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Date: 2021-09-09 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of August 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 August 2021.
  • A total of 1245 samples were tested.
  • 1207 samples were declared to be of Standard Quality.
  • 37 samples were declared as Not of Standard Quality.
  • 0 samples were declared as Spurious.
  • 1 sample was declared as Misbranded.

Key Changes - Not of Standard Quality

  • Acivir-200 DT (Aciclovir Dispersible Tablets I.P. 200 mg), batch number SA91192, manufactured by M/s. Cipla Ltd., Sikkim, failed due to non-uniformity of dispersion.
  • Phenytoin Sodium Injection 50mg / ml, batch number P0492, manufactured by M/s. Bharat Parenterals Ltd., Gujarat, failed due to pH & Volume issues.
  • Folic Acid & Ferrous Sulphate Tablets I.P. (IFA Large), batch numbers 086, 017, 085, 154, and 150, manufactured by M/s. Deep Pharma, Gujarat, failed due to description issues.
  • Dispersible Paracetamol Tablets B.P. 125 mg, batch number T200558, manufactured by M/s. Micron Phamaceuticals, Gujarat, failed due to fineness of dispersion.
  • Favimax - 400 (Favipiravir Tablets 400 mg), batch numbers TP-0421907 and TP-0421903, manufactured by M/s. Max Relief Health Care, Himachal Pradesh, failed identification & assay test.
  • Hydrocortisone Sodium Succinate Injection I.P., batch number HDI121A, manufactured by M/s. Himalaya Meditek Private Limited, Uttarakhand, failed due to clarity of solution, particulate matter, and assay of Hydrocortisone.
  • Cofset - AT Syrup (Ambroxol Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup, 100 ml), batch number DVLD950, manufactured by M/s. Digital Vision, Himachal Pradesh, failed due to assay of Terbutaline Sulphate.
  • Absorbent Cotton Wool I.P., batch number C150520, manufactured by M/s. Shanti Surgicals Pvt. Ltd., Uttar Pradesh, failed due to Sulphated Ash.
  • Fluvir (Oseltamivir Phosphate Oral Suspension I.P. 12mg/ ml), batch number GD20430A, manufactured by M/s. Hetero Healthcare Limited, Assam, failed due to Related Substances.
  • Dexamethasone Sodium Phosphate IP, batch number APL/02020/E-21, manufactured by M/s. Anuh Pharma Ltd., Maharashtra, failed due to Related Substances.
  • Atenolol Tablets I.P. 50 mg, batch number ATTJ20002, manufactured by M/s. Vivek Pharmachem (India) Ltd., Jammu, failed due to Disintegration.
  • Paracetamol Tablets IP 500 mg (TEMPNIL-500), batch number 20NT0404, manufactured by M/s. Nuclotec Remedies Pvt. Ltd., Uttarakhand, failed due to Dissolution.
