BLOOD BANK FILES PENDING FOR WANT OF BLOOD BANK REPLY FOR THE STATE OF TAMIL NADU

Transcription

1 Status of Pending at CDSCO South zone (Chennai) (as on ) BLOOD BANK INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF TAMIL NADU 1. M/s. Deen Dayal Hospital (DD Hospital ), Tiruvallur 2. M/s Sri Muthukumaran Medical College & Hospital, Chennai 3. M/s Govt. Head Quarters Hospital, Erode 4. M/s Sriram Blood Bank, Gobichettipalayam 5. M/s. Apollo Speciality Hospital, Trichy 6. M/s. SRM Medical College Hospital & Research Centre, (Grant), Vadapalani, Chennai 7. M/s. SRM Medical College Hospital & Research Centre, (Renewal) Kattankulathur /08/ Joint inspection proposed /10/ Joint inspection proposed /10/ Joint inspection proposed on /01/2013 Joint inspection proposed on 11/11/ /05/14 Joint inspection proposed /08/ Joint inspection proposed /07/ Joint inspection proposed BLOOD BANK FILES PENDING FOR WANT OF BLOOD BANK REPLY FOR THE STATE OF TAMIL NADU 1. M/s. Kanya Blood Bank, Nagercoil /12/2011 Query raised, Reply not 2. M/s. Satyam Blood Bank, Madurai /03/2013, Reply not

2 3. M/s. Moses Blood Bank, Tuticorin /10/2012 Blood Bank is not ready for inspection 4. M/s. Abirami Blood Bank(Annai Abirami Trust), Madurai /07/ Query raised for submission of NOC from SBTC 5. M/s. Ambigai Blood Bank, 3810 Thanjavur 6. M/s. AA Lab Services, Chennai /12/2011 SBTC NOC not Submitted 14/12/2012 Query raised, Reply not 7. M/s. Dindigul Blood Bank (Run by srinivasa medical service trust), Dindigul 8. M/s. Govt Hospital, Kallakurichi 9. M/s. Karur Educational & Charitable Trust (Earlier Name: Karur Blood Bank), Karur /01/ Query raised, Reply not /11/2013 Blood Bank not ready for inspection /08/ SBTC approval issued in the name of trust not in the name of Blood Bank. Waiting for Clarification. 10. M/s. Govt.Hospital, Theni /12/2011 Query raised, Reply not 11. M/s. Lions Blood Bank & Research Centre, Chennai 12. M/s. AVM Hospital, Tuticorin 13. M/s. Sivaramji Blood Bank (Jana seva Trust), Salem 14. M/s. Govt District Headquarters Hospital, Usilampatti 15. M/s. Hi-Tech Blood Bank & Research Foundation, Cuddalore 16. M/s. Thangam Blood Bank, Nagercoil 17. M/s. Indian Red Cross Blood Bank, Thanjavur 18. M/s. Annai Blood Bank, Salem /02/2013 Query raised, Reply not /03/2013 Query raised, Reply not /07/ Query raised, Reply not /07/13 Query raised, Reply not /05/2013 Query raised, Reply not /11/2013 SBTC NOC not submitted /05/2013 The Blood Bank not ready for inspection /06/, Reply not

3 19. M/s. Bensam Blood Bank, Nagarcoil /08/, Reply not 20. M/s. SHHARC, Namakkal /08/2013 SBTC NOC not submitted 21. M/s. Jeevan Blood Bank, Madurai 22. M/s. SIMS (SRM Institute of Medical sciences), Chennai 23. M/s. Annai Blood bank, Sivakasi 24. M/s. SRM Medical College Hospital & Research Centre, (Grant) Kattankulathur 25. M/s. Lords Blood Bank, Nagercoil 26. M/s.Vikram Blood Bank, Theni /11/2013 SBTC approval not submitted /08/ Query raised, Reply not /05/ Query raised, Reply not /07/ Query raised, Reply not /07/ SBTC NOC not submitted /09/2013 SBTC approval not given BLOOD BANK INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF KERALA 1. M/s. Govt. District Hospital, Kanhangad /01/ Joint inspection date postponed by SLA & proposed in the month of November 2. M/s. Korambayil Hospital & Diagnostic Centre (P) Ltd, Manjeri 3. M/s. Malabar Medical college hospital & research centre (MMC Hospital), Calicut 4. M/s. Malabar Institute of Medical Sciences Ltd., Malapuram /01/ Joint inspection date postponed by SLA & proposed in the month of November /07/ Joint inspection date postponed by SLA & proposed in the month of November /05/ Joint inspection date postponed by SLA & proposed in the month of November

