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Date: 2016-04-05 Category: Not Applicable State: Union Government Country: India

Drugs Alert for the month of March 2016

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

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Executive Summary & Key Takeaways

Key Changes

  • Manufacturers listed are from various states including Karnataka, Gujarat, Uttarakhand, Himachal Pradesh, Assam and Delhi.
  • Testing was conducted by CDSCO sub-zones and various RDTLs and CDLs.
  • 18 items are listed in the gazette as Not of Standard Quality/Spurious/Adulterated/Misbranded.
  • The listed items include tablets, injections, capsules and suspensions.
  • Reasons for failure include Dissolution, Sterility, Description & Particulate Matter, Related Substances, Assay, Disintegration and Uniformity of Content and Misbranded.

What it means

  • The gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for March 2016.

Impact Analysis

Manufacturers

  • Manufacturers should review their quality control processes, including testing and supplier qualification.

Consumers

  • Consumers should report any adverse events or concerns related to the listed products to the appropriate authorities.

Regulatory Agencies

  • The notification highlights the importance of robust quality control and monitoring mechanisms.

Our Company

  • Communicate this notification to our quality assurance and regulatory affairs teams for immediate review and action.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, responsible for regulating drugs and cosmetics in India. RDTL: Regional Drugs Testing Laboratory, responsible for testing and analysis of drugs. CDL: Central Drugs Laboratory, a national laboratory for testing and quality control of drugs and pharmaceuticals. State Drug Control Departments: State-level regulatory bodies responsible for licensing, monitoring, and enforcement of drug regulations within their respective states.
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 March, 2016 Sl. Name of Batch No./Date of Reason for Drawn By From No Drugs/medical Manufacture/Date of failure . device/cosmetics Expiry/Manufactured By 1. Norfloxacin Tablets B. No.:1801414, Dissolution CDSCO, Sub- CDTL, IP 400mg Mfg dt: 03/2014 Zone, Chennai Exp dt: 02/2017 Bangalore Mfd by: M/s. Karnataka Anibiotics & Pharmaceutical Ltd., Plot No. 14, II Phase Peenya, Bangalore-560058 2. T-Stat Injection B. No.:15302016, Sterility CDSCO, Sub- CDTL, (Tranexamic Acid Mfg dt: 11/2015 Zone, Chennai Injection BP) Exp dt: 10/2018 Bangalore Mfd by: M/s. Mercury Laboratories Ltd., Industrial Estate, Gorwa, Vadodara- 390016 3. Lobegesic B. No.: AA7-707, Description & CDSCO, North CDL, (Buprenorphine Mfg dt: 07/2015 Particulate Zone, Kolkata Injection I.P.) Exp dt: 06/2017 Matter Ghaziabad Mfd by: M/s. Ambic Aayurchem Ltd., Khasra No. 169, Tanshipur, Roorkee, UK 4. Hyox-10 B. No.: 3727, Related CDSCO, East CDL, (Hydroxyzine Mfg dt: 06/2014 Substances Zone, Kolkata Kolkata Hydrochloride Exp dt: 05/2016 Tablets B.P.) Mfd by: M/s. Tee & Tee Health Care, Vill. Chewa, P.O. Kumarhatti, Solan-173229 (H.P.) 5. Dried Aluminium B. No.: JT31016 Assay CDSCO, North RDTL, Hydroxide Gel, Mfg dt: 01/2014 Zone, Chandigarh Magnesium Exp dt: 06/2016 Ghaziabad Aluminium Silicate Mfd by: M/s. Omega Biotech & Magnesium Ltd., 7th Mile Stone, Hydroxide