35 samples as NSQ and 773 as SQ in July 2020: CDSCO

35 samples as NSQ and 773 as SQ in July 2020: CDSCO

210
CDSCO DCGI FDA

The Central Drugs Standard Control Organisation (CDSCO) in its monthly surveillance report pan-India has declared 773 drug samples as standard quality (SQ) based on analysis and testing done on 808 samples in July 2020 done through its random sampling exercise.

It concluded that there were 35 samples which were declared as not of standard quality (NSQ) with one declared of spurious quality. The manufacturers of the drugs are based in Himachal Pradesh, Uttarakhand, Bangaluru, Kolkata, Delhi, Punjab and Maharashtra.

The 35 NSQ drugs include Preginate (doxylamine succinate & pyridoxine hydrochloride tablets) manufactured by Skymap Pharmaceuticals failed the test of description & assay of doxylamine succinate. Zonerab (rabeprazole sodium gastroresistant tablets IP), Himachal Pradesh, which failed the test of dissolution in acid stage & assay. Levocetirizine hydrochloride tablets IP 5 mg manufactured by Bangaluru and Uttarakhand, pantoprazole tablets IP 40 mg manufactured by Caplet India Private Limited, Kolkata, paracetamol tablets IP 500 mg manufactured by Maxchem Pharmaceuticals, Uttarakhand, failed the test of dissolution. Zepara – XT tablets 650 mg (paracetamol tablets 650 mg) manufactured by Zee Laboratories, Himachal Pradesh, ondansetron tablets IP 4 mg manufactured by Mars Therapeutics & Chemicals Ltd., Telangana, which failed the test of dissolution and assay. Ramigal 5 (ramipril tablets IP 5 mg) manufactured by Visa Drugs & Pharmaceuticals Pvt. Ltd, Himachal Pradesh failed the test of assay. Sterile Inner Cavity Medical Stents and Introducer System (Esophageal stent) manufactured by Changzhou New District Garson Medical Stent Apparatus Co. Ltd, China failed the test of sterility based on the analysis done by Central Drugs Laboratory (CDL), Kolkata.

Also read: Smuggling of Covid drugs: Two more held from Jhajjar; 13 arrested…

Maygriss sanitizer manufactured by Vive Cosmetics, Punjab failed the test of assay of ethyl alcohol. Isopropyl alcohol 70% hand sanitizer (sanezer hand sanitizer) manufactured by Noel Pharma (India) Pvt. Ltd, Himachal Pradesh, (moist hand sanitizer gel) manufactured by Gary Pharmaceuticals Pvt Limited, Punjab, 70% alcohol hand cleanser (Seven Seas) manufactured by Seven Seas Beauty Products G.T, Delhi for failing the test of assay of isopropyl alcohol. Diclofenac potassium and paracetamol tablets (amgesic tablets) manufactured by Martin & Brown Bio-Sciences, Himachal Pradesh which failed the test of uniformity of weight. Calcium carbonate, methylcobalamin, l-methyl folate, pyridoxal 5 phosphate and vitamin d3 tablets (verecal plus tablets) manufactured by Spectrum Formulation Pvt. Ltd, Haridwar, failed the test of assay of pyridoxal-5 phosphate, lmethylfolate calcium. Escitalopram tablets IP 10 mg) manufactured by Alliaance Biotech, Himachal Pradesh, and ciprofloxacin tablets IP 500 mg manufactured by Daffodills Pharmaceuticals Ltd; Uttar Pradesh failed the test of assay and dissolution.

Another drug include albendazole tablets IP 400 mg manufactured by Healthy Life Pharma Pvt. Ltd, Maharashtra failed the test of dissolution. Fluconazole injection USP 0.2% W/V) manufactured by Aishwarya Healthcare, Himachal Pradesh which failed the test of organic impurities. Calcium and vitamin D3 tablets IP) manufactured by Wings Biotech, Himachal Pradesh for failing the test of dissolution of calcium carbonate. Isopropyl Rubbing Alcohol IP (addiisure instant hand sanitizer) manufactured by Addii Biotech Pvt. Ltd which failed the test of limit of non volatile residue. Olibliss hand cleanser gel manufactured by Olicare Cosmoceuticals, Delhi, Panchvati hand cleanser gel manufactured by Baldev Industries, Delhi, for failing the test of identification of isopropyl alcohol. Isopropyl alcohol emollients and moisturizer hand rub IP (purehandrub plus) manufactured by Edwin Lab, Punjab failed the test of identification and assay of isopropyl alcohol. Methylcobalamin, folic acid, alpha lipoic acid, pyrodoxine HCI, chromium picolinate and selenium tablets (M-neuron plus tablets) manufactured by Med Manor Organics Pvt. Ltd, Uttarakhand for failing the test of identification of selenium and assay of chromium picolinate, selenious acid calculated as elemental selenium. Beard hood hand cleaner manufactured by mbrosia Herbals, Delhi and Seejal +Instant Hand Sanitizer) manufactured by JPEE drugs, Uttarakhand, failed the test of assay of isopropyl alcohol based on the analysis done by Regional Drugs Testing Laboratory (RDTL) Chandigarh.

Glimepiride tablets IP 2mg manufactured by Mascot Health Series Pvt. Ltd, Haridwar and domperidone & omeprazole capsules (ROCID D capsules) manufactured by Ronak Life Care Pvt. Ltd, Gujurat for failing the test of dissolution and nefidinol retard10 tablets manufactured by Rhydburg pharmaceuticals Ltd, Dehradun, which failed the test of non-compliance with physical description of tablets and unfit for human consumption based on the analysis done by RDTL Guwahati.

The Health Master is now on Telegram. For latest update on health and Pharmaceuticals, subscribe to The Health Master on Telegram.