F. No. CT/84/2012-DCG (I) Directorate General of Health Services Office of Drugs Controller General (India) (Biological Division) To FDA Bhawan New Delhi Dated: 2 8 DEe 2012 MIs Baxter (India) Pvt. Ltd., 2nd Floor, Tower C. Buildling No.8, DLF Cyber Park, DLF Cyber city, DLF Phase II, Gurgaon. Subject: A Phase III clinical trial entitled "A Phase 3 Prospective, Multicenter Study Evaluating Efficacy and Safety in Previously Treated Patients with Severe (FIX level < 1%) or Moderately Severe (FIX level S; 2%) Hemophilia B Undergoing Surgical or Other Invasive Procedures" Protocol No. 251002 AMENDMENT 1 VERSION: 11 October 20 l l-reg. Reference: Your letter no BAX/BS-BAX326 Sur Ph31RFA/0812 dated 23/0812012 our diary No. 35052 dated 28.05.2012. Sir, Permission is hereby granted to you under the provisions of Rule 122 DA of Drugs and Cosmetics Rules to conduct Phase III clinical trial with the said drug at the sites and under the supervision of the investigators as mentioned below and as per the protocol forwarded to this Directorate. 1. Dr. Shashikant Janardan Apte, Sahayadri Speciality Hospital, A unit of Sahyadri Hospitals Limited, 30C, Erandwane, Karve Road, Pune 411004, India. 2. Dr. Naresh Gupta, LNJP Maulana Azad Medical College & Associated Hospital, New Delhi - 110002 3. Dr. Vijay Ramanan, Jehangir Hospital and Research Center, Pune -411016 At the time of submitting clinical trials reports to this Directorate for evaluation you are required to comply with the following requirements: 1. Submit complete report of clinical trials as per the approved protocol from the individual investigator duly signed by him along with his observations/remarks on the drug. 2. Indicating the date of commencement and conclusion of the clinical trial at each center (in case the study is multi-centric). 3. Approval of the Ethical Committee of the concerned center/institution for conducting the clinical trial with the said drug. You are requested to submit to this Directorate an annual status report on each clinical trial viz. ongoing, completed or terminated. In case the trial is terminated the reasons for the same should be communicated to this Directorate. In case any unexpected serious adverse reaction is observed during trial, the same should be immediately communicated. It may kindly be noted that merely granting permission to conduct clinical trials with the drug does not conveyor imply that based on the clinical trial data generated with the drug, permission to market this drug in the country will automatically be granted to you. You are also requested to follow Ethical aspects of the clinical trial as described in the booklet "Ethical Guidelines for Biomedical Research on Human Subjects" published by Indian Council of Medical Research (ICMR), New Delhi, and 'GCP' guideline issued by this Department and to obtain
Transcript
F. No. CT/84/2012-DCG (I)Directorate General of Health Services
Office of Drugs Controller General (India)(Biological Division)
To
FDA Bhawan New Delhi
Dated: 2 8 DEe 2012
MIs Baxter (India) Pvt. Ltd.,2nd Floor, Tower C. Buildling No.8,DLF Cyber Park, DLF Cyber city,DLF Phase II, Gurgaon.
Subject: A Phase III clinical trial entitled "A Phase 3 Prospective, Multicenter Study Evaluating Efficacyand Safety in Previously Treated Patients with Severe (FIX level < 1%) or ModeratelySevere (FIX level S; 2%) Hemophilia B Undergoing Surgical or Other Invasive Procedures"Protocol No. 251002 AMENDMENT 1 VERSION: 11 October 20 l l-reg.
Reference: Your letter no BAX/BS-BAX326 Sur Ph31RFA/0812 dated 23/0812012 our diary No. 35052dated 28.05.2012.
Sir,
Permission is hereby granted to you under the provisions of Rule 122DA of Drugs and CosmeticsRules to conduct Phase III clinical trial with the said drug at the sites and under the supervision of theinvestigators as mentioned below and as per the protocol forwarded to this Directorate.
1. Dr. Shashikant Janardan Apte, Sahayadri Speciality Hospital, A unit of Sahyadri HospitalsLimited, 30C, Erandwane, Karve Road, Pune 411004, India.
