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Date: 2020-09-11 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of August 2020

Issued by Ministry of Health and Family Welfare · 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 August 2020.
  • A total of 843 samples were tested during the month.
  • Out of the tested samples, 821 were declared as of Standard Quality, 22 were declared as Not of Standard Quality, 0 were declared as Spurious, and 0 were declared as Misbranded.

Key Changes

  • 22 samples were found to be Not of Standard Quality.
  • The products that failed quality tests include Diclofenac gel, Folic Acid Tablets, Hypodermic Syringes, Winpress-XL 5mg (Prazosin Hydrochloride Sustained Release Tablets), Halopar (Haloperidol Injection IP), Aciclovir Tablets IP, Advanced Hand Rub 70% Alcohol, Isopropyl Alcohol and Chlorhexidine Gluconate Hand Sanitizer, Allyn Instant Dry Hand Rub, Clidinium Bromide, Chlordiazepoxide and Magnesium Hydroxide Tablets, Ethanol Hand Sanitizer, Ethyl Alcohol Solution 70%, Cefixime Dispersible Tablets, Amoxycillin & Potassium Clavulanate Tablets IP 625 mg, New Fame N Love Fairness Cream, Vitamin C, Vitamin B-12, Folic Acid and Niacinamide Injection, Ethyl Alcohol, Isopropyl Alcohol and Niacinamide Hand Sanitizer Gel, and Instant Hand Sanitizer Original Alcohol Based.
  • Reasons for failure include Assay issues, Sterility issues, Dissolution issues, Description & Particulate Matter, Uniformity of weight, Total Aerobic Microbial Count, Total yeast and Mould Count and presence of Pseudomonas aeruginosa per gram.

Impact Analysis

Manufacturers

  • There will be financial implications due to product recalls, disposal of substandard products, and potential legal actions.

Consumers

  • Increased awareness among consumers regarding the importance of purchasing from trusted sources and verifying product authenticity.

Government Agencies

  • Enhanced collaboration between central and state drug control authorities to improve the effectiveness of quality control measures.

Our Company

  • Communicate transparently with stakeholders about our commitment to quality and safety.

