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Date: 2018-01-02 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of December 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 December 2017.
  • The list includes the name of the product, batch number, manufacturing and expiry dates, manufacturer details, reason for failure, and the name of the office that drew the sample.

Key Changes

  • A total of 30 products are listed as Not of Standard Quality/Spurious/Adulterated/Misbranded.
  • Reasons for failure include: Assay issues (Vitamin D, Loperamide, Pantoprazole, Omeprazole, Ranitidine, Pyrazinamide, Clavogard Dry Syrups, Heparin Sodium Injection), Disintegration issues (Flatuna, Paracetamol Tablets, Rombipra Tablets, Paracetamol Tablets, Ibuprofen Tablets, Serratiopeptidase Tablets, Aceclofenac and Paracetamol Tablets, Lansoprazole Orally Disintegrating Tablets, Nano Curcumin Tablets), Dissolution issues (Lopamide, Paracetamol Tablets, Rombipra Tablets, Paracetamol Tablets, Ibuprofen Tablets, Lansoprazole Orally Disintegrating Tablets), pH (Abromycitin), Sterility issues (Big – Tum Ceftriaxone & Salbactam for Injection, Ondansetron Injection), Uniformity of Weight (Oflodil-OZ Tablets), Spurious Sample (Clotrimazole IP), Total Microbial Count (Amla/Ritha and Shikakai Shampoo, Lakme Perfecting Liquid Foundation, Calamine, Aloe vera and Light Liquid Paraffin Lotion), Overall Length of the Scale to Nominal Capacity Line (Sterile Disposable Syringe with Hypodermic Needle, STERIVAN Sterile Single Use Syringe), Description (Norfloxacin Oral Suspension), Identification (Dicyclomine Tablets IP).

Impact Analysis

Manufacturers

  • Action Item: Review manufacturing processes and quality control procedures to prevent future instances of substandard products. Implement corrective and preventive actions (CAPA) to address the root causes of the failures.

Consumers

  • Action Item: Healthcare providers should be informed about the list to avoid prescribing these specific batches of medications. Public awareness campaigns should be conducted to inform consumers about the affected products and encourage them to report any adverse effects.

Regulatory Agencies

  • Action Item: Conduct thorough investigations of the listed manufacturers to determine the extent of the quality control failures and implement appropriate sanctions. Strengthen inter-agency coordination to share information and resources for effective enforcement.