2. Dr. Naresh Gupta, LNJP Maulana Azad Medical College & Associated Hospital, New Delhi -110002
3. Dr. Vijay Ramanan, Jehangir Hospital and Research Center, Pune -411016
At the time of submitting clinical trials reports to this Directorate for evaluation you are required tocomply with the following requirements:
1. Submit complete report of clinical trials as per the approved protocol from the individualinvestigator duly signed by him along with his observations/remarks on the drug.
2. Indicating the date of commencement and conclusion of the clinical trial at each center (in casethe study is multi-centric).
3. Approval of the Ethical Committee of the concerned center/institution for conducting theclinical trial with the said drug.
You are requested to submit to this Directorate an annual status report on each clinical trial viz.ongoing, completed or terminated. In case the trial is terminated the reasons for the same should becommunicated to this Directorate. In case any unexpected serious adverse reaction is observed duringtrial, the same should be immediately communicated.
It may kindly be noted that merely granting permission to conduct clinical trials with the drugdoes not conveyor imply that based on the clinical trial data generated with the drug, permission tomarket this drug in the country will automatically be granted to you.
You are also requested to follow Ethical aspects of the clinical trial as described in the booklet"Ethical Guidelines for Biomedical Research on Human Subjects" published by Indian Council ofMedical Research (ICMR), New Delhi, and 'GCP' guideline issued by this Department and to obtain
Ethical Committee clearance of the Institute before initiation of the study. Ethical Committee clearanceshould be obtained before initiation of the study.
• It is mandatory to register this clinical trial at ICMR clinical trial registry at www.ctri.in beforeenrolling first patient in the study.
• In future correspondence, you may intimate this Directorate that you have registered the studyas mentioned above.
• In case of study related injury or death, you will provide complete medical care as well ascompensation for the injury or death and statement to this effect should be incorporated in theInformed Consent Form. Further in case of such injuries or deaths the details of compensationprovided should be intimated to this Directorate.
Yours faithfully,
(Dr. G. . Singh)Drugs Controller Gen ral (India)
:F. No. CT/84/2012-DCGIDirectorate General of Health Services
Office oirDrugs Controller General (India)(Biological Division)
FDABhawan, Kotla RoadNew Delhi 110002Dated:
To,MIs Baxter (India) Pvt. Ltd.,2nd Floor, Tower C. Building No.8,DLFCyber Park, DLFCyber city,DLFPhase II, Gurgaon -122002.
2 S OfC 2012
Subject: Export of biological samples by Mis Baxter (India) Pvt. Ltd., Gurgaon toSingapore, USA, Germany, and Austria for testing purpose.Protocol No. - 251002
Ref: Your letter no. BAX/BS-BAX326 Sur Ph3/RFA/0812 dated 23/08/2012 ourdiary No. 35052 dated 28.05.2012.
Sir,This directorate has no objection to your export of following quantity of
samples for test/ analysis at1. Covance Singapore, International Business Park, #05-12A/B The Synergy
Singapore.2. Covance Indianpolis, 8211 SciCor Drive, Indianpo1is, IN 46214, USA3. Esoterix Clinical Trial Services, David Burgos / Specimen Management, 750
Berlin, Campus Mitte, Chariteplatz 1, 10117, Berlin, Germany.6. Dr. Chridtof Geisen, DRK-B1ood Donor Service Baden - Wurttemberg - Hessen
gGmbH Institute of Transfusion, Medicine and Immunohematology,Sandhofstrabe 1,60528 Frankfurt, Germany.
Biological samples to Quantityexported
Whole Blood 78.4 mlPlasma 630 m1Serum 257.6 mlU:rine 189 ml
Yours Faithfully,
(Dr. ~ingh)DrugsControllt~~:ral (I)
To,
F. No. CT/84/12-DCGIDirectorate General of Health Services
Office of Drugs Controller General (India)(Biological Division)
FDA Bhawan, Kotla RoadNew Delhi 110 002
Dated: 2 S DEe 2012M/s Baxter (India) Pvt. Ltd.,2nd Floor, Tower C. Building No.8,DLF Cyber Park, DLF Cyber city,DLF Phase II, Gurgaon -122002.
