New Delhi, Sept 26: The Central Drug Standards Control Organisation (CDSCO) has issued a warning regarding more than 50 medications, commonly prescribed for conditions like high blood pressure, acid reflux, and erectile dysfunction, which have been deemed not-of-standard quality in a recent survey. The CDSCO, the regulatory body for drug approval and clinical trials, reported that certain batches of these drugs, produced by various manufacturers, were flagged for quality issues.

For example, a batch of Pulmosil (Sildenafil injection) from Sun Pharmaceuticals was identified as non-standard. The company claimed this batch was not theirs and labeled it as spurious. Another batch of Pantocid, used for treating acid reflux, was also reported as counterfeit by the same company.

Glenmark Pharmaceuticals reported that a specific batch of Telma H (Telmisartan 40mg and Hydrochlorothiazide 12.5mg tablets) did not meet quality standards, with the company asserting that it was not produced by them. Additionally, a batch of Amoxicillin and Potassium Clavulanate tablets (Clavam 625) from Alkem Health Science was found to be substandard.
A senior official from CDSCO emphasized that a single batch’s failure does not imply that all products under that name are substandard. “Quality issues are monitored regularly and addressed quickly to prevent public health risks,” the official stated.
Regulatory bodies routinely conduct random testing to detect potential violations of Good Manufacturing Practices (GMP). While officials noted no significant rise in substandard samples, they highlighted the government’s commitment to enhancing manufacturing standards and ensuring compliance.
The Central Drug Standards Control Organisation (CDSCO) is India’s national regulatory authority responsible for the regulation of pharmaceutical products and medical devices. Operating under the Ministry of Health and Family Welfare, the CDSCO plays a critical role in ensuring the safety, efficacy, and quality of drugs and medical devices marketed in the country.