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Date: 2019-08-07 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of July 2019

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

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Executive Summary & Key Takeaways

Key Changes

  • Ewit-DSR Capsules (Batch No.: C-6601) manufactured by M/s. A. S Lifesciences failed dissolution tests for Esomeprazole.
  • 18 samples failed quality tests out of 988 tested.
  • Albendazole Tablets IP 400 mg (Batch No.: ABT18032) manufactured by M/s. Vivek Pharmachem (India) Ltd. failed due to dissolution issues.
  • Pantoprazole Gastro Resistant Tablets IP 40 mg (Batch No.: T-7164) manufactured by M/s. Kwality Pharmaceuticals Ltd. failed dissolution tests.
  • Paracetamol Tablets IP 500 mg (Batch No.: PR1902) manufactured by M/s. Danish Health Care (P) Ltd. failed dissolution tests.
  • Calcium and Vitamin D3 Tablets IP (500 mg + 250 IU) (Batch No.: CWTV-56) manufactured by M/s. Nestor Pharmaceuticals failed Assay of Vitamin D3 test.
  • Tolperison Hydrochloride IP (Batch No.: CHT019001) manufactured by M/s. Sai Tech Pharmaceuticals Pvt. Ltd. failed test for Piperidine Hydrochloride.
  • Diclofenac Sodium Injection I.P. (Batch No.: I-17507) manufactured by M/s. Jackson Laboratories Pvt. Ltd. failed Description & Particulate Matter test.
  • Phenytoin Oral Suspension I.P. (Batch No.: 8L03129) manufactured by M/s. Ciron Drugs & Pharmaceuticals Pvt Ltd. failed Assay test.
  • Fexofendine Tablets I.P. 180 mg (Batch No.: JDT-3617) manufactured by M/s. Jpee Drugs failed Dissolution test.
  • Regunac - 50 (Diclofenac Gastro-Resistant Tablets I.P. 50 mg) (Batch No.: FZ57F801) manufactured by M/s. Zim Laboratories Limited failed Description test.
  • Diclofenac Sodium Tablets I.P. 50 mg (Batch No.: 1511917) manufactured by M/s. Karnataka Antibiotics & Pharmaceutical Limited failed Disintegration & Related Substances test.
  • Diclofenac Sodium Tablets I.P. 50 mg (Batch No.: 1508318) manufactured by M/s. Karnataka Antibiotics & Pharmaceutical Limited failed Related Substances test.
  • Diclofenac Sodium Tablets I.P. 50 mg (Batch No.: 1512117) manufactured by M/s. Karnataka Antibiotics & Pharmaceutical Limited failed Disintegration & Related Substances test.
  • Parazim 650 (Paracetamol Tablets I.P. 650 mg) (Batch No.: FAX8A801) manufactured by M/s. ZIM Laboratories Limited failed Dissolution test.
  • Prednisolone Acetate and Moxifloxacin Ophthalmic Suspension(M-Floxin-P Eye Drops) (Batch No.: O-066) manufactured by M/s. Oscar Remedies Pvt. Ltd. failed Particle size and Assay of Predisolone Acetate test.
  • Ciprofloxacin Tablets IP (P-CIP 500 Tabelets) (Batch No.: R-21119) manufactured by M/s. Pansun Pharmaceuticals failed Identification and Assay of Drugs test.
  • (Cefotaxime Injection IP) (Batch No.: B028004A) manufactured by M/s.ANG Lifesciences India Ltd. failed Related Substances test.
  • Multivitamin Tablets with minerals and Trace Elements (Supradyn Tablets) (Batch No.: MH3080) manufactured by M/s. Piramal Enterprises Ltd. failed Assay of Cyanocobalamin test.

What it means

  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for July 2019.
  • A total of 988 samples were tested, with 970 samples meeting the standard quality and 18 samples declared as Not of Standard Quality. There were no samples declared as Spurious or Misbranded.

Impact Analysis

Manufacturers

  • Potential impact on brand reputation and market share for the manufacturers involved.

