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Date: 2020-02-10 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of January 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 (NSQ), Spurious, Adulterated, or Misbranded for January 2020.
  • A total of 1177 samples were tested.
  • 1143 samples were declared to be of Standard Quality.
  • 34 samples were declared as Not of Standard Quality.
  • No samples were declared as Spurious or Misbranded.

Key Changes - Not of Standard Quality Products

  • 34 products failed quality tests and are listed as Not of Standard Quality.
  • The listed products include Absorbent Cotton Wool, various tablets (Ranitidine, Diclofenac, Fluconazole, Pantoprazole, Albendazole, Frusemide, Nimesulide, Telmisartan, Paracetamol, Methylprednisolone, Olmesartan Medoxomil), Pro-Biotic Capsules, Amoxycillin & Potassium Clavulanate Tablets, Gabapentin Tablets, Domperidone Suspension, Ferrous Sulphate and Folic Acid Tablets, Doxylamine Succinate and Pyridoxine Hydrochloride Tablets, Ranitidine Oral Solution, Surgical Dressing, Vitamin B-complex Tablet, Expectorant, Ampicillin Capsules, Valaciclovir Hydrochloride, Hydrated and Oral Rehydration Salts.
  • Reasons for failure include issues with Water Soluble Substances, Sulphated Ash Content, Particulate matter, Description, Disintegration, Uniformity of Dispersion, Assay, Dissolution, Drug Related substances, Sterility test, pH, and Related Substances and Adulteration.

Impact Analysis

Impact on Manufacturers

  • Action Item: Conduct thorough internal audits of manufacturing processes and quality control procedures.

Impact on Distributors/Retailers

  • Action Item: Implement a system for verifying the quality and authenticity of pharmaceutical products received from manufacturers.

Impact on Consumers

  • Action Item: Public awareness campaigns should be conducted to inform consumers about the listed NSQ products and potential health risks.