  • Ciprofloxacin Tablets IP 500 mg, batch number CPT20005, manufactured by M/s. Vivek Pharmachem (India) Ltd., Rajasthan, failed due to Dissolution.
  • Paracetamol Tablets IP 500 mg (TEMPNIL-500), batch number 20NT0310, manufactured by M/s. Nuclotec Remedies Pvt. Ltd., Uttarakhand, failed due to Dissolution.
  • Ranitidine Tablet 150 mg (ACITEK-150), batch number AT1A020, manufactured by M/s. Actinova Private Limited, Himachal Pradesh, failed due to Dissolution.
  • Atorvastatin Tablets I.P. 20 mg, batch number AVBT806, manufactured by M/s. Unicure India Ltd., Uttar Pradesh, failed due to Dissolution.
  • Atorvastatin Tablets I.P. 20 mg, batch number AVAT21001, manufactured by M/s. Galpha Laboratories Ltd., Himachal Pradesh, failed due to Dissolution.
  • Pregabalin Capsules IP 75 mg, batch number T20056, manufactured by M/s. Trugen Pharmaceuticals Pvt. Ltd., Uttarakhand, failed due to Dissolution.
  • Doulcet-M Tablets, (Levocetrizine Dihydrochloride & Montelukast Sodium), batch number UDT-20163C, manufactured by M/S Ultra Drugs Pvt. Ltd., Himachal Pradesh, failed due to Dissolution of Montelukast.
  • BETAMETHASONE SODIUM PHOSPHATE TABLETS IP 0.5 mg (BETNECON), batch number VNT-19L17, manufactured by M/s. Venus biosciences Pvt. Ltd., Himachal Pradesh, failed due to Assay.
  • Atenolol Tablets IP 50 mg, batch number ATTJ20002, manufactured by M/s. Vivek Pharmachem (India) Ltd., Jammu, failed due to Disintegration.
  • Oxytocin sample in plastic bottle from Patna, the drug does not bear label of the product. Sample in plastic bottle contains colorless liquid/solution with black particles visible with bare eyes.
  • AFFTITUDE HAND RUB, batch number HI-102, manufactured by M/s. HERBS INIDA, Delhi, failed Identification (Negative for Ethyl Alcohol).
  • OXYTOCIN INJECTION I.P., batch number OTC-232A, manufactured by M/s. Pushkar Pharma, Himachal Pradesh, failed Assay of Oxytocin Activity.
  • Bupropion Hydrochloride Extended Release Tablets USP 150 mg (BUPIDEP-150 ER TABLETS), batch number CT-12330321, manufactured by M/s. Clevus Lifesciences, Himachal Pradesh, failed Dissolution.
  • DEXTROMETHORPHAN HYDROBROMIDE SYRUP IP 30MG/5ML, batch numbers GL0015 and GL0016, manufactured by M/s. OMEGA PHARMA, Uttarakhand, failed Assay.
  • Piroxicam Capsules IP 20 mg PIROCAM-20 CAPSULES, batch number PC0014, manufactured by M/s. OMEGA PHARMA, Uttarakhand, failed Water.
  • NORFLOXACIN TABLETS IP 400 MG, batch number GPT9412, manufactured by M/s. OMEGA PHARMA, Uttarakhand, failed Dissolution.
  • ACECLOFENAC IP, batch number MIACE085420, manufactured by M/s. Magma Industries Limited, Uttar Pradesh, failed Related Substances.

