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1 BLOOD BANK INSPECTIONS PROPOSED BY THIS OFFICE S. No. Name of the File (available with 1 M/s. Life Cell International Pvt. Ltd., /11/2014 M/s. Annai Terasa Blood Bank & Apheresis Centre, M/s. Dhanalakshmi Srinivasan Medical College, Perumbalur 4. M/s. Sri Ramachandra Medical College and Research Centre, 5. M/s. Jeyashekaran Hospital & Nursing, Nagercoil 6. M/s. Govt. Hospital, Padmanabapuram 7. M/s. Government Dist. HQ Hospital Blood Bank, Nagapattinam 8. M/s. Govt. Hospital, Pudukottai 9. M/s. Bethel Blood Bank Services Trust, Tirunelveli Town 10. M/s. Victory Blood Bank, Trichirapalli (Compliance Verification) 1 M/s. Vinayaka Mission s Kirupananda Variar Medical College Hospital, Salem (Compliance Verification) 1 M/s. Vangal Ammam Health Service Ltd, Coimbatore 1 M/s. Royal Blood Bank, Nagercoil (Compliance Verification) Awaiting for instruction from the O/o. Drugs Controller General (India) /04/ Joint inspection was postponed as per Blood Bank request. Joint inspection proposed in the month of April /10/2015 Since licence valid up to /12/ /01/ /01/2016 Since the licence valid up to March 2016 Since, the licence valid up to March /12/ /02/ /12/ /03/2016 Under Scrutiny /03/ /03/ /03/2016

2 BLOOD BANK FILES PENDING FOR WANT OF BLOOD BANK REPLY (available with M/s. Sivanthi Blood Bank, Nagercoil /11/2014 M/s. Shanthi Social Services (Blood Bank Division), Coimbatore M/s. Salem Blood Bank, Salem M/s. Thangam Blood Bank, Nagercoil M/s. Suham Blood Bank, Madurai M/s. Lords Blood Bank, Nagercoil M/s. Indian Blood Bank, Dindigul M/s. Essar Blood Bank, Chengalpattu Purpose Grant of Blood Bank licence for processing of Blood Components /02/2016 Renewal of licence for to /03/ /11/ /02/2016 Grant of licence due to change of premises Renewal of licence for to for Whole Human Blood Grant of licence /09/2015 Renewal of licence for to /11/2015 Renewal of licence for to /02/2016 Grant of licence for processing of WHB IP Reason & Remarks Query raised for submission of SBTC NOC M/s. Lions Club of Coimbatore Legend Blood Bank & Research Centre, Coimbatore M/s. Madurai Voluntary Blood Bank & Research Centre, Madurai M/s. Apollo Speciality Hospital, /01/2016 Renewal of licence for to /01/2016 Grant of Blood Bank licence for processing of WHB IP, Components & Apheresis 74 15/04/2015 Grant of licence for processing of Apheresis Query raised for submission of documents & SBTC. 2

3 M/s. Doctors Blood Bank & Research Centre, Trichy M/s. Apollo Hospitals Enterprises Ltd, M/s. Friends Blood Bank, Trichy M/s. K.M.R. Blood Bank, Thanjavur M/s. Govt. Vellore Medical College Hospital, Vellore /10/2015 Grant of Blood Bank licence for processing of Apheresis /10/2015 Renewal of licence /02/2016 Grant of Blood Bank licence for processing of Apheresis /12/2015 Renewal of licence /03/2016 Renewal of licence Query raised for submission of documents BLOOD BANK INSPECTIONS PROPOSED BY THIS OFFICE M/s. Government Medical College, Ernakulam M/s. Kozhikode District Co-Operative Hospital Ltd, Kozhikode /02/2016 Awaiting letter from Drugs Controller, Kerala /03/2016 BLOOD BANK FILES PENDING FOR WANT OF BLOOD BANK REPLY M/s. Sara Memorial Blood Bank, Kannur /02/2016 Query raised for submission of SBTC. BLOOD BANK INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF PUDUCHERRY M/s. Venkateshwara Medical College Hospital, Puducherry /03/2016 3

4 BLOOD BANK FILES PENDING FOR WANT OF BLOOD BANK REPLY M/s. Puducherry Private Hospital Association, Puducherry /02/2016 Query raised for submission of documents COPP INSPECTIONS PROPOSED BY THIS OFFICE M/s. Vivimed labs, Alathur Pvt Ltd, Alathur /01/ M/s. Vinkem Labs Ltd, Kakkalur /12/2015 M/s. Hospira Healthcare India Pvt Ltd, /02/2015 M/s. Wardex Pharmaceuticals Pvt Ltd, /12/2015 Letter given by the firm to postpone the inspection after 3 rd week of April 2016 This office received application on Query raised Reply received on Joint inspection proposed in the month of April Manufacturer requested postponement inspection M/s. Orchid Healthcare, Irunkattukottai, Kancheepuram (Plot. B-5, B-6) /01/2016 M/s. B. Braun Medical India Pvt Ltd, Chengalpet /12/2015 Manufacturer requested postponement of inspection. 7. M/s. Aurolab, Madurai /01/ M/s. Sterling Labs, Hosur /04/ M/s. Mylan Laboratories, Hosur /01/2016 4

