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Date: 2016-07-04 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of June 2016

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 the month of June 2016.
  • The list includes the name of the drug/medical device/cosmetic, batch number, date of manufacture, date of expiry, manufacturer details, reason for failure, and the name of the laboratory that conducted the testing.

Key Changes

  • A total of 17 items are listed as Not of Standard Quality/Spurious/Adulterated/Misbranded.
  • Reasons for failure include Dissolution, Assay, Ferric ions & Assay of Ferrous Sulphate, Water content, Sterility, BET, pH, Disintegration, and being Misbranded or Spurious.
  • The listed items were manufactured by various companies located across India, including Karnataka, Telangana, Himachal Pradesh, Madhya Pradesh, Rajasthan, Gujarat, Assam and others.
  • Testing was conducted by CDSCO labs (CDL Kolkata, various zonal offices) and State Drugs Testing Laboratories (RDTL Guwahati, RDTL Chandigarh).

Impact Analysis

Consumers

  • Action Item: Issue a public advisory to inform consumers about the recalled products and advise them to discontinue use.

Manufacturers

  • Action Item: Engage with regulatory authorities to understand the specific concerns and demonstrate commitment to compliance.

Distributors and Retailers

  • Action Item: Strengthen quality control procedures to prevent the distribution of substandard products.

Regulatory Authorities

  • Action Item: Strengthen the drug testing infrastructure and capacity to detect substandard products.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory authority for pharmaceuticals and medical devices in India. CDL Kolkata: Central Drugs Laboratory, Kolkata, a central drug testing laboratory under the CDSCO. RDTL Guwahati: Regional Drugs Testing Laboratory, Guwahati, a state drug testing laboratory. Drugs and Cosmetics Act, 1940: The primary legislation governing the quality, safety, and efficacy of drugs, medical devices, and cosmetics in India (Implied).
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 June, 2016 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. Novex DS B. No.: ND-13-013, Dissolution CDSCO, CDL, (Ormeloxifen Mfg dt: 01/2014, Bangalore Kolkata Hydrochloride Exp dt: 12/2016, Tablets I.P.) Mfd by: M/s. HLL Lifecare Limited, S No. 76/3, 75/1, 59/1 & 2, Kanagala - 591225, Belgaum, Karnataka 2. Paracetamol Tablets B. No.: PMTG-14588, Dissolution CDSCO, CDL, I.P. 500 mg Mfg dt: 05/2014, Hyderabad Kolkata Exp dt: 04/2017, Zone Mfd by: M/s. Seeko Biotics Krishnanagar – 522502. 3. Seropen – DP B. No.: NT-150417, Assay of CDSCO, CDL, (Diclofenac Mfg dt: 04/2015, Serratiopeptida Ahmedabad Kolkata Potassium, Exp dt: 03/2017, se Zone Paracetamol and Mfd by: M/s. Gracure Serratiopeptidase Pharmaceuticals Ltd., Brahman Tablets) Beli Road, Vill- Belidyod, Nalagarh, Dist- Solan (H.P.) 4. Dried Ferrous B. No.: Fsg/10803/0215, Ferric ions & CDSCO, CDL, Sulphate Granules Mfg dt: 02/2015, Assay of West Zone, Kolkata Exp dt: 02/2018 Ferrous Mumbai. Mfd by: M/s. Sheha Chemicals & Sulphate Pharmaceuticals Ltd., Village: Rajoda, Sanwer Road, Indore (MP). 