Last Updated on January 21, 2021 by The Health Master
The Central Drugs Standard Control Organisation (CDSCO) has declared 928 drug samples as standard quality (SQ) based on analysis and testing done on 943 samples last month as part of the random sampling.
However, it concluded that there were 15 samples which were declared as not of standard quality (NSQ), spurious and misbranded.
To read or download the details of NSQ drugs alerts of December 2020, click here
The manufacturers of these drugs are based in Maharashtra, Gujarat, Himachal Pradesh, Uttar Pradesh, Telangana and Uttarakhand.
The 15 NSQ drugs include Alora 0.25 (alprazolam tablets IP 0.25 mg) manufactured by Shine Pharmaceuticals Limited, Gujarat, and Telmicept – 40 (telmisartan tablets IP 40 mg) manufactured by Concept, Pharmaceuticals Ltd, Maharashtra failed the test of dissolution based on analysis done by Central Drugs Laboratory (CDL), Kolkata.
Other drugs include hand sanitizer manufactured by Vowcare Products, Jammu Kashmir for failing the test of assay of isopropyl alcohol, hydrogen peroxide, and glycerol.
Pantoprazole sodium tablets IP 40 mg manufactured by ANG Lifesciences India Ltd, Himachal Pradesh, and paracetamol tablets IP 650 mg PARLIN650 tablets manufactured by Unisafe Bioscience Pvt. Ltd, Ahmedabad, Gujarat for failing the test of dissolution.
Doctors care hand sanitizer manufactured by Beaubelle’Z Health & Beauty Care, Gujarat which failed the test of assay of ethyl alcohol.
Sulfasalazine tablets BP 500 mg manufactured by Unicure India, Uttar Pradesh failed the test of related substances.
Fluconazole tablets IP 150 mg Flucol tablets manufactured by Ortin Laboratories Ltd, Telangana, and Tramadol prolonged release tablets (Corlividol-100 SR tablets) manufactured by Perk Pharmaceuticals, Uttar Pradesh which failed the test of dissolution and related substances.
Ciprofloxacin tablets IP 500 mg manufactured by Daffodills Pharmaceuticals, Uttar Pradesh and levofloxacin tablets IP L-FOX-500 tablets manufactured by Spectrum Formulation, Uttarakhand for failing the test of uniformity of weight.
Calamine, diphenhydramine hydrochloride and camphor lotion nanzidryl lotion manufactured by Nanz Med Science Pharma Pvt. Ltd, Himachal Pradesh failed the test of assay of camphor based on analysis done by Regional Drugs Testing Laboratory (RDTL), Chandigarh.
It also includes rosuvastain tablets IP 20 mg and pantoprazole tablets IP 40 mg manufactured by Bharat Parenterals Ltd, Gujarat which failed the test of dissolution.
Cystecot-600 (N – acetylcysteine tablets) manufactured by Mascot Health Series, Uttarakhand for failing the test of assay based on analysis done by Central Drugs Testing Laboratory, Mumbai.
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