13 Injectable Samples Fail In Sterility, Bacterial Endotoxins And 4 In Identification Tests During Oct-22 Drawn By CDSCO Inspectors

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New Delhi : The Central Drugs Standard Control Organisation (CDSCO) has declared 50 samples of drugs it has tested in the month of October as not of standard quality as per the Drug Alert list Oct 2022, almost 3.906 per cent of the total drug samples, it has tested during the month. The samples tested as not of standard quality include batches from Sun Pharma Laboratories, Hindustan Antibiotics, Aristo Pharmaceuticals, Mascot Health Series, Pure & Cure, Tab (India), Laboratories Griffon & Himalaya Meditek among others.

The drug regulator has tested a total of 1,280 samples during the month of October and declared 50 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 19 failed in assay, 10 in Dissolution, 7 in Description, 3 in related ubstance tests, 4 in identification, 11 sample in Sterility tests and 9 in Bacterial Endotoxin tests .

The failed samples include medicines Iron folic acid, Antibiotics, anti Parkinson’s drugs, antipyretics, GI disorders, anti allergic, anti asthmatic, anti emetic, bllod clotting, 5 α-Reductase Inhibitors, Prostaglandin analogues, Prebiotic & Probiotics, anthelmintics, antiepileptic, Anti H. pylori drugs, corticosteroids, Multivitamin Infusion, Vitamins, ACE Inhibitors, antiplatelet, Ringer lactate, NS, Hypolipidaemics, cough syp, androgens, Catheters and a general anaesthetic.

Total 13 samples of injectables failed. These include Five RL 500 ml of Swaroop Pharmaceuticals Pvt Ltd, Aligarh – 202 001; Five RL-500 ml of Ives Drugs (India) Pvt Ltd, Ghatabillod, Dist. Dhar; One NS-500 ml of Swaroop Pharmaceuticals Pvt Ltd, Aligarh – 202 001 and One Chromostat Inj. of Life Pharmaceuticals Pvt Ltd, Howrah – 711316. All samples failed in Bacterial Endotoxins and Sterility/ Sterility. These drugs were harmful to human life and may cause death.

19 samples failed in assay includes Midazolam Inj of Pushkar Pharma, Montek® LC (Montelukast Sodium & Levocetirizine Hydrochloride Tab IP) of Sun pharma laboratories, Markmox-500  (Amoxycillin Cap IP 500 mg) of J.R.S. Oryx Pharmaceuticals (P) Ltd, Onkam (Ondansetron Oral Solution IP) of Gujarat Pharmalab PvtLtd, Pantop-DSR (Pantoprazole Sodium Gastro-resistant & Domperidone Prolonged release Cap IP) of Aristo Pharmaceuticals Pvt Ltd, Misoprostol Tab IP 200 mcg of Ridley Life Science Pvt Ltd, Diacowin-Plus Caps of Zee Laboratories, Misoprostol Tab IP 200 mcg of Ridley Life Science Pvt Ltd, Albendazole Tab IP 400 mg of Ornate Labs Pvt Ltd, Predace-4 (Methylprednisolone Tab IP 4 mg) of Malik Life Sciences Pvt Ltd, Tilvit (Multivitamin Infusion) 10 ml of Tab (India) Ltd, Otocap Cap (Alpha Lipoic Acid Ginkgo Biloba Chromium Picolinate Methylcobalamin, Zinc Vitamin B6 and Vitamin C Cap) of Ishaanav Nutraceuticals Pvt Ltd, Mycobal-Plus Cap (Methylcobalamin, Alpha Lipoic Acid Pyridoxine Hydrochloride & Folic Acid Cap) of Progressive Lifesciences Pvt Ltd, Enalapril Maleate Tab IP 5 mg of Trugen Pharmaceuticals Pvt Ltd, Clariford-500 (Clarithromycin Tab IP 500 mg) of Himalaya Meditek Pvt Ltd, Ondasetron Tab IP 4 mg of ANG Lifesciences India Ltd, Bromhexine Hydrochloride Tarbutaline Sulphate Guaiphenesin and Menthol Syrup (Cinafroz BR Cough Syrup) of Healcure Lifesciences, Nandrolone Decanoate USP 250 mg/ml (Decagen) of Code No. : PB/Drugs/1633- B & PB/Drugs/1619-OSP. Pantoprazole Sodium Gastro-Resistant Tab (Pantario-40 Tab) of Anon Pharmaceutical and Midazolam Inj IP of Pushkar Pharma.

4 samples failed in Identification and Assay includes samples of Montek® LC of Sun pharma laboratories ltd. Plot No. 107-108, Namli Block, P.O. Ranipool, East-Sikkim-737135; Pantop-DSR (Pantoprazole Sodium Gastro-resistant & Domperidone Prolonged release Cap IP) of ARISTO Pharmaceuticals Private Limited Plot Nos.: 2040-46, N.H. 10, Baghey Khola, P.O.Majhitar, East-Sikkim, 737136; DIACOWIN-PLUS Cap (Prebiotic & Probiotics Cap) of Zee Laboratories, 47 Industrial Area, Paonta Sahib -173 025, Himachal Pradesh and Mycobal-Plus Cap (Methylcobalamin, Alpha Lipoic Acid Pyridoxine Hydrochloride & Folic Acid Cap) of Progressive Lifesciences Pvt. Ltd., Latherdevahoon, P.O. Jhabrera, Roorkee, Dist. Haridwar -247665 Uttarakhand.

Nine medicine samples manufactured by various pharmaceutical firms in Himachal Pradesh are declared substandard nationwide. The firms include Lifevision Healthcare, DM Pharma Pct Ltd, Salus Pharmaceuticals, Shiva Biogenetic Laboratories, Health Biotech, ANG Lifesciences India Ltd, Healcure Lifesciences, Pushkar Pharma and Zee Laboratories.

Eleven Samples manufactured from from Uttarakhand failed in quality tests. These are from Om Biomedic Pvt Ltd, Mascot Health Series Pvt Ltd, Unimark Healthcare Ltd, Pure & Cure Healthcare Pvt Ltd, Malik Life Sciences Pvt Ltd, Ishaanav Nutraceuticals Pvt Ltd, Progressive Lifesciences Pvt Ltd, Trugen Pharmaceuticals Pvt Ltd, Psychotropics India Limited, Himalaya Meditek Pvt Ltd and Rhydburg Pharamaceuticals Ltd.

These failed samples are tested by 14 by RDTL, Guwahati; 28 by CDL, Kolkata; 2 by CDTL, Mumbai; 5 by RDTL Chandigarh; by 1 by CDTL, Hyderabad.

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.

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