Impact on Regulatory Authorities

  • Action Item: Enhance collaboration between central and state drug control authorities to improve the effectiveness of drug quality monitoring and enforcement.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. CDL: Central Drugs Laboratory RDTL: Regional Drugs Testing Laboratory Drugs and Cosmetics Act: The primary legislation governing the regulation of drugs, medical devices, and cosmetics in India. (Implicit) State Drug Control Offices: State-level regulatory bodies responsible for enforcing the Drugs and Cosmetics Act within their respective states.
Official Source Record View Original Source →
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0List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of January 2020 Total number of samples tested 1177 Total number of samples declared as of Standard Quality 1143 Total number of samples declared as Not of Standard Quality 34 Total number of samples declared as Spurious Nil Total number of samples declared as Misbranded Nil 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. Absorbent Cotton Wool B. No.: A/1812, Water Soluble CDSCO, CDL, I.P., Mfg dt: 12/2018, Substances and Ahmedabad Kolkata Exp dt: 11/2021, Sulphated Ash Mfd by: M/s. Altus Content Surgical Pvt. Ltd., 21/D, Mahagujarat Ind. Estate, Sarkhej-Bavla Road, Moraiya, Ahmedabad. 2. Ranitidine Injection I.P. B. No.: RI-138, Particulate matter CDSCO, CDL, Mfg dt: 12/2018, North Zone, Kolkata Exp dt: 11/2020, Ghaziabad Mfd by: M/s. Rathi Laboratories (Hindustan) Pvt. Ltd. Industrial Area, Patna- 800013. 3. REGUNAC – 50 B. No.: FZ57F801, Description CDSCO, CDL, (Diclofenac Gastro- Mfg dt: 06/2018, East Zone, Kolkata Exp dt: 05/2021, Resistant Tablets I.P. 50 Kolkata Mfd by: M/s. Zim mg) Laboratories Limited, B- 21/22, MIDC Area, Kalmeshwar -441 501, Dist. Nagpur, Maharashtra.4. Diclofenac Sodium B. No.: DF-R008, Disintegration CDSCO, CDL, Tablets I.P. Mfg dt: 02/2019, East Zone, Kolkata Exp dt: 01/2021, Kolkata Mfd by: M/s. Bengal Chemicals & Pharmaceuticals Ltd., 115-C, Industrial Estate, Pologround, Indore – 452 015. 5. Fluconazole Tablets B. No.: TOH-02, Uniformity of CDSCO, CDL, Mfg dt: 04/2019, Dispersion East Zone, Kolkata Exp dt: 03/2021, Kolkata Mfd by: M/s. Om Biomedic Pvt. Ltd., Plot No. 68,69, 82 & 83, Sector -6A, Sidcul, Haridwar – 249403 (Uttarakhand). 6. THEOIMMUNE B. No.: GC190060, Assay of CDSCO, CDL, (Pro-Biotic Capsules) Mfg dt: 02/2019, Streptococus East Zone, Kolkata Exp dt: 01/2021, Kolkata faecalis, Mfd by: M/s. Theon Clostridium Pharmaceuticals Ltd., butyricum, Vill: Saini Majra, Tehsil Bacillus Nalagarh, Dist. Solan, Himachal Pradesh -174 mesentericus, 101. and Lactic Acid bacillus 7. Pantoprazole Gastro- B. No.: T-6988, Description CDSCO, CDL, resistant Tablets I.P. Mfg dt: 08/2018, Sub-Zone, Kolkata Exp dt: 07/2020, Guwahati Mfd by: M/s. Kwality Pharmaceuticals Ltd., Nagkalan, Majitha Road, Amritsar Punjab. 8. Amloclav 625 B. No.: BT136026, Water, CDSCO, CDL, (Amoxycillin & Mfg dt: 04/2018, Dissolution and Bangalore Kolkata Exp dt: 03/2020, Potassium Clavulanate Assay Mfd by: M/s. Shashi Tablets I.P.) Pharma, S.N. 77/P, At Vill. Dhanot, Chhatral - 382729, Ta. Kalol. Dist. Gandhinagar (Guj.) 9. Gabapentin Tablets IP B. No.: STN-181861, Description and Drug RDTL, 300 Mg Mfg dt: 03/2019, Related Control Chandigarh Exp dt: 02/2021, substances Office Mfd by: M/s. Terrace District- Pharmaceuticals (P) BilaspurLtd. 