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Date: 2022-05-18 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of April 2022

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

Gazette Overview

  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for April 2022.
  • A total of 1164 samples were tested.
  • 1137 samples were declared to be of Standard Quality.
  • 27 samples were declared as Not of Standard Quality.
  • 0 samples were declared as Spurious.
  • 0 samples were declared as Misbranded.

Key Changes - Not of Standard Quality

  • Rabeprazole Tablets I.P. 20 mg (Batch No.: RPR-117) failed dissolution test. Manufactured by M/s. C.I. Laboratories, Kolkata.
  • CalciQuick-500 (Calcium and Vitamin D3 Tablets I.P.) (Batch No.: T-1H0250) failed assay test. Manufactured by M/s. Morepen Laoratories Ltd., Himachal Pradesh.
  • Ofloxacin & Ornidazole Tablets IP (Batch No.: TB1058A) failed description & dissolution tests. Manufactured by M/s. Navkar Life Sciences, Himachal Pradesh.
  • Alphacept - D4 (Silodosin and Dutasteride Tablets) (Batch No.: SGUL0192) failed related substances of Silodosin test. Manufactured by M/s. Swiss Garnier Genexiaa Sciences Pvt. Ltd., Sikkim.
  • Alprazolam Tablets IP 0.25 mg (Batch No.: SUO2102) failed assay test. Manufactured by M/s. Coral Laboratories Ltd., Uttarakhand.
  • Alphacept – D8 (Silodosin and Dutasteride Tablets) (Batch No.: SGUL0191) failed related substances of Silodosin test. Manufactured by M/s. Swiss Garnier Genexiaa Sciences Pvt. Ltd., Sikkim.
  • Sodium Valproate Tablets I.P. 200 mg (Batch No.: BT5871) failed dissolution test. Manufactured by M/s. Brilliant Lifesciences Pvt Ltd., Gujarat.
  • Albithral 500 (Azithromycin Tablets IP) (Batch No.: DD21007) failed description test. Manufactured by M/s. Skymap Pharmaceutical Pvt. Ltd., Uttarakhand.
  • Diaset 1 (Glimepiride Tablets I.P. 1 mg) (Batch No.: C22F81) failed dissolution test. Manufactured by M/s. Stadmed Private Limited, Kolkata.
  • Glimepiride & Metformin Hcl (Sustained Release) Tablets (Synopride-M4 Forte) (Batch No.: AT2110122A) failed dissolution test. Manufactured by M/s. ADDII BIOTECH PVT. LTD., Himachal Pradesh.
  • Ibuprofen Tablets IP 400 mg (Batch No.: BPT20003) failed dissolution test. Manufactured by M/s. Vivek Pharmachem ( India) Limited., Rajasthan.
  • Paracetamol, Phenylephrine Hydrochloride, Caffeine and Diphenhydramine Hydrochloride (SNEZEE 500) (Batch No.: TP1020810) failed identification and assay tests. Manufactured by M/s. Maxrelief Healthcare, Himachal Pradesh.
  • Ibuprofen Tablets I.P. 400 mg (Batch No.: BPT20005) failed dissolution test. Manufactured by M/s. Vivek Pharmachem ( India) Ltd., Rajasthan.
  • Amlodipine Tablets IP (Batch No.: TL20-25) failed assay test. Manufactured by M/s. Om Biomedic Pvt. Ltd., Uttarakhand.
  • Paracetamol Tablets IP (Batch No.: ADT-08-0541) failed dissolution test. Manufactured by M/s. Adwin Pharma, Himachal Pradesh.
  • Ursodeoxycholic Acid Tablets IP 300mg (Udiliv 300) (Batch No.: 250923D7) failed identification and assay tests. Manufactured by M/s. Abbott India Limited, Goa.
  • Telmisartan Tablets IP 40mg (Batch No.: TETY-01) failed dissolution test. Manufactured by M/s. Nestor Pharmaceuticals Limited, Haryana.
  • Levocetirizine Dihydrochloride and Montelukast Sodium Tablets IP (Batch No.: 21112701) failed dissolution test. Manufactured by M/s. Mercury Laboratories Ltd. Unit No. 2, Gujarat.
  • Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP (Batch No.: LMT21001MB) failed dissolution test. Manufactured by M/s. Sri Ram Healthcare Pvt. Ltd., Himachal Pradesh.
  • Amoxicillin and Potassium Clavulanate Tablets IP (Batch No.: 21441454) failed assay test. Manufactured by M/s. Alkem Health Science A Unit of Alkem Laboratories Limited, Sikkim.
  • Pantoprazole Gastro Resistant and Domperidone Prolonged-Release Capsules IP (Batch No.: RPB0651A) failed identification and assay tests. Manufactured by M/s. Sun Pharma Laboratories Ltd., Sikkim.
  • Misoprostol Tablets I.P. 200mcg (Batch No.: MOT20002) failed assay test. Manufactured by M/s. Vivek Pharmachem ( India) Ltd., Rajasthan.
  • Omeprazole Capsules IP (Batch No.: CO40-001) failed dissolution test. Manufactured by M/s. Medipol Pharmaceutical India Pvt. Ltd., Himachal Pradesh.
  • Omeprazole Capsules IP (Batch No.: CO40-002) failed dissolution test. Manufactured by M/s. Medipol Pharmaceutical India Pvt. Ltd., Himachal Pradesh.
  • Primaquine Tablets I.P. 2.5 mg (Batch No.: AHT-2768) failed dissolution and assay tests. Manufactured by M/s. Algen Healthcare Limited, Himachal Pradesh.
  • Calcium Lactate Vit. D3, Cyanocobalamine, L-Lysine Hcl & L-Glutamic Acid (Batch No.: D11) failed assay test. Manufactured by M/s. Swiss-de-cheme At, West Bengal.

