BLOOD BANK INSPECTIONS PROPOSED BY THIS OFFICE S. No. Name of the File 1 M/s. Life Cell International Pvt. Ltd., 127 2255 13/11/2014 2. M/s. Annai Terasa Blood Bank & Apheresis Centre, 3. M/s. Dhanalakshmi Srinivasan Medical Collge, Perumbalur 4. M/s. Maruthi Blood Bank, Salem 5. M/s. Palaniandi Mudaliar Memorial Hospital, Salem 6. M/s. KSM Blood Bank, Salem 7. M/s. The Salvation Army Catherine Booth Hospital, Nagercoil 8. M/s. Galaxy Hospital, Tirunelveli 2380 23/11/2015 9. M/s. St. Joseph Hospital, Dindigul 10. M/s. Thoothukudi Medical College Hospital, Thoothukudi 1 M/s. Sri Ramachandra Medical College and Research Centre, Awaiting for instruction from the O/o. Drugs Controller General (India) 280 27/04/2015 Blood Bank requested additional time for joint inspection 2075 23/10/2015 the month of April 2016. Since licence valid up to 20.03.2016. 668 01/06/2015 Joint inspection proposed on 08.02.2016 2961 18/01/2016 Joint inspection proposed on 09.02.2016 3732 23/03/2015 Joint inspection proposed on 10.02.2016 Blood bank has submitted rectification report on 06.12015 for renewal of 2266 06/11/2015 licence. Awaiting letter from SLA for verification of compliance of previous inspection. 2580 15/12/2015 2584 15/12/2015 2623 21/12/2015 12. M/s. Southern Railway Hospital Blood Bank, 2669 22/12/2015 13. M/s. Jeyashekaran Hospital & Nursing, Nagercoil 2951 18/01/2016 the month of February 2016. on 04.02.2016 the month of February 2016. the month of April 2016. Since the licence valid up to March 2016 the month of February 2016. 14. M/s. Govt. Hospital, 2686 28/12/2015 Joint inspection proposed
Thiruvarur on 05.02.2016 15. M/s. Govt. Hospital, Padmanabapuram 2802 05/01/2016 16. M/s. Govt. Hospital Blood Bank, Erode 2685 28/12/2015 the month of April 2016. Since the licence valid up to March 2016 the month of February 2016. BLOOD BANK FILES PENDING FOR WANT OF BLOOD BANK REPLY 2. 3. 4. 5. (available with M/s. Sivanthi Blood Bank, Nagercoil 2222 10/11/2014 M/s. Thangam Blood Bank, Nagercoil M/s. Kongu Blood Bank & Components Centre, Erode M/s. Swaasam Blood Bank, Coimbatore M/s. Lords Blood Bank, Nagercoil Purpose Grant of Blood Bank licence for processing of Blood Components Renewal of licence for the period from 2233 03/11/2015 26.10.2015 to 25.10.2020 for Whole Human Blood 1103 09/07/2015 Grant of licence due to change in constitution 866 16/06/2015 Renewal of licence for the period from 04.05.2016 to 03.05.2021 & Grant of Components 1899 30/09/2015 Renewal of licence for the period from 308.2015 to 30.08.2020 2232 03/11/2015 Renewal of licence 6. M/s. Indian Blood Bank, Dindigul 7. M/s. Sriram Blood 2447 27/11/2015 Grant of licence due to Bank Trust, Erode change in constitution M/s. Madras Egmore 2661 21/12/2015 Renewal of licence 8. Lions Blood Bank & Research Foundation, M/s. Pollachi Blood 1026 06/07/2015 Grant of Blood Bank 9. Bank Service, licence due to Change Pollachi of Premises 10. M/s. Bethel Blood 2626 21/12/2015 Renewal of licence Reason & Remarks Query raised for submission of SBTC NOC. 2
