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Date: 2021-12-20 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of November 2021

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

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Executive Summary & Key Takeaways

Gazette Notification Overview

  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for November 2021.
  • A total of 1102 samples were tested.
  • 1080 samples were declared to be of Standard Quality.
  • 22 samples were declared as Not of Standard Quality.
  • No samples were declared as Spurious or Misbranded.

Key Changes - List of Not of Standard Quality Items

  • The notification provides a detailed list of 22 drugs, medical devices, and cosmetics that failed quality tests.
  • The list includes the name of the product, batch number, date of manufacture, date of expiry, manufacturer, reason for failure, and the testing laboratory.
  • Reasons for failure include Sterility, Dissolution, Related Substances, Description, Assay of Vitamin B1 & Calcium Pantothenate, Particulate Matter, Identification of Vitamin D3, Assay of Vitamin A Acetate & Vitamin D3, Dissolution, Identification of Ofloxacin, Assay of Ofloxacin & Ornidazole, Dissolution and Assay, Moisture content, Uniformity of weight, Assay of Amlodipine, Assay of Adrenaline, Related Substances, Assay of Ofloxacin & Metronidazole.
  • The products were manufactured by various companies located across India, including Madhya Pradesh, Tamil Nadu, Jammu, Uttar Pradesh, Gujarat, Telangana, Punjab, Himachal Pradesh, Maharashtra, Uttarakhand and Haryana.

Impact Analysis

Impact on Manufacturers

  • Suggested action: Conduct thorough investigations into the causes of the quality failures and implement robust CAPA measures to prevent recurrence. Engage with regulatory authorities to address concerns and demonstrate commitment to quality.

Impact on Consumers

  • Suggested action: Healthcare providers should be informed about the list of Not of Standard Quality products and advise patients accordingly. Strengthen pharmacovigilance programs to monitor and report adverse drug events.

Impact on Regulatory Authorities

  • Suggested action: Increase the frequency and rigor of inspections, particularly for manufacturers with a history of quality issues. Strengthen collaboration between central and state drug control authorities to improve surveillance and enforcement.