Key Entities Referenced

Drugs Control Department: State government agency responsible for regulating the manufacture, sale, and distribution of drugs and cosmetics within the state. CDSCO (Central Drugs Standard Control Organization): National regulatory body responsible for regulating pharmaceuticals and medical devices in India. RDTL (Regional Drugs Testing Laboratory): Laboratory responsible for testing drug samples to determine their quality and compliance with standards.
Official Source Record View Original Source →
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List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of August 2020 Total number of samples tested 843 Total number of samples declared as of Standard Quality 821 Total number of samples declared as Not of Standard Quality 22 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. Diclofenac gel B.P. B. No.: 8916 ASSAY Drugs Control RDTL, 1% w/w Mfg dt: 09/2019 Department, Guwahati Assam Exp dt: 08/2020 Mfd by: M/s. Syncom Healthcare Ltd.D-42,IIE SIDCUL, Selaqui, Dehradun-248197, U.K. 2. Folic Acid Tablets B. No.: T9125 ASSAY Drugs Control RDTL, I.P. 5mg. Mfg dt: 05/2019 Department, Guwahati Assam Exp dt: 04/2022 Mfd by: M/s. Bharat Parenterals Ltd. ViLL- Haripura, TA. Savli, Dist- Vadodara-391520, Gujarat. 3. Hypodermic B. No.: 19501 Sterility Drugs Control RDTL, Syringe 2ml. Mfg dt: 12/2019 Department, Guwahati Gujarat Exp dt: 11/2021 Mfd by: M/s. Gurumangalam International Rancharda-382115 (TA, Kalol, Dist-Gandhinagar). 4. Hypodermic B. No.: 19503 Sterility Drugs Control RDTL, Syringe 2ml. Mfg dt: 12/2019 Department, Guwahati Gujarat Exp dt: 11/2021 Mfd by: M/s. Gurumangalam International Rancharda-382115 (TA. Kalol, Dist-Gandhinagar). 5. Hypodermic B. No.: 19703 Sterility Drugs Control RDTL, Syringe 5ml. Mfg dt: 12/2019 Department, Guwahati Gujarat Exp dt: 11/2021 Mfd by: M/s.Gurumangalam International Rancharda-382115 (TA. Kalol, Dist-Gandhinagar). 6. Winpress-XL 5mg B. No.: PST9001 Dissolution CDSCO, East CDL, (Prazosin Mfg dt: 02/2019 Zone, Kolkata Kolkata Hydrochloride Exp dt: 01/2021 Sustained Release Mfd by: M/s. Vivimed Labs Tablets) Limited, D-125 &128, Phase III, IDA, Jeedimetla, Hyderabad-500055, Telangana. 7. Halopar B. No.: DP9004 Description & CDSCO, CDL, (Haloperidol Mfg dt: 01/2019 Particulate Ahmedabad Kolkata Injection IP Matter Exp dt: 12/2020 5mg/ml) 1ml. Mfd by: M/s. Divine Laboratories Pvt. Ltd., Block No. 471, Dabhasa, Ta.: Padra. Dist. Vadodara. 8. Aciclovir Tablets IP B. No.: DVT197055 Uniformity of CDSCO North- RDTL, (Herpivir-800 Mfg dt: 07/2019 weight Zone, Chandigarh Tablets) Exp dt: 06/2021 Ghaziabad (UP) Mfd by: M/s. Digital Vision 176, Mauza Ogli, Nahan Road, Kala-Amb, Distt. Sirmour (H.P.)-173030. 9. Advanced Hand B. No.: BO208586 Assay of Drug Control, RDTL, Rub 70% Alcohol Mfg dt: 03/2020 Isopropyl Department, Chandigarh (RYAAL) Exp dt: 02/2022 Alcohol and Govt .of N.C.T Chlorhexidine of Delhi, Mfd by: M/s. Bo Gluconate International A91, Wazirpur Solution Industrial Area, New Delhi- 110052. 10. Isopropyl Alcohol B. No.: 231H Assay of Drug Control, RDTL, and Chlorhexidine Mfg dt: 06/2020 Isopropyl Department, Chandigarh Gluconate Hand Exp dt: 05/2022 Alcohol Himachal Sanitizer Pradesh Mfd by: M/s. Haustus (Vibpure Hand Biotech Pvt. Ltd. 44-45, Ind. Sanitizer) Area, Tahliwal, Distt. Una (H.P.). 11. (Allyn Instant Dry B. No.: PKE-06 Assay of Ethyl Drug Control, RDTL, Hand Rub) Mfg dt: 06/2020 Alcohol Department, Chandigarh Exp dt: 05/2023 Govt. of N.C.T. of Delhi Mfd by: M/s. P.K.COSMETICS C-152,Sector-2, DSIIDC, Bawana Industrial Area, Delhi- 110039. 