Distributors and Retailers

  • Action Item: Implement a system for verifying the quality and authenticity of drugs and medical devices before stocking them. Ensure proper storage and handling of pharmaceutical products to maintain their quality.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. CDTL: Central Drugs Testing Laboratory, a central drug testing laboratory in India. RDTL: Regional Drugs Testing Laboratory, a regional drug testing laboratory in India. Drugs and Cosmetics Act: The primary legislation in India regulating the manufacture, sale, and distribution of drugs and cosmetics. State Drug Control Departments: State-level agencies responsible for enforcing the Drugs and Cosmetics Act within their respective states.
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 December, 2017 Sl. Name of Batch No./Date of Reason for failure Drawn By From No. Drugs/medical Manufacture/Date of device/cosmetics Expiry/Manufactured By 1. Calcitas-D Tablets B. No.: IOL-161003, Assay of Vitamin D CDSCO, CDTL, 3 (Calcium with Mfg dt: 10/2016, West Zone, Mumbai Vitamin D Tablets) Exp dt: 09/2018, Mumbai 3 Mfd by: M/s. Oasis Pharma & Phytomolecules Pvt. Ltd., Village Nandpur, Nalagarh, Distt. Solan (H.P.). 2. Flatuna B. No.: AE1739, Disintegration CDSCO, CDTL, (Simethicone and Mfg dt: 08/2017, West Zone, Mumbai Activated Charcoal Exp dt: 07/2020, Mumbai Tablets) Mfd by: M/s. Meridian Enterprises Pvt. Ltd., 418, GIDC, Kabilpore, Navsari- 396424. 3. Lopamide B. No.: T-7533, Assay & Dissolution CDSCO, CDL, (Loperamide Mfg dt: 12/2016, East Zone, Kolkata Hydrochloride Exp dt: 11/2019, Kolkata Tablets I.P. 2 mg) Mfd by: M/s. Gopish Pharma Ltd, Ropar Road, Near Dherowal Barrier, Village Beharampur, Tehsil Nalagarh, Dist Solan, H.P. 4. Pantoprazole B. No.: TPTS16-021, Assay CDSCO, CDL, Tablets I.P. Mfg dt: 11/2016, Hyderabad Kolkata Exp dt: 10/2018, Zonal office Mfd by: M/s. Greenland Organics, 6-174-1, Industrial Area, Surampalli – 521 212. 5. Abromycitin B. No.: AU-16119, pH CDSCO CDL, (Chloramphenicol Mfg dt: 03/2017, (HQ), Kolkata Palmitate Oral Exp dt: 02/2019, New Delhi Suspension I.P.) Mfd by: M/s. Arbro Pharmaceuticals Pvt Ltd, 6/14, Kirti Nagar, Industrial Area, New Delhi-110015. 6. Big – Tum 1. Ceftriaxone & Salbactam Sterility of Sterile CDSCO CDL, (Ceftriaxone & for Injection: Water for Injection (HQ), Kolkata Salbactam for B. No.: 5067002, New Delhi I.P. Injection), Mfg dt: 01/2017, Exp dt: 12/2018, Mfd by: M/s. Innova Captab Pvt. Ltd., 1281/1, Hiltop Industrial Estate, Jharmajri, Baddi, Distt. Solan (H.P.). Sterile Water for 2. Sterile Water for Injection Injection I.P. 10 ml IP 10 ml: B. No.: 02160901, Mfg dt: 09/2016,Exp dt: 08/2019, Mfd by: M/s. Sunrise Pharma, 114-B, EPIP, Phase- I, Jharmajri, Baddi 173 205. 7. Paracetamol B. No.: BT70105, Dissolution Drugs RDTL, Tablets Mfg dt: 05/2017, Control Guwahati Exp dt: 04/2019, Department, Mfd by: M/s. Omega Biotech Assam Ltd., 7th Mile Stone, Dehradun Road, Roorkee, Uttarakhand-247667. 