Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

In December 2024, the Indian drug regulator, CDSCO, flagged 51 drugs as Not of Standard Quality (NSQ). As part of continuous regulatory surveillance, Central and State Drug authorities routinely collect samples of drug products from points of sale and distribution and test them at government laboratories.

Among the samples tested, Rabeprazole Injection, Amikacin Sulphate Injection, Bupivacaine Hydrochloride in Dextrose Injection, and Sodium Lactate Injection were the most frequently cited for quality issues by Central Laboratories. These issues included sterility, particulate matter, and clarity of solution. In total, 51 instances of NSQ drugs were identified by CDSCO laboratories and the top reasons for failure were: seventeen (17) for dissolution, ten (10) for particulate matter, five (5) for clarity of solution, six (6) for sterility, and sixteen (16) for assay of active ingredients. Other quality failures included pH, uniformity, description, and related substances. Drug Manufacturers Life Max Cancer Laboratories, Alliaance Biotech, and Martin & Brown Biosciences Pvt. Ltd. were repeatedly cited for NSQ drugs. The samples were tested at CDTL Mumbai, Kolkata, Chennai & RDTL Guwahati, and Chandigarh.

Additionally, CDSCO reported 84 drugs found to be NSQ in tests at state laboratories, with major issues being content and assay failures (49 instances) and dissolution failures (24 instances). These samples were tested at state laboratories in Kerala, Tamil Nadu, Telangana, Puducherry, Jammu & Kashmir, Himachal Pradesh, Tripura, Ladakh, and Karnataka.

Leave a Comment