CDSCO Uncovers Substandard Batches in 50 Commonly Prescribed Drugs
In a recent investigation conducted by the Central Drug Standards Control Organisation (CDSCO), alarming findings revealed that more than 50 commonly prescribed medications, ranging from treatments for high blood pressure and acid reflux to erectile dysfunction, were identified as being of substandard quality.
These substandard drugs, despite failing to meet safety and efficacy standards, continue to be readily available in the market, raising concerns about the potential risks they pose to public health.
Top Pharmaceutical Companies Under Scrutiny
The CDSCO’s data released last month shed light on the subpar quality of multiple drug batches produced by some of the leading pharmaceutical companies in the country. For instance, a batch of Pulmosil (Sildenafil injection) manufactured by Sun Pharmaceuticals was flagged as substandard.
However, Sun Pharmaceuticals denied any responsibility for the questionable batch, claiming it to be counterfeit. Similarly, a batch of Pantocid, a widely prescribed medication for acid reflux, was also identified as fake according to the report.
Glenmark Pharmaceuticals also found itself in hot water after a batch of Telma H (Telmisartan 40 mg and Hydrochlorothiazide 12.5 mg tablets IP), used for treating high blood pressure, failed to meet the required quality standards. Like Sun Pharmaceuticals, Glenmark refuted the allegations of manufacturing the substandard batch. Additionally, Alkem Health Science faced issues with a batch of Clavam 625 (Amoxicillin and Potassium Clavulanate tablets IP), which did not meet the necessary standards, as mentioned in the report.
CDSCO’s Reassurance on Drug Safety
A senior official from CDSCO was quoted in the report emphasizing that the identification of substandard results for specific drug batches does not imply that all drugs of the same name are of poor quality. The official further assured the public that quality concerns are consistently monitored, and any issues that arise are promptly addressed to mitigate potential risks to public health.
The CDSCO remains committed to upholding stringent quality standards to ensure the safety and efficacy of medications available in the market.
Steps Towards Enhancing Drug Quality
As part of its regulatory function overseeing drug approvals and clinical trials, the CDSCO routinely conducts random drug sampling to verify compliance with Good Manufacturing Practices (GMP). While there has been no significant increase in the prevalence of substandard drugs, government officials reiterated their dedication to enhancing manufacturing processes and maintaining high-quality standards across the pharmaceutical industry, as reported.
In conclusion, the recent findings by the CDSCO highlight the importance of stringent quality control measures in the manufacturing and distribution of medications to safeguard public health and ensure the effectiveness of prescribed treatments. It is imperative that pharmaceutical companies adhere to the highest standards of quality to prevent the circulation of substandard drugs in the market, ultimately prioritizing the well-being of patients nationwide.
