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The Central Drugs Standard Control Organisation (CDSCO) has declared 1,233 drug samples as standard quality (SQ) based on analysis and testing done on 1,271 samples in the month of February, 2020 done through its random sampling.
However, it concluded that there were 38 samples which were declared as not of standard quality (NSQ).
The manufacturers of these drugs are based in Chennai, Punjab, Madhya Pradesh, China, Himachal Pradesh, Gujarat, Uttarakhand, Rajasthan, Delhi and Maharashtra.
The 38 NSQ drugs include Serratiopeptidase tablets IP 10 mg manufactured by Sai Mirra Innopharm Pvt. Ltd., Chennai which failed the test for Assay, Glyjack –1 (glimepiride tablets I.P.), Fexodil 120 mg (fexofenadine hydrochloride tablets) manufactured by Jackson Laboratories Pvt. Ltd., Punjab, which failed the test of dissolution, Ondansetron injection I.P. 2 mg/ml, 2 ml manufactured by Modern Laboratories, Madhya Pradesh, Cyanocobalamin inj. I.P. 1 ml manufactured by Nandini Medical Laboratories, failed the test of description and particulate matter, oxytetracycline hydrochloride (VET) IP/EP/USP, oxytetracycline hydrochloride I.P manufactured by Hebei Jainmin Starch Glucose Co. Ltd and Hebei Shengxue Dacheng Pharmaceuticals Co. Ltd., China which failed the test of water content, Tymolytic AP (aceclofenac, paracetamol & trypsin chymotrypsin capsules) manufactured by Life Vision Healthcare, Himachal Pradesh failed the test of Assay of trypsin chymotrypsin, Cecon –XT tablets (ferrous ascorbate, folic acid, vitamin B12 & zinc tablets) manufactured by Spas Remedise, Himachal Pradesh which failed the test of Assay/content of folic acid, elemental iron and elemental zinc, phenytoin sodium tablets I.P. 100 mg manufactured by Jackson Laboratories failed the test of assay and description, STECLIN injection veterinary 50 mg/ml (oxytetracycline hydrochloride injection I.P. 30 ml) manufactured by Zydus Animal Health, Gujarat which failed the test of bacterial endotoxins test, Everolimus manufactured by Zhejiang Medicines & Health Products Import & Export Co. Ltd., China which failed the test of assay, water and chromatographic purity on the analysis done by Central Drugs Laboratory (CDL), Kolkata.
Albendazole tablets I.P. 400mg (Zenebend) manufactured by IBN Herbals Khasra, Himachal Pradesh, Albendazole 400mg.tablets I.P manufactured by Biomax Biotechnics (P) Ltd, Haryana, pantoprazole sodium tablets I.P, pantoprazole gastro resistant tablets I.P.40 mg manufactured by Kwality Pharmaceuticals Ltd Punjab, pantoprazole tablets I.P. (PANTA-40) manufactured by Orison Pharmaceuticals, albendazole tablets I.P. 400 mg manufactured by Vivek Pharmachem (India), Rajasthan, metronidazole tablets I.P. 400mg (Neuzol-400) manufactured by Neutec Healthcare Pvt. Ltd, Delhi, Ondansetron tablet I.P. (Ondem-4) manufactured by Alkem Health Sciences, South Sikkim for failing the test of dissolution based on analysis done by Regional Drugs Testing Laboratory (RDTL), Guwahati.
Amoxycillin capsules I.P. (Amoxytor-250) manufactured by Himalaya Medical Pvt. Ltd, Uttarakhand, domperidone suspension (Dom-H) manufactured by Harsh Healthcare, Madhya Pradesh, failed the test of Assay. Ferrous sulphate and folic acid tablets I.P manufactured by HLL Lifecare Ltd, Indore failed the test of disintegration, based on analysis done by RDTL, Guwahati.
Compound sodium lactate injection IP (ringers lactate solution for injection) manufactured by Hindustan Antibiotics Ltd, Pune which failed the test of sterility based on the analysis done by Central Drugs Testing Laboratory (CDTL), Chennai.
Biodipin 5 (amlodipine tablets IP) manufactured by Skymap Pharmaceuticals Pvt. Ltd, Uttarakhand, failed the test of related substances, ambroxol hydrochloride IP manufactured by Anuh Pharma Ltd, Maharashtra for failing the test of Assay and related substances based on the analysis done by CDTL, Mumbai.
Other drugs include amoxycillin and potassium clavulanate tablets IP (Angiclave-625 tablets) manufactured by Shri Sai Balaji Pharmatech Pvt. Ltd, Himachal Pradesh failed the test of identification of clavulanic acid, erythromycin stearate tablets IP 250 mg, manufactured by Globela Pharma Pvt. Ltd, Gujarat for failing the test of dissolution, mefenamic acid and dicyclomine hydrochloride tablets IP (Kolispas tablets) manufactured by Psychotropics India, Uttarakhand which failed the test of description, enzitec digestive enzyme syrup manufactured by Unibiotech Formulations, Himachal Pradesh, failed the test of identification of diastase and Assay of pepsin, lactulose solution manufactured by Terrace Pharmaceuticals failed the test of Assay of lactulose, clindamycin phosphate gel USP (1% w/w) manufactured by Rhydburg Pharmaceuticals Ltd, Uttarakhand which failed the test of Assay of clindamycin phosphate, sucralfate and oxetacaine suspension (Sucrace-O Suspension) manufactured by Mascot Health Series Pvt. Ltd, Haridwar for failing the test of Assay of oxetacaine based on the analysis done by RDTL, Chandigarh.
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