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

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Status of Pending at CDSCO South zone (Chennai) (as on 30.10.) 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 1308 05/08/ Joint inspection proposed 1869 09/10/ Joint inspection proposed 1865 01/10/ Joint inspection proposed on 10.11. 2767 01/01/2013 Joint inspection proposed on 11/11/ 507 27/05/14 Joint inspection proposed 1293 05/08/ Joint inspection proposed 1088 14/07/ 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 3740 28/12/2011 Query raised, Reply not 2. M/s. Satyam Blood Bank, Madurai 3456 19/03/2013, Reply not

3. M/s. Moses Blood Bank, Tuticorin 2040 11/10/2012 Blood Bank is not ready for inspection 4. M/s. Abirami Blood Bank(Annai Abirami Trust), Madurai 1188 23/07/ Query raised for submission of NOC from SBTC 5. M/s. Ambigai Blood Bank, 3810 Thanjavur 6. M/s. AA Lab Services, Chennai 2601 03/12/2011 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 5632 22/01/ Query raised, Reply not 5167 05/11/2013 Blood Bank not ready for inspection 1335 06/08/ SBTC approval issued in the name of trust not in the name of Blood Bank. Waiting for Clarification. 10. M/s. Govt.Hospital, Theni 3719 28/12/2011 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 3095 01/02/2013 Query raised, Reply not 3577 22/03/2013 Query raised, Reply not 1192 25/07/ Query raised, Reply not 4435 15/07/13 Query raised, Reply not 4014 15/05/2013 Query raised, Reply not 5197 07/11/2013 SBTC NOC not submitted 3950 03/05/2013 The Blood Bank not ready for inspection 861 23/06/, Reply not

19. M/s. Bensam Blood Bank, Nagarcoil 1338 06/08/, Reply not 20. M/s. SHHARC, Namakkal 4645 13/08/2013 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 5228 14/11/2013 SBTC approval not submitted 1293 05/08/ Query raised, Reply not 320 05/05/ Query raised, Reply not 1259 28/07/ Query raised, Reply not 1062 11/07/ SBTC NOC not submitted 4868 17/09/2013 SBTC approval not given BLOOD BANK INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF KERALA 1. M/s. Govt. District Hospital, Kanhangad 5686 30/01/ 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 5658 23/01/ Joint inspection date postponed by SLA & proposed in the month of November 1158 22/07/ Joint inspection date postponed by SLA & proposed in the month of November 383 13/05/ Joint inspection date postponed by SLA & proposed in the month of November

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 1534 28/08/ Joint inspection proposed 1400 14/08/ Joint inspection proposed 1839 01/10/ Joint inspection proposed 2039 27/10/ 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 3475 12/12/2011 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

1. M/s Bafna Pharmaceuticals, Chennai 2. M/s. Orchid Health Care, (A-10), (A-11), Alathur, Kancheepuram 712 16/06/ Joint inspection proposed in the month of 10.11. & 11.11. 6075 28/02/ 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 949 02/07/, Reply not from the 2. M/s. Cassel Research Lab Pvt Ltd (Unit-1), Chennai 375 09/05/, Reply not from the 3. M/s Regenix, Alathur 1759 22/09/, Reply not from the 4. M/s Global Pharma Tech, Hosur 1221 25/07/ 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 5313 05/12/2013 Firm requested to postpone the inspection 6072 27/02/ Firm requested to postpone the inspection 6073 28/02/, Reply not from the 6989 15/10/, Reply not from the 2135 30/10/, Reply not from the

10. M/s Abhilash Chemicals Pvt Ltd, Madurai 1952 13/10/, Reply not from the COPP INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF KERALA 1. M/s Capsulation Drugs& Pharmaceuticals, Alapuzha, Kerala 624 02/06/ 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 2089 28/10/, Reply not from the 2688 28/10/, Reply not from the 2072 28/10/, Reply not from the COPP INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF PUDUCHERY

1. M/s Sterile Gene Life Sciences (P) Ltd, Puducherry 2. M/s Shasun Pharmaceuticals, Puducherry 3. M/s Natural Capsules Pvt Ltd, Puducherry 1797 24/09/ Joint inspection proposed 144 15/04/ Joint inspection proposed 1708 15/09/ 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 1911 09/10/, Reply not from the 1905 09/10/, Reply not from the 6145 13/03/ 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 6287 25/03/ Joint inspection proposed

MEDICAL DEVICES FILES PENDING FOR WANT OF MANUFACTURER REPLY FOR THE STATE OF TAMIL NADU 1. M/s Sisco Medical Device Pvt Ltd, Chennai 3040 29/01/2013, Reply not yet 2. M/s Aurolab, Madurai 1333 06/08/, 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 2010 27/10/, Reply not yet

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 1071 11/07/ 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 1999 27/10/ 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 2043 27/10/, Reply not from the 1469 21/08/, Reply not from the

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

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/1418 18/07/14 Application by post, informed to the Person for want of documents. NOC/EXP/1417 18/07/14 Application by post, informed to the Person for want of documents. NOC/EXP/1419 18/07/14 Application by post, informed to the Person for want of documents. NOC/EXP/1420 18/07/14 Application by post, informed to the Person for want of documents. 5. Kemwell Pvt Ltd NOC/EXP/1464 12/08/14 Application by post, query letter sent on 13/08/14. 6. M/s. Kemwell NOC/EXP/1570 08/10/ 7. M/s. Kemwell NOC/EXP/1571 08/10/ 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/1573 08/10/ NOC/EXP/1578 13/10/ NOC/EXP/1580 14/10/ NOC/EXP/1581 14/10/ NOC/EXP/1599 28/10/ NOC/EXP/1603 29/10/ NOC/EXP/1605 29/10/ NOC/EXP/1607 29/10/

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/3927 07/10/ 4. M/s. Aashutosh NOC/DU/4012 29/10/ 5. M/s. Aashutosh NOC/DU/4013 29/10/ 6. M/s. Novus NOC/DU/4025 31/10/