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Date: 2021-01-11 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of December 2020

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

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Executive Summary & Key Takeaways

Gazette Overview

  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for December 2020.
  • A total of 943 samples were tested.
  • 928 samples were declared as of Standard Quality.
  • 15 samples were declared as Not of Standard Quality.
  • 0 samples were declared as Spurious.
  • 0 samples were declared as Misbranded.

Key Changes - Products Declared Not of Standard Quality

  • Alora 0.25 (Alprazolam Tablets I.P. 0.25 mg), batch number 03A19T02, manufactured by M/s. Shine Pharmaceuticals Limited, was found to have failed dissolution testing.
  • Telmicept – 40 (Telmisartan Tablets I.P. 40 mg), batch number C21T479003, manufactured by M/s. Concept Pharmaceuticals Ltd., was found to have failed dissolution testing.
  • HAND SANITIZER, batch number V20EL011, manufactured by M/s. VOWCARE PRODUCTS, failed assay of Isopropyl Alcohol, Hydrogen Peroxide, and Glycerol.
  • PANTOPRAZOLE SODIUM TABLETS IP 40 MG, batch number ATPP-2011, manufactured by M/s. ANG Lifesciences India Ltd., failed dissolution testing.
  • DOCTORS CARE HAND SANITIZER, batch number 114D, manufactured by M/s. Beaubelle’Z Health & beauty Care, failed assay of Ethyl Alcohol.
  • Paracetamol Tablets IP 650 mg PARLIN-650 TABLETS, batch number CD505598, manufactured by M/s. Unisafe Bioscience Pvt. Ltd., failed dissolution testing.
  • SULFASALAZINE TABLETS B.P. 500 mg, batch number SSZT718, manufactured by M/s. Unicure India Ltd., failed related substances testing.
  • Fluconazole Tablets IP 150 mg FLUCOL TABLETS, batch number BY20002, manufactured by M/s. Ortin Laboratories Ltd., failed dissolution and related substances testing.
  • CIPROFLOXACIN TABLETS I.P. 500 mg, batch number DT-281, manufactured by M/s. Daffodills Pharmaceuticals Ltd., failed uniformity of weight testing.
  • Levofloxacin Tablets IP L-FOX-500 TABLETS, batch number SPTG-20639, manufactured by M/s. SPECTRUM FORMULATION PVT.LTD., failed uniformity of weight testing.
  • Tramadol Prolonged Release Tablets (CORLIVIDOL-100 SR TABLETS), batch number PTN-026, manufactured by M/s. Perk Pharmaceuticals Ltd., failed dissolution and related substances testing.
  • Calamine, Diphenhydramine Hydrochloride and Camphor Lotion NANZIDRYL LOTION, batch number NYL-002, manufactured by M/s. Nanz Med Science Pharma Pvt.Ltd., failed assay of Camphor.
  • Rosuvastain Tablets IP 20 mg, batch number T9329, manufactured by M/s. Bharat Parenterals Ltd., failed dissolution testing.
  • Cystecot-600 (N - Acetylcysteine Tablets), batch number MT191313, manufactured by M/s. Mascot Health Series Pvt. Ltd., failed assay testing.
  • Pantoprazole Tablets IP 40 mg, batch number T9356, manufactured by M/s. Bharat Parenterals Ltd., failed dissolution testing.

Impact Analysis

Impact on Manufacturers

  • Increased monitoring and testing of products will likely be mandated by regulatory bodies.

Impact on Consumers

  • Consumers should check batch numbers and avoid using the listed products.

Impact on Regulatory Bodies

  • This notification highlights the need for continuous monitoring of drug quality and safety.

Suggested Action Items

  • Communicate transparently with regulatory authorities and consumers regarding the issue and the steps being taken to resolve it.

