Drug alert: 16 out of 1001 samples declared as NSQ in January 2021: CDSCO

Drug alert: 16 out of 1001 samples declared as NSQ in January 2021: CDSCO

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Last Updated on March 3, 2021 by The Health Master

The Central Drugs Standard Control Organisation (CDSCO) has declared 985 drug samples as standard quality (SQ) based on random testing done on 1001 samples in the month of January 2021. 

However, it concluded that there were only 16 samples which were declared as not of standard quality (NSQ).

For detailed NSQ list, click here

The manufacturers of these drugs are based in Maharashtra, Gujarat, Himachal Pradesh, Uttar Pradesh, Telangana, Uttarakhand and Bengaluru.

CDSCO FDA

The 16 NSQ drugs include:

Omnikacin – 250 (Amikacin injection IP) manufactured by Akums Drugs & Pharmaceuticals, Uttarakhand failed the test of Assay.

Ontic Syrup (ondansetron oral solution IP- 30 ml) manufactured by Corona Remedies, Himachal Pradesh

Diclofenac Gastro resistant tablets IP 50 mg (Regunac -50) manufactured by Zim Laboratories, Maharashtra


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Amitriptyline tablets IP manufactured by Medipol Pharmaceutical, Himachal Pradesh for failing the test of description.

Tolvat 30 (tolvaptan tablets 30 mg) manufactured by MSN Laboratories Private Limited, Telangana which failed the test of dissolution.

Disilox MPS (Aluminium, Magnesium & Simethicone oral suspension IP) manufactured by Stadmed Private Limited, Kolkata failed the test of Microbial Contamination (total aerobic viable count).

Nitzo – 2.6 (controlled release tablets of nitroglycerin) manufactured by Zee Laboratories, Himachal Pradesh which failed the test of assay of glyceryl trinitrate.

Amlor -2.5(amlodipine besylate tablets IP 2.5 mg) manufactured by Ortin Laboratories Ltd, Telangana for failing the test of dissolution, related substances and assay.

Ancef 1 gm (ceftriaxone injection IP) manufactured by Osper Formulations Pvt. Ltd, Himachal Pradesh

Sterile water for injection IP 10 ml manufactured by Iegency Remedies Pvt. Ltd., Himachal Pradesh failed the test of particulate matter & clarity of solution based on analysis done by Central Drugs Laboratory (CDL), Kolkata.

Vedark Instant Hand Sanitizer manufactured by Gladios Products Pvt. Ltd, Gujarat for failing the test of identification of chlorhexidine gluconate.

Days 2x Hand Sanitizer manufactured by Yadav’s Health & Beauty Herbal Products, Himachal Pradesh which failed the test of assay of ethyl alcohol.

Doxycycline and Lactic Acid Bacillus Capsules (Mesodox LB capsules) manufactured by Haustus Biotech Pvt. Ltd, Himachal Pradesh failed the test of uniformity of filled weight.

Hand Sanitizer manufactured by Vowcare Products, Jammu & Kashmir which failed the test of Assay of isopropyl alcohol hydrogen peroxide glycerol based on analysis done by Regional Drugs Testing Laboratory (RDTL), Chandigarh.

Omeprazole capsules IP 20 mg manufactured by Karnataka Antibiotics & Pharmaceuticals Ltd, Bengaluru failed the test of dissolution (acid stage).

Omecot Capsules (Omperazole capsules IP) manufactured by Mascot Health, Uttarakhand for failing the test of assay & dissolution.

Clopidogrel & Aspirin tablets manufactured by Medipol Pharmaceutical India Pvt Ltd., Himachal Pradesh which failed the test of free salicylic acid, disintegration, assay of aspirin based on analysis done by Central Drugs Testing Laboratory (CDTL), Mumbai.