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Date: 2022-07-11 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of June 2022

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 June 2022.
  • A total of 1096 samples were tested.
  • Out of the tested samples, 1070 were declared to be of Standard Quality.
  • 26 samples were declared as Not of Standard Quality.
  • No samples were declared as Spurious or Misbranded in this notification.

Key Changes

  • 26 samples failed quality tests and are listed as Not of Standard Quality.
  • The listed products include Rolled Bandage, Ibuprofen Tablets, Cyfolac Forte Capsules, Salmeterol and Fluticasone Propionate Inhalation, Atorvastatin Calcium Tablets, Albendazole Tablets, Amoxycillin and Potassium Clavulanate Tablets, Atorvastatin Tablets, Ciprofloxacin Tablets, Rabeprazole Gastro Resistant Tablets, Omeprazole Capsules, PARACETAMOL PAEDIATRIC ORAL SUSPENSION, ISOXSUPRINE HYDROCHLORIDE TABLETS, MONTELUKAST TABLETS, IRON AND FOLIC ACID TABLETS, PRE AND PROBIOTIC CAPSULES and Povidone-Iodine Ointment.
  • Reasons for failure include issues with Threads per dm, Length, Width, Weight in gm/m2, Foreign Matter & Fluorescence, Assay, Dissolution, Description, Disintegration and Uniformity of Content.
  • The products were drawn by CDSCO, Drug Control Department and RDTL from various zones and sub-zones including Guwahati, Kolkata, Chandigarh and Ghaziabad.
  • Manufacturers of the substandard drugs are located across India, including in Uttar Pradesh, Haryana, Himachal Pradesh, Gujarat, West Bengal, Andhra Pradesh, Karnataka and Uttarakhand.

Impact Analysis

Impact on Pharmaceutical Companies

  • Action Item: Review manufacturing processes and quality control measures to prevent future occurrences. Implement corrective and preventive actions (CAPA).

Impact on Consumers

  • Action Item: Issue public advisories to inform consumers about the affected products and advise them to discontinue use and consult healthcare professionals.

Impact on Regulatory Agencies (CDSCO, State Drug Control)

  • Action Item: Conduct thorough investigations of the listed manufacturers to determine the root causes of the quality failures. Increase vigilance on manufacturers with repeated failures.

Impact on Our Company

  • Action Item: Review our supplier list and assess their compliance with quality standards. Implement additional quality checks on products from suppliers located in the affected regions.