1 12. 13. 14. Bank Services Trust, Tirunelveli Town M/s. V. Dhanasamy - Parimaladevi Medical Trust Blood Bank, Vidhunagar M/s. Apollo Speciality Hospital, M/s. Doctors Blood Bank & Research Centre, Trichy M/s. Apollo Hospitals Enterprises Ltd, 37 10/04/2015 Grant of Blood Bank licence for processing of Blood Components 74 15/04/2015 Grant of Apheresis 1910 01/10/2015 Grant of Blood Bank licence for processing of Apheresis 2060 19/10/2015 Renewal of licence Query raised for submission of documents & SBTC. 15. 16. M/s. Government Dist. HQ Hospital Blood Bank, Nagapattinam M/s. K.M.R. Blood Bank, Thanjavur 2564 14/12/2015 Endorsement of additional blood components 2512 14/12/2015 Renewal of licence BLOOD BANK INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF KERALA M/s. Jubilee Mission Hospital, Thrissur 2. M/s. Medical College Hospital, Thrissur 3. M/s. Medical Trust Hospital, Cochin 4. M/s. Taluk Headquarters Hospital, Chirayinkeezhu 5. M/s. Muthoot Medical Centre, Pathanamthitta 6. M/s. Aster Medcity, Kochi 7. M/s. St. James Hospital, Chalakudy 2345 18/11/2015 2565 14/12/2015 2672 22/12/2015 2941 14/01/2016 2625 21/12/2015 2684 23/12/2015 2671 22/12/2015 3
2. COPP INSPECTIONS PROPOSED BY THIS OFFICE M/s. Apex Laboratories Pvt Ltd, Alathur, Kancheepuram Dist 2792 02/01/2015 M/s. Vivimed labs, Alathur Pvt Ltd, Alathur 2749 01/01/2016 The manufacturer requested for postponement of joint inspection due to renovation work.. 3. 4. 5. 6. 7. 8. M/s. Vinkem Labs Ltd, Kakkalur 2681 23/12/2015 M/s. Malladi Drugs & Pharmaceuticals Pvt Ltd, Ranipet M/s. Hospira Healthcare India Pvt Ltd, 2321 17/11/2015 3184 09/02/2015 M/s. Wardex Pharmaceuticals Pvt Ltd, 2595 16/12/2015 M/s. Orchid Healthcare, Irunkattukottai, Kancheepuram (Plot. B-5, B-6) 2747 01/01/2016 M/s. B. Braun Medical India Pvt Ltd, Chengalpet 2583 15/12/2015.. This office received application on 09.02.2015. Query raised 27.02.2015. Reply received on 06.12.2015. Joint inspection proposed in the month of February 2016.. the month of March 2016.. COPP FILES PENDING FOR WANT OF MANUFACTURER REPLY 2. M/s. Innvol Medical India Ltd, Kanchipuram. 4 6287 25/03/2014 M/s. Sara Pharmaceuticals, Nagercoil. 2508 04/12/2014 Application received on 25.03.2014. Query raised on 18.06.2014, Awaiting reply Application received on 04.12.2014. Query raised on 05.02.2015, Awaiting reply
3. 4. 5. 6. 7. 8. 9. 10. 1 12. 13. 14. 15. 16. 17. 18. M/s. Sterling Labs, Hosur Joint inspection postponed due 284 28/04/2015 to maintenance work in the premises M/s. Aurolab, Madurai 2760 04/01/2016 submission, Awaiting reply M/s. Aurolab, Madurai 2752 01/01/2016 submission, Awaiting reply M/s. Piramal Healthacare, 2675 22/11/2015 submission, Awaiting reply M/s. Arvind Remedies, 2685 23/12/2015 submission, Awaiting reply M/s. Global Calcium, Hosur (Unit III) 2611 17/12/2015 M/s. Global Calcium, Hosur (Unit I) 2612 17/12/2015 M/s. Alchymars, Alathur 2743 01/01/2016 M/s. Global Pharma Healthcare, Alathur M/s. Mylan Laboratories, Hosur M/s. Global Pharmatech Pvt Ltd, Hosur 2505 14/12/2015 M/s. Micro Labs Ltd, Hosur 2743 01/01/2016 2750 01/01/2016 2716 30/12/2015 M/s. Strides Shasun Pvt Ltd, Cuddalore 2673 22/12/2015 M/s. Orchid Healthcare, Alathur (Plot No. B-77), Kancheepuram Dt. 2745 01/01/2016 M/s. Franco Indian Remedies Pvt Ltd, 2744 01/01/2016 M/s. Steadman Pharmaceuticals Pvt Ltd, Alathur 2444 27/11/2015 Firm requested for postponement 5
