Last Updated on January 5, 2024 by The Health Master
The Central Drugs Standard Control Organisation (CDSCO) in its monthly surveillance report pan-India has declared 731 drugs as standard quality (SQ) based on analysis and testing done on 746 samples in November 2020 done through its random sampling exercise.
It concluded that there were 14 samples which were declared as not of standard quality (NSQ).
To download the alert list of NSQ samples, click here
The manufacturers of the drugs are based in Himachal Pradesh, Madhya Pradesh, Goa and Ahmedabad.
The 14 NSQ drugs include pheniramine maleate tablets IP manufactured by Medipol Pharmaceutical India Pvt. Ltd, Himachal Pradesh.
Levocetrizine tablets IP 5mg manufactured by Deepin Pharmaceuticals Pvt. Ltd, Madhya Pradesh failed the test of description.
Folic acid tablets IP manufactured by HLL Lifecare limited, Indore which failed the test of hydrolysis products & assay.
Glimas-1, Glimepiride tablets IP 5mg manufactured by Mascot Health Series Pvt. Ltd, Uttarakhand failed the test of dissolution.
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Erythromycin stearate tablets IP, 250 mg manufactured by Modern Laboratories which failed the test of dissolution and description based on the analysis done by Central Drugs Laboratory (CDL), Kolkata.
Another drugs include ethyl alcohol, isopropyl alcohol (xerorub hand santizer) manufactured by Seamac Formulations Pvt. Ltd, Himachal Pradesh for failing the test of assay of ethyl alcohol, isopropyl alcohol.
Telmisartan tablets IP (telmimac 40 mg tablets) manufactured by IOSIS Remedies, Himachal Pradesh which failed the test of description.
Isopropyl Rubbing Alcohol IP hand sanitizer (pure-hand zenitizer) manufactured by Ramesh Industry Pvt. Ltd, Himachal Pradesh for failing the test of specific gravity, acidity, limit of non volatile residue and assay of isopropyl alcohol.
Paracetamol paediatric oral suspension IP (Parawin –DS suspension) manufactured by Apple Formulations, Uttarakhand which failed the test of related substances.
Ranitidine injection IP 25mg/ml (Aciloc injection) manufactured by Cadila Pharmaceuticals, Ahmedabad failed the test of particulate matter.
Pregabalin and methylcobalamin capsules IP (Mobil-P capsules) manufactured by ION Healthcare, Himachal Pradesh, for failing the test of description based on the analysis done by Regional Drugs Testing Laboratory (RDTL) Chandigarh.
It also include Hebose-50 (acarbose tablets IP 50 mg) manufactured by Mascot health, Uttarakhand which failed the test of dissolution & assay.
Paracetamol tablets IP 500 mg manufactured by Goa Antibiotics & Pharmaceuticals, Goa failed the test of dissolution.
Rosloy ASP 10/75 (rosuvastatin & aspirin capsules) manufactured by Synokem Pharmaceuticals Ltd, Uttarakhand for failing the test of assay of rosuvastatin based on the analysis done by Central Drugs Testing Laboratory (CDTL), Mumbai.
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