Impact on Supply Chain

  • Suggested action: Implement robust tracking and tracing systems to quickly identify and remove substandard products from the supply chain. Work with manufacturers to ensure a reliable supply of quality-assured products.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. State Drug Control Departments: State-level regulatory bodies responsible for enforcing drug regulations within their respective states. Drugs and Cosmetics Act, 1940: The primary legislation governing the regulation of drugs, cosmetics, and medical devices in India. Drugs and Cosmetics Rules, 1945: Rules framed under the Drugs and Cosmetics Act, 1940, providing detailed guidelines for the manufacture, sale, and distribution of drugs and cosmetics. List of Manufacturers: M/s. Ives Drugs (India) Pvt. Limited, M/s. Eurokem Laboratories Pvt. Ltd., M/s. Ethicare Laboratories, M/s. Unicure India Ltd., M/s. Bharat Parenterals Ltd., M/s. Ortin Laboratories Ltd., M/s. Amkon Pharmaceuticals, M/s. Zee Laboratories, M/s. Ashish Lifesciences Pvt. Ltd., M/s. Danish Health Care (P) Ltd., M/s. Psychotropics India Ltd., M/s IBN Herbals, M/s. Health Biotech Ltd., M/s. Hab Pharmaceuticals & Research Limited, M/s. Celebrity Bipharma Ltd., M/s. CREST LIFESCIENCES PVT. LTD., M/s. Combitic Global Caplet Pvt. Ltd.
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List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of November – 2021. Total number of samples tested 1102 Total number of samples declared as of Standard Quality 1080 Total number of samples declared as Not of Standard Quality 22 Total number of samples declared as Spurious - Total number of samples declared as Misbranded - S.No. Name of Batch No./Date of Reason for Drawn By From Drugs/medical Manufacture/Date of failure device/cosmetic Expiry/Manufactured By s 1. RL (Compound B. No.: 103111 Sterility Drug CDL Sodium Lactate Mfg dt: 03/2021 Control Kolkata injection I.P. 500 Department Exp dt: 02/2023 ml) (Ringe Lactate Madhya Mfd by: M/s. Ives Drugs Solution for Pradesh (India) Pvt. Limited, Works: Injection I.P.) Ghatabillod, Distt. Dhar, Madhya Pradesh. 2. Glimepiride B. No.: GP108 Dissolution & CDSCO CDL Tablets I.P. 1mg Mfg dt: 04/2021 Related South Zone Kolkata Substances Chennai Exp dt: 03/2023 Mfd by: M/s. Eurokem Laboratories Pvt. Ltd., C- 25, Sidco Pharmaceuticals Complex, Alathur, Thiruporur-603110 Tamil Nadu. 3. Mineral B. No.: ET-210101 Description CDSCO CDL Supplements Mfg dt: 01/2021 South Zone Kolkata Tablets Chennai Exp dt: 12/2022 Mfd by: M/s. Ethicare Laboratories, 15, Industrial Estate, Digiana, Jammu- 180010. 4. Vitamin B – B. No.: VPT801 Description, CDSCO CDL Complex Tablets Mfg dt: 06/2020 Assay of South Zone Kolkata NFI III Exp dt: 11/2021 Vitamin B1 & Chennai Calcium Mfd by: M/s. Unicure India Pantothenate Ltd., C- 21,22 & 23, Sector-3, Noida 201301, Dist. Gautam Budh Nagar, Uttar Pradesh.5. Phytomenadione B. No.: P0383 Description, CDSCO CDL Injectoin IP Mfg dt: 07/2020 Particulate Hyderabad Kolkata 10mg/ml (Vitamin Matter and Exp dt: 06/2022 K Injection)1 ml Sterility 1 Mfd by: M/s. Bharat Parenterals Ltd., Vill, Haripura, Ta. Savli, Dist. Vadodara-391520, Gujarat. 6. MULVIT (Multi B. No.: CU20003 Description, CDSCO CDL Vitamin Tablets) Mfg dt: 12/2020 Identication of East Zone Kolkata Vitamin D3, Kolkata Exp dt: 05/2022 Assay of Mfd by: M/s. Ortin Vitamin A Laboratories Ltd., 275 & Acetate & 278 (part), I.D.A. Vitamin D3 Pashamilaram – 502307, Telangana. 7. Telmopac – AM B. No.: APT/04282 Dissolutoin, CDSCO CDL (Telmisartan Mfg dt: 04/2021 Related East Zone Kolkata & Substances Kolkata Exp dt: 03/2023 Amlodipine and Assay Mfd by: M/s. Amkon Tablets) Pharmaceuticals, Plot No. 242, Ind. Area. Phase IX, S.A.S. Nagar, Mohali – 160062(Punjab). 