Key Changes - Misbranded

  • Life Plus Hand Sanitizer (Alcohol 70% v/v, Chlorhexidine Gluconate Soln 2.5% w/v), batch number not mentioned, manufactured by not printed, Head Office: Life Plus Healthcare Private Limited, Kolkata, is misbranded.

Impact Analysis

Impact on Manufacturers

  • Manufacturers should review their quality control processes, raw material sourcing, and manufacturing practices to ensure compliance with regulatory standards.

Impact on Consumers

  • Consumers should be advised to report any adverse events or suspected quality issues to the appropriate regulatory authorities.

Impact on Regulatory Authorities

  • Strengthening collaboration between central and state drug control authorities is essential for effective regulation.

Suggested Action Items

  • Engage with regulatory authorities to understand the implications of the notification and demonstrate our commitment to quality and compliance.

Key Entities Referenced

CDSCO CDL Kolkata: Central Drugs Standard Control Organization, Central Drugs Laboratory, Kolkata. This is a government laboratory responsible for testing and analyzing drug samples. Drug Control Department Odisha: State Drug Control Department of Odisha, responsible for regulating the manufacture, sale, and distribution of drugs within the state. Drug Control Department Andhra Pradesh: State Drug Control Department of Andhra Pradesh, responsible for regulating the manufacture, sale, and distribution of drugs within the state. CDSCO South Zone Chennai: Central Drugs Standard Control Organization, South Zone, Chennai. Regional office of the CDSCO responsible for drug regulation in the southern region of India. CDSCO West Zone CDTL Mumbai: Central Drugs Standard Control Organization, West Zone, Central Drug Testing Laboratory, Mumbai. Regional office and testing laboratory of the CDSCO responsible for drug regulation in the western region of India. CDSCO Sub-Zone RDTL Guwahati: Central Drugs Standard Control Organization, Sub-Zone, Regional Drugs Testing Laboratory, Guwahati. Regional office and testing laboratory of the CDSCO responsible for drug regulation in the North East region of India. Drug Control Department Guwahati: Drug Control Department in Guwahati. Drug Control Department Assam: Drug Control Department in Assam. Drug Control Department Jharkhand: Drug Control Department in Jharkhand. Drug Control Department Patna: Drug Control Department in Patna. Drug Control Department Chandigarh: Drug Control Department in Chandigarh. Drug Control Department Delhi: Drug Control Department in Delhi. Drug Control Department Jammu & Kashmir: Drug Control Department in Jammu & Kashmir. Drug Control Department Uttar Pradesh: Drug Control Department in Uttar Pradesh. Drug Control Department Himachal Pradesh: Drug Control Department in Himachal Pradesh. Drug Control Department Bihar: Drug Control Department in Bihar.
