New Delhi: HL September 06, 2026
A recent drug-quality testing exercise has raised concerns over the quality and composition of several medicines commonly used for heart disease, fever, diabetes, blood pressure and other conditions. According to the report shown, 199 drug samples failed to meet prescribed quality standards, while one sample was identified as counterfeit during testing by the Central Drugs Standard Control Organisation (CDSCO).
The findings highlight the importance of effective quality control throughout the pharmaceutical supply chain, particularly for medicines used to manage serious and chronic illnesses.
Heart medicine found with inadequate active ingredients
Among the more concerning findings was a combination medicine containing clopidogrel and aspirin, commonly used to reduce the risk of blood clots in cardiovascular patients.
One tested sample reportedly contained only 38.20% clopidogrel and 21.8% aspirin of the labelled quantities, meaning that a substantial portion of the expected active ingredients was absent.
Another clopidogrel-aspirin formulation also failed quality testing. The sample reportedly contained 77.13% aspirin and 12.01% free salicylic acid, raising concerns about the medicine’s composition and performance.
Stomach medicines also fail testing
Quality problems were also reported in medicines used for gastrointestinal conditions.
A capsule of samay pharma containing 20 mg rabeprazole and 30 mg domperidone reportedly showed zero quantity of both active ingredients during testing.
In another case, a 300 mg pregabalin capsule contained only 211.16 mg of the medicine. A 100 mg etizolam formulation reportedly contained 63.54 mg, while a 5 mg ramipril formulation was found to have only 64.20% of the stated active ingredient.
Such variations can potentially affect the expected therapeutic effect of medicines and underline the need for stringent manufacturing and testing standards.
Oxytocin injection fails identification test
The report also mentions an oxytocin injection manufactured by Jackson Laboratories among the products included in the testing list.
The sample reportedly failed the identification test against the prescribed standard. Oxytocin is used in clinical settings, including during childbirth to help manage uterine contractions, making quality assurance particularly important.
Omeprazole and other medicines under scrutiny
Several samples of omeprazole reportedly failed dissolution testing. Other medicines were found to have issues involving the quantity or identification of their active pharmaceutical ingredients, while some tablets reportedly showed problems with uniformity of dosage.
The findings suggest that quality concerns were not restricted to one particular category of medicine.
Products from major pharmaceutical companies also listed
The report indicates that the failed samples included products associated with both smaller manufacturers and established pharmaceutical companies. It names companies including Lupin, Sun Pharma, Zydus Healthcare, IPCA Laboratories, Glenmark, Macleods Pharmaceuticals, Wellesomepharmaline Pharmaceuticals and Cadila Pharmaceuticals, among others.
The presence of products from recognised manufacturers in the testing list demonstrates why batch-level quality testing and regulatory surveillance remain essential across the pharmaceutical sector.
Antibiotics and paracetamol formulations face quality concerns
The report also highlights problems involving antibiotics. In one JMH pharma formulation, a product labelled as containing 250 mg amoxicillin reportedly showed 10.86 mg amoxicillin and 67.73 mg clavulanic acid during testing.
Other antibiotic samples reportedly showed issues related to active-ingredient quantity, dissolution or identification.
Paracetamol, one of the most frequently used medicines for fever and pain, was also among the products facing quality-related concerns. The report says several paracetamol formulations failed testing, including products from companies such as Coratek Formulations, Zydus Drugs and Alveta Pharma.
A paediatric paracetamol syrup was also reportedly found deficient in a microbiological examination.
Why drug quality matters
Medicines are expected to contain the correct amount of active pharmaceutical ingredients so that patients receive the intended therapeutic dose. If the active ingredient is significantly lower than the labelled strength, treatment may not produce the expected effect. Conversely, problems involving excess ingredients, impurities, dissolution or formulation can create other risks.
For patients taking medicines for heart disease, diabetes, hypertension, infections, pain or fever, maintaining consistent medicine quality is particularly important because treatment often depends on regular and accurately dosed medication.
The findings reinforce the need for strong pharmaceutical manufacturing practices, independent quality testing, regulatory inspections and prompt action against substandard or counterfeit medicines.
Important: A drug being listed in a quality-testing report does not by itself establish wrongdoing by a company or manufacturer. Regulatory authorities generally investigate individual batches and determine the appropriate action based on applicable rules.