8. Oflopac – OZ B. No.: APT/03047 Identification of CDSCO CDL Tablet (Ofloxacin & Mfg dt: 04/2020 Ofloxacin, and East Zone Kolkata Ornidazole Tablets Dissolution & Kolkata Exp dt: 03/2022 I.P.) Assay of Mfd by: M/s. Amkon Ofloxacin & Pharmaceuticals, Plot No. Ornidazole 242, Phase – 9, Industrial Area, Mohali- 160062 (Punjab). 9. LECETZY B. No.: 420-1286 Dissolution CDSCO CDL (Levocetirizine Mfg dt: 10/2020 and Assay East Zone Kolkata Tablets I.P.) Kolkata Exp dt: 09/2022 Mfd by: M/s. Zee Laboratories, 47, Industrial Area, Paonta Sahib- 173025, Himachal Pradesh. 10. Ashialben 300 B. No.: ALT-9096 Moisture CDSCO CDTL (Albendazole 300 Mfg dt: 08/2021 content West Zone Mumbai mg Bolus) Mumbai Exp dt: 07/2025 Mfd by: M/s. Ashish Lifesciences Pvt. Ltd., J- 137, MIDC, TarapurMaharashtra, India. 11. Ashialben 300 B. No.: ALT-8958 Moisture CDSCO CDTL (Albendazole 300 Mfg dt: 05/2021 content West Zone Mumbai mg Bolus) Mumbai Exp dt: 04/2025 Mfd by: M/s. Ashish Lifesciences Pvt. Ltd., J- 137, MIDC, Tarapur, Maharashtra, India 12. Ashialben 600 B. No.: ALT-8703 Moisture CDSCO CDTL (Albendazole Mfg dt: 12/2020 content West Zone Mumbai Bolus 600 mg) Mumbai Exp dt: 11/2024 Mfd by: M/s. Ashish Lifesciences Pvt. Ltd., J- 137, MIDC, Tarapur, Maharashtra, India. 13. Ashialben 300 B. No.: ALT-9090 Moisture CDSCO CDTL (Albendazole 300 Mfg dt: 08/2021 content West Zone Mumbai mg Bolus) Mumbai Exp dt: 07/2025 Mfd by: M/s. Ashish Lifesciences Pvt. Ltd., J- 137, MIDC, Tarapur Maharashtra, India. 14. Dixogyl-400 B. No.: DLY2101 Uniformity of CDSCO CDTL (Metronidazole Mfg dt: 01/2021 weight Sub Zone Mumbai Tablets IP 400 mg) Indore Exp dt: 12/2022 Mfd by: M/s. Danish Health Care (P) Ltd., 76/27-28, Industrial Estate, Maxi Road, Ujjan 456010, Madhya Pradesh. 15. CLOPIDOGREL & B. No.: ALA21002 Description CDSCO CDTL ASPIRIN Mfg dt: 02/2021 Zonal Office Hyderabad TABLETS IP Hyderabad Exp dt: 01/2023 (PILOGRELTM_ Mfd by: M/s. Psychotropics A75) India Ltd. Plot No. 46 & 49, Sector-6A, IIE SIDCUL, Ranipur, Haridwar- 249403, Uttarakhand. 16. Diclofenac Sodium B. No.: IDM20020 Dissolution Drug RDTL Prolonged Release Mfg dt: 05/2020 Control Guwahati Tablets IP Department Exp dt: 04/2023 (FENCO-100 SR) Kohima Mfd by: M/s IBN Herbals, {A unit of Curetech Formulations (P) Ltd.}, Khasra No. 63, Vill.- JuddiKalan, Baddi, Dist.- Solan Himachal Pradesh. 17. ATENOLOL AND B. No.: Z20-660 Assay of CDSCO RDTL AMLODIPINE Mfg dt: 05/2020 Amlodipine Sub-Zone Chandigarh TABLETS Baddi Exp dt: 04/2022 Mfd by: M/s. Zee Laboratories Ltd. Behind 47, Industrial Area, Paonta Sahib -173205, Himachal Pradesh. 18. Lignocaine and B. No.: HILR2006F Assay of Drug RDTL Adrenaline Mfg dt: 11/2020 Adrenaline Control Chandigarh Injection IP (A- Department Exp dt: 10/2022 CAINE ADR Himachal Mfd by: M/s. Health INJECTION) Pradesh Biotech Ltd. Village: Sandoli, Nalagarh Road, Baddi, Distt. Solan, Himachal Pradesh - 173205. 19. Amlodipine B. No.: 1154-12 Assay of Drug RDTL Besylate and Mfg dt: 05/2021 Amlodipine Control Chandigarh Atenolol Tablets Department Exp dt: 04/2024 (CARDINOL PLUS Himachal Mfd by: M/s. Hab TABLETS) Pradesh Pharmaceuticals & Research Limited 10, Pharmacity, SIDCUL, Selaqui, Dehradun- 248011, Uttarakhand. 20. Atorvastatin B. No.: CATO009001 Related CDSCO RDTL Calcium Tablets IP Mfg dt: 09/2020 Substances Sub Zone Chandigarh 10 mg Jammu Exp dt: 08/2022 Mfd by: M/s. Celebrity Bipharma Ltd. Vill. Panga, Jharmajri, Hill Top Estate, Barotiwala, Distt. Solan H.P. 174103. 21. Ofloxacin and B. No.: CLOF1014 Assay of CDSCO RDTL Metronidazole Mfg dt: 09/2021 Ofloxacin Sub-Zone Chandigarh Suspension & Baddi Exp dt: 08/2023 (OFLOX OZ Metronidazole Mfd by: M/s. CREST SUSPENSION ) LIFESCIENCES PVT. LTD. Plot No. 127-128, EPIP Phase-1, Jharmajri, Tehsil Baddi, Dist. Solan, Himachal Pradesh - 174103.22. NORFLOXACIN B. No.: RJNL-17 Dissolution CDSCO RDTL TABLETS IP Mfg dt: 06/2021 North Zone Chandigarh 400 mg Exp dt: 05/2024 Mfd by: M/s. Combitic Global Caplet Pvt. Ltd., M- 15, D-2, D-3, Ind.Area, Sonepat-131001, Haryana.

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