3-B (a), Phase-III, (H.P.) Industrial Area Sansarpur Terrace, Distt. Kangra ( H.P)-176501 10. (Amoxycillin Dispersible B. No.: LBT-1578, Uniformity of Drug RDTL, Tablets IP 250 mg ) Mfg dt: 03/2019, Dispersion Control Chandigarh Exp dt: 09/2020, Office Mfd by: M/s. Legen District - Healthcare, Plot No.20, Mandi Sector -5, Parwanoo, (H.P.) Distt.Solan.(H.P.) 173 220 11. Albendazole Tablets IP B. No.: 8600219, Dissolution Drug RDTL, 400MG Mfg dt: 01/2019, Control Chandigarh Exp dt: 12/2021, Office Mfd by: M/s. Karnataka Ghaziabad Antibiotics & (UP) Pharmaceuticals Limited Plot no.14, II Phase, Peenya, Bangalore- 560058. 12. Albendazole Tablets IP B. No.: ABTW-05, Dissolution Drug RDTL, 400 MG Mfg dt: 01/2019, Control Chandigarh Exp dt: 12/2021, Office Mfd by: M/s. Nestor Ghaziabad Pharmaceuticals Limited (UP) 11, Western Extension Area, Faridabad-121001 (Haryana). 13. Albendazole Tablets IP B. No.: 8600119, Dissolution CDSCO, RDTL, 400 MG Mfg dt: 01/2019, Sub-Zone, Chandigarh Exp dt: 12/2021, Jammu Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited Plot No.14, II Phase, Peenya, Bangalore- 560058. 14. Dom-H (Domperidone B. No.: 1801, Assay Drugs RDTL, Suspension) Mfg dt: 03/2018, Control Guwahati Exp dt: 02/2020, Department, Mfd by: M/s. Harsh Arunachal Healthcare 100-101, Pradesh Industrial Area Rau- 453331 Madhya Pradesh. 15. Albendazole Tablets I.P. B. No.: 8491015, Dissolution Drugs RDTL,400mg Mfg dt: 03/2019, Control Guwahati Exp dt: 02/2021, Department, Mfd by: M/s. Bengal Arunachal Chemicals & Pradesh Pharmaceuticlas Ltd. 164, Maniktala Main Road, Kolkata-700054. 16. Albendazole Tablets I.P. B. No.: 9622, Dissolution Drugs RDTL, 400mg Mfg dt: 02/2019, Control Guwahati Exp dt: 01/2022, Department, Mfd by: M/s. Orissa Arunachal Drugs & Chemicals Ltd. Pradesh 1, Mancheswar Industrial Estate, Bhubaneswar Odisha. 17. Frusemide Tablets I.P. B. No.: 7127, Dissolution Drugs RDTL, 40 mg. (Rasix) Mfg dt: 06/2017, Control Guwahati Exp dt: 05/2020, Department, Mfd by: M/s.Ramson Arunachal Remedies 186-187, Pradesh Insustrial Focal Point, Amritsar, A.O. 2G Floor, Baktawar, Malabar Hill, Mumbai-6. 18. Nimesulide Tablets B. No.: NP17016, Dissolution Drugs RDTL, 100mg Mfg dt: 09/2017, Control Guwahati Exp dt: 08/2020, Department, Mfd by: M/s. Navketan Arunachal Pharma Pvt. Ltd., F-106, Pradesh MIDC, Waluj, Aurangabad-431136 Maharashtra. 19. Telmisartan Tablets I.P. B. No.: TMA1001, Dissolution Drugs RDTL, 40mg Mfg dt: 02/2019, Control Guwahati Exp dt: 01/2021, Department, Mfd by: M/s. Sai Mirra Arunachal Innopharm Pvt. Ltd. 288 Pradesh & 299, SIDCUL Estate, Ambattur, Chennai- 600098 Tamilnadu. 20. Ferrous Sulphate and B. No.: IFTJ18028, Disintegration Drugs RDTL, Folic Acid Tablets I.P. Mfg dt: 09/2018, Control Guwahati Exp dt: 08/2020, Department, Mfd by: M/s. Vivek Assam Pharmachem (India) Ltd. EPIP, Bari Brahmana, Jammu- 181133. 21. Preginate (Doxylamine B. No.: ZD18715, Adulterated Drugs RDTL,Succinate and Mfg dt: 07/2018, Control Guwahati Pyridoxine Exp dt: 06/2020, Department, Mfd by: M/s. Skymap Hydrochloride Tablets) Nagaland Pharmaceuticals Pvt. Ltd. B-3, Dev Bhoomi Industrial Estate Puhana, Iqbalpur Road, Roorkee- 247667Uttarakhand. 