12. Clidinium Bromide, B. No.: ULGT20031 Assay of CDSCO North- RDTL, Chlordiazepoxide Mfg dt: 01/2020 Clidinium Zone, Chandigarh and Magnesium Bromide Ghaziabad (UP) Exp dt: 12/2021 Hydroxide Tablets Mfd by: M/s. UNIMARCK (Ulcon Tablets) HEALTHCARE LTD. Plot No.25 & 37, Sector-6A, SIDCUL, Haridwar-249403 (Uttarakhand). 13. Ethanol Hand B. No.: 247H Assay of Drug Control, RDTL, Sanitizer M fg dt: 06/2020 Ethanol Department, Chandigarh (Instawash Hand Exp dt: 05/2022 Himachal Sanitizer) Pradesh Mfd by: M/s. Haustus Biotech Pvt. Ltd. 44-45, Ind. Area, Tahliwal, Distt. Una (H.P.). 14. Ethyl Alcohol B. No.: HDZC-016 Assay of Drug Control, RDTL, Solution 70% Mfg dt: 05/2020 Ethanol Department, Chandigarh (Handzon Instant Exp dt: 04/2022 Govt of N.C.T. Hand Sanitizer) of Delhi Mfd by: M/s. RPL (India) Pharmaceuticals Pvt. Ltd., D-8/5 & D-8/6, Okhla, Industrial Area, Phase-1, New Delhi-110020. 15. (Allyn Instant Dry B. No.: PKEA-07 Assay of Ethyl Drug Control, RDTL, Hand Rub) Mfg dt: 07/2020 Alcohol Department, Chandigarh Exp dt: 07/2023 Govt. of N.C.T. of Delhi Mfd by: M/s. P.K.COSMETICS C-152, Sector-2, DSIIDC, Bawana Industrial Area, Delhi- 110039. 16. Cefixime B. No.: FBT19-186B Assay Drug Control, RDTL, Dispersible Tablets Mfg dt: 06/2019 Department, Chandigarh (Micfox-100 Dt Exp dt: 05/2021 Govt .of N.C.T. Tablets) of Delhi Mfd by: M/s. Athens Life Sciences Mauza Rampur Jattan, Nahan Road, Kala Amb, Distt.Sirmour, H.P.173030. 17. Amoxycillin & B. No.: KPT-3348 Dissolution Drug Control, RDTL, Potassium Mfg dt: 11/2019 (Amoxycillin Department, Chandigarh Clavulanate Exp dt: 04/2021 Trihydrate Govt .of N.C.T.Tablets IP 625 mg Mfd by: M/s. G NINE of Delhi (Amzeclav-625 BIOCEUTICALS PVT. Ltd, Tablets) 208-F, Sector-3, HSIDC, Industrial Estate, Karnal- 132001 (Haryana). 18. New Fame N Love B. No.: 5 Total Aerobic Drug Control, RDTL, Fairness Cream Mfg dt: 07/2020, Microbial Count, Department, Chandigarh Exp dt: 06/2023, Total yeast and Govt .of N.C.T. Mould Count, of Delhi Mfd by: M/s. Pseudomonas P.C.COSMETICS aeruginosa per gram 19. Vitamin C, Vitamin B. No.: 20NI0210 Particulate CDSCO North- RDTL, B-12, Folic Acid Mfg dt: 02/2020, Matter Zone, Chandigarh and Niacinamide Ghaziabad (UP) Exp dt: 01/2022, Injection ( Eldervit- Mfd by: M/s. Nuclotec 12 Im/Iv Drip) Remedies Pvt. Ltd. 14-Mile Stone, Rudrapur-Kashipur Road, Gadarpur, Distt- U.S.Nagar, (Uttarakhand)- 263152. 20. Vitamin C, Vitamin B. No.: 20NI0212 Sterility A, CDSCO (North- RDTL, B-12, Folic Acid Mfg dt: 02/2020 Sterility B Zone), Chandigarh and Niacinamide Ghaziabad (UP) Exp dt: 01/2022 Injection Mfd by: M/s. Nuclotec (Eldervit-12 Im/Iv Remedies Pvt. Ltd. 14-Mile Drip) Stone, Rudrapur-Kashipur Road, Gadarpur, Distt- U.S.Nagar, (Uttarakhand)- 263152. 21. Ethyl Alcohol, B. No.: SM041 Assay of Ethyl Drug Control, RDTL, Isopropyl Alcohol Mfg dt: 03/2020 Alcohol, Department, Chandigarh and Niacinamide Exp dt: 02/2022 Isopropyl Govt .of N.C.T. Hand Sanitizer Gel Alcohol of Delhi Mfd by: M/s. Swiss Biotech ( Tanzo) Parentrals Kewat No.1138, VPO-Kachhwa, Karnal 132001 (Haryana). 22. Instant Hand B. No.: SM/2020/508 Identification for Drug Control, RDTL, Sanitizer Original Mfg dt: 02/2020 Alcohol (Ethyl Department, Chandigarh Alcohol Based Exp dt: 01/2022 Alcohol) Srinagar (Safe Me Mfd by: M/s. KDM Sanitizer) GOLDSTAR CO. New Delhi-110019.

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