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Date: 2022-02-09 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of January 2022

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

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Executive Summary & Key Takeaways

Key Changes - List of Not of Standard Quality Items

  • The items were manufactured by various manufacturers located across India, including Madhya Pradesh, Himachal Pradesh, Punjab, Tamil Nadu, Uttarakhand, Telangana, Delhi, Maharashtra.
  • A total of 27 items are listed as Not of Standard Quality.
  • The listed items include tablets, injections, syrups and hand sanitizers.
  • Reasons for failure include: Uniformity of Content, Assay, Dissolution, Related Substances, Sterility, Description & Particulate Matter, Assay of Pepsin & Fungal Diastase, Assay of Methylcobalamin & Vitamin D3, Clarity of Solution & Particulate matter, Disintegration and Identification.
  • The items were drawn by CDSCO (Central Drugs Standard Control Organization) and Drug Control Departments from various zones and states.

Gazette Notification Overview

  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for January 2022.
  • A total of 1227 samples were tested.
  • 1200 samples were declared to be of Standard Quality.
  • 27 samples were declared to be Not of Standard Quality.
  • No samples were declared as Spurious or Misbranded in this notification.

Impact Analysis

Impact on Manufacturers

  • Suggested action: Review manufacturing processes, quality control procedures, and supplier qualifications to identify and address potential weaknesses.

Impact on Distributors and Retailers

  • Suggested action: Implement a system for quickly identifying and removing recalled or substandard products from inventory.

Impact on Consumers

  • Suggested action: Communicate the potential risks to consumers and advise them to consult healthcare professionals if they have concerns.