19. M/s. Orchid Pharma Ltd, Alathur (Plot.121-128) 2746 01/01/2016 COPP INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF KERALA M/s. Holden Medical Laboratories at M/s. Sance Laboratories Pvt ltd, Kottayam 1937 06/10/2015 Application received on 06/10/2015. Query raised on 09/10/2015, Awaiting reply Reply from manufacturer received on 15/12/2015. COPP FILES PENDING FOR WANT OF MANUFACTURER REPLY FOR THE STATE OF KERALA M/s. Labinduss Ltd, Palakkad 2072 28/10/2014 Application received on 20.10.2014. Query raised on 14.12014, Awaiting reply from the manufacturer. COPP INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF PUDUCHERRY 2. 3. 4. M/s. Micro Labs Ltd (Unit -III), Puducherry M/s. Goodman Pharmaceuticals, Puducherry M/s. Strides Shasun Pvt Ltd, Puducherry M/s. Restech Pharma, Puducherry 2437 26/11/2015 Firm requested joint inspection in the month of March 2016 due to up gradation of facility 2697 19/01/2016 Under Scrutiny 2649 18/01/2016 State Drugs Inspector not ready for inspection. 2751 01/01/2016 6
COPP FILES PENDING FOR WANT OF MANUFACTURER REPLY FOR THE STATE OF PUDUCHERRY- M/s. Safetab Life Science, Puduchery 6145 13/03/2014 Application received on 13.03.2014. Query raised on 03.04.2014, Awaiting reply from the manufacturer. MEDICAL DEVICE FILES PROPOSED BY THIS OFFICE 2. 3. 4. 5. M/s. Excel Optics Pvt., Ltd, (available with 1912 11/10/2015 M/s. Eagle Osteon Technologies, 1804 16/09/2015 M/s. AI-Optics Ltd, M/s. Synkromax Biotech Pvt Ltd, (Compliance Verification) M/s. Medevis Rubplast India Pvt Ltd, Coimbatore 2986 21/01/2016 2771 04/01/2016 506 14/05/2015 Joint inspection proposed in the month of February 2016 The firm requested sometime for joint inspection Under Scrutiny Joint inspection proposed on 03 rd & 04 th February 2016 Joint inspection proposed on 11 th & 12 th February 2016 MEDICAL DEVICE FILES PROPOSED BY THIS OFFICE FOR THE STATE OF KERALA M/s. HLL Lifecare Ltd, Thiruvananthapuram 1036 06/07/2015 This office received application on 06/07/2015. Query raised on 07/07/2015. Reply received on 23/10/2015. Joint inspection proposed in the month of February 2016. 7
MEDICAL DEVICE FILES PENDING FOR WANT OF MANUFACTURER REPLY FOR THE STATE OF KERALA M/s. Jayon Implants Pvt Ltd, Palakkad (Compliance verification 1546 19/08/2015 Query raised, reply not received from the manufacturer VACCINE FILES PENDING FOR WANT OF MANUFACTURER REPLY M/s. Mediclone Biotech Pvt Ltd, (Renewal) (available with 3068 17/02/2015 Query raised, reply not received from the manufacturer BA/BE INSPECTIONS PROPOSED BY THIS OFFICE M/s. Quest Life Sciences, 2360 19/11/2015 Awaiting letter from DCG(I ), New Delhi for Joint inspection EU WRITTEN CONFIRMATION FILES PROPOSED BY THIS OFFICE M/s. Shasun Pharmaceuticals Ltd, Cuddalore 1898 29/09/2015 This office received application on 29/09/2015. The firm requested for postponement due to heavy rain. The firm submitted another application for COPP on 22/12/2015. Query raised on 12/01/2016. Reply from manufacturer yet to be received. 8
2. M/s. Sun Pharma, 2672 22/12/2015 the month of February 2016 3. M/s. Pharmazell India Pvt Ltd, 2816 06/01/2015 the month of February 2016 EU WRITTEN CONFIRMATION PENDING FOR WANT OF MANUFACTURER REPLY M/s. Eucare Pharmaceuticals, 2748 01/01/2016 Query raised. Reply yet to be received EU WRITTEN CONFIRMATION PENDING FOR WANT OF MANUFACTURER REPLY FOR THE STATE OF PUDUCHERRY M/s. Natural Capsules, Puducherry 1840 21/09/2015 Application received on 21/09/2015. Query raised on 06/10/2015, Awaiting reply from the manufacturer. PENDING LIST OF NOC FOR DUAL USE FILES S. No. Name of the File (Available with NIL 9
PENDING LIST OF NOC FOR FORM-29 FILES S. No. Name of the File (Available with NIL PENDING LIST OF NOC FOR EXPORT-NOC FILES S. No. Name of the File (Available with NIL PENDING LIST OF NOC FOR TEST LICENCE (FORM - 11) FILES S. No. Name of the File (Available with NIL 10