Sir,With reference to your letter no. BAXIBS-BAX326 Sur Ph3/RFA/0812 dated 23108/2012
our diary No. 35052 dated 28.05.2012, please find enclosed herewith the "license forexamination, test and analysis" bearing Nos. T- 3~o9--\j'2- under the provision of Drugs andCosmetics Act & Rules to import the drugl drugs mentioned in your application(s).
You are requested to comply with the following conditions in addition to the conditionslaid down under Rule 33 of Drugs and Cosmetics Act & Rules thereunder ;-
1. The drugs imported under this license shall not be used for clinical studies/trials unlessspecifically permitted so by the licensing authority.
2. The drugs imported under this license shall not be directed to or for CommercialMarketing including export purposes.
3. You shall obtain No Objection Certificate from the Narcotics Commissioner ofIndia, 19,The Mall Morar, Gwalior for the import of drugs falling under the purview of theNarcotic Drugs and Psychotropic Substances Act and Rules 1985.
Kindly acknowledge receipt of this letter and its enclosures.
Yours faithfully,
(Dr. G. . Singh)Drugs Controller eneral (I)
Copy together with a copy of License No. T- 3sos)...IIL ,dated_-----."',...."2 B DEe 2012
Forwarded for information to»
1. The Asstt. Drugs Controller, India, New Customs House, Mumbai2. The Asstt. Drugs Controller, India, Custom House, Calcutta3. The Asstt. Drugs Controller, India, Custom House, Chennai4. The Asstt. Drugs Controller, India, IGI Airport, Air Cargo Unit, New Delhi
]8'. No. CT /84/ 12-DCGITHE DRUGS AND COSMETICS RULES, 1945
FORM-II(SEE RULE - 33)
LICENCE TO IMPORT DRUGS FOR THE PURPOSE OF EXAMINATION, TEST OR ANALYSIS
Number of Licence T- 3SoS~ \ I~
Mis Baxter (India) Pvt. Ltd.,2nd Floor, Tower C. Building No.8, DLF Cyber Park, DLFCyber city,DLF Phase II, Gurgaon -122002, India is hereby licensed to import from TheoremClinical Research GmbH, Konigsteriner Strabe 10, 65812 Bad Soden / Ts, Germany. Thedrugs specified below for purposes of examination, test or analysis for clinical trial {ProtocolNo. 251002 AMENDMENT 1 VERSION: 11 October 20ll} in India or in such other places asthe Iicensing authority may from time to time authorize.
1. The license is subject to the conditions prescribed in the Rules under the Drugs andCosmetics Act, 1940.
2. This license shall unless previously suspended or revoked, be in force for period of oneyear from date specified below:
S.No. Name of Drugs Total Quantity to beimport
1. Recombinant Factor IX (rFIX) 1436 Kits
Each kit will include:• 1 vial of lyophilized powder with
nominal potency of 500, 1000 or 2000IU/vial
• 1 vial with 5ml sterile water forinjections
• 1 needleless transfer device forreconstitution (BAXJET II).
2. Device Kit 660 KitsThe ancillary package contains:• 10, 20 and 30 ml plastic syringes• A 23- gauge winged infusion set
(Item One (02) only)Not for any Commercial Purposes
New DelhiDate_~2J-.-.J8!;t-OEC ?012
(Dr.b~Singh)Drugs Controller General (I)
Directorate General of Health Services
Conditions of License (Also see Rule 33)
1. The licensee shall use the substances imported under the license exclusively forpurpose of examination, test or analysis and shall carry on such examination, test oranalysis in the place specified in the license, or in such other places as the licensingauthority may from time to time authorise.
2. The licensee shall allow any inspector authorized by the licensing authority in thisbehalf to enter, with or without prior notice, the premises where the substances arekept, and to inspect the premises, and investigate the manner in which thesubstances are being used to take samples thereof;
3. The licensee shall keep a record of, and shall report to the licensing authority, thesubstances imported under the license, together with the quantities imported, thedate of importation and the name of the manufacturer.
4. The licensee shall comply with such further requirements, if any, applicable to theholders of licenses for examination, test or analysis as may be specified in any rulessubsequently made under Chapter III of the Act and of which the licensingauthority has given to him not less than one month's notice.
