Home India Ministry of Health and Family Welfare Drug Alert list for month of April 2017...
Date: 2017-05-02 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of April 2017

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 April 2017.
  • The list includes the name of the product, batch number, manufacturing and expiry dates, manufacturer, reason for failure, and the zone and lab that conducted the testing.

Key Changes

  • A total of 23 products are listed as Not of Standard Quality/Spurious/Adulterated/Misbranded.
  • The reasons for failure include pH, Sterility, Bacterial Zone, endotoxins, Dissolution, Uniformity of Dispersion, Description & Dissolution, Assay & Related Substances, Assay, Related Substances & Disintegration, Assay, Uniformity of Weight, Disintegration.

Impact Analysis

Manufacturers

  • Manufacturers should review their quality control processes, testing protocols, and supplier qualifications.

Distributors and Retailers

  • Distributors and retailers should verify the authenticity and quality of products from these manufacturers before future procurement.

Consumers

  • The government should ensure that information regarding affected products is readily available to the public.

Regulatory Authorities

  • Stringent enforcement actions against manufacturers of substandard drugs are required to deter future violations.

Key Entities Referenced

M/s. Shivalik Remedies Pvt. Ltd., Khasra No. 509/1-2 & 520, Vill-Bhagwanpur, Roorkee-Dehradun Road, Uttarakhand-247667: Manufacturer of Almefkem - 500 Tablets CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. DCO: Drugs Control Officer RDTL: Regional Drugs Testing Laboratory CDTL: Central Drugs Testing Laboratory M/s. BDH Industires Limited, Nair Baug, Akurli Road, Kandivli (E), Mumbai - 400101: Manufacturer of Donica-SR (Indomethacin Extended Release Capsules USP 75 mg) M/s. Life Vission Healthcare, 140, EPIP, Phase 1, Jharmajri, Baddi, Solan (H.P): Manufacturer of Swinrab-DSR (Rabeprazole 20 mg & Domperidone 10 mg (IR), Domperidone 20 mg (SR) Capsules) M/s. Nikvin Healthcare (I) Pvt. Ltd., Baddi, Barotiwala Road, Behind Govt. Timber Depot, Vill. Katha, Baddi (H.P.) - 173 205: Manufacturer of Ciphi 200 (Cefixime Dispersible Tablets) M/s. Minopharm Laboratories Pvt. Ltd., Hyderabad 500 073, Work: Opp. I.D.A. Pernamitta, 523: Manufacturer of Erythromycin Stearate Tablets I.P. 250 mg M/s. Bharat Parenterals Ltd., Survey No. 144 & 146, Jarod Samlaya Road, Vill: Haripura, Tal.: Savli, Distt. Vadodara 391 510, Gujarat, India: Manufacturer of Methyl Ergometrine Maleate Tablets I.P. 0.125 mg M/s. Ratnamani Healthcare Pvt. Ltd., Survey No. 750/1, Ahmedabad-Mehsana, Vill: Indrad 382721, Tal.: Kadi, Distt. Mehsana, Gujarat, India: Manufacturer of Metformin Tablets I.P. 500 mg M/s. Biogenetic Drugs Pvt. Ltd., Jharmazri, Baddi-174103, Dist-Solan, HP: Manufacturer of Paracetamol tablets IP 500 mg M/s. Medoz Pharmaceuticals Pvt. Ltd., Chanal Majra, Tah. Nalagarh, Dist. Solan, (H.P.): Manufacturer of Avotine (Promethazine Theoclate Tablets I.P. 25mg) M/s. Vama Pharma, Plot No. 2, Maruti Audyogik Vasahat, Near, M.I.D.C., Wadi, Nagpur-440023, Maharashtra: Manufacturer of Diclofenac Tablets IP 50mg M/s. Kwality Pharmaceuticals Ltd., Nag Kalan, Majitha Road, Amritsar-India: Manufacturer of Paracetamol Paediatric Oral Suspension IP 125mg/5ml M/s. Unital Formulations Plt.No. 114-B EPIP, Phase-1 Jharmajri Baddi Distt. Solan (H.P): Manufacturer of Rabeprazole Sodium Tablets IP (Rabtal-20 Tablets) and Enteric Coated Pantoprazole Sodium and Domperidone Sustained Release Capsules (Pantover-DSR Capsules) M/s. Karnataka Antibiotics & Pharmaceuticals Limited 11, Western Extension Area, Faridabad-121001(India): Manufacturer of Calcium and Colectciferol Tablets BP (500mg+250IU) (Calcium and Vitamin D3 (Colecalciferol) Tablets M/s. Aurochem Laboratories (India) Pvt. Ltd., 333, Gundecha Industrieal Complex, 3rd Floor, Akurli Road, Kandivil (East), Mumbai-400101: Manufacturer of Hydrochloride, Tretinoin, Mometasone Furoate Cream (Skinlite Cream) M/s. Twenty First Century Pharmaceuticals Pvt. Ltd., 360, SIDCO Estate, Chennai-600098: Manufacturer of P - 500 Tablets M/s. Ridley Life Science Pvt. Ltd., D-1651, DSIDC Indl. Complex, Narela,Delhi-110040: Manufacturer of Astharid Tablets M/s. Unicure India Ltd.,C-22 & 23, Sector-3, Noida-201301: Manufacturer of Zinc Sulphate Tablets
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List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, For the Month of APRIL, 2017 Sl. Name of Batch No./Date of Reason for Drawn By From No. Drugs/medical Manufacture/Date of failure device/cosmetics Expiry/Manufactured By 1. Unlabelled sealed B. No.: Nil, pH, Sterility, CDSCO, East CDL, Plastic container Mfg dt: Nil, Bacterial Zone, Kolkata Kolkata white colour with Exp dt: Nil, endotoxins aluminium cap Mfd by: M/s. Nil containing transparent liquid filled approx 150 ml purported to be Oxytocin Injection 2. Unlabelled sealed B. No.: Nil, pH, Sterility, CDSCO, East CDL, Plastic container Mfg dt: Nil, Bacterial Zone, Kolkata Kolkata white colour with Exp dt: Nil, endotoxins aluminium cap Mfd by: M/s. Nil containing transparent liquid filled approx 200 ml purported to be Oxytocin Injection 3. Donica-SR B. No.: 020216, Dissolution CDSCO, East CDL, (Indomethacin Mfg dt: 02/2016, Zone, Kolkata Kolkata Extended Release Exp dt: 01/2019, Capsules USP 75 Mfd by: M/s. BDH Industires mg) Limited, Nair Baug, Akurli Road, Kandivli (E), Mumbai - 400101 4. Swinrab-DSR B. No.: LVC-2558, Dissolution CDSCO, CDL, (Rabeprazole 20 Mfg dt: 09/2015, Hyderabad Kolkata mg & Exp dt: 08/2017, Zone Domperidone 10 Mfd by: M/s. Life Vission mg (IR), Healthcare, 140, EPIP, Phase Domperidone 20 1, Jharmajri, Baddi, Solan mg (SR) Capsules) (H.P) 5. Ciphi 200 B. No.: 60830T, Uniformity of CDSCO, CDL, (Cefixime Mfg dt: 08/2016, Dispersion Hyderabad Kolkata Dispersible Exp dt: 07/2018, Zone Tablets) Mfd by: M/s. Nikvin Healthcare (I) Pvt. Ltd., Baddi, Barotiwala Road, Behind Govt. Timber Depot, Vill. Katha, Baddi (H.P.) - 173 205. 6. Erythromycin B. No.: ES-1611, Description & CDSCO, CDL, Stearate Tablets Mfg dt: 04/2016, Dissolution South Zone, Kolkata I.P. 250 mg Exp dt: 03/2018, Chennai Mfd by: M/s. Minopharm Laboratories Pvt. Ltd., Hyderabad 500 073, Work: Opp. I.D.A. Pernamitta, 523 0027. Methyl B. No.: T6197, Assay & CDSCO, CDL, Ergometrine Mfg dt: 07/2016, Related Ahmedabad Kolkata Maleate Tablets Exp dt: 06/2018, Substances Zone I.P. 0.125 mg, Mfd by: M/s. Bharat Parenterals Ltd., Survey No. 144 & 146, Jarod Samlaya Road, Vill: Haripura, Tal.: Savli, Distt. Vadodara 391 510, Gujarat, India 8. Metformin Tablets B. No.: BT155, Dissolution CDSCO, CDL, I.P. 500 mg Mfg dt: 06/2016, Ahmedabad Kolkata Exp dt: 05/2018, Zone Mfd by: M/s. Ratnamani Healthcare Pvt. Ltd., Survey No. 750/1, Ahmedabad- Mehsana, Vill: Indrad 382721, Tal.: Kadi, Distt. Mehsana, Gujarat, India 9. Paracetamol tablets B. No.: 24065-BKR6, Dissolution CDSCO, South CDTL, IP 500 mg Mfg dt: 06/2015, Zone, Chennai Exp dt: 05/2018, Chennai Mfd by: M/s. Biogenetic Drugs Pvt. Ltd., Jharmazri, Baddi- 174103, Dist-Solan, HP. 10. Avotine B. No.: MGT-16139, Assay CDSCO, West