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Date: 2021-03-15 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of February 2021

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

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Executive Summary & Key Takeaways

Gazette Notification Overview

  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for February 2021.
  • Out of 1204 samples tested, 1190 were declared as of Standard Quality, 14 were declared as Not of Standard Quality, and 0 samples were declared as Spurious or Misbranded.

Key Changes - List of Not of Standard Quality Items

  • The notification identifies 14 specific drugs that failed quality tests. Each entry includes the drug name, batch number, manufacturing and expiry dates, manufacturer, reason for failure, and the testing laboratory.
  • Reasons for failure include issues with Assay, Dissolution, Uniformity of Content, Related Substances, Particulate Matter, Clarity of Solution, Uniformity of Weight, Disintegration Time, and tests for specific ingredients like Salicylic Acid and Potassium Clavulanate.
  • The listed drugs include: ULGEL – A, DELSONE-M 16 Tablets, Amoxycillin & Potassium Clavulanate Tablets I.P. 625 mg, Cardirid (Carvedilol Tablets IP), RAMZE-5 (Ramipril Tablets I.P.), Theopenam -1g (Meropenem Injection I.P.), Rosuvas 20 (Rosuvastatin Tablets I.P.), Amoxycillin Capsules IP 500 mg, Doxylamine Succinate & Pyridoxine Hydrochloride Tablets, Prolonged-release Diltiazem Tablets BP 90mg, Revol-CC (Calcium Carbonate Magnesium Oxide, Manganese Sulphate, Zinc & Vitamin D3 Tablets), Aspirin Gastro-Resistant Tablets IP 150 mg, Ciprofloxacin Hydrochloride Tablets IP 500 mg, Cefpodoxime Proxetil Dispersible Tablets (BROTOCEF-100 DT TABLETS).

Impact Analysis

Impact on Manufacturers

  • Increased scrutiny from regulatory bodies is expected, potentially leading to more frequent inspections and stricter enforcement.

Impact on Consumers

  • Increased awareness and vigilance among consumers regarding drug quality are necessary.

Impact on Regulatory Agencies (CDSCO, State Drug Controllers)

  • The notification highlights the need for continuous monitoring and improvement of drug quality control measures.