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 Drug Control Department: State-level regulatory authority responsible for drug regulation and enforcement. M/s. Anamika Udyog: Manufacturer of Rolled Bandage M/s. Hindustan Antibiotics Ltd.: Manufacturer of Ibuprofen Tablets I.P. 400 mg M/s. Swiss Garnier Biotech Pvt. Ltd.: Manufacturer of Cyfolac* Forte (Prebiotic & Probiotics Capsules) M/s. Oxalis Labs: Manufacturer of Salmeterol 25 mcg and Fluticasone Propionate 250 mcg Inhalation IP M/s. Shine Pharmaceuticals Limited: Manufacturer of Atorvastatin Calcium Tablets I.P. 40 mg M/s. Healer's Lab Unit II: Manufacturer of Albendazole Tablets I.P. M/s. Astam Healthcare Pvt. Ltd.: Manufacturer of Amoxycillin and Potassium Clavulanate Tablets IP M/s. Galpha Laboratories Ltd.: Manufacturer of Atorvastatin Tablets IP 20 mg. M/s. Ornate Labs Pvt. Ltd.: Manufacturer of Ciprofloxacin Tablets IP M/s. Revat Laboratories Pvt. Ltd.: Manufacturer of Rabeprazole Gastro Resistant Tablets I.P. 20mg. M/s. Zenith Drugs Pvt. Ltd.: Manufacturer of Omeprazole Capsules IP 20mg M/s. Strassenburg Pharmaceuticals Ltd.: Manufacturer of PARACETAMOL PAEDIATRIC ORAL SUSPENSION IP M/s. Karnataka Antibiotics & Pharmaceuticals Limited: Manufacturer of Omeprazole Capsules IP 20mg M/s. Alco Formulation (India): Manufacturer of Paracetamol Tablets IP 650mg. M/s. Mercury Laboratories Limited: Manufacturer of Salbutamol Tablets IP 4mg. M/s. Pro Laboratories Private Limited: Manufacturer of Omeprazole Capsules IP 20mg. M/s. Salud Care (I) Pvt. Ltd.: Manufacturer of ISOXSUPRINE HYDROCHLORIDE TABLETS IP M/s. MOREPEN LABORATORIES LTD.: Manufacturer of MONTELUKAST TABLETS IP 10 MG M/s. NESTOR PHARMACEUTICALS LIMITED: Manufacturer of IRON AND FOLIC ACID TABLETS IP M/s. Unicure India Ltd.: Manufacturer of PRE AND PROBIOTIC CAPSULES M/s. Elder Labs Limited: Manufacturer of Povidone-Iodine Ointment USP 5% w/w (ELDINE OINTMENT)
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List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of June – 2022. Total number of samples tested 1096 Total number of samples declared as of Standard Quality 1070 Total number of samples declared as Not of Standard Quality 26 Total number of samples declared as Spurious - Total number of samples declared as Misbranded - 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. Rolled Bandage B. No.: A104 Test for CDSCO CDL Mfg dt: 10/2019 Threads per Sub-Zone Kolkata Guwahati Exp dt: 09/2022 dm, Length, Mfd by: M/s. Anamika Width, Weight Udyog 127, Multan in gm/m2, Nagar, Meerut, Uttar Foreign Matter Pradesh (India). & Fluorescence 2. Ibuprofen Tablets B. No.: IDTY-04 Assay CDSCO CDL I.P. 400 mg Mfg dt: 06/2021 & North Zone Kolkata Exp dt: 05/2023 Dissolution Ghaziabad Mfd by: M/s. Hindustan Antibiotics Ltd., At-11, W.E.A. Faridabad 121001, Haryana. 3. Cyfolac* Forte B. No.: 23CCF050 Assay CDSCO CDL (Prebiotic & Mfg dt: 06/2021 South Zone Kolkata Probiotics Exp dt: 11/2022 Chennai Capsules) Mfd by: M/s. Swiss Garnier Biotech Pvt. Ltd., 21, Industrial Area, Mehatpur, Dist. UNA, Himachal Pradesh – 174 315. 