tablets Deharadun Road, Roorkee- (EMGICID-MS 247667 (Uttarakhand) ANTACID ANTIFLATULENT CHEWABLE TABLETS) 6. Rabeprazole Sodium B. No.: V141-085 Assay Zone-1, RDTL, and domperidone SR Mfg dt: 09/2014 DFCO, Muthi, Chandigarh Capsules Exp dt: 08/2016 Jammu (RABITRO-DSR Mfd by: M/s. Venus CAPSULES) Bioscience Pvt. Ltd., 116, EPIP-1, Export Promotion, Industrial Park, Phase-1 Jharmajri, Baddi, Distt. Solan- 173205 (H.P.)7. Bisacodyl Tablets IP B. No.: TBS023 Assay CDSCO, North RDTL, 5mg Mfg dt: 07/2014 Zone, Chandigarh Exp dt: 06/2016 Ghaziabad Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, Baddi Dist. Solan, H.P., 8. Amoxycillin and B. No.: PD 1942 Assay CDSCO, Sub- RDTL, Potassium Mfg dt: 01/2015 Zone, Chandigarh Clavulanate Oral Exp dt: 06/2016 Chandigarh Suspension I.P. (C- Mfd by: M/s. Affy Parenterals, MOX CLAV DRY Vill, Gullerwala, P.O. Baddi, SYRUP) Distt. Solan-173205 (H.P.) 9. Omeprazole and B. No.: CU-8025 Assay CDSCO, Sub- RDTL, Domperidone Mfg dt: 03/2015 Zone, Jammu Chandigarh Capsules Exp dt: 02/2017 (OMERAX-D Mfd by: M/s. Cotec Health CAPSULES) Care (P) Ltd., N.H. No. 74, Roorkee Dehradun Highway, Kishanpur, Roorkee, (Uttarakhand) 10. Ibuprofen Tablets IP B. No.: TIF-1401 Dissolution CDSCO, North RDTL, 600mg (RIBOFEN- Mfg dt: 07/2014 Zone, Chandigarh 600 TABLETS) Exp dt: 06/2017 Ghaziabad Mfd by: M/s. Ridley Life Science Pvt. Ltd., D-1651, DSIDC Indl. Complex, Narela, Delhi-110040 11. Metoclopramide B. No.: TPN-1401 Related CDSCO, North RDTL, Tablets IP Mfg dt: 04/2014 Substances Zone, Chandigarh (RIDNORM Exp dt: 03/2017 Ghaziabad TABLETS) Mfd by: M/s. Ridley Life Science Pvt. Ltd., D-1651, DSIDC Indl. Complex, Narela, Delhi-110040 12. Diclofenac Sodium B. No.: OBT-304 Disintegration CDSCO, North RDTL, Tablets IP Mfg dt: 12/2015 Zone, Chandigarh (LARFEN Exp dt: 11/2017 Ghaziabad TABLETS) Mfd by: M/s. Om Biomedic Pvt. Ltd., Plot No. 68,69,82,83,Sector-6A, I.I. E., SIDCUL, Haridwar-249403 (UK) 13. Levocetirizine B. No.: CBT-538/14 Uniformity of Drugs Control RDTL, Hydrochloride Mfg dt: 11/2014 Content Department, Guwahati Exp dt: 10/2016 Cachar, Tablets Mfd by: M/s. C.B. Healthcare, Assam. Vill-Messa Tibba, Nalagarh, Dist-Solan H.P-174101 14. Ofloxacin & B. No.: ULL-4117 Assay Drugs Control RDTL, Ornidazole Mfg dt: 09/2014 Department, Guwahati Exp dt: 08/2016 Arunachal Suspensions Mfd by: M/s. Ultratech Pradesh. Pharmaceuticals, Vill-Tipra, Haripur Road, P.O- Barotiwala, Dist- Solan (H.P)15. Norfloxacin Tablets B. No.: NR4-209 Dissolution Drugs Control RDTL, Mfg dt: 07/2015 Department, Guwahati Exp dt: 06/2018 Barpeta, Mfd by: M/s. Ghanshyam Assam. Pharmaceuticals, D-14, Rani Industrial Area, Kamrup, Assam. 16. Semotil Tablets B. No.: STL-23 Assay Drugs Control RDTL, Mfg dt: 04/2013 Department, Guwahati Exp dt: 03/2016 Cachar, Mfd by: M/s. Combitic Global Assam. Caplet Pvt. Ltd., M-15, D-2, D- 3, Ind. Area, Sonepat, 131001 17. Norfloxacin Tablets B. No.: NR4-202 Dissolution Drugs Control RDTL, Mfg dt: 03/2015 Department, Guwahati Exp dt: 02/2018 Jorhat, Assam. Mfd by: M/s. Ghanshyam Pharmaceuticals, D-14, Rani Industrial Area, Kamrup, Assam 18. Dexa Injection B. No.: DX-2020 Misbranded Drugs Control RDTL, Mfg dt: 04/2015 Department, Guwahati Exp dt: 03/2017 Arunachal Mfd by: M/s. Vardhaman Pradesh. Pharma, 32 Indl. Area, Trilukpur Road, Kala-Amb, Dist-Sirmour, H.P.

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