Several widely-used medicines, including antacid Pan D, calcium supplement Shelcal, anti-diabetic drug Glimepiride, and hypertension medication Telmisartan, have been flagged for failing quality tests in the latest monthly drug alert issued by the Central Drugs Standards Control Organisation (CDSCO), India’s drug regulatory authority.
The “Not of Standard Quality” (NSQ) alert for August identified over 50 drugs as substandard. These findings are based on random sampling conducted by state drug officers. Among the flagged drugs are essential medicines produced by well-known pharmaceutical companies such as Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), and Karnataka Antibiotics & Pharmaceuticals Ltd. These companies, however, have contested the findings, asserting that the flagged batches are counterfeit and were not produced by them.
Notable Drugs Failing Quality Tests
One of the major concerns highlighted in the report is the failure of multiple batches of Telmisartan, a popular drug for treating hypertension. These batches were manufactured by Life Max Cancer Laboratories, a Haridwar-based company. Additionally, Metronidazole, a common medication for treating stomach infections, produced by Hindustan Antibiotics Limited (HAL), also failed quality checks. Shelcal, a widely-used calcium supplement manufactured by Pure & Cure Healthcare and sold by Torrent Pharmaceuticals, was also listed.
Further, antibiotic Clavam 625 and Pan D, produced by Alkem Health Science, were deemed spurious by a drug-testing laboratory in Kolkata. The same lab found Hyderabad-based Hetero’s Cepodem XP 50 Dry Suspension, prescribed for bacterial infections in children, to be of substandard quality. Paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd were also flagged for quality concerns.
Pharmaceutical Companies Deny Responsibility
Several top pharmaceutical companies, whose drugs were listed in the NSQ alert, have denied manufacturing the spurious products. Sun Pharmaceuticals, whose Pantocid, Pulmosil, and Ursocol 300 were listed, refuted the findings, claiming that the flagged batches were counterfeit. Similarly, Alkem Laboratories and Glenmark denied producing the flagged batches of their respective drugs.
A spokesperson from Alkem stated, “The flagged products appear to be spurious and were not manufactured by us. We are working with the authorities to resolve this issue.” Sun Pharma echoed these concerns, stating that the tested batches of their drugs were not produced by the company.
The denial by the companies has raised concerns about counterfeit drugs circulating in the market. The CDSCO acknowledged these claims in the alert, noting that investigations are ongoing to confirm whether the flagged drugs are indeed counterfeit.
A Growing Concern for Patients and Healthcare Providers
The repeated instances of substandard medicines have alarmed health experts. The July report also flagged several popular brands, signaling a worrisome trend. Dr. Sumit Ray, Medical Director at Holy Family Hospital, expressed concern over the impact of substandard drugs on patients. “When medications are of poor quality, patients often require longer treatments or higher doses, which not only delays recovery but also adds financial strain due to increased medical costs and doctor visits,” Dr. Ray noted.
The growing frequency of such incidents highlights the need for stricter regulation and monitoring of pharmaceutical products in India to safeguard public health.