4. Salmeterol 25 mcg B. No.: NSB2201C Assay CDSCO, CDL and Fluticasone Mfg dt: 01/2022 Ahmedabad Kolkata Propionate 250 mcg Exp dt: 12/2024 Inhalation IP Mfd by: M/s. Oxalis Labs, Village- Theda, P.O. Lodhimajra, Tehsil- Baddi, Dist. Solan, Himachal Page 1 of 6Pradesh - 174 101. 5. Salmeterol 25 mcg B. No.: NSB2201B Assay CDSCO, CDL and Fluticasone Mfg dt: 01/2022 Ahmedabad Kolkata Propionate 250 mcg Exp dt: 12/2024 Inhalation IP Mfd by: M/s. Oxalis Labs, Village- Theda, P.O. Lodhimajra, Tehsil- Baddi, Dist. Solan, Himachal Pradesh - 174 101. 6. Atorvastatin B. No.: 17T20T07 Dissolution CDSCO CDL Calcium Tablets I.P. Mfg dt: 10/2020 East Zone Kolkata 40 mg Exp dt: 09/2023 Kolkata Mfd by: M/s. Shine Pharmaceuticals Limited, Plot No. 132, Karjan- Vemardi Road, Juni Jitherdi, Ta. Karjan 391 240, Distt. Vadodara (Gujarat). 7. Albendazole B. No.: ALO-522 Description CDSCO CDL Tablets I.P. Mfg dt: 01/2021 East Zone Kolkata Exp dt: 12/2022 Kolkata Mfd by: M/s. Healer's Lab Unit II, Plot No. 33, H.P.S.I.D.C. Extn. Baddi, Dist. Solan, Himachal Pradesh. 8. Amoxycillin and B. No.: 20A1430 Assay of Drug Control RDTL Potassium Mfg dt: 10/2020 Clavulanic Acid Department Guwahati Clavulanate Tablets Exp dt: 09/2022 Jharkhand IP Mfd by: M/s. Astam Healthcare Pvt. Ltd. Vill. Theda, Teh. Nalagarh, Distt. Solan - 174101, Himachal Pradesh. 9. Atorvastatin Tablets B. No.: AVAT21001 Dissolution CDSCO RDTL IP 20 mg. Mfg dt: 02/2021 Sub Zone Guwahati Exp dt: 01/2023 Guwahati Mfd by: M/s. Galpha Assam Laboratories Ltd., Village: Thane, Baddi, Himachal Pradesh- Page 2 of 6173205. 10. Ciprofloxacin B. No.: OCFG5-20-229 Assay & Drug Control RDTL Tablets IP Mfg dt: 11/2020 Dissolution Department Guwahati Exp dt: 10/2022 Jharkhand Mfd by: M/s. Ornate Labs Pvt. Ltd., Bela Industrial Estate, Muzaffarpur- 842005, Bihar. 11. Rabeprazole Gastro B. No.: RRZT-009 Description Drug Control RDTL Resistant Tablets Mfg dt: 05/2021 Department Guwahati I.P. 20mg. Exp dt: 04/2023 Bihar Mfd by: M/s. Revat Laboratories Pvt. Ltd. 12-321 Opp. I.D.A. Kurnool Road, Pernamitta Ongole- 523002, Andhra Pradesh. 12. Omeprazole B. No.: C-0038 Dissolution Drug Control RDTL Capsules IP 20mg Mfg dt: 11/2020 Department Guwahati Exp dt: 10/2022 Jharkhand Mfd by: M/s. Zenith Drugs Pvt. Ltd. (A WHO-GMP Certified Company) 72/5, Muradpura (Orangpura) Dhar Road, Near Kalaria, Indore- 453001 Madhya Pradesh, India. 13. PARACETAMOL B. No.: PFSC081019 Assay Drug Control RDTL PAEDIATRIC ORAL Mfg dt: 10/2019 Department Guwahati SUSPENSION IP Exp dt: 09/2022 Jharkhand Mfd by: M/s. Strassenburg Pharmaceuticals Ltd. at. 247, D.H. Road, 24Pgs (S), Pin- 700104, West Bengal. 14. Rabeprazole Gastro B. No.: RRZT-011 Description & Drug Control RDTL Resistant Tablets IP Mfg dt: 11/2021 Assay Department Guwahati 20mg. Exp dt: 10/2023 Bihar Mfd by: M/s. Revat Laboratories Pvt. Ltd. 12-321 Opp. I.D.A. Page 3 of 6Kumool Road, Pernarmitta Ongole- 523002, Andhra Pradesh. 15. Omeprazole B. No.: 5704620 Dissolution Drug Control RDTL Capsules IP 20mg Mfg dt: 09/2020 Department Guwahati Exp dt: 08/2022 Jharkhand Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited (A Govt. of India Enterprise) Plot No. 14 II Phase Peenya, Bengaluru- 560058. 