Key Changes - Misbranded

  • Ampicillin Capsules IP (Batch No.: AMI-1901) was declared as Misbranded. Manufactured by M/s. Ridley Lifescience Pvt. Ltd., Delhi.

Impact Analysis

Manufacturers

  • There is a potential impact on the manufacturer's reputation and brand image.

Consumers/Patients

  • There is a need for enhanced pharmacovigilance to monitor and address any adverse effects related to these drugs.

Regulatory Agencies (CDSCO, State Drug Controllers)

  • The regulatory agencies need to collaborate with manufacturers to ensure compliance with quality standards.

Pharmacies/Distributors

  • There is a need to ensure that drugs are stored and handled according to the prescribed conditions.

Action Items

  • Implementation of stricter penalties for manufacturers of substandard drugs.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. RDTL: Regional Drugs Testing Laboratory Drugs and Cosmetics Act, 1940: The primary legislation governing the quality and safety of drugs, cosmetics, and medical devices in India. Drugs and Cosmetics Rules, 1945: Rules framed under the Drugs and Cosmetics Act, 1940, providing detailed regulations for the manufacture, sale, and distribution of drugs and cosmetics. IP: Indian Pharmacopoeia
Official Source Record View Original Source →
See Full Document Text
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of April– 2022. 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 S.No. Name of Batch No./Date of Reason for Drawn By From Drugs/medical Manufacture/Date of failure device/cosmetics Expiry/Manufactured By 1. Rabeprazole B. No.: RPR-117 Dissolution CDSCO CDL Tablets I.P. 20 mg Mfg dt: 12/2021 East Zone Kolkata Kolkata Exp dt: 11/2023 Mfd by: M/s. C.I. Laboratories, 24 - B, B. L. Shah Road, Kolkata 700053. 2. CalciQuick-500 B. No.: T-1H0250 Assay of CDSCO CDL (Calcium and Mfg dt: 08/2021 Vitamin D3 East Zone Kolkata Vitamin D3 Tablets Kolkata Exp dt: 07/2023 I.P.) Mfd by: M/s. Morepen Laoratories Ltd., Morepen Village, Malkumajra, Baddi, Dist. Solan, Himachal Pradesh – 173 205. 3. Ofloxacin & B. No.: TB1058A Description & CDSCO CDL Ornidazole Tablets Mfg dt: 02/2021 Dissolution Guwahati Kolkata IP Exp dt: 01/2023 Mfd by: M/s. Navkar Life Sciences, Plot No. 76, Lodhi Majra, Industrial Area, Baddi, Distt. Solan, Himachal Pradesh. 4. Alphacept - D4 B. No.: SGUL0192 Related CDSCO CDL (Silodosin and Mfg dt: 09/2021 Substances of South Zone Kolkata Dutasteride Tablets) Exp dt: 08/2023 Silodosin Chennai 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. 5. Alprazolam Tablets B. No.: SUO2102 Assay CDSCO CDL IP 0.25 mg Mfg dt: 09/2021 South Zone Kolkata Chennai Exp dt: 08/2023 Mfd by: M/s. Coral Laboratories Ltd., Plot No. 27/28, Pharmacity Selaqui, Dehradun - 248011, Uttarakhand, India. 