4 5. M/s. JosgiriHospital Blood Bank, Kannur 6. M/s Holy Family Hospital, Idukki 7. M/s Bharath Charitable Hopspital, Kottayam 8. M/s Sara Memorial Blood Bank & Component Seperation Unit, Kannur /08/ Joint inspection proposed /08/ Joint inspection proposed /10/ Joint inspection proposed /10/ Joint inspection proposed BLOOD BANK FILES PENDING FOR WANT OF BLOOD BANK REPLY FOR THE STATE OF KERALA 1. M/s. Indo American Hospital Brain & Spine Centre, Chemmanakary, Kerala /12/2011 SBTC rejected the application. Hence, no joint inspection planned BLOOD BANK INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF PONDICHERY Nil COPP INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF TAMIL NADU

5 1. M/s Bafna Pharmaceuticals, Chennai 2. M/s. Orchid Health Care, (A-10), (A-11), Alathur, Kancheepuram /06/ Joint inspection proposed in the month of & /02/ Joint inspection proposed COPP FILES PENDING FOR WANT OF MANUFACTURER REPLY FOR THE STATE OF TAMIL NADU 1. M/s. Cologenesis Healthcare Pvt Ltd, Salem /07/, Reply not from the 2. M/s. Cassel Research Lab Pvt Ltd (Unit-1), Chennai /05/, Reply not from the 3. M/s Regenix, Alathur /09/, Reply not from the 4. M/s Global Pharma Tech, Hosur /07/ Firm requested to postpone the inspection 5. M/s Sanmar Speciality Chemicals, Hosur, Krishnagiri 6. M/s Eucare Pharmaceuticals P Ltd, Chennai 7. M/s Nouvau Medicament Ltd, Chennai 8. M/s Sun Pharmaceutials Industries Ltd, Kancheepuram Dist. 9. M/s Baxter India Ltd, Chennai /12/2013 Firm requested to postpone the inspection /02/ Firm requested to postpone the inspection /02/, Reply not from the /10/, Reply not from the /10/, Reply not from the

6 10. M/s Abhilash Chemicals Pvt Ltd, Madurai /10/, Reply not from the COPP INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF KERALA 1. M/s Capsulation Drugs& Pharmaceuticals, Alapuzha, Kerala /06/ Joint inspection proposed COPP FILES PENDING FOR WANT OF MANUFACTURER REPLY FOR THE STATE OF KERALA 1. M/s Sance Laboratories Ltd, Kerala 2. M/s Pulse laboratories on M/s Sance Laboratories, Kottayam 3. M/s Labinduss Ltd, Palakkad /10/, Reply not from the /10/, Reply not from the /10/, Reply not from the COPP INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF PUDUCHERY

7 1. M/s Sterile Gene Life Sciences (P) Ltd, Puducherry 2. M/s Shasun Pharmaceuticals, Puducherry 3. M/s Natural Capsules Pvt Ltd, Puducherry /09/ Joint inspection proposed /04/ Joint inspection proposed /09/ Joint inspection proposed COPP FILES PENDING FOR WANT OF MANUFACTURER REPLY FOR THE STATE OF PUDUCHERRY 1. M/s Sun Glow Pharmaceuticals, Puducherry 2. M/s Appasamy Ocular Devices Ltd, Puducherry 3. M/s Safetab Life Science, Puduchery /10/, Reply not from the /10/, Reply not from the /03/ Manufacturer not ready for inspection MEDICAL DEVICES INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF TAMIL NADU 1. M/s Innvol-Medical India Ltd, Sriperumbadur /03/ Joint inspection proposed

