In a recent revelation by the Central Drugs Standard Control Organisation (CDSCO), nearly 5.5% of drug samples tested in October 2023 have been deemed not of standard quality (NSQ). The affected samples include products from well-known pharmaceutical companies such as Intas Pharmaceuticals, Emcure Pharmaceuticals, RPG Life Sciences, and Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL).
Key Findings:
1. Percentage of NSQ Samples: Out of 1,108 samples tested, 61 (5.5%) were declared as not meeting the standard quality.
2. Companies Affected: Notable pharmaceutical companies like Intas Pharmaceuticals, Emcure Pharmaceuticals, RPG Life Sciences, and PSU KAPL are among those whose samples did not meet the required standards.
3. Types of NSQ Samples: The list of NSQ samples includes various products such as unlabeled vials, disinfecting surface cleaners, bisoprolol fumarate tablets, levocarnitine injection, amikacin sulfate injection, and spironolactone tablets.
Insights from Industry Representatives:
Laghu Udyog Bharati (LUB), representing micro and small industries, emphasized the need for a holistic approach in assessing NSQ samples. They highlighted factors like transportation breakages, laboratory analysis efficiency, and storage conditions contributing to the classification of drugs as NSQ.
LUB urged the CDSCO to release detailed information on NSQ samples to enhance transparency and maintain trust in Indian medicines. They emphasized addressing underlying issues rather than solely targeting the pharmaceutical industry.
Industry Response:
Dr. Rajesh Gupta, All India Head with Laghu Udyog Bharti Pharmaceutical Committee, stressed the importance of understanding various factors leading to a drug’s failure during testing. The industry calls for the CDSCO to publish details of drugs that pass quality tests, fostering a more comprehensive understanding of the drug alert process.
Considering India’s diverse geography and climatic conditions, the industry advocates for a nuanced approach, acknowledging the impact of logistics and storage conditions on product stability.
As discussions unfold, the pharmaceutical industry awaits further insights from the CDSCO and seeks collaborative efforts to enhance drug quality and safety standards across the nation. Stay tuned for more updates on this evolving scenario.
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