Consumers/Patients

  • Healthcare providers should be informed about the list of substandard drugs to avoid prescribing them.

Regulatory Authorities

  • Authorities should strengthen post-market surveillance to detect substandard drugs and take appropriate action.

Our Organization

  • Communicate this information to our relevant departments, including procurement, quality assurance, and medical affairs.

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 CDL Kolkata: Central Drugs Laboratory, Kolkata IP: Indian Pharmacopoeia
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 July 2019 Total number of samples tested 988 Total number of samples declared as of Standard Quality 970 Total number of samples declared as Not of Standard Quality 18 Total number of samples declared as Spurious 0 Total number of samples declared as Misbranded 0 S. Name of Batch No./Date of Reason for failure Drawn By From N. Drugs/medical Manufacture/Date of device/cosmetics Expiry/Manufactured By 1. Albendazole B. No.: ABT18032, Dissolution Drug Control RDTL, Tablets I.P. 400 Mfg dt: 08/2018, Department, Guwahati Exp dt: 07/2020, mg Assam Mfd by: M/s. Vivek Pharmachem (India) Ltd. NH-8, Chimanpura, Amer, Jaipur-303102 (Rajasthan). 2. Pantoprazole B. No.: T-7164, Dissolution Drug Control RDTL, Gastro Resistant Mfg dt: 10/2018, (Both Acid Stage & Department, Guwahati Exp dt: 09/2020, Buffer Stage) Tablets I.P. 40 mg Assam Mfd by: M/s. Kwality Pharmaceuticals Ltd. Nag Kalan, Majitha Road, Amritsar (Punjab) 3. Paracetamol B. No.: PR1902, Dissolution Drug Control RDTL, Tablets I.P. 500 Mfg dt: 01/2019, Department, Guwahati mg Exp dt: 12/2020, Mizoram Mfd by: M/s. Danish Health Care (P) Ltd. 76/27-28, Industrial Estate, Maxi Road, Ujjain-456010 (M.P). 4. Ewit-DSR B. No.: C-6601, Dissolution for CDSCO, CDTL, Capsules Mfg dt: 08/2018, Esomeprazole West Zone, Mumbai Exp dt: 07/2020, (Esomeprazole- Mumbai Mfd by: M/s. A. S 40mg (E.C) & Lifesciences. 136, Ind. Domperidone 30 Estate Kutana-124001 mg (SR) Capsules) (Haryana) India.5. Calcium and B. No.: CWTV-56, Assay of Vitamin CDSCO, CDTL, Vitamin D3 Tablets Mfg dt: 09/2018, D3 West Zone, Mumbai IP Exp dt: 08/2020, Mumbai (500 mg + 250 IU) Mfd by: M/s. Nestor Pharmaceuticals., 11, Western Extension Area, Faridabad-121001 (Haryana). 6. Tolperison B. No.: CHT019001, Test for Piperidine CDSCO, CDTL, Hydrochloride IP Mfg dt: 02/2019, Hydrochloride West Zone, Mumbai Exp dt: 01/2022, Mumbai Mfd by: M/s. Sai Tech Pharmaceuticals Pvt. Ltd., A-145/B, Khairane MIDC, Navi Mumbai- 400705. 7. Diclofenac Sodium B. No.: I-17507, Description & CDSCO, CDL, Kolkata Injection I.P. Mfg dt: 07/2018, Particulate Matter Jammu Exp dt: 06/2020, Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar-143001. 8. Phenytoin Oral B. No.: 8L03129, Assay CDSCO, CDL, Kolkata Suspension I.P. Mfg dt: 04/2018, Jammu Exp dt: 03/2020, Mfd by: M/s. Ciron Drugs & Pharmaceuticals Pvt Ltd., N-118, N-119, N- 113, M.I.D.C., Tarapur, Boisar, Dist. Palghar – 401506. 