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Date: 2021-02-10 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of January 2021

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

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Executive Summary & Key Takeaways

What it means

  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for January 2021.
  • A total of 1001 samples were tested, with 985 declared as of Standard Quality and 16 as Not of Standard Quality. No samples were declared as Spurious or Misbranded.

Key Changes

  • 16 samples were found to be Not of Standard Quality out of 1001 tested.
  • The products that failed quality checks include injections, syrups, tablets, capsules and hand sanitizers.
  • Reasons for failure include issues with Assay, Description, Dissolution, Microbial Contamination, Particulate Matter, Clarity of Solution, Identification of Chlorhexidine Gluconate, Uniformity of filled weight, Assay of Isopropyl Alcohol, Free salicylic acid, Disintegration, and Assay of Aspirin.
  • Manufacturers of the failed products are located across various states including Uttarakhand, Himachal Pradesh, Telangana, Maharashtra, Gujarat, Karnataka and Jammu & Kashmir.

Impact Analysis

Pharmaceutical Companies

  • Action Item: Review manufacturing processes and quality control procedures to prevent future occurrences. Implement corrective and preventive actions (CAPA) immediately.

Consumers

  • Action Item: Public awareness campaigns should be initiated to inform consumers about the affected products and batches. Consumers should be advised to discontinue use and return the products.

Regulatory Agencies (CDSCO, State Drug Control)

  • Action Item: Conduct thorough investigations of the manufacturing facilities of the listed companies. Increase the frequency of random sampling and testing of pharmaceutical products in the market.

Distributors and Retailers

  • Action Item: Implement a system to quickly identify and remove substandard products from the supply chain. Work with manufacturers to ensure proper storage and handling of pharmaceutical products.

