Samples of 59 Drugs Declared as ‘Not of Standard Quality’: CDSCO
New Delhi, Dec 4 – In a recent alert issued by the Central Drugs Standard Control Organisation (CDSCO), it has been revealed that samples of 59 drugs, including those manufactured by reputed companies, have been declared as not of standard quality. A total of 1,105 samples were tested, out of which 61 were found to be substandard.
The CDSCO conducted tests in various statutory laboratories authorized by the organization. The samples that were determined as not of standard quality include Cefixime Oral Suspension IP, Amoxycillin, Potassium Clavulanate and Lactic Acid Bacillus Tablets (GAMPCLAV-625 LB Tablets), Rabeprazole Sodium (Enteric Coated) and Domperidone (Sustained Release) Capsules (20 mg/30 mg), Diclofenac Sodium Tablets IP 50 mg, Albendazole Tablets I.P. 400 mg, Ofloxacin, Ornidazole, Itraconazole and Clobetasol Propionate Cream (Derma -RX Cream). Additionally, samples of Vitamin C (Orange Syrup) were also found to be substandard.
Among the samples, two drugs were repeated, which brings the count down to 59. The CDSCO alert also noted that two samples of unlabelled vials with white seal, allegedly containing Tigecycline 50 mg, and two samples of phenolic disinfecting multi-purpose surface cleaner-cum-deodorizer (Lytner) were declared as substandard.
The CDSCO’s findings raise concerns about the quality and efficacy of these drugs in the market. However, it is important to note that the test results do not imply immediate recall from the market. The CDSCO will now investigate further and take appropriate regulatory actions to address the issue.
The alert serves as a reminder for both consumers and healthcare professionals to remain vigilant while procuring and prescribing medications, ensuring that they are from reliable sources and adhere to quality standards. Authorities are urging individuals to report any adverse reactions or concerns related to drug quality to the CDSCO.
The CDSCO plays a crucial role in regulating the quality, safety, and efficacy of pharmaceutical products in the country. This incident highlights the importance of robust quality control measures to safeguard public health.
As the investigation continues, it is imperative for all stakeholders, including pharmaceutical companies and regulatory bodies, to collaborate and prioritize the safety and well-being of the consumers. The CDSCO is expected to provide further updates on the progress made in rectifying the situation and ensuring improved drug quality in the market.
Overall, this incident underscores the need for stringent quality assurance processes and serves as a reminder for authorities to remain vigilant and actively monitor the drug market to protect public health.