8. Rombipra Tablets B. No.: 2124, Dissolution Drugs RDTL, Mfg dt: 08/2016, Control Guwahati Exp dt: 07/2018, Department, Mfd by: M/s. Anchal Mizoram Lifesciences Pvt. Ltd., K.H. No. 19, Village Raipur, Roorkee, Uttarakhand. 9. Paracetamol B. No.: HT 60452, Dissolution Drugs RDTL, Tablets Mfg dt: 11/2016, Control Guwahati Exp dt: 10/2018, Department, Mfd by: M/s. Omega Biotech Assam Ltd., 7th Mile Stone, Dehradun Road, Roorkee, Uttarakhand-247667. 10. Clavogard Dry B. No.: UBD-7030B, Assay Drugs RDTL, Syrups Mfg dt: 02/2017, Control Guwahati Exp dt: 07/2018, Department, Mfd by: M/s. Ultra Drugs Arunachal Pvt. Ltd., Manpura, Pradesh Nalagarh, Dist. Solan, (H.P.). 11. OMPEPRAZOLE B. No.: B70580, Assay CDSCO, CDTL, CAPSULES IP Mfg dt : 07/2017, South Zone, Chennai 20 mg Exp. dt : 06/2019, Chennai Mfd By: M/s. Bochem Healthcare Pvt. Ltd, 83, 84, Industrial Area, Dewas Road, Nagziri, Ujjian- 456010 (MP), India. 12. RANITIDINE B. No.: B61670, Assay CDSCO, CDTL, HYDROCHLORID Mfg dt : 03/2017, South Zone, Chennai E TABLETS IP Exp.dt : 02/2019, Chennai 150 MG Mfd by: M/s. Bochem Healthcare Pvt. Ltd, 83, 84, Industrial Area, Dewas Road, Nagziri, Ujjian (MP) - 456010, India 13. IBUPROFEN B. No.: B70339, Dissolution CDSCO, CDTL, TABLETS IP Mfg. dt : 05/2017, South Zone, Chennai 200 mg Exp. dt : 04/2019, Chennai Mfd by: M/s. Bochem Healthcare Pvt. Ltd, 83, 84, Industrial Area, Dewas Road, Nagziri, Ujjian - 456010 (MP), India.14. PYRAZINAMIDE B. No.: T-8932, Assay CDSCO, CDTL, 1500 TABLETS Mfg. dt : 07/2016, Zonal Chennai Exp. dt : 06/2019, Office, (Pyrazinamide Mfd. by: M/s. Jackson Hyderabad. Tablets BP) Laboratories Pvt. Ltd., Plot No. 56 & 61, Industrial Area, Phase-III, Sansarpur Terrace, Distt. Kangra (H.P)-176501. 15. OFLODIL-OZ B. No.: OZT-0416, Uniformity of CDSCO, CDTL, TABLETS Mfg. dt : 03/2016, Weight Sub Zone, Chennai (OFLOXACIN & Exp. dt : 02/2018, Bangalore ORNIDAZOLE Mfd. by: M/s. Indian Drugs TABLETS) & Pharmaceuticals Ltd., Dundahera, Gurgaon-122016 (HR). 16. Clotrimazole IP B. No.: 20170205, Spurious Sample DDC(I), CDTL, Mfg. dt : 02/2017, (Identification CDSCO, Chennai Exp. dt : 02/2019, Negative for Aircargo Mfd. By: M/s. Guangzhou Clotrimazole) Complex Hanpu Pharma Co. Ltd, Airport, No.9, Junfeng, North Road, Ahmedabad Aotou Town Conghua City, Guangzhou, China. 17. Amla/Ritha and B. No.: 56925D96S, Total Microbial Drugs RDTL, Shikakai Shampoo Mfg. dt : 07/2017, Count Control Chandigarh (NEW HARBING Exp. dt : 06/2020, Department HERBAL Mfd. By: M/s. Quality NCT, Delhi SHAMPOO) Cosmetics India. 18. Serratiopeptidase B. No.: KR-1720, Disintegration Test CDSCO, RDTL, Tablets IP Mfg. dt : 12/2016, in Acid Stage Sub-Zone, Chandigarh (DANZEN FORTE Exp. dt : 11/2018, Baddi TABLETS) Mfd. By: M/s. Park Pharmaceuticals 272, Industrial Area, Phase-II, Panchkula-134113. 19. STERILE B. No.: 21702S6217, Overall Length of CDSCO, RDTL, DISPOSABLE Mfg. dt : 08/2017, the Scale to Nominal North Zone, Chandigarh SYRINE WITH Exp. dt : 07/2022 Capacity Line Ghaziabad HYPODERMIC Mfd. By: M/s. SRS NEEDLE MEDITECH LTD., I-14, UPSIDC, SITE-V, KASNA GREATER, NOIDA- 201306, DIST. GAUTAMBUDH NAGAR (U.P.) NCR. INDIA. 