New Delhi: In its latest drug safety alert, the Central Drugs Standard Control Organization (CDSCO) has flagged 27 medicine batches as not of Standard Quality for the month of April 2022. The drugs samples include Morepen Labs' CalciQuick-500, Abbott's Ursodeoxycholic Acid Tablets IP 300mg, Alkem Health Science's Amoxicillin and Potassium Clavulanate Tablets, Sun Pharma's Pantoprazole Gastro Resistant and Domperidone Prolonged-Release Capsules.
This came after analysis and test were conducted by the CDSCO, Drugs Control Departments on 1164 samples. Out of this, 1137 samples were found of standard quality while 27 of them were declared as Not of Standard Quality. No sample was found as spurious and misbranded.
Some of the reasons for the failure of drugs are dissolution, Assay of Vitamin D3, description, related substances of Silodosin.
The samples collected were tested in four laboratories namely CDL Kolkata, CDTL Mumbai, CDTL Hyderabad, RDTL Guwahati.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of April 2022, reads;
Total number of samples tested 1164 Total number of samples declared as of Standard Quality 1137 Total number of samples declared as Not of Standard Quality 27 Total number of samples declared as Spurious 0 Total number of samples declared as Misbranded 0
Total number of samples tested
Total number of samples declared as of Standard Quality
Total number of samples declared as Not of Standard Quality
Total number of samples declared as Spurious
Total number of samples declared as Misbranded
Name of Drugs/medical device/cosmetics
Batch No./Date of Manufacture/Date of Expiry/Manufactured By
Rabeprazole Tablets I.P. 20 mg
Mfd by: M/s. C.I. Laboratories, 24 - B, B. L. Shah Road, Kolkata 700053.
CalciQuick-500 (Calcium and Vitamin D3 Tablets I.P.)
Mfd by: M/s. Morepen Laoratories Ltd., Morepen Village, Malkumajra, Baddi, Dist. Solan, Himachal Pradesh – 173 205.
Mfd by: M/s. Navkar Life Sciences, Plot No. 76, Lodhi Majra, Industrial Area, Baddi, Distt. Solan, Himachal Pradesh.
Alphacept - D4 (Silodosin and Dutasteride Tablets)
B. No.: SGUL0192 Mfg dt: 09/2021 Exp dt: 08/2023
Mfd by: M/s. Swiss Garnier Genexiaa Sciences Pvt. Ltd., (Unit II), Plot No. 568- 569 & 576-579, Tarpin Block, Rhenock, Rongli East Sikkim 737133.
Mfd by: M/s. Coral Laboratories Ltd., Plot No. 27/28, Pharmacity Selaqui, Dehradun - 248011, Uttarakhand, India.
Alphacept – D8 (Silodosin and Dutasteride Tablets)
Mfd by: M/s. Swiss Garnier Genexiaa Sciences Pvt. Ltd., (Unit II), Plot No. 568- 569 & 576-579, Tarpin Block, Rhenock, Rongli East Sikkim 737133.
Sodium Valproate Tablets I.P. 200 mg
Mfd by: M/s. Brilliant Lifesciences Pvt Ltd., At Chuval Dangarwa, Ta.- Detroj Distt. Ahmedabad, Gujarat.
Mfd by: M/s. Skymap Pharmaceutical Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee – 247667, Uttarakhand.
Mfd by: M/s. Stadmed Private Limited, 15,Jawpore Road, Kolkata 7000074.
Glimepiride & Metformin Hcl (Sustaned Release) Tablets (Synopride- M4 Forte)
Mfd by: M/s. ADDII BIOTECH PVT. LTD., ViLL. Kaundi, P.P. Thana, Tah. Baddi, Distt. Solan – 173205, Himachal Pradesh.
Mfd by: M/s. Ridley Lifescience Pvt. Ltd., D-1651, DSIDC, Indl. Complex, Narela, Delhi-110040.
Drug Control Department Arunachal Pradesh
Mfd by: M/s. Vivek Pharmachem ( India) Limited., NH-8, Chimanpura, Amer, Jaipur – 303102, Rajasthan.
Paracetamol, Phenylephrine Hydrochloride, Caffeine and Diphenhydramine Hydrochloride (SNEZEE 500)
Mfd by: M/s. Maxrelief Healthcare, Vill. Anji, Solan, Himachal Pradesh- 173212.
Mfd by: M/s. Vivek Pharmachem ( India) Ltd.,NH-8, Chimanpura, Amer, Jaipur-303102, Rajasthan.
Exp dt: 11/2022 Mfd by: M/s. Om Biomedic Pvt. Ltd., Plot NO. 68, 69, 82 & 83, Sector-6A, IIE, SIDCUL, Haridwar- 249403, Uttarakhand.
Mfd by: M/s. Adwin Pharma, Vill- Rampur Jattan, Trilokpur Road, Kala-Amb, Tehsil- Nahan, Distt. Sirmour, Himachal Pradesh - 173030.
Ursodeoxycholic Acid Tablets IP 300mg (Udiliv 300)
Exp dt: 05/2023 Mfd by: M/s. Abbott India Limited, L-18/19, Verna Industrial Area, Verna, Salcette, Goa- 403722.
Mfd by: M/s. Nestor Pharmaceuticals Limited, 11, Western Extension Area, Faridabad - 121001, Haryana, INDIA.
Levocetirizine Dihydrochloride and Montelukast Sodium Tablets IP
Mfd by: M/s. Mercury Laboratories Ltd. Unit No. 2, Halol-Baroda Road, Village:Jarod, Tal. Waghodia, Dist. Vadodara-391510, Gujarat.
Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP
Mfd by: M/s. Sri Ram Healthcare Pvt. Ltd., 81-C/2, EPIP-I, Jharmajri, Baddi, Distt. Solan, Himachal Pradesh -173205.
Amoxicillin and Potassium Clavulanate Tablets IP
Mfd by: M/s. Alkem Health Science A Unit of Alkem Laboratories Limited, Unit-2, Samardung, Karek Block, PO. Nanthang, South Sikkim- 737137.
Pantoprazole Gastro Resistant and Domperidone Prolonged-Release Capsules IP
Mfd by: M/s. Sun Pharma Laboratories Ltd., Plot No. 107-108, Namli Block, P.O. Ranipool, East Sikkim- 737135.
Mfd by: M/s. Vivek Pharmachem ( India) Ltd., NH-8, Chimanpura, Amer, Jaipur-303102, Rajasthan.
Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, Baddi, Distt. Solan, Himachal Pradesh, INDIA.
Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, Baddi, Distt. Solan, Himachal Pradesh, INDIA.
Mfd by: M/s. Algen Healthcare Limited, 134/2, Vill. Khara Khari, Sadhaura Road, Kala Amb, Distt. Sirmour, Himachal Pradesh – 173030.
Cyanocobalamine, L-Lysine Hcl & L- Glutamic Acid
Mfd by: M/s. Swiss-de- cheme At: Mithanpura- 842002, H.O. 96, Lock Gate Road, Sri Krishnapur, P.O. Kulghacia, Distt. Howrah- 711306, West Bengal.
For more details, check out a full notice on the link below:
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODQzOQ==
Ruchika joined Medical Dialogue an Desk Editor for the Business Section in 2019. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate from Delhi University. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
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