Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
CDSCO has published list of sixtyseven Drugs & Medicinal products as Not of Standard Quality (NSQ) in September 2024. Central and State Drug authorities routinely pick samples of drug products from point of sale and distribution points and get the products tested at government laboratories as part of continuous regulatory surveillance.
Fortynine products were found to be NSQ during testing at Central laboratories and eighteen at State laboratories. Testing at Central laboratories found 23 products failing for Assay and Content, 17 for Dissolution and 10 products for Particulates. Other parameters which were not of standard quality include Description, Identification, Uniformity, Microbial parameters. Products that were found to be not of standard quality include medicines from Pharma Majors like Alkem (Pan 40, Clavam 625) and Cadilla (CIPRODAC 500). The products were tested at the Central laboratories CDL Kolkata, RDTL Guwahati, CDTL Mumbai, CDTL Hyderabad, RDTL Chandigarh.
18 medicinal products were also found NSQ by State Drug Testing Laboratories at Srinagar and Thiruvananthapuram. The Quality issues found during testing at State laboratories include failure in Dissolution (5 cases), Assay (7 cases) and other parameters like Description and Microbial Quality.
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