5. Lizopil – 600 B. No.: MNT-141386, Dissolution CDSCO, CDL, (Linezolid Tablets Mfg dt: 11/2014, East Zone, Kolkata I.P.) Exp dt: 10/2016 Kolkata Mfd by: M/s. Terrace Pharmaceuticals (P) Ltd., 3-B (a), Phase III, Industrial Area, Sansarpur Terrace – 176501. 6. Omeprazole Sodium B. No.: OSS/042/13, Water CDSCO, CDL, B.P. (Sterile) Mfg dt: 01/2014, North Zone, Kolkata Exp dt: 12/2016 Ghaziabad Mfd by: M/s. Rajasthan Antibiotics Ltd., Plot No. 619 & 630, Phase-1, RIICO Indl. Area, Bhiwadi – 301019, Distt. Alwar, Rajasthan. 7. Perizen Tablets B. No.: TT-5044, Dissolution Drugs RDTL, Mfg dt: 07/2015, Control Guwahati Exp dt: 06/2017 Department, Mfd by: M/s. Olcare Laboratories, Mizoram. Pharma Complex, B/H Marketing, GIDC Estate, Dist-Surendranagar, Gujrat-363035.8. Aciclovir Tablets B. No.:TPVR4-008, Assay Drugs RDTL, Mfg dt: 02/2015, Control Guwahati Exp dt: 01/2017 Department, Mfd by: M/s. Medipol Nalbari, Pharmaceuticals India Pvt. Ltd., Assam. 1199/3, Bhud, Baddi, Solan, H.P 9. Para Tablets B. No.:PR-2020, Dissolution, Drugs RDTL, Mfg dt: 05/2015, Assay, Control Guwahati Exp dt: 04/2017 Uniformity of Department, Mfd by: M/s. Saibliss Drugs & Weight Arunachal Pharmaceuticals, 66/67, Gondpur Pradesh. Indstl. Area, Paonta Sahib 10. Oxytocin Injection B. No.:04, Sterility, BET, Drugs RDTL, Mfg dt: 08/2015, pH Control Guwahati Exp dt: 07/2017 Department, Mfd by: M/s. Hindustan Arunachal Medicines Pvt. Ltd., Barauni- Pradesh. 851112 11. Norfloxacin Tablets B. No.: 371015, Dissolution Drugs RDTL, Mfg dt: 10/2015, Control Guwahati Exp dt: 09/2017 Department, Mfd by: M/s. Veejay Kamrup, Laboratories, Unit of Grace Assam. Laboratories Pvt. Ltd., EPIP zone, Amingaon, Guwahati, Assam- 781031 12. Dexa Injection B. No.: DX-2020, Assay Drugs RDTL, Mfg dt: 04/2015, Control Guwahati Exp dt: 03/2017 Department, Mfd by: M/s. Vardhman Pharma, Arunachal 32 Indl. Area, Trilokpur Road, Pradesh. Kala-Amb, Dist-Sirmour, H.P 13. Alcecost–P Tablets B. No.:HT-1342, Misbranded Drugs RDTL, Mfg dt: 09/2015, Control Guwahati Exp dt: 08/2017 Department, Mfd by: M/s. VIP Lakhimpur, Pharmaceuticals Pvt. Ltd, Vill- Assam. Manpura, Tehsil Nalagarh, Dist- Solan, H.P-174101 14. Apclox-LB Capsules B. No.:MS-2020, Spurious & Drugs RDTL, Mfg dt: 04/2015, Misbranded Control Guwahati Exp dt: 03/2017 Department, Mfd by: M/s. Vardhman Pharma, Arunachal 32 Indl. Area, Trilokpur Road, Pradesh. Kala-Amb, Dist-Sirmour, H.P 15. Gentamycin B. No.:GT-2020, Spurious Drugs RDTL, Sulphate Mfg dt: 05/2015, Control Guwahati Exp dt: 04/2017 Department, Injections Mfd by: M/s. AIMS International, Mizoram. Dehradun Road, Rampur Ghat, Paonta Sahib, H.P 16. Ceflox 500 B. No.:PCDJT-002, Dissolution CDSCO, CDTL, (Ciprofloxacin Mfg dt: 09/2014, West Zone, Mumbai Exp dt: 08/2017 Mumbai Tablets IP) Mfd by: M/s. Laborate Pharmaceuticals India ltd., 51,Indl. Area, Paonta Sahib, (H.P.) 17. Ibuprofen and B. No.:A150683, Disintegration CDSCO, RDTL, Paracetamol Tablets Mfg dt: 06/2015, North Zone, Chandigarh Exp dt: 05/2018 Ghaziabad (Combiflam Tablets) Mfd by: M/s. Sanofi India Limited, 3501, 3503-15, 6310, B- 14, GIDC Estate, Ankleshwar- 393002.

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