6. Alphacept – D8 B. No.: SGUL0191 Related CDSCO CDL (Silodosin and Mfg dt: 09/2021 Substances of South Zone Kolkata Dutasteride Tablets) Silodosin Chennai 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. 7. Sodium Valproate B. No.: BT5871 Dissolution CDSCO CDTL Tablets I.P. 200 mg Mfg dt: 08/2021 West Zone Mumbai Mumbai Exp dt: 07/2023 Mfd by: M/s. Brilliant Lifesciences Pvt Ltd., At Chuval Dangarwa, Ta.- Detroj Distt. Ahmedabad, Gujarat. 8. Albithral 500 B. No.: DD21007 Description CDSCO CDTL (Azithromycin Mfg dt: 01/2021 West Zone Mumbai Tablets IP) Mumbai Exp dt: 12/2022 Mfd by: M/s. Skymap Pharmaceutical Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee – 247667, Uttarakhand. 9. Diaset 1 B. No.: C22F81 Dissolution CDSCO CDTL (Glimepiride Tablets Mfg dt: 09/2021 South Zone Mumbai I.P. 1 mg) Goa Exp dt: 08/2024 Mfd by: M/s. Stadmed Private Limited, 15, Jawpore Road, Kolkata 7000074.10. Glimepiride & B. No.: AT2110122A Dissolution CDSCO CDTL Metformin Hcl Mfg dt: 10/2021 Zonal Office Hyderabad (Sustaned Release) Hyderabad Exp dt: 09/2023 Tablets (Synopride- Mfd by: M/s. ADDII M4 Forte) BIOTECH PVT. LTD., ViLL. Kaundi, P.P. Thana, Tah. Baddi, Distt. Solan – 173205, Himachal Pradesh. 11. Ampicillin Capsules B. No.: AMI-1901 Assay and Drug Control RDTL IP Mfg dt: 07/2019 Misbranded Department Guwahati Arunachal Exp dt: 06/2022 Pradesh Mfd by: M/s. Ridley Lifescience Pvt. Ltd., D-1651, DSIDC, Indl. Complex, Narela, Delhi-110040. 12 Ibuprofen Tablets IP B. No.: BPT20003 Dissolution Drug Control RDTL 400 mg Mfg dt: 09/2020 Department Guwahati Assam Exp dt: 08/2022 Mfd by: M/s. Vivek Pharmachem ( India) Limited., NH-8, Chimanpura, Amer, Jaipur – 303102, Rajasthan. 13. Paracetamol, B. No.: TP1020810 Identification Drug Control RDTL Phenylephrine Mfg dt: 10/2020 and Department Guwahati Hydrochloride, Assay Jharkhand Exp dt: 09/2022 Caffeine and Mfd by: M/s. Maxrelief Diphenhydramine Healthcare, Vill. Anji, Hydrochloride Solan, Himachal (SNEZEE 500) Pradesh- 173212. 14. Ibuprofen Tablets B. No.: BPT20005 Dissolution Drug Control RDTL I.P. 400 mg Mfg dt: 09/2020 Department Guwahati Assam Exp dt: 08/2022 Mfd by: M/s. Vivek Pharmachem ( India) Ltd.,NH-8, Chimanpura, Amer, Jaipur-303102, Rajasthan. 15. Amlodipine Tablets B. No.: TL20-25 Assay Drug Control RDTL IP Mfg dt: 12/2020 Department Guwahati Meghalaya 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. 16. Paracetamol B. No.: ADT-08-0541 Dissolution Drug Control RDTL Tablets IP Mfg dt: 08/2020 Department Guwahati Assam Exp dt: 07/2022 Mfd by: M/s. Adwin Pharma, Vill- Rampur Jattan, Trilokpur Road, Kala-Amb, Tehsil- Nahan, Distt. Sirmour, Himachal Pradesh - 173030. 17. Ursodeoxycholic B. No.: 250923D7 Identification Drug Control RDTL Acid Tablets IP Mfg dt: 01/2021 and Department Guwahati 300mg (Udiliv 300) Assay Assam Exp dt: 05/2023 Mfd by: M/s. Abbott India Limited, L-18/19, Verna Industrial Area, Verna, Salcette, Goa- 403722. 