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 - A laboratory that tests drugs. CDTL: Central Drugs Testing Laboratory - A laboratory that tests drugs. Drugs and Cosmetics Act: The primary legislation governing the quality and safety of drugs, medical devices, and cosmetics in India (Implicit).
Official Source Record View Original Source →
See Full Document Text
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of December-2020 Total number of samples tested 943 Total number of samples declared as of Standard Quality 928 Total number of samples declared as Not of Standard Quality 015 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. Alora 0.25 B. No.: 03A19T02 Dissolution CDSCO CDL (Alprazolam Tablets Mfg dt: 11/2019 East Zone Kolkata I.P. 0.25 mg) Exp dt: 10/2022 Kolkata Mfd by: M/s. Shine Pharmaceuticals Limited, Plot No. 132, Karjan – Vemardi Road, Juni Jitherdi, Te. Karjan – 391 240, Dist. Vadodara, Gujarat. 2. Telmicept – 40 B. No.: C21T479003 Dissolution CDSCO CDL (Telmisartan Tablets Mfg dt: 09/2019 Sub-Zone Kolkata I.P. 40 mg) Exp dt: 08/2022 Guwahati Mfd by: M/s. Concept Pharmaceuticals Ltd., A- 28/3, MIDC, Chikalthana, Aurangabad – 431 006 Maharashtra. 3. HAND SANITIZER B. No.: V20EL011 Assay of Drugs Control RDTL Mfg dt: 04/2020 Isopropyl Department Chandigarh Exp dt: 08/2022 Alcohol, Srinagar Hydrogen Mfd by: M/s. VOWCARE Peroxide, PRODUCTS Plot No. 77, Glycerol Zone 4th, I.G.C., SIDCO Lassipora, Dist. Pulwama Jammu & Kashmir - 192305. 4. PANTOPRAZOLE B. No.: ATPP-2011 Dissolution CDSCO RDTL SODIUM TABLETS Mfg dt: 06/2020 Sub-Zone Chandigarh IP 40 MG Exp dt: 05/2022 Jammu Mfd by: M/s. ANG Lifesciences India Ltd. At Kh No. 139/2, VillageJodhapur, Barotiwala, Dist. Solan, (HP). 5. DOCTORS CARE B. No.: 114D Assay of CDSCO RDTL HAND SANITIZER Mfg dt: 04/2020 Ethyl Alcohol North-Zone Chandigarh Exp dt: 03/2022 Mfd by: M/s. Beaubelle’Z Health & beauty Care, NH8, Gujarat. 6. Paracetamol Tablets B. No.: CD505598 Dissolution CDSCO RDTL IP 650 mg PARLIN- Mfg dt: 12/2019 North-Zone Chandigarh 650 TABLETS Exp dt: 11/2021 Mfd by: M/s. Unisafe Bioscience Pvt. Ltd., At 3726/27, GIDC, Vatwa, Ahmedabad Gujarat. 7. SULFASALAZINE B. No.: SSZT718 Related CDSCO RDTL TABLETS B.P. 500 mg Mfg dt: 03/2020 Substances North-Zone Chandigarh Exp dt: 02/2022 Mfd by: M/s. Unicure India Ltd.C-21, 22 & 23, Sector- 3, Noida-201301 Distt. Gautam Budh Nagar Uttar Pradesh. 8. Fluconazole Tablets B. No.: BY20002 Dissolution CDSCO RDTL IP 150 mg FLUCOL Mfg dt: 03/2020 and Related North-Zone Chandigarh TABLETS Substances Exp dt: 02/2022 Mfd by: M/s. Ortin Laboratories Ltd. 275 & 278 (Part), I.D.A. Pashamilaram-502307, Sanga Reddy Dist. Telangana. 9. CIPROFLOXACIN B. No.: DT-281 Uniformity of CDSCO RDTL TABLETS I.P. 500 Mfg dt: 01/2020 weight Sub-Zone Chandigarh mg Exp dt: 06/2021 Jammu Mfd by: M/s. Daffodills Pharmaceuticals Ltd. Jawahar Nagar, Rohta Road, Meerut-250001, Uttar Pradesh. 10. Levofloxacin Tablets B. No.: SPTG-20639 Uniformity of CDSCO RDTL IP L-FOX-500 Mfg dt: 10/2020 weight North-Zone Chandigarh TABLETS Exp dt: 09/2022 Mfd by: M/s. SPECTRUM FORMULATION PVT.LTD. Khasra No.12, Makhanpur, Bhagwanpur, Roorkee, Haridwar- Uttarakhand. 11. Tramadol Prolonged B. No.: PTN-026 Dissolution Drugs Control RDTL Release Tablets Mfg dt: 05/2020 and Related Department Chandigarh (CORLIVIDOL-100 Substances Govt. of Exp dt: 04/2022 SR TABLETS) N.C.T. of Mfd by: M/s. Perk Delhi Pharmaceuticals Ltd. A-7, Industrial Estate,Partapur- 250103 Uttar Pradesh. 12. Calamine, B. No.: NYL-002 Assay of Drugs Control RDTL Diphenhydramine Mfg dt: 09/2019 Camphor Department Chandigarh Hydrochloride and Himachal Exp dt: 08/2022 Camphor Lotion Pradesh Mfd by: M/s. Nanz Med NANZIDRYL LOTION Science Pharma Pvt.Ltd. (A unit of Med Science Canada Inc.) Rampur Ghat, Paonta Sahib- 173205.District-Sirmour Himachal Pradesh. 13. Rosuvastain Tablets B. No.: T9329 Dissolution CDSCO CDTL IP 20 mg Mfg dt: 09/2019 West Zone Mumbai Exp dt: 08/2022 Mumbai Mfd by: M/s. Bharat Parenterals Ltd., Vill Haripura, Tal Savli, Vadodara-391520, Gujarat. 14. Cystecot-600 B. No.: MT191313 Assay CDSCO CDTL (N - Acetylcysteine Mfg dt: 08/2019 West Zone Mumbai Tablets) Exp dt: 07/2021 Mumbai Mfd by: M/s. Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sector 6 A, IIE, SIDCUL, Haridwar- 249403, Uttarakhand. 15. Pantoprazole Tablets B. No.: T9356 Dissolution CDSCO CDTL IP 40 mg Mfg dt: 09/2019 West Zone Mumbai Exp dt: 08/2022 Mumbai Mfd by: M/s. Bharat Parenterals Ltd., Vill Haripura, Tal Savli, Vadodara-391520, Gujarat.

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