Suggested Action Items

  • For Consumers: Be vigilant about drug quality, purchase medications from reputable sources, and report any suspected quality issues to the appropriate authorities.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. State Drug Controllers: State-level regulatory authorities responsible for enforcing drug regulations within their respective states. GMP: Good Manufacturing Practices, a set of guidelines and regulations for ensuring the quality and safety of pharmaceutical products. Alembic Pharmaceuticals Ltd.: One of the manufacturers listed in the gazette whose product ULGEL – A failed quality tests. Psychotropics India Ltd.: One of the manufacturers listed in the gazette whose product DELSONE-M 16 Tablets failed quality tests. Stride Organics Private Ltd.: One of the manufacturers listed in the gazette whose product Amoxycillin & Potassium Clavulanate Tablets I.P. 625 mg failed quality tests. Ridley Life Science Pvt. Ltd.: One of the manufacturers listed in the gazette whose product Cardirid (Carvedilol Tablets IP) failed quality tests. Zee Laboratories: One of the manufacturers listed in the gazette whose product RAMZE-5 (Ramipril Tablets I.P.) failed quality tests. Theon Pharmaceuticals Ltd.: One of the manufacturers listed in the gazette whose product Theopenam -1g (Meropenem Injection I.P.) failed quality tests. Sun Pharma Laboratories Ltd.: One of the manufacturers listed in the gazette whose product Rosuvas 20 (Rosuvastatin Tablets I.P.) failed quality tests. Yeluri Formulations Pvt. Ltd.: One of the manufacturers listed in the gazette whose product Amoxycillin Capsules IP 500 mg failed quality tests. Pure & Cure Healthcare Pvt. Ltd.: One of the manufacturers listed in the gazette whose product Doxylamine Succinate & Pyridoxine Hydrochloride Tablets failed quality tests. Skymap Pharmaceuticals Pvt. Ltd.: One of the manufacturers listed in the gazette whose product Prolonged-release Diltiazem Tablets BP 90mg failed quality tests. Mascot Health Series Pvt. Ltd.: One of the manufacturers listed in the gazette whose product Revol-CC (Calcium Carbonate Magnesium Oxide, Manganese Sulphate, Zinc & Vitamin D3 Tablets) failed quality tests. Unicure India ltd.: One of the manufacturers listed in the gazette whose product Aspirin Gastro-Resistant Tablets IP 150 mg failed quality tests. Karnataka Antibiotics & Pharmaceuticals Limited: One of the manufacturers listed in the gazette whose product Ciprofloxacin Hydrochloride Tablets IP 500 mg failed quality tests. J.M. Laboratories: One of the manufacturers listed in the gazette whose product Cefpodoxime Proxetil Dispersible Tablets (BROTOCEF-100 DT TABLETS) failed quality tests.
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0List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of February 2021 Total number of samples tested 1204 Total number of samples declared as of Standard Quality 1190 Total number of samples declared as Not of Standard Quality 14 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. ULGEL – A 200 ml B. No.: 1808001807 Assay of CDSCO, CDL, (Magaldrate, Mfg dt: 12/2018 Oxetacaine North Zone Kolkata Exp dt: 11/2021 Simethicone & Mfd by: M/s. Alembic Oxetacaine Oral Pharmaceuticals Ltd., Suspension) Samardung Basti, Karek Block, Namthang Ilaka, South Sikkim – 737 126. 2. DELSONE-M 16 Tablets B. No.: ART29005 Dissolution CDSCO, CDL, (Methylprednisolone Mfg dt: 11/2019 Hyderabad Kolkata Exp dt: 10/2021 Tablets I.P. 16 mg) Mfd by: M/s. Psychotropics India Ltd., Plot No. 46 & 49, Sector- 6A, IIE, SIDCUL, Ranipur, Haridwar-249403 Uttarakhand. 3. Amoxycillin & Potassium B. No.: 0017 Dissolution & CDSCO, CDL, Clavulanate Tablets I.P. Mfg dt: 11/2019 Assay of Hyderabad Kolkata Exp dt: 04/2021 Potassium 625 mg Mfd by: M/s. Stride Clavulanate Organics Private Ltd., Sy. No. 265/P, Kondapur (Vill.), Ghatkesar, Medchal District (T.S.), Telangana. 4. Cardirid (Carvedilol B. No.: CAR-2001 Uniformity of CDSCO, CDL, Tablets IP) Mfg dt: 06/2020 Content and Hyderabad Kolkata Exp dt: 05/2022 Related Mfd by: M/s. Ridley Life Substances Science Pvt. Ltd., D 1651, DSIDC Indl. Complex, Narela, Delhi-110 040.5. RAMZE-5 (Ramipril B. No.: 420-578 Assay CDSCO, East CDL, Tablets I.P.) Mfg dt: 05/2020 Zone, Kolkata Kolkata Exp dt: 04/2022 Mfd by: M/s. Zee Laboratories, 47, Industrial Area, Paonta Sahib – 173025 Himachal Pradesh. 6. Theopenam -1g B. No.: MERM19015A Particulate CDSCO, East CDL, (Meropenem Injection Mfg dt: 07/2019 Matter and Zone, Kolkata Kolkata Exp dt: 06/2021 I.P.) Clarity of Mfd by: M/s. Theon Solution Pharmaceuticals Ltd., Village Saini Majra, Teh. Nalagarh, Distt. Solan Himachal Pradesh – 174101. 7. Rosuvas 20 B. No.: EMX0174 Uniformity of CDSCO, East CDL, (Rosuvastatin Tablets Mfg dt: 01/2020 Weight, Zone, Kolkata Kolkata Exp dt: 06/2022 I.P.) Dissolution Mfd by: M/s. Sun Pharma and Assay Laboratories Ltd., Plot No. 107-108, Namli Block, P.O. Ranipool, East-Sikkim-737 135. 8. Amoxycillin Capsules IP B. No.: YAT91054 Assay CDSCO, CDTL, 500 mg Mfg dt: 11/2019 West Zone, Mumbai Exp dt: 10/2021 Mumbai Mfd by: M/s. Yeluri Formulations Pvt. Ltd., Sy. No. 296/7/6, I.D.A. Bollaram, Sangareddy, District-502325, Telangana. 9. Doxylamine Succinate & B. No.: PF8B101 Disintegration CDSCO, CDTL, Pyridoxine Mfg dt: 08/2019 Time West Zone, Mumbai Exp dt: 07/2021 Hydrochloride Tablets Mumbai Mfd by: M/s. Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A, 27-30, Sector-8A, I.I.E., SIDCUL, Haridwar- 249403, Uttrakhand. 10. Prolonged-release B. No.: GM20128 Dissolution CDSCO, CDTL, Diltiazem Tablets BP Mfg dt: 11/2020 West Zone, Mumbai Exp dt: 10/2022 90mg Mumbai Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee-247667 Uttarakhand.11. Revol-CC (Calcium B. No.: MT191325 Assay of CDSCO, CDTL, Carbonate Magnesium Mfg dt: 08/2019 Vitamin D3 West Zone, Mumbai Exp dt: 07/2021 Oxide, Manganese Mumbai Mfd by: M/s. Mascot Health Sulphate, Zinc & Series Pvt. Ltd., Plot No. Vitamin D3 Tablets) 79, 80, Sec-6A, IIE, Siducul, Haridwar- 249403, Uttrakhand. 12. Aspirin Gastro-Resistant B. No.: APET716 Test for CDSCO, CDTL, Tablets IP 150 mg Mfg dt: 06/2019 Salicylic Acid West Zone, Mumbai Exp dt: 05/2021 Mumbai Mfd by: M/s. Unicure India ltd., C-21, 22 & 23, Sector- 3, Noida- 201301, Distt: Gautam Budh Nagar (U.P). 13. Ciprofloxacin B. No.: 0703419 Dissolution CDSCO, RDTL, Hydrochloride Tablets Mfg dt: 09/2019 North Zone Chandigarh Exp dt: 08/2022 IP 500 mg Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited Plot No. 14, II Phase, Peenaya, Bengaluru- 560058. 14. Cefpodoxime Proxetil B. No.: CT1904E Assay CDSCO, RDTL, Dispersible Tablets Mfg dt: 12/2019 Sub-Zone, Chandigarh Exp dt: 11/2021 (BROTOCEF-100 DT Jammu Mfd by: M/s. J.M. TABLETS) Laboratories Village- Bhanat, P.O. - Ghatti, Subathu Road, Solan Himachal Pradesh- 173211.

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