18. Telmisartan Tablets B. No.: TETY-01 Dissolution Drug Control RDTL IP 40mg Mfg dt: 04/2021 Department Guwahati Jharkhand Exp dt: 03/2023 Mfd by: M/s. Nestor Pharmaceuticals Limited, 11, Western Extension Area, Faridabad - 121001, Haryana, INDIA. 19. Levocetirizine B. No.: 21112701 Dissolution CDSCO RDTL Dihydrochloride and Mfg dt: 01/2021 Sub - Zone Guwahati Montelukast Sodium Guwahati Exp dt: 12/2022 Tablets IP Mfd by: M/s. Mercury Laboratories Ltd. Unit No. 2, Halol-Baroda Road, Village:Jarod, Tal. Waghodia, Dist. Vadodara-391510, Gujarat. 20. Montelukast Sodium B. No.: LMT21001MB Dissolution Drug Control RDTL and Levocetirizine Mfg dt: 01/2021 Department Guwahati Hydrochloride Assam Exp dt: 12/2022 Tablets IP Mfd by: M/s. Sri Ram Healthcare Pvt. Ltd., 81-C/2, EPIP-I, Jharmajri, Baddi, Distt. Solan, Himachal Pradesh -173205.21. Amoxicillin and B. No.: 21441454 Assay Drug Control RDTL Potassium Mfg dt: 05/2021 Department Guwahati Clavulanate Tablets Assam Exp dt: 10/2022 IP Mfd by: M/s. Alkem Health Science A Unit of Alkem Laboratories Limited, Unit-2, Samardung, Karek Block, PO. Nanthang, South Sikkim- 737137. 22. Pantoprazole B. No.: RPB0651A Identification Drug Control RDTL Gastro Resistant Mfg dt: 01/2021 and Department Guwahati and Domperidone Assay Assam Exp dt: 12/2022 Prolonged-Release Mfd by: M/s. Sun Capsules IP Pharma Laboratories Ltd., Plot No. 107-108, Namli Block, P.O. Ranipool, East Sikkim- 737135. 23. Misoprostol Tablets B. No.: MOT20002 Assay Drug Control RDTL I.P. 200mcg Mfg dt: 06/2020 Department Guwahati Assam Exp dt: 05/2022 Mfd by: M/s. Vivek Pharmachem ( India) Ltd., NH-8, Chimanpura, Amer, Jaipur-303102, Rajasthan. 24. Omeprazole B. No.: CO40-001 Dissolution Drug Control RDTL Capsules IP Mfg dt: 06/2020 Department Guwahati Jharkhand Exp dt: 05/2022 Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, Baddi, Distt. Solan, Himachal Pradesh, INDIA. 25. Omeprazole B. No.: CO40-002 Dissolution Drug Control RDTL Capsules IP Mfg dt: 06/2020 Department Guwahati Jharkhand Exp dt: 05/2022 Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, Baddi, Distt. Solan, Himachal Pradesh, INDIA.26. Primaquine Tablets B. No.: AHT-2768 Dissolution CDSCO RDTL I.P. 2.5 mg Mfg dt: 10/2021 and Assay Sub-Zone Guwahati Guwahati Exp dt: 09/2023 Mfd by: M/s. Algen Healthcare Limited, 134/2, Vill. Khara Khari, Sadhaura Road, Kala Amb, Distt. Sirmour, Himachal Pradesh – 173030. 27. Calcium Lactate B. No.: D11 Assay Drug Control RDTL Vit. D3, Mfg dt: 05/2020 Department Guwahati Cyanocobalamine, Bihar Exp dt: 04/2022 L-Lysine Hcl & L- Mfd by: M/s. Swiss-de- Glutamic Acid cheme At: Mithanpura- 842002, H.O. 96, Lock Gate Road, Sri Krishnapur, P.O. Kulghacia, Distt. Howrah- 711306, West Bengal.

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