Jaipur : The Central Drugs Standard Control Organisation (CDSCO) has put a list of samples failed in quality tests during June, 2022 by CDL, Kolkata; RDTL, Guwahati and RDTL, Chandigarh. Other laboratories functioning under CDSCO has not declared any sample during this month not of Standard Quality.
14 Samples during this month failed in Assay test. But, no mention is made in the Bulletin about the percentage of active drug ingredient found in these samples. These samples as per the alert were purported to be manufactured by Hindustan Antibiotics Ltd, Faridabad; Swiss Garnier Biotech Pvt Ltd, Mehatpur; Oxalis Labs, Theda; Astam Healthcare Pvt Ltd Vill. Theda; Ornate Labs Pvt Ltd, Muzaffarpur; Strassenburg Pharmaceuticals Ltd, WB; Revat Laboratories Pvt Ltd, Pernarmitta Ongole; Salud Care (I) Pvt Ltd, Roorkee; Unicure India Ltd, Village Raipur and Elder Labs Limited Vill: Kishanpura.
9 Samples from this list failed in dissolution test, 6 Samples in Description and One sample in Uniformity of Content (Folic Acid). No sample failed in Sterility or Bacterial Endotoxin test during the month.
The CDSCO has not categorized the reports on the basis of ‘Guidelines for taking action on samples of drugs declared spurious or not of standard quality in the light of enhanced penalties under the Drugs and Cosmetics (Amendment) Act, 2008.’ Neither mentioned that the samples were original products of manufacturer or fake/ counterfeit formulations.
Columns of Spurious and misbranded drugs are left blank as usual in the alert.