New Delhi : The Central Drugs Standard Control Organisation (CDSCO) has declared 83 samples of drugs it has tested in the month of November as not of standard quality as per the Drug Alert list Nov 2022, almost 5.5817 per cent of the total drug samples, it has tested during the month. The samples tested as not of standard quality include batches from Aristo Pharmaceuticals Pvt Ltd, Pure and Cure Healthcare Pvt Ltd, Hindustan Antibiotics, Themis Medicare Limited, Morepen Laboratories, Lark Laboratories (India) Ltd, Solace Biotech Limited, Karnataka Antibiotics & Pharmaceuticals Ltd and Vivek Pharmachem (India) Limited.
The drug regulator has tested a total of 1,487 samples during the month of November and declared 83 out of them as not of standard quality. There were no spurious or misbranded drugs among the samples, according to data released by the CDSCO.
Out of these samples 6 failed in Identification and Assay, One in Identification, 38 failed in assay, 19 in Dissolution, 3 in Disintegration, 9 in Description, 4 in particulate matter, 4 in ‘pH’, 3 in related substance tests, 7 sample in Sterility tests & One in Bacterial Endotoxin and Sterility tests. Some samples failed in multiple parameters.
The failed samples include medicines Analgesics, antipyretics, Angiotensin (AT1) receptor blockers, Gastric Acid Suppressants, Antimicrobials, Vitamins, Antimalarials, Antiemetics, Calcium+VitD3 supplements, Antihistamines, antidiarrheal, Anthelmintics, Anti Cold, Leukotriene Antagonists, Antacids, Hypnotics, Local Anaesthetics, General Anaesthetics, diuretics, Anticonvulsants, Infusions, Corticosteroids, Carbamates, Antiepileptic, anti hypertensive drugs, anti platelet drugs, surgical Cotton etc.
Total 28 samples of injectables failed. These include Cefoperazone & Sulbactam for Injection 2g of Karnataka Antibiotics & Pharmaceuticals Ltd, Bupicain- Heavy 4 ml (Bupivacaine Hydrochloride with Dextrose Injection USP) of Themis Medicare Limited, RL-500ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection IP) of Ives Drugs (India) Pvt Ltd, 14 Samples of Nixi Laboratories Pvt Ltd (Proposol Inj 10 ml, Nexofol Injection 20 ml, Mepdofol Injection 20 ml, Pfolol-20 Injection, Prozofol Inj 20 ml, Propoven Injection-20 ml, Ropula Injection-20 ml, Pufolin Injection- 20 ml and Nenfol Injection-10 ml. Total 9 Brands of Propofol Injection), 5 Samples Compound Sodium Lactate Injection IP (RL) 500 ml of Pharma Impex Laboratories Pvt Ltd, Neostigmine Injection IP 0.5 mg /ml of Acro Lifesciences (India) Pvt Ltd, Ceftal (Ceftriaxone Injection IP) of Unital Formulations, MIDZOCULE 10 Injection (Midazolam Injection IP 1mg/ml of Safe Parenterals Pvt Ltd, Gollapadu-522408 & Cefoperazone and Sulbactam For Injection (Suf-DT Injection) of Subham Remedies. These drugs were harmful to human life and may cause death.
6 samples failed in Identification and assay includes Pantop-DSR® (Pantoprazole Sodium Gastro-resistant & Domperidone Prolonged- release Capsules IP) of Purported to be manufactured by Aristo Pharmaceuticals Private Limited, Norfloxacin and Tinidazole Tablets (Norflox-TZ RF) of Shivalik Remedies Pvt Ltd, SHELCAL®-500 (Calcium And Vitamin D3 Tablets IP) Purported to be manufactured by Pure and Cure Healthcare Pvt Ltd, Pantop- D SR® (Pantoprazole Sodium Gastro-resistant & Domperidone Prolonged-release Capsules IP) of Purported to be manufactured by Aristo Pharmaceuticals Private Limited, Calcium and Vitamin D3 Tablets IP of Modern Laboratories and Sensikast-LC Tablets (Levocetirizine Hydrochloride & Montelukast Sodium Tablets) of Amkon Pharmaceuticals.
One sample of Domperidone Tablets IP 10 mg (Domcolic Tablets) of Skymap Pharmaceuticals Pvt Ltd, B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee – 247667 failed in Identification test.
One sample of RL-500ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection IP) of Ives Drugs (India) Pvt Ltd, Works: Ghatabillod, Distt. Dhar, H.O. 504, Chetak Centre, RNT Marg, Indore – 1 failed in Bacterial Endotoxins & Sterility tests.
7 Samples of Frusemide Injection IP 2ml of Nandani Medical Laboratories Pvt Ltd, 221/5, Bicholi Hapsi Kanadla Road, Indore; Bupivacaine Hydrochloride Injection IP (0.5% w/v) – 20 ml of Jackson Laboratories Pvt Ltd, 22-24, Majitha Road, Bye Pass, Amritsar – 143 001, RL-500ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection IP) of Ives Drugs (India) Pvt Ltd, Works: Ghatabillod, Distt. Dhar, H.O. 504, Chetak Centre, RNT Marg, Indore – 1 & 4 Samples of Compound Sodium Lactate Injection IP (RL) 500 ml of Pharma Impex Laboratories Pvt Ltd, South Uttarbhag, Ramnagar, Baruipur, Dist. South 24 Pgs, West Bengal – 743387 failed in Sterility tests.
26 medicines manufactured by various pharmaceutical firms of Himachal Pradesh are declared substandard nationwide. The firms include ANG Lifesciences India Ltd, Morepen Laboratories, C.B. Healthcare, Nixi Laboratories Pvt Ltd, Ultra Drugs Pvt Ltd, Unital Formulations, Healer’s Lab., Unit-II, Zee Laboratories Ltd and ScottEdil Pharmacia Ltd.
17 drugs manufactured from Uttarakhand failed in quality tests. These are from Shivalik Remedies Pvt Ltd, Unimarck Healthcare Ltd, s. Pure and Cure Healthcare Pvt Ltd, Apple Formulations Pvt Ltd, Solace Biotech Limited, Skymap Pharmaceuticals Pvt Ltd, Lucent Biotech Limited, (Unit II), Themis Medicare Limited, Jainsons Healthcare and Subham Remedies, Ravian Life Sciences Pvt Ltd.
These failed samples are tested by 29 by RDTL, Guwahati; 41 by CDL, Kolkata; 1 by CDTL, Mumbai; 10 by RDTL Chandigarh; by 2 by CDTL, Chennai.
38 samples were sent by CDSCO inspectors, 13 by Himachal, 9 by Bihar, 6 Mizoram, 5 Assam, 7 Jharkhand, 2 Nagaland, 2 Orissa and one by Meghalaya.
The CDSCO has not categorized the reports on the basis of ‘Guidelines for taking action on samples of drugs declared spurious or not of standard quality in the light of enhanced penalties under the Drugs and Cosmetics (Amendment) Act, 2008.’ Neither mentioned that the samples were original products of manufacturer or fake/ counterfeit formulations.
Columns of Spurious drugs are left blank as usual in the alert, whether the sample may have failed in identification or grossly in assay. DCGI has also ignored the Section 27 (a) of the Act, which specifies that “the drug deemed to be adulterated under section 17-A or spurious under section 17-B when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body as would amount to grievous hurt within the meaning of section 320 of the Indian Penal Code (45 of 1860).
It is necessary to categorize the reports on the basis of ‘Guidelines for taking action on samples of drugs declared spurious or not of standard quality in the light of enhanced penalties under the Drugs and Cosmetics (Amendment) Act, 2008.’ for public information.