9. Fexofendine B. No.: JDT-3617, Dissolution CDSCO, CDL, Kolkata Tablets I.P. 180 Mfg dt: 09/2018, North Zone, Exp dt: 08/2020, mg Ghaziabad Mfd by: M/s. Jpee Drugs, Plot No. 53, Sector-6A, SIDCUL, Haridwar, (Uttarakhand). 10. ® B. No.: FZ57F801 Description CDSCO, East CDL, Kolkata Regunac - 50 Mfg dt: 06/2018, Zone, Kolkata (Diclofenac Gastro- Exp dt: 05/2021, Resistant Tablets Mfd by: M/s. Zim I.P. 50 mg) Laboratories Limited, B-21/22, MIDC Area, Kalmeshwar-441 501, Dist. Nagpur, Maharashtra. 11. Diclofenac Sodium B. No.: 1511917, Disintegration & CDSCO, East CDL, Kolkata Tablets I.P. 50 mg Mfg dt: 10/2017, Related Zone, Kolkata Exp dt: 09/2019, Substances Mfd by: M/s. Karnataka Antibiotics & Pharmaceutical Limited,Plot No. 14, II Phase, Peenya, Bangalore- 560058. 12. Diclofenac Sodium B. No.: 1508318, Related CDSCO, East CDL, Kolkata Tablets I.P. 50 mg Mfg dt: 05/2018, Substances Zone, Kolkata Exp dt: 04/2020, Mfd by: M/s. Karnataka Antibiotics & Pharmaceutical Limited, Plot No. 14, II Phase, Peenya, Bangalore- 560058 13. Diclofenac Sodium B. No.: 1512117, Disintegration & CDSCO, East CDL, Kolkata Tablets I.P. 50 mg Mfg dt: 11/2017, Related Zone, Kolkata Exp dt: 10/2019, Substances Mfd by: M/s. Karnataka Antibiotics & Pharmaceutical Limited, Plot No. 14, II Phase, Peenya, Bangalore- 560058. 14. Parazim 650 B. No.: FAX8A801, Dissolution CDSCO, East CDL, Kolkata (Paracetamol Mfg dt: 01/2018, Zone, Kolkata Exp dt: 12/2020, Tablets I.P. 650 Mfd by: M/s. ZIM mg) Laboratories Limited, B- 21/22, MIDC, Area, Kalmeshwar 441501, Dist Nagpur, Maharastra. 15. Prednisolone B. No.: O-066, Particle size and FDA Bhiwani, RDTL, Acetate and Mfg dt: 04/2018, Assay of Haryana Chandigarh Exp dt: 03/2020, Moxifloxacin Predisolone Mfd by: M/s. Oscar Ophthalmic Acetate Remedies Pvt. Ltd. Oscar Suspension(M- House Baddi Majara, Floxin-P Eye Yamuna Nagar- Drops) 135001(Haryana). 16. Ciprofloxacin B. No.: R-21119, Identification and Sirmour office RDTL, Tablets IP (P-CIP Mfg dt: 12/2018, Assay of Drugs Chandigarh Exp dt: 11/2020, 500 Tabelets) Inspector Mfd by: M/s. Pansun Nahan H.P. Pharmaceuticals Plot No. 183, Sector 6 A, IIE, Sidhgual, Haridwar (Uttarakhand). 17. (Cefotaxime B. No.: B028004A, Related CDSCO Sub- RDTL, Injection IP) Mfg dt: 07/2018, Substances Zone, Jammu Chandigarh Exp dt: 06/2020, Mfd by: M/s.ANG Lifesciences India Ltd. Village Kishanpura, Nalagarh Road, Tehsil : Baddi, Distt: Solan, Himachal Pradesh-174101. 18. Multivitamin B. No.: MH3080, Assay of CDSCO Sub- RDTL, Tablets with Mfg dt: 02/2019, Cyanocobalamin Zone, Baddi Chandigarh Exp dt: 10/2020, minerals and Trace Mfd by: M/s. Piramal Elements Enterprises Ltd. K-1, (Supradyn Tablets) Addl. MIDC area, Mahad- 402302, Maharashtra.

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