22. Radin Syrup (Ranitidine B. No.: S18J025, Assay Drugs RDTL, Oral Solution I.P.) Mfg dt: 10/2018, Control Guwahati Exp dt: 09/2020, Department, Mfd by: M/s. Shri Hari Mizoram Pharmaceuticals Plot No. 767/1, Vadsar- Motibhoyan Road, Vill- Vadsar- 382721, Taluka, Kalol, Dist- Gandhinagar, Gujarat. 23. Paracetamol Tablets B. No.: TPT-190266, Dissolution Drugs RDTL, I.P. 650 (Cule 650) Mfg dt: 02/2019, Control Guwahati Exp dt: 01/2021, Department, Mfd by: M/s. Talwar Assam Pharma Jhabrera Road, Kurdi, Manglour- 247656, Roorkee, Dist- Haridwar Uttarakhand. 24. Dressipad (1 Surgical B. No.: KSCD-29, Sterility test Drugs RDTL, Dressing 10cm. X Mfg dt: 01/2019, Control Guwahati Exp dt: 12/2021, 10cm.) Department, Mfd by: M/s.K.S. Kerala Surgical Pvt. Ltd. Vill- Begmabad, Budhana, Unchi Sadak, Modi Nagar, U.P. 25. Dressipad (1 Surgical B. No.: KSCD-12, Sterility test Drugs RDTL, Dressing 10cm. X Mfg dt: 11/2017, Control Guwahati Exp dt: 10/2020, 10cm.) Department, Mfd by: M/s. K.S. Kerala Surgical Pvt. Ltd. Vill- Begmabad, Budhana, Unchi Sadak, Modi Nagar, U.P. 26. Vitamin B-complex B. No.: T8605, Assay of Vitamin Drugs CDTL, Tablet (Prophylactic) Mfg dt: 12/2018, B1 Inspector, M u m b a i Exp dt: 05/2020, NFI (III) CDSCO, Mfd by: M/s. Zest Sub Zone, Pharma, Plot No.275, Indore Sector F, Sanwer Road,Indore (M.P.) 452015. 27. Depotex 16 mg B. No.: AFV1010, Dissolution CDSCO, CDTL, (Methylprednisolone Mfg dt: 03/2019, West Zone, Mumbai Exp dt: 02/2021, Tablets IP) Mumbai Mfd by: M/s. Zydus Healthcare Ltd., Manufatured at : Vill. Saini Majra, Nalagarh- Ropar Road, Nalagarh, Distt.: Solan-HP. 28. Olmemark-40 B. No.: TPT8689, Dissolution CDSCO, CDTL, (Olmesartan Medoxomil Mfg dt: 06/2018, Sub Zone, Mumbai Exp dt: 05/2020, Tablet IP 40 mg) Indore. Mfd by: M/s. Trugen Pharmaceuticals Pvt. Ltd., Village-Tejjupur, Near Chodiala Rly. Station Roorkey, Dist- Haridwar (UK)- 247661. 29. Decodil Expectorant B. No.: LF19008, pH CDSCO, CDTL, Mfg dt: 02/2019, West Zone, Mumbai Exp dt: 01/2021, Mumbai Mfd by: M/s. Ortin Laboratories Ltd., 275 & 278 (part) I.D.A. Pashamilaram 502307, Sanga Reddy Dist. Telangana. 30. Ampicillin Capsules I.P. B. No.: CB181217, Assay CDSCO, CDTL, 250 mg Mfg dt: 12/2018, West Zone, Mumbai Exp dt: 11/2020, Mumbai Mfd by: M/s. Micron Pharmaceuticals, 2117, A-2, Phase III, G.I.D.C, Vapi-396195, Gujarat. 31. Valaciclovir B. No.: AA41927, Related CDSCO, CDTL, Hydrochloride, Hydrated Mfg dt: 05/2019, Substances Sub Zone, Mumbai Exp dt: 04/2022, Ph. Eur. Indore. Mfd by: M/s. Sun Pharmaceutical Industries Limited, Industrial Area No.3, Dewas 455001 Madhya Pradesh. 32. Valaciclovir B. No.: AA41926, Related CDSCO, CDTL, Hydrochloride, Hydrated Mfg dt: 04/2019, Substances Sub Zone, Mumbai Exp dt: 03/2022, Ph. Eur. Indore. Mfd by: M/s. Sun PharmaceuticalIndustries Limited, Industrial Area No.3, Dewas 455001 M.P. 33. Oral Rehydration Salts B. No.: GP19127, Assay for CDSCO, CDTL, IP Mfg dt: 02/2019, Potassium West Zone, Mumbai Exp dt: 01/2022, Mumbai Mfd by: M/s. Globela Pharma Pvt. Ltd., 357, 358 GIDC, Sachin, Surat-394230, Gujarat. 34. Oral Rehydration Salts B. No.: GP19128, Assay for CDSCO, CDTL, IP Mfg dt: 02/2019, Potassium West Zone, Mumbai Exp dt: 01/2022, Mumbai Mfd by: M/s. Globela Pharma Pvt. Ltd., 357, 358 GIDC, Sachin, Surat-394230, Gujarat.

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