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 – 2021. Total number of samples tested 1245 Total number of samples declared as of Standard Quality 1207 Total number of samples declared as Not of Standard Quality 37 Total number of samples declared as Spurious 0 Total number of samples declared as Misbranded 01 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. Acivir-200 DT B. No.: SA91192 Uniformity of CDSCO CDL (Aciclovir Dispersible Mfg dt: 02.2019 Dispersion Hyderabad Kolkata Tablets I.P. 200 mg) Exp dt: 01/2022 Mfd by: M/s. Cipla Ltd., Kumrek, Rangpo, Sikkim 737132. 2. Phenytoin Sodium B. No.: P0492 pH & Volume CDSCO CDL Injection 50mg / ml Mfg dt: 09/2020 Hyderabad Kolkata Exp dt: 08/2022 Mfd by: M/s. Bharat Parenterals Ltd.,Vill. Haripura, Ta. Savli, Dist. Vadodara -391520 Gujarat. 3. Folic Acid & Ferrous B. No.: 086 Description CDSCO CDL Sulphate Tablets I.P. Mfg dt: 02/2021 Ahmedabad Kolkata (IFA Large) Exp dt: 01/2023 Mfd by: M/s. Deep Pharma, Khedut Sabha Building, Dholka – 382 225, Dist. Ahmedabad, Gujarat. 4. Folic Acid & Ferrous B. No.: 017 Description CDSCO CDL Sulphate Tablets I.P. Mfg dt: 01/2021 Ahmedabad Kolkata (IFA Large) Exp dt: 12/2022 Mfd by: M/s. Deep Pharma, Khedut Sabha Building, Dholka – 382 225, Dist. Ahmedabad.5. Folic Acid & Ferrous B. No.: 085 Description CDSCO CDL Sulphate Tablets I.P. Mfg dt: 02/2021 Ahmedabad Kolkata (IFA Large) Exp dt: 01/2023 Mfd by: M/s. Deep Pharma, Khedut Sabha Building, Dholka – 382 225, Dist. Ahmedabad. 6. Folic Acid & Ferrous B. No.: 154 Description CDSCO CDL Sulphate Tablets I.P. Mfg dt: 02/2021 Ahmedabad Kolkata (IFA Large) Exp dt: 01/2023 Mfd by: M/s. Deep Pharma, Khedut Sabha Building, Dholka – 382 225, Dist. Ahmedabad. 7. Folic Acid & Ferrous B. No.: 150 Description CDSCO CDL Sulphate Tablets I.P. Mfg dt: 02/2021 Ahmedabad Kolkata (IFA Large) Exp dt: 01/2023 Mfd by: M/s. Deep Pharma, Khedut Sabha Building, Dholka – 382 225, Dist. Ahmedabad. 8. Dispersible B. No.: T200558 Fineness of CDSCO CDL Paracetamol Tablets Mfg dt: 05/2020 Dispersion Ahmedabad Kolkata B.P. 125 mg Exp dt: 04/2022 Mfd by: M/s. Micron Phamaceuticals, 2117, A- 2, Phase III,G.I.D.C, Vapi - 396195 Gujarat. 9. Favimax - 400 B. No.: TP-0421907 Identification & Drug Control CDL (Favipiravir Tablets Mfg dt: 04/2021 Assay Department Kolkata 400 mg) Odisha Exp dt: 03/2023 Mfd by: M/s. Max Relief Health Care, Vill. - Anji, Solan, Himachal Pradesh – 173 212. 10. Favimax - 400 B. No.: TP-0421903 Identification & Drug Control CDL (Favipiravir Tablets Mfg dt: 04/2021 Assay Department Kolkata 400 mg) Odisha Exp dt: 03/2023 Mfd by: M/s. Max Relief Health Care, Vill. - Anji, Solan, Himachal Pradesh – 173 212.11. Hydrocortisone B. No.: HDI121A Clarity of Drug Control CDL Sodium Succinate Mfg dt: 01/2020 Solution, Department Kolkata Injection I.P. Particulate Odisha Exp dt: 12/2021 matter, Mfd by: M/s. Himalaya Assay of Meditek Private Limited, Hydrocortisone Plot No. 35 & 36, Pharmacity, Selaqui Industrial Area, Dehradun, Uttarakhand - 248197. 12. Cofset - AT Syrup, B. No.: DVLD950 Assay of Drug Control CDL (Ambroxol Mfg dt: 11/2019 Terbutaline Department Kolkata Hydrochloride, Sulphate Andhra Exp dt: 10/2021 Terbutaline Sulphate, Pradesh Mfd by: M/s. Digital Guaiphenesin & Vision, 176, Mauza Ogli, Menthol Syrup, 100 Nahan Road, Kala-Amb, ml) Distt. Sirmour, Himachal Pradesh – 173 030. 