The Central Drugs Standard Control Organisation (CDSCO) has declared 452 drug samples as standard quality (SQ) based on analysis and testing done on 477 samples in the month of May 2020 done through its random samplings.
It concluded that there were 25 samples which were declared as not of standard quality (NSQ). The manufacturers of the drugs are based in Amritsar, Himachal Pradesh, Andhra Pradesh, Ahmadabad, Gujarat and Madhya Pradesh.
The 25 NSQ drugs include clonazepam tablets IP (Clozep 0.5 mg) manufactured by Jackson Laboratories Pvt. Ltd, Amritsar, alprazolam tablets IP manufactured by Medipol Pharmaceutical India Pvt. Ltd., Himachal Pradesh, Nucerin -50 capsules (diacerein capsules IP 50 mg) manufactured by Mascot Health Services Pvt. Ltd., Haridwar, Cipjohn 500 (ciprofloxacin tablets IP 500 mg) manufactured by Himalaya Meditek, Dehradun and Calcigard -10 (nifedipine capsules IP) manufactured by Torrent Pharmaceuticals, Daman which failed due to dissolution.
Doxin – 75 (doxepin hydrochloride capsules IP 75 mg) manufactured by Intas Pharmaceuticals, South Sikkim, which failed the test of description and assay, Iofer -12 (iron, folic acid & vitamin B 12 capsules) manufactured by Ortin Laboratories, Andhra Pradesh failed the test of assay of vitamin B12, Fungdid- B cream (clotrimazole with beclomethasone dipropionate cream) 15 g manufactured by Rednex Pharmaceuticals, failed the test of assay of beclomethas.
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One dipropionate, ReGermina (prebiotic &probiotics capsules) manufactured by Morepen Laboratories, Himachal Pradesh, which failed the test of content of streptococcus faecalis and clostridium butyricum, Onstal – 4 (ondansetron tablets IP 4 mg) manufactured by Stallion Laboratories, Pvt. Ltd., failed the test of description and Gauze Swabs BP:88: Type 17 manufactured by Premier Enterprises which failed the test of Threads per stated Length and Wt. per Unit Area based on the analysis done by Central Drugs Laboratory (CDL), Kolkata.
Atorfirst-10 (atorvastatin tablets IP 10 mg) manufactured by Bayberry Pharmaceuticals Pvt. Ltd., Himachal Pradesh failed the test of dissolution on the analysis done by Central Drugs Testing Laboratory (CDTL), Mumbai.
Ofloxacin tablets IP (Floxa-200 tablets) manufactured by Anecxa Pharma, Uttarakhand which failed the test of identification, metoclopramide hydrochloride injection IP 5 mg/ml manufactured by Modern Laboratories, Indore failed the test of PH, dexamethasone injection IP (UniDexa injection) manufactured by Unital Formulations, Himachal Pradesh which failed the test of sterility, free dexamethas one and the assay of dexamethas one sodium phosphate and levetiracetam injection (Nuatam injection) manufactured by SBS Biotech, Himachal Pradesh failed the test of particulate matter based on the analysis done by Regional Drugs Testing Laboratory (RDTL), Chandigarh.
P-QUIN-2.5 (primaquine tablets IP 2.5 mg) manufactured by Quest Laboratories Pvt Ltd, Madhya Pradesh failed the test of assay and dissolution, cefpodoxime tablets IP 200 mg manufactured by Nootan Pharmaceuticals failed the test of dissolution and ferrous sulphate and folic acid syrup IP manufactured by HLL Lifecare Limited, Madhya Pradesh which failed the test of assay of folic acid and pH based on analysis done from RDTL, Guwahati.