication for hypertension, manufactured by Life Max Cancer Lab. Even non-drug items such as a non-sterile gauze roll made it onto the CDSCO’s list of flagged products.
Ayurvedic Products Under the Scanner
The scrutiny wasn’t limited to allopathic medicines; Ayurvedic products were also found to be substandard. Bhaskara Vilasam Vaidyasala’s Haridrakhandam and Yogaraja Guggulu, both popular Ayurvedic remedies, failed quality tests for their pH levels as per the Ayurvedic Pharmacopoeia of India.
This follows an earlier regulatory crackdown when the CDSCO banned 156 fixed-dose drug combinations in August, including many over-the-counter fever, pain, and allergy medications.
Pharmaceutical Companies Deny Involvement
In response to the CDSCO report, several pharmaceutical companies have denied responsibility for producing the flagged drugs. Some companies, including Sun Pharma and Glenmark, have claimed that the batches tested were counterfeit or spurious. Sun Pharma, which had three drugs—Pulmosil (for erectile dysfunction), Pantocid (for acid reflux), and Ursocol 300—failing the tests, stated that they did not manufacture the flagged batches. Glenmark also rejected claims that their hypertension drug Telma H was part of the substandard findings.
Macleods Pharma, which faced allegations over its arthritis medication Defcort 6, also denied responsibility, asserting that the drug was either counterfeit or spurious.
Public Health and Drug Safety
The CDSCO’s quality alerts serve as a critical tool in protecting public health. Identifying harmful or ineffective drugs can help prevent adverse reactions, treatment failures, and serious health complications. These regulatory actions are essential for maintaining trust in India’s healthcare system and ensuring that patients receive safe and effective treatments.
While pharmaceutical companies continue to deny responsibility, investigations are ongoing to determine the root causes behind these quality failures. Monitoring the outcome of these investigations will be crucial for ensuring the long-term safety of India’s drug supply.
(With inputs from agencies)