13. Absorbent Cotton B. No.: C150520 Sulphated Ash CDSCO CDL Wool I.P. Mfg dt: 05/2020 South Zone Kolkata Chennai Exp dt: 04/2023 Mfd by: M/s. Shanti Surgicals Pvt. Ltd., G-28, Panki Industrial Area, Site No. 1, Kanpur, Uttar Pradesh - 208 022. 14. Fluvir (Oseltamivir B. No.: GD20430A Related CDSCO CDL Phosphate Oral Mfg dt: 04/2020 Substances South Zone Kolkata Suspension I.P. Chennai Exp dt: 03/2022 12mg/ ml) Mfd by: M/s. Hetero Healthcare Limited, AIIDC Industrial Growth Centre, Changsari, NIZ Sindurighopa (Village), Sila Sindurighopa (Mouza), Kamrup (Dist.) Assam – 781 101. 15. Dexamethasone B. No.: APL/02020/E-21 Related CDSCO West CDTL Sodium Phosphate IP Mfg dt: 05/2021 Substances Zone Mumbai Mumbai Exp dt: 04/2024 Mfd by: M/s. Anuh Pharma Ltd., M/s. Great Pacific Exports Pvt. Ltd., Plot No. D-5/8 & 5/9, TTC, Industrial Area,MIDC Turbhe, Navi Mumbai – 400703. 16. Atenolol Tablets I.P. B. No.: ATTJ20002 Disintegration CDSCO Sub- RDTL 50 mg. Mfg dt: 04/2020 Zone Guwahati Guwahati Exp dt: 03/2022 Mfd by: M/s. Vivek Pharmachem (India) Ltd.EPIP, Bari Brahmana, Jammu-181133. 17. Paracetamol Tablets B. No.: 20NT0404 Dissolution CDSCO Sub- RDTL IP 500 mg. Mfg dt: 04/2020 Zone Guwahati (TEMPNIL-500) Guwahati Exp dt: 03/2022 Mfd by: M/s. Nuclotec Remedies Pvt. Ltd. 14 Mile Stone, Rudrapur- Kashipur Road, Gadarpur, Dist. U.S. Nagar, Uttarakhand - 263152. 18. Ciprofloxacin Tablets B. No.: CPT20005 Dissolution Drug Control RDTL IP 500 mg Mfg dt: 06/2020 Department Guwahati Guwahati Exp dt: 05/2022 Mfd by: M/s. Vivek Pharmachem (India) Ltd., NH-8, Chimanpura, Amer, Jaipur, Rajasthan - 303102. 19. Paracetamol Tablets B. No.: 20NT0310 Dissolution Drug Control RDTL IP 500 mg. Mfg dt: 03/2020 Department Guwahati (TEMPNIL-500) Assam Exp dt: 02/2022 Mfd by: M/s. Nuclotec Remedies Pvt. Ltd. 14 Mile Stone, Rudrapur- Kashipur Road, Gadarpur, Dist. U.S. Nagar, Uttarakhand - 263152. 20. Ranitidine Tablet B. No.: AT1A020 Dissolution Drug Control RDTL 150 mg Mfg dt: 01/2021 Department Guwahati (ACITEK-150) Jharkhand Exp dt: 12/2022 Mfd by: M/s. Actinova Private Limited, At-147, Mauza Sansiwala, Post- Barottwala, Tehsil- Kasauli, Distt.-Solan, 173205Himachal Pradesh. 21. Atorvastatin Tablets B. No.: AVBT806 Dissolution CDSCO Sub- RDTL I.P. 20 mg. Mfg dt: 10/2020 Zone Guwahati Guwahati Exp dt: 09/2022 Mfd by: M/s. Unicure India Ltd. C-21, 22 & 23, Sector-3, Noida-201301, Distt.- Gautam Budh Nagar, Uttar Pradesh. 22. Atorvastatin Tablets B. No.: AVAT21001 Dissolution Drug Control RDTL I.P. 20 mg. Mfg dt: 02/2021 Department Guwahati Assam Exp dt: 01/2023 Mfd by: M/s. Galpha Laboratories Ltd. Vill. Thana, Baddi, Himachal Pradesh - 173205 23. Pregabalin Capsules B. No.: T20056 Dissolution Drug Control RDTL IP 75 mg Mfg dt: 05/2020 Department Guwahati Assam Exp dt: 04/2022 Mfd by: M/s. Trugen Pharmaceuticals Pvt. Ltd., Vill: Tejjupur, Near Chodiala Rly Station Roorkee, Dist. Haridwar, Uttarakhand. 24. Life Plus Hand B. No.: Not mentioned Misbranded Drug Control RDTL Sanitizer (Alcohol Mfg dt: 03/2020 Department Guwahati 70% v/v, Exp dt: 03/2022 Jharkhand Chlorhexidine Mfd by: Not Printed, One Gluconate Soln 2.5% Address mentioned: Life w/v) Plus Healthcare Private Limited, India, Head Office: 18 Ganesh Chandra Avenue, Kolkata-700013. 