20. STERIVAN B. No.: 34602S1215, Overall Length of CDSCO, RDTL, STERILE SINGLE Mfg. dt : 12/2015, the Scale to Nominal North Zone, Chandigarh USE SYRINGE 2 Exp. dt : 11/2020, Capacity Line Ghaziabad ML Mfd. By: M/s. SRS MEDITECH LTD., I-14, UPSIDC, SITE-V, KASNA GREATER, NOIDA- 201306, DIST. GAUTAMBUDH NAGAR (U.P.) NCR. INDIA.21. ONDANSETRON B. No.: I-13300, Sterility CDSCO, RDTL, INJECTION IP Mfg. dt : 01/2017, Sub-Zone, Chandigarh Exp. dt : 12/2018 Jammu Mfd. By: M/s. Jackson Laboratories Pvt. Ltd., Majitha Road, Bye Pass, Amritsar-143001. 22. DICLOFENAC B. No.: DI1G17, Disintegration CDSCO, RDTL, SODIUM Mfg. dt : 03/2017, North Chandigarh TABLETS IP 50 Exp. dt : 02/2020 Ghaziabad MG Mfd. By: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, L- 43, Verna, Indl. Estate, Verna, Slacete, Goa-403722. 23. Aceclofenac and B. No.: CT 62019, Disintegration CDSCO, RDTL, Paracetamol Mfg. dt : 01/2017, Sub-Zone, Chandigarh Tablets Exp. dt : 12/2018 Jammu (TOPFENAC P Mfd. By: M/s. Cosmas TABLETS) Pharmacls Ltd., Buranwala Road, Village Kotla, P.O.: Barotiwala, Solan (H.P.)- 174103 24. Norfloxacin Oral B. No.: KS5350, Description Drugs RDTL, Suspension Mfg. dt : 02/2016, Department, Chandigarh (NORCIN Exp. dt : 01/2018, NCT, Delhi SUSPENSION) Mfd. By: M/s. Omega Biotech Ltd., 7th Mile Stone, Dehradun Road, Roorkee - 247667 (Uttarakhand). 25. Heparin Sodium B. No.: BIO 17238, Assay Drugs RDTL, Injection IP 25000 Mfg. dt : 02/2017, Control Chandigarh units (PYRIN Exp. dt : 01/2019, Department, INJECTION) Mfd. By: M/s. Health Chandigarh Biotech Ltd., Unit-II, Nalagarh Road, Baddi- 173205 Distt. Solan (H.P.). 26. Calamine, Aloe B. No.: R041, Total Microbial CDSCO, RDTL, vera and Light Mfg. dt : 08/2017, Count Sub-Zone, Chandigarh Liquid Paraffin Exp. dt : 07/2019 Baddi Loton (CALCHILL Mfd. By: M/s. HELIOS LOTION) PHARMACEUTICALS, Village Malpur, P.O. Bhud, Baddi, Tehsil Nalagarh, Dist. Solan (H.P.)-173205. 27. LAKME B. No.: Not Mentioned, Total Microbial Drugs RDTL, PERFECTING Mfg. dt : Not Mentioned Count Department, Chandigarh LIQUID Exp. dt : Not Mentioned NCT, Delhi FOUNDATION Mfd. By: M/s. Hindustan Unilever Ltd., Unit-4, Ind. Estate, Haridwar-249403, Uttarakhand. 28. DICYCLOMINE B. No.: DCL-03, Identification A Drugs RDTL, TABLETS IP Mfg. dt : 07/2017, Control Chandigarh Exp. dt : 12/2018 Department, Mfd. By: M/s. Therawin HimachalFormulations 69-71, Jasmeet Pradesh Nagar, Ambala-134003. 29. Lansoprazole B. No.: LVT-22318, Dissolution (In Drugs RDTL, Orally Mfg. dt : 04/2017, Acidic Medium) and Control Chandigarh Disintegrating Exp. dt : 03/2019, the Assay of Department Tablets 15 mg Mfd. By: M/s. Life Vision Lansoprazole Jammu (LANKID Healthcare, Plot No. 140, TABLETS) E.P.I.P., Phase-I, Jharmjri, Baddi, Solan (H.P.). 30. Nano Curcumin, B. No.: MNT-31710, Disintegration CDSCO, RDTL, Boswellia Serrata Mfg. dt : 03/2017, North Zone, Chandigarh and Piperine Exp. dt : 02/2019 Ghaziabad Tablets (BUT- Mfd. By: M/s. Medicant NANO TABLETS) Nutrients (An ISO & GMP Certified Company) Plot No. 653, Phase-II, Ind. Area, Barhi-131101.

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