8 MEDICAL DEVICES FILES PENDING FOR WANT OF MANUFACTURER REPLY FOR THE STATE OF TAMIL NADU 1. M/s Sisco Medical Device Pvt Ltd, Chennai /01/2013, Reply not yet 2. M/s Aurolab, Madurai /08/, Reply not yet MEDICAL DEVICES INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF KERALA NIL MEDICAL DEVICES FILES PENDING FOR WANT OF MANUFACTURER REPLY FOR THE STATE OF PUDUCHERRY 1. M/s Appasamy Ocular Devices, Puducherry /10/, Reply not yet

9 TESTING LABS INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF TAMIL NADU 1. M/s Global Calcium Innovation Centre, Hosur & M/s Global Calcium Pvt Ltd, Hosur /07/ Joint inspection proposed in the month of November TESTING LABS INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF PUDUCHERRY 1. M/s Synthiya Research Labs Pvt ltd, Villianur, Puducherry /10/ Joint inspection proposed for Verification of Compliance BA/BE FILES PENDING FOR WANT OF MANUFACTURER REPLY FOR THE STATE OF TAMIL NADU 1. M/s Microtherapeutics Research Lab Pvt Ltd, Chennai 2. M/s Orchid Healthcare, SIPCOT, Sriperambudur /10/, Reply not from the /08/, Reply not from the

10 Sl.no Name of the Applicant 1. Stabicon Life Sciences Pvt Ltd, Bangalore. 2. Shasun Pharmaceuticals Limited, puducherry 3. Kemwell Bio pharma Ltd, Bangalore 4. Strides Arcolab Limited, Bangalore 5. Micro Labs Limited, 6. Cipla Ltd, Bangalore Pending Applications for NOC for Form -29 Inward No. NOC/29/907, dtd 19/03/14 NOC/29/1115 Dtd 01/10/14 NOC/29/1116 Dtd 01/10/14 NOC/29/1124 Dtd 14/10/14 NOC/29/1128, 1120, 1122 & 1123 Dtd: 13/10/14 & Dtd 30/10/14 NOC/29/1128 Dtd 30/10/14 Application recd by Post, informed to the Person for want of documents, when he came to this office. Application recd by Post, Query letter raised and issued to firm Application recd by Post, Query letter raised and issued to firm Application recd by Post, Query letter raised and issued to firm Application recd by Post, Query letter raised and issued to firm Application recd by Post, Query letter raised and issued to firm No-Response No-Response No-Response No-Response No-Response No-Response

11 Pending Applications for Export NOC Sl.no Name of the Applicant 1. Kemwell Pvt Ltd 2. Kemwell Pvt Ltd 3. Kemwell Pvt Ltd 4. Kemwell Pvt Ltd Inward No. Date of Receipt NOC/EXP/ /07/14 Application by post, informed to the Person for want of documents. NOC/EXP/ /07/14 Application by post, informed to the Person for want of documents. NOC/EXP/ /07/14 Application by post, informed to the Person for want of documents. NOC/EXP/ /07/14 Application by post, informed to the Person for want of documents. 5. Kemwell Pvt Ltd NOC/EXP/ /08/14 Application by post, query letter sent on 13/08/ M/s. Kemwell NOC/EXP/ /10/ 7. M/s. Kemwell NOC/EXP/ /10/ 8. M/s. Kemwell 9. M/s. Kemwell 10. M/s. Kemwell 11. M/s. Kemwell 12. M/s. Strides Arcolab 13. M/s. Jubilant Life Sciences 14. M/s. Cipla Ltd 15. M/s. Cipla Ltd NOC/EXP/ /10/ NOC/EXP/ /10/ NOC/EXP/ /10/ NOC/EXP/ /10/ NOC/EXP/ /10/ NOC/EXP/ /10/ NOC/EXP/ /10/ NOC/EXP/ /10/

12 PENDING LIST OF NOC FOR DUAL USE FILES S. No. Name of the applicant Inward No. (Available with 1. M/s. Givaudan (India) Pvt. Ltd., Bangalore NOC/DU/3527 Reason & Remarks 06/06/ 2. M/s. Sai Life Sciences 24/09/ NOC/DU/3887 Ltd 3. M/s. Kawarlal CDEF NOC/DU/ /10/ 4. M/s. Aashutosh NOC/DU/ /10/ 5. M/s. Aashutosh NOC/DU/ /10/ 6. M/s. Novus NOC/DU/ /10/