New Delhi : The Central Drugs Standard Control Organisation (CDSCO) has declared 67 samples of drugs it has tested in the month of January, 2023 as not of standard quality as per the Drug Alert list Jan 2023, almost 4.970 per cent of the total drug samples, it has tested during the month. The samples tested as not of standard quality include batches labelled to be products of Karnataka Antibiotics and Pharmaceuticals Ltd, Cipla Ltd, Ipca Laboratories Ltd , Alkem Health Science and Sun Pharma Laboratories Ltd. But, we are sure these are spurious and not manufactured by the manufacturers.
The drug regulator has tested a total of 1,348 samples during the month of January, 2023 and declared 67 out of them as not of standard quality. There are 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, 17 in Assay, 15 in Dissolution, 4 in Disintegration, 11 in Description, 2 in particulate matter, 3 in ‘pH’, 2 in related substance tests, One in Bacterial Endotoxin and Sterility tests. Some samples failed in multiple parameters.
The failed samples include proton Pump inhibitors, Antibiotics, Antidiarrheals solution, Angiotensin (AT1) Receptor Blockers, antifungal Triazole, B-Complex, Absorbent Cotton, Antiepileptic Hydantoin, H1 Antagonist Second Generation antihistamine, Infusions, Calcium Supplements, Short acting Corticosteroid, weight reducing drug lipase inhibitor, PGs, Multi Vitamins and Minerals, Uterine relaxant, Antiasthmatic Leukotriene antagonist, Hypolipidemic Statins, Antiasthmatic inhalation, antiamoebic, anti Rheumatic gels, antidiabetic dipeptidyl peptidase 4 inhibitor, anti inflammatory, Dialysis Solution and Diuretic drugs.
Total 4 samples of injectables failed. These include RL-500 ml Compound Sodium Lactate Injection IP of SWAROOP Pharmaceuticals Pvt Ltd, Hycorlin 100 mg (Hydrocortisone Sodium Succinate Injection IP) of Scott – Edil Pharmecia Ltd and two samples of SECROX (Cefuroxime Injection IP 1.5 gm), Sterile water for Injection IP 20 ml of Bengene Life Sciences Pvt Ltd, Village Kishanpura, HP. These drugs were harmful to human life and may cause death.
No sample of Eye Drops is tested.
6 samples failed in Identification and assay includes Pan -D (Pantoprazole Gastro-Resistant and Domperidone Prolonged Release Caps IP) of Alkem Health Science, Sikkim; Pantocid DSR (Pantoprazole Gastro-Resistant and Domperidone Prolonged Release Caps IP) of Sun Pharma Laboratories Ltd, Ranipool, East Sikkim 737 135; Alpha Lipoic Acid, Folic Acid, Mecobalamin Pyridoxine, Vitamin D3 Tab (NILCOBAL-D TABS) of Relieve Pharmaceuticals, Two samples of Aceclofenac 100 mg & Thiocolchicoside 4 mg Tabs (Zerodol TH 4 Tabs) of s. Ipca Laboratories Ltd and Loose Powder (Purported to be containing Telmisartan) which was not labeled with statutory details.
17 Samples failed in Assay includes Three samples Rabeprazole Gastro Resistant Tabs IP 20 mg of Revat Laboratories Pvt Ltd, Two samples of KOOCAL-500 Tabs (Calcium with Vitamin D Tabs IP) of Athens Life Sciences, Neurace (Vitamin A, C, E & Selenium Caps ) of East West Pharma (India) Pvt Ltd, Misoprostol Tabs IP 200 mcg of Ridley Lifescience Pvt Ltd, Two samples of Romavit Caps (Amino Acids, Biotin, Folic Acid, Vitamins and Minerals Caps) of Kaizen Research Labs India Pvt Ltd, Budecort Respules 0.5 mg (Budesonide Nebuliser Suspension BP) of Cipla Ltd, Montellion-10 (Montelukast Tabs IP 10 mg) of Stallion Laboratories Pvt Ltd, Chymnetra-Forte (TrypsinChymotrypsin Tabs) of D.R. Johns Lab Pvt Ltd, Cloxacillin Sodium Caps IP 500 mg of Ridley Life Science Pvt Ltd, Two Samples of Peritoneal Dialysis Solution IP with 1.5% w/v Dextrose of . Mitra Industries (P) Ltd, Loose yellow colored Tabs (Purported to contain Rosuvastatin 10 mg) and Aceclofenac and Thiocolchicoside Tabs (AcetanTH Tabs) of Renowed Life Sciences, SIDCUL, Haridwar-249403.
16 medicines manufactured by various pharmaceutical firms of Himachal Pradesh are declared substandard nationwide. The firms include L V Life Sciences, Celebrity Biopharma Ltd, Navkar Lifesciences, Vobb Healthcare, Athens Life Sciences, Acme Generics Pvt Ltd, Bengene Life Sciences Pvt Ltd, Elfin Drugs Pvt Ltd, Curetech Skincare, Relieve Pharmaceuticals, Trizal Formulation and Affine Formulations Ltd.
13 drugs manufactured from Uttarakhand failed in quality tests. These are from Apple Formulations Pvt Ltd, Unimarck Healthcare Ltd, Maxmed Lifesciences Pvt Ltd, Life Max Cancer Laboratories, East West Pharma (India) Pvt Ltd, D.R. Johns Lab Pvt Ltd and Renowed Life Sciences, SIDCUL, Haridwar-249403.
These failed samples are tested 25 by RDTL, Guwahati; 15 by CDL, Kolkata; 9 by CDTL, Mumbai; 16 by RDTL Chandigarh; by One by CDTL, Chennai and One CDTL, Hyderabad.
41 samples were drawn by CDSCO inspectors, 12 Drugs Control Dept, Bihar; 2 Drug Control Department, Assam; 4 Drug Control Department, Mizoram; 5 Drug Control Department, Jharkhand; 2 Drug Control Department, Meghalaya and 1 Drug Control Department, Himachal Pradesh.
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.