5 M/s. Bestcare Formulations (P) Ltd., Puducherry /03/2016 M/s. Franco Indian Remedies Pvt Ltd, /01/2016 M/s. Piramal Healthcare, /11/2015 Application submitted on Query raised for documents submission. Reply received from the manufacturer on Under Scrutiny Joint inspection proposed on & Joint inspection proposed on & M/s. Global Pharma Healthcare, Alathur /01/2` M/s. Global Calcium, Hosur (Unit III) /12/2015 M/s. Orchid Healthcare, Alathur (Plot No. B-77), Kancheepuram Dt /01/2016 M/s. Orchid Pharma Ltd, Alathur (Plot ) /01/ M/s. Eucare Pharmaceuticals, /01/2016 COPP FILES PENDING FOR WANT OF MANUFACTURER REPLY M/s. Innvol Medical India Ltd, Kanchipuram. M/s. Sara Pharmaceuticals, Nagercoil. M/s. Arvind Remedies, /03/ /12/ Query raised on , Awaiting reply Query raised on , Awaiting reply /12/2015 Query raised for documents submission, Awaiting reply 5

6 4. M/s. Alchymars, Alathur /01/2016 Query raised for documents submission Awaiting reply M/s. Micro Labs Ltd, Hosur /12/2015 M/s. Nouveau Medicant (P) Ltd, Kancheepuram /02/2016 M/s. Medopharm Pvt Ltd, Guduvancherry /01/2016 Query raised for documents submission Awaiting reply Query raised for documents submission Awaiting reply Query raised for documents submission Awaiting reply COPP INSPECTIONS PROPOSED BY THIS OFFICE M/s. Holden Medical Laboratories at M/s. Sance Laboratories Pvt ltd, Kottayam /10/ /10/2015. Query raised on 09/10/2015, Awaiting reply Reply from manufacturer received on 15/12/2015. the month of April 2016 COPP FILES PENDING FOR WANT OF MANUFACTURER REPLY M/s. Labinduss Ltd, Palakkad M/s. HLL Lifecare Ltd, Thiruvananthapuram Dist /10/ Query raised on , Awaiting reply from the manufacturer /02/2016 Query raised on , Awaiting reply from the manufacturer 6

7 COPP INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF PUDUCHERRY M/s. Goodman Pharmaceuticals, Puducherry M/s. Byma Laboratories Pvt Ltd., Puducherry /01/ Query raised on /02/ Reply from the manufacturer received on Under scrutiny the month of May 2016 COPP FILES PENDING FOR WANT OF MANUFACTURER REPLY FOR THE STATE OF PUDUCHERRY- M/s. Safetab Life Science, Puduchery M/s. Micro Labs Ltd (Unit -III), Puducherry /03/ Query raised on , Awaiting reply from the manufacturer /11/2015 Query raised and Firm has also requested joint inspection after March 2016 due to up gradation of facility MEDICAL DEVICE FILES PROPOSED BY THIS OFFICE 4. M/s. Excel Optics Pvt., Ltd, (available with /10/2015 M/s. Eagle Osteon Technologies, /02/2016 M/s. Jayon Implants Pvt Ltd, Palakkad /03/2016 M/s. Jayon Implants Pvt Ltd, Palakkad (Compliance verification /08/2015 Joint inspection proposed in the month of April 2016 The firm is not ready for inspection. Joint inspection proposed in the month of May 2016 Joint inspection proposed in the month of May

8 VACCINE FILES PENDING FOR WANT OF MANUFACTURER REPLY M/s. Mediclone Biotech Pvt Ltd, (Renewal) (available with /02/2015 Query raised, reply not received from the manufacturer TESTING LAB FILES PENDING FOR WANT OF MANUFACTURER REPLY M/s. Nebulae Hi -Tech Laboratories, (available with /02/2016 Query raised, reply not received from the manufacturer BA/BE INSPECTIONS PROPOSED BY THIS OFFICE M/s. Quest Life Sciences, /11/2015 Awaiting letter from DCG(I ), New Delhi for inspection EU WRITTEN CONFIRMATION FILES PROPOSED BY THIS OFFICE M/s. Pharmazell India Pvt Ltd, /01/2015 M/s. Sun Pharmaceuticals, Kancheepuram /02/2016 M/s. Natco Organics Ltd, /03/ the month of May 2016 the month of July Since the licence is valid upto Under Scrutiny

9 EU WRITTEN CONFIRMATION PENDING FOR WANT OF MANUFACTURER REPLY FOR THE STATE OF PUDUCHERRY M/s. Natural Capsules, Puducherry /09/ /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 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 9