Homeโ€บ Indiaโ€บ Ministry of Health and Family Welfareโ€บ Drug Alert list for month of October 2020...
Date: 2020-11-06 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of October 2020

Issued by Ministry of Health and Family Welfare ยท 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 October 2020.
  • A total of 644 samples were tested, with 8 samples declared as Not of Standard Quality and none declared as Spurious or Misbranded.

Key Changes

  • Out of 644 samples tested, 636 were declared as of Standard Quality.
  • 8 samples were declared as Not of Standard Quality.
  • Propylene Glycol I.P. batch PG-IP/2019-20/2123, manufactured by M/s. Manali Petrochemicals Limited, failed due to Water content.
  • Ondansetron Tablets I.P. 8 mg batch SMAT 703, manufactured by M/s. Unicure India, failed due to Description.
  • Verticot โ€“ 8 Tablets (Betahistine DiHCL Tablets I.P.) batch MT191390, manufactured by M/s. Mascot Health Series Pvt. Ltd., failed due to Assay & Dissolution.
  • Linezolid Tablets I.P. 600 mg batch GT200228, manufactured by M/s. Theon Pharmaceuticals Ltd., failed due to Dissolution.
  • Amoxycillin Oral Suspension I.P. 125mg/5ml Dry Syrup batch 9909619, manufactured by M/s. Karnataka Antibiotics & Pharmaceuticals limited, failed due to Assay.
  • Methylcobalamin, Benfotiamine, Folic Acid, Chromium Polynicotinate, Myo-Inositol and Pyridoxine Hydrochloride Tablets (NUHENZ TABLETS) batch T0501969, manufactured by M/s. Standord Laboratories Pvt. Ltd. failed due to Assay of Chromium Polynicotinate.
  • ISO PROPYL ALCOHOL IP batch IPA/DRM/2020/0035, manufactured by M/s. Deepak Fertilizers & Petro Chemicals, failed due to Water content.
  • ISO PROPYL ALCOHOL IP batch IPA/GCPL/532, manufactured by M/s. Gujrat Chempac Pvt.Ltd. failed due to Water content.

Impact Analysis

Manufacturers

  • M/s. Manali Petrochemicals Limited, M/s. Unicure India, M/s. Mascot Health Series Pvt. Ltd., M/s. Theon Pharmaceuticals Ltd., M/s. Karnataka Antibiotics & Pharmaceuticals limited, M/s. Standord Laboratories Pvt. Ltd, M/s. Deepak Fertilizers & Petro Chemicals and M/s. Gujrat Chempac Pvt.Ltd. should take immediate action.

Consumers/Patients

  • Consumers should be made aware of the listed products and advised to discontinue their use and return them to the point of purchase.

Regulatory Agencies

  • The Drugs Control Department, Himachal Pradesh needs to ensure better oversight.

Our Company

  • Enhance our vigilance on products manufactured by M/s. Manali Petrochemicals Limited, M/s. Unicure India, M/s. Mascot Health Series Pvt. Ltd., M/s. Theon Pharmaceuticals Ltd., M/s. Karnataka Antibiotics & Pharmaceuticals limited, M/s. Standord Laboratories Pvt. Ltd, M/s. Deepak Fertilizers & Petro Chemicals and M/s. Gujrat Chempac Pvt.Ltd..

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, responsible for regulating drugs, medical devices, and cosmetics in India. CDL Kolkata: Central Drugs Laboratory, Kolkata CDTL Mumbai: Central Drugs Testing Laboratory, Mumbai RDTL Chandigarh: Regional Drugs Testing Laboratory, Chandigarh Drugs Control Department, Himachal Pradesh: State Drugs Control Department responsible for regulating drugs and cosmetics in Himachal Pradesh.
Official Source Record View Original Source โ†’
See Full Document Text
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of October-2020 Total number of samples tested 644 Total number of samples declared as of Standard Quality 636 Total number of samples declared as Not of Standard Quality 08 Total number of samples declared as Spurious 00 Total number of samples declared as Misbranded 00 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. Propylene Glycol B. No.: PG-IP/2019- Water CDSCO, CDL, I.P. 20/2123, South Zone, Kolkata Mfg dt: 07/2019, Chennai Exp dt: 06/2024, Mfd by: M/s. Manali Petrochemicals Limited, Plant II, 1/6, Sathangadu Village, Manali, Chennai โ€“ 600 068. 2. Ondansetron B. No.: SMAT 703, Description CDSCO, CDL, Tablets I.P. 8 mg Mfg dt: 11/2019, North Zone, Kolkata Exp dt: 10/2021, Ghaziabad Mfd by: M/s. Unicure India, C โ€“ 21, 22 & 23, Sector โ€“ 3, Noida โ€“ 201 301, Distt. Gautam Budh Nagar (U.P.). 3. Verticot โ€“ 8 Tablets B. No.: MT191390, Assay & CDSCO, CDL, (Betahistine DiHCL Mfg dt: 08/2019, Dissolution Hyderabad Kolkata Tablets I.P.) Exp dt: 07/2021, Zone Mfd by: M/s. Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sector โ€“ 6A, IIE, Sidcul, Haridwar โ€“ 249 403, Uttarakhand. 4. Linezolid Tablets B. No.: GT200228, Dissolution CDSCO, CDL, I.P. 600 mg Mfg dt: 02/2020, South Zone, Kolkata Exp dt: 01/2022, Chennai. Mfd by: M/s. Theon Pharmaceuticals Ltd., Vill. Saini Majara, Teh. Nalagarh, Distt. Solan (H.P.) โ€“ 174 101.5. Amoxycillin Oral B. No.: 9909619, Assay CDSCO, CDTL, Suspension I.P. Mfg dt: 08/2019, West Zone, Mumbai 125mg/5ml Dry Exp dt: 01/2021, Mumbai Syrup Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals limited (A govt. of India Enterprise) plot No. 14, II Phase, Peenya, bengaluru, 560058. 6. Methylcobalamin, B. No.: T0501969, Assay of Drugs Control RDTL, Benfotiamine, Folic Mfg dt: 07/2019, Chromium Department, Chandigarh Acid, Chromium Exp dt: 06/2021, Polynicotinate Himachal Polynicotinate, Myo- Pradesh Mfd by: M/s. Standord Inositol and Laboratories Pvt. Ltd. 8, Pyridoxine Industrial Area, Mehatpur Hydrochloride Distt. Una, (H.P.)-174315. Tablets ( NUHENZ TABLETS) 7. ISO PROPYL B. No.: Water Drugs Control RDTL, ALCOHOL IP IPA/DRM/2020/0035, Department, Chandigarh Mfg dt: 02/2020, Himachal Pradesh Exp dt: 01/2023, Mfd by: M/s. Deepak Fertilizers & Petro Chemicals, Maharashtra. 8. ISO PROPYL B. No.: IPA/GCPL/532, Water Drugs Control RDTL, ALCOHOL IP Mfg dt: 05/2020, Department, Chandigarh Himachal Exp dt: 04/2023, Pradesh Mfd by: M/s. Gujrat Chempac Pvt.Ltd. Valsad Gujarat.

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