Impact on Regulatory Agencies

  • Suggested action: Enhance collaboration between central and state regulatory agencies to improve the effectiveness of drug quality control.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. Drug Control Department: State-level regulatory agencies responsible for enforcing drug regulations within their respective states. IP: Indian Pharmacopoeia, the official book of standards for drugs manufactured and marketed in India.
Official Source Record View Original Source →
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List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of January – 2022. Total number of samples tested 1227 Total number of samples declared as of Standard Quality 1200 Total number of samples declared as Not of Standard Quality 27 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/cosmetics Expiry/Manufactured By 1. Ferrous Sulphate B. No.: B210049 Uniformity of CDSCO CDL & Mfg dt: 06/2021 Content of East Zone Kolkata Folic Acid Tablets IP Folic Acid Kolkata Exp dt: 05/2023 Mfd by: M/s. Bochem Healthcare Pvt. Ltd., 83- 84, Industrial Area, Dewas Road, Nagziri, Ujjain 456010, Madhya Pradesh, India. 2. NITZO -2.6 (Controlled B. No.: 420-1291 Assay CDSCO CDL Release Tablets of Mfg dt: 10/2020 East Zone Kolkata Nitrogylcerin) Kolkata Exp dt: 09/2022 Mfd by: M/s. Zee Laboratories 47, Industrial Area, Paonta Sahib -173 025, Himachal Pradesh. 3. Levetripac-500 Tablets B. No.: APT/04306 Dissolution CDSCO CDL (Levetiracetam Tablets Mfg dt: 04/2021 & East Zone Kolkata IP 500 mg) Assay Kolkata Exp dt: 03/2023 Mfd by: M/s. Amkon Pharmaceuticals, Plot No. 242, Phase 9, Industrial Area, Mohali- 160062, Punjab. 4. Clopidogrel & Aspirin B. No.: TACB-017 Related CDSCO CDL Tablets I.P. Mfg dt: 05/2020 Substances West Zone Kolkata Exp dt: 04/2022 Mumbai Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Budh, Baddi, Dist. Solan,Himachal Pradesh, India. 5. Pantoprazole for B. No.: AA011068 Sterility Drug Control CDL Injection B.P. 40 mg Mfg dt: 04/2021 Department Kolkata Madhya Exp dt: 03/2023 Pradesh Mfd by: M/s. ANG Lifesciences India Ltd., Village- Kishanpura, Nalagarh Road, Tehsil- Baddi, Distt. Solan, Himachal Pradesh -174 101. 6. Adrenochrome B. No.: 01ACA295 Description & CDSCO CDL Monosemicarbazone Mfg dt: 02/2021 Particulate South Zone Kolkata Injection, 2 ml Matter Chennai Exp dt: 07/2022 Mfd by: M/s. SPM Drugs (P) Ltd., S.F. 52/1 Main Road, K.R. Palayam, Bhavani – 638 301 Tamil Nadu. 7. WARZYME Digestive B. No.: AA21036 Assay of CDSCO CDL Enzymes (Pepsin & Mfg dt: 06/2021 Pepsin & South Zone Kolkata Fungal Diastase Fungal Chennai Exp dt: 11/2022 Syrup), 200 ml Diastase Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee-247667, Uttarakhand. 8. Mymi D (Alpha Lipoic B. No.: TT21031 Assay of CDSCO CDL Acid, Pyridoxine Mfg dt: 06/2021 Methylcobala South Zone Kolkata Hydrochloride, min & Vitamin Chennai Exp dt: 05/2023 Methylcobalamin, Folic D3 Mfd by: M/s. Kausikh Acid & Vitamin D3 Therapeutics(P) Ltd., Tablets) Unit II, Plot No. 54, SIDCO Industrial Estate, Thirumudivakkam, Chennai -600044. 9. Pantoprazole Gastro- B. No.: TF1036A Dissolution CDSCO CDTL Resistant Tablets IP Mfg dt: 06/2021 Sub Zone Chennai Bangalore Exp dt: 11/2022 Mfd by: M/s. Navkar Lifesciences, Plot No.76, Lodhi Majra, Industrial Area, Baddi, Distt. Solan, Himachal Pradesh.10. ENALAPRIL B. No.: GA21002 Dissolution CDSCO CDTL MALEATE TABLETS Mfg dt: 02/2021 & Zonal Office Hyderabad IP 5 mg Assay Hyderabad Exp dt: 01/2023 Mfd by: M/s. Ortin Laboratories Ltd., 275 & 278 (part), IDA, Pashamylaram-502307, Sanga Reddy, Dist. Telangana. 11. Ceftriaxone Injection B. No.: I.269 Clarity of Drug Control RDTL IP Mfg dt: 04/2021 Solution & Department Guwahati Particulate Jharkhand Exp dt: 03/2023 matter Mfd by: M/s. Jackson Laboratories Pvt. Ltd. 22-24, Majitha Road, Bye pass, Amritsar- 143001, Punjab (India). 12. Pantoprazole Sodium B. No.: SL20098 Dissolution Drug Control RDTL Tablets I.P. 40 mg Mfg dt: 11/2020 Department Guwahati Jharkhand Exp dt: 10/2022 Mfd by: M/s. IBN Herbals (A unit of Curetech Formulations (P) Ltd.), Khasra No. 63, Vill. JuddiKalan, Baddi, Dist. Solan, Himachal Pradesh. 