CDTL, (Promethazine Mfg dt: 03/2016, Zone, Mumbai Mumbai Theoclate Tablets Exp dt: 08/2018, I.P. 25mg) Mfd by: M/s. Medoz Pharmaceuticals Pvt. Ltd., Chanal Majra, Tah. Nalagarh, Dist. Solan, (H.P.) 11. Diclofenac Tablets B. No.: TDNBB161, Related CDSCO, West CDTL, IP 50mg Mfg dt: 02/2016, Substances & Zone, Mumbai Mumbai Exp dt: 01/2018, Disintegration Mfd by: M/s. Vama Pharma, Plot No. 2, Maruti Audyogik Vasahat, Near, M.I.D.C., Wadi, Nagpur-440023, Maharashtra 12. Paracetamol B. No.: S-2120, Assay DCO, Ambala- RDTL, Paediatric Oral Mfg dt: 08/2016, 1 Chandigarh Suspension IP Exp dt: 07/2018, 125mg/5ml Mfd by: M/s. Kwality Pharmaceuticals Ltd., Nag Kalan, Majitha Road, Amritsar-India. 13. Rabeprazole B. No.:UFT-705, Assay CDSCO, Sub- RDTL, Sodium Tablets IP Mfg dt: 02/2016, Zone, Baddi Chandigarh (Rabtal-20 Tablets) Exp dt: 01/2018, Mfd by: M/s. Unital Formulations Plt.No. 114-B EPIP, Phase-1 Jharmajri Baddi Distt. Solan (H.P) 14. Rabeprazole B. No.:UFT-800, Assay CDSCO, Sub- RDTL, Sodium Tablets IP Mfg dt: 11/2016, Zone, Baddi Chandigarh (Rabtal-20 Tablets) Exp dt: 10/2018,Mfd by: M/s. Unital Formulations Plt.No. 114-B EPIP, Phase-1 Jharmajri Baddi Distt. Solan (H.P) 15. Enteric Coated B. No.: UFC-246, Assay CDSCO, Sub- RDTL, Pantoprazole Mfg dt: 09/2016, Zone, Baddi Chandigarh Sodium and Exp dt: 08/2018, Domperidone Mfd by: M/s. Unital Sustained Release Formulations Plt. No. 114-B Capsules EPIP, Phase-1 Jharmajri Baddi (Pantover-DSR Distt. Solan (H.P) Capsules) 16. Calcium and B. No.: CUTT-93, Assay CDSCO, RDTL, Colectciferol Mfg dt: 11/2016, North-Zone, Chandigarh Tablets BP Exp dt: 10/2018, Ghaziabad (500mg+250IU) Mfd by: M/s. Karnataka (Calcium and Antibiotics & Pharmaceuticals Vitamin D3 Limited 11, Western Extension (Colecalciferol) Area, Faridabad-121001(India) Tablets 17. Hydrochloride, B. No.: ZAS102, Assay DCO, Yamuna RDTL, Tretinoin, Mfg dt: 04/2016, Nagar Chandigarh Mometasone Exp dt: 09/2017, Furoate Cream Mfd by: M/s. Aurochem (Skinlite Cream) Laboratories (India) Pvt. Ltd., 333, Gundecha Industrieal Complex, 3rd Floor, Akurli Road, Kandivil (East), Mumbai-400101 18. P - 500 Tablets B. No.: PFT6154S, Related Drugs Control RDTL, Mfg dt: 08/2016, Substances Department, Guwahati Exp dt: 07/2019, Assam. Mfd by: M/s. Twenty First Century Pharmaceuticals Pvt. Ltd., 360, SIDCO Estate, Chennai-600098 19. P - 500 Tablets B. No.: PFT6190S, Related Drugs Control RDTL, Mfg dt: 08/2016, Substances Department, Guwahati Exp dt: 07/2019, Assam. Mfd by: M/s. Twenty First Century Pharmaceuticals Pvt. Ltd., 360, SIDCO Estate, Chennai-600098 20. P - 500 Tablets B. No.: PFT6059S, Related Drugs Control RDTL, Mfg dt: 03/2016, Substances Department, Guwahati Exp dt: 02/2019, Assam. Mfd by: M/s. Twenty First Century Pharmaceuticals Pvt. Ltd., 360, SIDCO Estate, Chennai-600098 21. Astharid Tablets B. No.: TSF-1401, Assay Drugs Control RDTL, Mfg dt: 05/2014, Department, Guwahati Exp dt: 04/2017, West Bengal. Mfd by: M/s. Ridley Life Science Pvt. Ltd., D-1651, DSIDC Indl. Complex, Narela,Delhi-110040 22. Zinc Sulphate B. No.: ZST03-90, Uniformity of Drugs Control RDTL, Tablets Mfg dt: 08/2015, Weight, Department, Guwahati Exp dt: 07/2017, Disintegration Assam. Mfd by: M/s. Unicure India Ltd.,C-22 & 23, Sector-3, Noida-201301 23. Almefkem - 500 B. No.: ASR5017, Disintegration Drugs Control RDTL, Tablets Mfg dt: 02/2015, Department, Guwahati Exp dt: 01/2018, Assam. Mfd by: M/s. Shivalik Remedies Pvt. Ltd., Khasra No. 509/1-2 & 520, Vill- Bhagwanpur, Roorkee- Dehradun Road, Uttarakhand- 247667

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