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: The primary legislation in India regulating the manufacture, sale, and distribution of drugs and cosmetics. Akums Drugs & Pharmaceuticals Ltd.: One of the manufacturers listed in the notification for producing Not of Standard Quality product. Corona Remedies Pvt. Ltd.: One of the manufacturers listed in the notification for producing Not of Standard Quality product. MSN Laboratories Private Limited: One of the manufacturers listed in the notification for producing Not of Standard Quality product. Stadmed Private Limited: One of the manufacturers listed in the notification for producing Not of Standard Quality product. Zee Laboratories: One of the manufacturers listed in the notification for producing Not of Standard Quality product. Zim Laboratories Ltd.: One of the manufacturers listed in the notification for producing Not of Standard Quality product. Ortin Laboratories Ltd.: One of the manufacturers listed in the notification for producing Not of Standard Quality product. Medipol Pharmaceutical India Pvt. Ltd.: One of the manufacturers listed in the notification for producing Not of Standard Quality product. Osper Formulations Pvt. Ltd.: One of the manufacturers listed in the notification for producing Not of Standard Quality product. Legency Remedies Pvt. Ltd.: One of the manufacturers listed in the notification for producing Not of Standard Quality product. Gladios Products Pvt. Ltd.: One of the manufacturers listed in the notification for producing Not of Standard Quality product. Yadav’s Health & Beauty Herbal Products: One of the manufacturers listed in the notification for producing Not of Standard Quality product. Haustus Biotech Pvt. Ltd.: One of the manufacturers listed in the notification for producing Not of Standard Quality product. Vowcare Hydrogen Products: One of the manufacturers listed in the notification for producing Not of Standard Quality product. Karnataka Antibiotics & Pharmaceuticals Ltd.: One of the manufacturers listed in the notification for producing Not of Standard Quality product. Mascot Health Series Pvt Ltd.: One of the manufacturers listed in the notification for producing Not of Standard Quality product.
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0List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of January 2021 Total number of samples tested 1001 Total number of samples declared as of Standard Quality 985 Total number of samples declared as Not of Standard Quality 16 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. Omnikacin – 250 B. No.: C2VAR02 Assay CDSCO, CDL, (Amikacin Injection I.P.) Mfg dt: 01/2020 South Kolkata Exp dt: 12/2021 Zone Mfd by: M/s. Akums Drugs & Pharmaceuticals Ltd., 2, 3, 4 & 5, Sector 6-B, I.I.E., SIDCUL, Ranipur, Haridwar- 249403 Uttarakhand. 2. Ontic Syrup B. No.: CL19136 Description CDSCO, CDL, (Ondansetron Oral Mfg dt: 10/2019 Hyderabad Kolkata Exp dt: 09/2021 Solution I.P- 30 ml) Mfd by: M/s. Corona Remedies Pvt. Ltd., Vill. Jatoli, P.O. Oachghat, Tehsil: Solan, Dist. Solan Himachal Pradesh - 173223. 3. Tolvat 30 (Tolvaptan B. No.: BRA02174D Dissolution CDSCO, CDL, Tablets 30 mg) Mfg dt: 02/2020 Hyderabad Kolkata Exp dt: 01/2023 Mfd by: M/s. MSN Laboratories Private Limited, Plot No. 42, Anrich Industrial Estate, Bollaram, Sangareddy District-502325, Telangana. 4. Disilox MPS B. No.: C20C92 Microbial CDSCO, CDL, (Aluminium, Magnesium Mfg dt: 06/2019 Contamination East Zone, Kolkata Exp dt: 05/2022 Kolkata & Simethicone Oral (Total Aerobic Mfd by: M/s. Stadmed Suspension I.P.) Viable Count) Private Limited, 15, Jawpore Road, Kolkata-700074.5. Nitzo - 2.6 (Controlled B. No.: 419-1544 Assay of CDSCO, CDL, Release Tablets of Mfg dt: 11/2019 Glyceryl East Zone, Kolkata Exp dt: 10/2021 Nitroglycerin) Trinitrate Kolkata Mfd by: M/s. Zee Laboratories, 47, Industrial Area, Paonta Sahib – 173025, Himachal Pradesh. 6. Diclofenac Gastro B. No.: FZ57K801 Description CDSCO, CDL, Resistant Tablets I.P. 50 Mfg dt: 10/2018 East Zone, Kolkata Exp dt: 09/2021 Kolkata mg (Regunac -50) Mfd by: M/s. Zim Laboratories Ltd., B-21/22, MIDC Area, Kalmeshwar, Nagpur, Maharashtra. 7. Amlor -2.5(Amlodipine B. No.: KN20001 Dissolution, CDSCO, CDL, Besylate Tablets I.P. 2.5 Mfg dt: 05/2020 Related East Zone, Kolkata Exp dt: 04/2022 Kolkata mg) Substances Mfd by: M/s. Ortin and Assay Laboratories Ltd., 275 & 278 (Part), I.D.A. Pashamylaram -502307, Sangareddy Dist. T.S., Telangana. 8. Amitriptyline Tablets I.P. B. No.: TAMF-026 Description CDSCO, CDL, Mfg dt: 03/2020 East Zone, Kolkata Exp dt: 02/2022 Kolkata Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, Baddi, Dist. Solan, Himachal Pradesh. 9. 1. Ancef 1 gm B. No.: 13018A Particulate CDSCO, CDL, (Ceftriaxone Injection Mfg dt: 03/2019 Matter & Sub Zone, Kolkata I.P.) Exp dt: 02/2021 Clarity of Baddi Mfd by: M/s. Osper Solution Formulations Pvt. Ltd., Plot No. 134-B, Export Promotion Industrial Park, Phase- 1, Jharmajri Baddi, Dist. Solan, Himachal Pradesh. B. No.: 1902022 2. Sterile Water For Mfg dt: 02/2019 Injection I.P. 10 ml Exp dt: 01/2022 Mfd by: M/s. legency Remedies Pvt. Ltd., P.O. Baddi, Dist. Solan Himachal Pradesh.10. VEDARK INSTANT B. No.: A-142 Identification of CDSCO RDTL, HAND SANITIZER Mfg dt: 05/2020 Chlorhexidine North Zone Chandigarh Exp dt: 04/2022 Gluconate Mfd by: M/s. Gladios Products Pvt. Ltd., 31, Virat industrial Estate, Dhanot Gandhinagar-382721 Gujarat. 11. DAYS 2X HAND B. No.: BYHS29 Assay of Ethyl Drug RDTL, SANITIZER Mfg dt: 09/2020 Alcohol Control Chandigarh Exp dt: 08/2023 Departmen Mfd by: M/s. Yadav’s Health t Himachal & Beauty Herbal Products Pradesh Plot No.25, EPIP, Phase-2, Thana, Baddi, Distt. Solan, Himachal Pradesh -173205. 12. Doxycycline and Lactic B. No.: HBC-4052 Uniformity of CDSCO RDTL, Acid Bacillus Capsules Mfg dt: 02/2020 filled weight North Zone Chandigarh Exp dt: 07/2021 (Mesodox LB Capsules) Mfd by: M/s. Haustus Biotech Pvt. Ltd. 44-45, Indl.Area, Tahliwal, Distt.Una Himachal Pradesh. 13. Hand Sanitizer B. No.: V20EL011 Assay of Drug RDTL, Mfg dt: 04/2020 Isopropyl Control Chandigarh Exp dt: 08/2022 Alcohol Departmen Mfd by: M/s. Vowcare Hydrogen t Srinagar Products Plot No.77, Zone Peroxide 4th, I.G.C., SIDCO Glycerol Lassipora, Dist. Pulwama Jammu & Kashmir 192305. 14. (Omeprazole Capsules B. No.: 5703320 Dissolution CDSCO, CDTL, I.P.) 20 mg Mfg dt: 06/2020 (Acid Stage) West Zone Mumbai Exp dt: 05/2022 Mumbai Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Ltd., (A Govt. of India Enterprise), Plot No.14, II Phase, Peenya, Bengaluru - 560 058 Karnataka. 15. Omecot Capsules B. No.: MC 19235 Assay & CDSCO, CDTL, (Omperazole Capsules Mfg dt: 08/2019 Dissolution West Zone Mumbai Exp dt: 07/2021 IP) Mumbai Mfd by: M/s. Mascot Health Series Pvt Ltd., Plot No. 79, 80, Sector 6 A, IIE, Sidcul, Haridwar 249 403, Uttarakhand.16. Clopidogrel & Aspirin B. No.: TACB-013 Free salicylic CDSCO, CDTL, Tablets Mfg dt: 07/2019 acid, West Zone Mumbai Exp dt: 06/2021 Disintegration, Mumbai Mfd by: M/s. Medipol Assay of Pharmaceutical India Pvt Aspirin Ltd., 1199/3, Bhud, Baddi, Dist. Solan Himachal Pradesh .

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