13. Alprazolam Tablets IP B. No.: TP.1901 Dissolution Drug Control RDTL Mfg dt: 12/2019 Department Guwahati Bihar Exp dt: 11/2022 Mfd by: M/s. Achemic Pharmaceuticals (INDIA) Pvt. Ltd. 71-A, I.D.A. (Etn) Phase-II, Mangalpur Nacharam, Hyderabad - 500076. 14. Isopropyl Rubbing B. No.: SP-851 Assay Drug Control RDTL Alcohol I.P. Mfg dt: 05/2020 Department Guwahati Jharkhand Exp dt: 04/2023 Mfd by: M/s. Sritech Pharma, F-19, UPSIDC Industrial Area, Gajraula JP Nagar, Uttar Pradesh – 244235. 15. Doxycycline B. No.: DOX-2009 Description Drug Control RDTL Hydrochloride & Department GuwahatiAmbroxol HCl Tablets Mfg dt: 01/2021 Assam Exp dt: 12/2022 Mfd by: M/s. RIDLEY LIFE SCIENCE PVT. LTD., D-1651, DSIDC Indl. Complex, Narela, Delhi-110040 16. Favipiravir Tablets B. No.: TP-0421903 Identification, Drug Control RDTL 400 mg Mfg dt: 04/2021 Dissolution & Department Guwahati Assay Jharkhand Exp dt: 03/2023 Mfd by: M/s. Maxrelief Healthcare, Vill.-Anji, Solan, Himachal Pradesh- 173212. 17. Trypsin, Bromelain & B. No.: GT200466 Description & CDSCO RDTL Rutoside Trihydrate Mfg dt: 03/2020 Disintegration Sub-Zone Guwahati Tablets Guwahati Exp dt: 02/2022 Mfd by: M/s. Theon Pharmaceuticals Ltd. Vill. Saini Majra, Teh. Nalagarh, Distt. Solan, Himachal Pradesh- 174101. 18. Pantoprazole Sodium B. No.: TN-5142 Dissolution Drug Control RDTL Tablets I.P. 40 mg Mfg dt: 11/2020 Department Guwahati Assam Exp dt: 10/2022 Mfd by: M/s. Naptune Life Sciences Pvt. Ltd. 100-B, EPIP, Phase-II, Thana, Baddi -173205 Himachal Pradesh. 19. Pantoprazole Gastro- B. No.: AT201095 Dissolution Drug Control RDTL Resistant Tablets I.P. Mfg dt: 03/2021 Department Guwahati 40 mg Jharkhand Exp dt: 02/2023 Mfd by: M/s. Aarpic Pharmaceuticals Pvt. Ltd., C1/306/5 Kerala G.I.D.C., Kerala, Bavla Road, Dist. Ahmedabad. 20. Paracetamol Tablets B. No.: FDR3A101 Dissolution CDSCO RDTL IP 650 mg Mfg dt: 01/2021 Sub-Zone Guwahati Guwahati Exp dt: 12/2022 Mfd by: M/s. ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar-441501, Dist. Nagpur, Maharashtra. 21. Calcium with Vitamin B. No.: CV-212 Dissolution Drug Control RDTLD3 Tablets Mfg dt: 11/2020 Department Guwahati Exp dt: 05/2022 Jharkhand Mfd by: M/s. VINTOCHEM PHARMACEUTICALS Industrial Area, Maxi Road, Ujjain- 456010 Madhya Pradesh. 22. Pantoprazole Gastro- B. No.: TA21-11 Dissolution Drug Control RDTL Resistant Tablets I.P. Mfg dt: 01/2021 Department Guwahati Meghalaya Exp dt: 12/2022 Mfd by: M/s. Om Biomedic Pvt. Ltd. Plot No. 68, 69, 82 & 83, Sector-6A, IIE SIDCUL, Haridwar – 249403 Uttarakhand. 23. Calcium with Vitamin B. No.: CV-212 Dissolution Drug Control RDTL D3 Tablets Mfg dt: 11/2020 Department Guwahati Jharkhand Exp dt: 05/2022 Mfd by: M/s. VINTOCHEM PHARMACEUTICALS Industrial Area, Maxi Road, Ujjain- 456010 Madhya Pradesh. 24. Atenolol Tablets IP B. No.: TPT GOV-21139 Disintegration CDSCO CDTL 50 mg. Mfg dt: 06/2021 West Zone Mumbai Mumbai Exp dt: 05/2023 Mfd by: M/s. Terrace Pharmaceutical (P) Ltd., 3-B (a) Phase III, Industrial Area, Sansarpur Terrace, Distt. Kangra, Himachal Pradesh – 176501. 25. Itraconazole Capsules B. No.: MC21250 Disintegration CDSCO RDTL 200 mg Mfg dt: 04/2021 North Zone Chandigarh Exp dt: 03/2023 Mfd by: M/s. Mascot Health Series Pvt. Ltd. Plot No. 79, 80, Sec.6A, IIE, SIDCUL, Haridwar- 249403 Uttarakhand. 26. Ondansetron Orally B. No.: RV21023 Dissolution CDSCO RDTL Disintegrating Tablets Mfg dt: 07/2021 Sub-Zone Chandigarh IP 4 mg (ONVIN-4MD Baddi Exp dt: 06/2023 TABLETS) Mfd by: M/s. RivpraFormulation Pvt. Ltd. Plot No. 8, Sector-6A, I.I.E. SIDCUL, Haridwar- 249403, Uttarakhand. 27. Alcohol/Chlorhexidine B. No.: 8267 Identification Drug Control RDTL Gluconate Hand Rub Mfg dt: 03/2020 Department Chandigarh (MICRO-CV HAND Himachal Exp dt: 02/2022 SANITIZER) Pradesh Mfd by: M/s. RAMSON REMEDIES 186-187, Industrial Focal Point, Amritsar A.O: 2, G.Floor Baktawar, Malabar Hill, MUMBAI – 6.

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