CDSCO flags substandard batches in over 50 commonly prescribed drugs

More than 50 widely prescribed medications, including treatments for high blood pressure, acid reflux, and erectile dysfunction, were identified as substandard in quality

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In a recent survey by the Central Drug Standards Control Organisation (CDSCO), over 50 commonly prescribed medications, including those for high blood pressure, acid reflux, and erectile dysfunction, were found to be of substandard quality. 

Despite failing to meet safety and efficacy standards, these drugs remain available in the market.

Top pharmaceutical companies under investigation

According to data released last month, multiple batches of drugs produced by leading pharmaceutical companies did not meet CDSCO's quality criteria. For example, a batch of Pulmosil (Sildenafil injection) from Sun Pharmaceuticals was flagged as substandard. 

However, Sun Pharmaceuticals denied responsibility for the batch, stating it was counterfeit. Similarly, a batch of Pantocid, a widely used acid reflux medication, was also identified as fake, the report said.

Glenmark Pharmaceuticals also came under scrutiny after a batch of Telma H (Telmisartan 40 mg and Hydrochlorothiazide 12.5 mg tablets IP), used for treating high blood pressure, was flagged. Glenmark similarly denied manufacturing the questionable batch. Additionally, Alkem Health Science faced issues with a batch of Clavam 625 (Amoxicillin and Potassium Clavulanate tablets IP), which failed to meet the required standards, the report said.

CDSCO reassures drug safety

The report quoted a senior CDSCO official as saying that a substandard result for a specific drug batch does not imply all drugs of the same name are of poor quality. The official further explained that quality concerns are regularly monitored, and issues are addressed promptly to mitigate public health risks, the report said.

Steps to enhance drug quality

As part of its regulatory role overseeing drug approvals and clinical trials, CDSCO regularly conducts random drug sampling to ensure adherence to Good Manufacturing Practices (GMP). While there has been no substantial increase in substandard drugs, officials reiterated the government’s commitment to improving manufacturing processes and upholding quality standards, the report stated.

(With agency inputs)