16. Paracetamol B. No.: PRT-938 Dissolution Drug Control RDTL Tablets IP 650mg. Mfg dt: 05/2021 Department Guwahati Exp dt: 04/2023 Assam Mfd by: M/s. Alco Formulation (India), 14/5, Mathura Road, Faridabad- 121003, Haryana. 17. Rabeprazole Gastro B. No.: RRZT-021 Description and Drug Control RDTL Resistant Tablets IP Mfg dt: 12/2021 Assay Department Guwahati 20mg. Exp dt: 11/2023 Bihar Mfd by: M/s. Revat Laboratories Pvt. Ltd. 12-321 Opp. I.D.A. Kurnool Rd, Pernamitta Ongole- 523002, Andhra Pradesh. 18. Salbutamol Tablets B. No.: 21112002 Disintegration Drug Control RDTL IP 4mg. Mfg dt: 05/2021 Department Guwahati Exp dt: 04/2024 Assam Mfd by: M/s. Mercury Laboratories Limited. Unit No.2, Halol-Baroda Road, Village: Jarod, Tal: Waghodia, Dist- Vadodara-391510, Gujarat. 19. Omeprazole B. No.: CAG-21014 Dissolution Drug Control RDTL Capsules IP 20mg. Mfg dt: 01/2021 Department Guwahati Exp dt: 12/2022 Assam Mfd by: M/s. Pro Page 4 of 6Laboratories Private Limited, 140-141, Makkanpur, Bhagwanpur, Roorkee, Dist. Haridwar, Uttarakhand - 247661. 20. Rabeprazole Gastro B. No.: RRZT-022 Assay and Drug Control RDTL Resistant Tablets Mfg dt: 12/2021 Description Department Guwahati I.P. Exp dt: 11/2023 Bihar 20mg. Mfd by: M/s. Revat Laboratories Pvt. Ltd. 12-321 Opp. I.D.A. Kurnool Road, Pernamitta Ongole- 523002, Andhra Pradesh. 21. Rabeprazole Gastro B. No.: RRZT-019 Description and Drug Control RDTL Resistant Tablets Mfg dt: 12/2021 Assay Department Guwahati I.P. Exp dt: 11/2023 Bihar 20mg. Mfd by: M/s. Revat Laboratories Pvt. Ltd. 12-321 Opp. I.D.A. Kurnool Road, Pernamitta Ongole- 523002, Andhra Pradesh. 22. ISOXSUPRINE B. No.: ST21-0729 Assay CDSCO RDTL HYDROCHLORIDE Mfg dt: 04/2021 North-Zone Chandigarh TABLETS IP Exp dt: 03/2023 Mfd by: M/s. Salud Care (I) Pvt. Ltd.435, Kashanpur, Roorkee- 247661, Uttarakhand. 23. MONTELUKAST B. No.: C-1D0342 Dissolution CDSCO RDTL TABLETS IP 10 MG Mfg dt: 04/2021 North-Zone Chandigarh Exp dt: 03/2023 Mfd by: M/s. MOREPEN LABORATORIES LTD. Unit-V, Plot No.12-C, Sector-2, Parwanoo, Distt. Solan, Himachal Pradesh -173220. 24. IRON AND FOLIC B. No.: IQTY-312 Uniformity of CDSCO RDTL ACID TABLETS IP Mfg dt: 11/2021 Content (Folic North-Zone Chandigarh Page 5 of 6Exp dt: 10/2023 Acid) Mfd by: M/s. NESTOR PHARMACEUTICALS LIMITED 11, Western Extension Area, Faridabad-121001, Haryana, INDIA. 25. PRE AND B. No.: SL1CB016 Identification CDSCO RDTL PROBIOTIC Mfg dt: 11/2021 and Assay of North-Zone Chandigarh CAPSULES Exp dt: 04/2023 Streptococcus Mfd by: M/s. Unicure faecalis India Ltd. Plot No.46(B), /49/B, Village Raipur, Bhagwanpur, Roorkee, Distt. Haridwar, Uttarakhand. 26. Povidone-Iodine B. No.: EE11004 Assay CDSCO RDTL Ointment USP 5% Mfg dt: 10/2021 Sub-Zone Chandigarh w/w (ELDINE Exp dt: 11/2023 Baddi OINTMENT) Mfd by: M/s. Elder Labs Limited Vill: Kishanpura, Baddi- Nalagarh Road, Baddi, Distt.-Solan, Himachal Pradesh - 174101. Page 6 of 6

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