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The Central Drug Regulatory Authority (CDSCO) has released a concerning report highlighting a significant number of drugs failing to meet quality standards in India. The report, covering the month of September, revealed that samples of 49 drugs were classified as 'Not of Standard Quality' (NSQ), raising serious concerns about the quality and efficacy of medications available to the public.
Among the 49 NSQ drugs identified, a wide range of medications were included, encompassing paracetamol, calcium and vitamin D3 supplements, Oxytocin, Metronidazole, and fluconazole. The report also highlighted that some of the failing batches originated from prominent pharmaceutical companies like Alkem Health Science, Aristo Pharmaceuticals, Camila Pharmaceuticals, Innova Captain, Hindustan Antibiotics, and Ipca Laboratories.
The CDSCO's rigorous inspection process is designed to ensure the quality and effectiveness of drugs circulating in the market. The authority emphasizes that the failure of a specific batch does not necessarily mean that all drugs marketed under the same name are substandard. However, the discovery of such a substantial number of NSQ drugs underscores the critical importance of consistent quality control measures throughout the pharmaceutical supply chain.
The CDSCO's report also identified four drugs as spurious, indicating they were manufactured by fake companies. These included widely used medications like Shelcal 500 (calcium supplement), Pan D (vitamin D3), Urimax D (used to treat Benign Prostate Hyperplasia), and Deca-Durabolin 25 Injection (used to treat osteoporosis). The presence of spurious drugs poses a serious threat to public health, as they may contain harmful substances or lack the intended active ingredients, potentially leading to adverse health outcomes.
Alkem Laboratories, one of the companies whose drugs were flagged in the report, responded by stating that the samples identified as NSQ were spurious and not manufactured by them. The company emphasized its commitment to producing high-quality drugs and its ongoing collaboration with authorities to address the issue of spurious drug circulation in the country.
The CDSCO's stringent action against substandard and spurious drugs is crucial for safeguarding public health in India. The report serves as a stark reminder of the importance of vigilant monitoring and enforcement to ensure that patients receive safe and effective medications. The CDSCO's efforts to curb the proliferation of less efficacious drugs and counterfeit products are essential for building public trust in the pharmaceutical industry and promoting patient well-being.
Source: Vitamin D3, Calcium tablets, 47 others fail CDSCO's quality tests | Full list