25. Doulcet-M Tablets, B. No.: UDT-20163C Dissolution of Drug Control RDTL (Levocetrizine Mfg dt: 02/2020 Montelukast Department Guwahati Dihydrochloride & Exp dt: 01/2022 Bihar Montelukast Sodium) Mfd by: M/S Ultra Drugs Pvt. Ltd. Manpura, Nalagarh, Disttt-Solan, Himachal Pradesh.26. BETAMETHASONE B. No.: VNT-19L17 Assay Drug Control RDTL SODIUM Mfg dt: 12/2019 Department Guwahati PHOSPHATE Exp dt: 11/2021 Jharkhand TABLETS IP 0.5 mg Mfd by: M/s. Venus (BETNECON) biosciences Pvt. Ltd. 116, Export Promotion Industrial Park, Phase –I, Jharmajri, Baddi, Dist. Solan-173205, Himachal Pradesh. 27. Atenolol Tablets IP B. No.: ATTJ20002 Disintegration Drug Control RDTL 50 mg Mfg dt: 04/2020 Department Guwahati Exp dt: 03/2022 Assam Mfd by: M/s. Vivek Pharmachem (India) Ltd., EPIP, Bari Brahmana, Jammu-181133. 28. Oxytocin as per test Sample in plastic bottle The drug Drug Control RDTL for identification does not bear label of the contained in Department Guwahati product. plastic bottle in Patna colorless liquid/solution. black particles are visible with bare eyes 29. AFFTITUDE HAND B. No.: HI-102 Identification Drug RDTL RUB Mfg dt: 05/2021 (Negative for Control Chandigarh Exp dt: 04/2023 Ethyl Alcohol) Department Mfd by: M/s. HERBS Delhi INIDA J-2977, DSIIDC, Narela Indl.Area, New Delhi-110040. 30. OXYTOCIN B. No.: OTC-232A Assay of Drug RDTL INJECTION I.P. Mfg dt: 02/2021 Oxytocin Control Chandigarh Exp dt: 07/2022 Activity Department Mfd by: M/s. Pushkar Jammu Pharma Bhandariwala, & Kheri, Kala-Amb-173030 Kashmir Himachal Pradesh. 31. Bupropion B. No.: CT-12330321 Dissolution Drug RDTL Hydrochloride Mfg dt: 03/2021 Control Chandigarh Extended Release Exp dt: 08/2022 Department Tablets USP 150 mg Mfd by: M/s. Clevus Himachal (BUPIDEP-150 ER Lifesciences, Near Apple PradeshTABLETS) Terminal Market, Sector- 6, Parwanoo-173220 Himachal Pradesh. 32. DEXTROMETHORP B. No.: GL0015 Assay Drug RDTL HAN Mfg dt: 04/2021 Control Chandigarh HYDROBROMIDE Exp dt: 03/2023 Department SYRUP IP Mfd by: M/s. OMEGA Uttar 30MG/5ML PHARMA Khasra Pradesh No.482, Village Saliyar Roorkee-247667, Distt.- Haridwar, Uttarakhand. 33. DEXTROMETHORP B. No.: GL0016 Assay Drug RDTL HAN Mfg dt: 04/2021 Control Chandigarh HYDROBROMIDE Exp dt: 03/2023 Department SYRUP IP Mfd by: M/s. OMEGA 30MG/5ML PHARMA Khasra Uttar No.482, Village Saliyar Pradesh Roorkee-247667, Distt.- Haridwar, Uttarakhand. 34. Piroxicam Capsules B. No.: PC0014 Water Drug RDTL IP Mfg dt: 04/2021 Control Chandigarh 20 mg PIROCAM-20 Exp dt: 03/2023 Department CAPSULES Mfd by: M/s. OMEGA Uttar PHARMA Khasra Pradesh No.482, Village-Saliyar, Roorkee-247667, Distt.Haridwar, Uttarakhand. 35. NORFLOXACIN B. No.: GPT9412 Dissolution Drug RDTL TABLETS IP 400 MG Mfg dt: 12/2019 Control Chandigarh Exp dt: 11/2021 Department Mfd by: M/s. OMEGA Uttar PHARMA Khasra Pradesh No.482, Village-Saliyar, Roorkee, Distt. Haridwar, Uttarakhand - 247667. 36. ACECLOFENAC IP B. No.: MIACE085420 Related Drug RDTL Mfg dt: 12/2020 Substances Control Chandigarh Exp dt: 11/2025 Department Mfd by: M/s. Magma Himachal Industries Limited C-24 to Pradesh28, UPSIDC Industrial Area, Begrajpur, Muzaffarnagar, Uttar Pradesh - 251203.

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