F. No. CT/21/11-DCG (I) Directorate General of Health ...ctri.nic.in/Clinicaltrials/WriteReadData/dcgi/1225562245...F.No.CT/21/11-DCG (I) Directorate General ofHealth Services Office

F. No. CT/21/11-DCG (I)Directorate General of Health Services

Office of Drugs Controller General (India)(New Drug Division)

ToM/s. Parexel International Synchron Pvt. Ltd.,Plot # 180, 3rd Floor, MFAR Silverline Tech Park,EPIP II Phase, Whitefield, Bangalore -560 066.

Subject: Clinical trial with Sitagliptin (Protocol No: 130-00) - regarding.CT No: CT/Drugs/l07 /2011Reference: Your letter no nil dated 26/05/201l.

Sir,This Directorate has no objection to your conducting clinical trials with the said drug

under the supervision of the investigators mentioned in your letter and as per the protocolforwarded to this Directorate subject to condition that patients aged ~ 18 yrs and ~ 65 yrsshould be enrolled in the study. At the time of submitting clinical trials reports to thisDirectorate for evaluation you are required to comply with the following requirements:-

l. Submit complete report of clinical trials as per the approved protocol from theindividual investigator duly signed by him along with his observations/remarks on thedrug.

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 conductingthe clinical trial with the said drug.

You are requested to submit to this Directorate an annual status report on each clinicaltrial viz. ongoing, completed or terminated. In case the trial is terminated the reasons for thesame should be communicated to this Directorate. In case any unexpected serious adversereaction is observed during trial, the same should be immediately communicated.

It may kindly be noted that merely granting permission to conduct clinical trials with thedrug 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 YOL1.

You are also requested to follow Ethical aspects of the clinical trial as described in thebooklet "Ethical Guidelines for Biomedical Research on Human Subjects" published by IndianCouncil of Medical Research (ICMR), New Delhi, and 'GCP' guideline issued by this Departmentand to obtain Ethical Committee clearance of the Institute before initiation of the study. EthicalCommittee clearance should be obtained before initiation of the study.

It is mandatory to register this clinical trial at ICMR clinical trial registry atwww.ct:r_~.in before enrolling first patient in the study.

In future correspondence, you rnay intimate this Directorate that you haveregistered the study as mentioned above.

In case of study related injury or death, you will provide complete medical care aswell as compensation for the injury or death and statement to this effect should beincorporated in the Informed Consent Form. Further in case of such injuries or deaths thedetails of compcn.sation. provided should be intimated to this Directorate.

Y urs faithfully,

t :

!

(Dr. Surinder Singh)Drugs Controller General (India)

F. No.CT/21/11-DCG (I)

Directorate General of Health Services

Office of Drugs Controller General (India)

(New Drug Division)

ToM/s. Parexellnternational Synchron Pvt. Ltd.,Plot # 180, 3rd Floor, MFAR Silverline Tech Park,EPIP II Phase, Whitefield, Bangalore - 560 066.

FDA BhawanKotla Road, New Delhi,Dated:

Dear Sir / Sirs, 1 -1 A,U G lOltWith reference to your letter no. nil dated 26/05/11. I am to forward herewith

Import License No. 202/CT -BE/11 For the drug / drugs mentioned in yourapplication.

Kindly acknowledge receipt of this letter and its enclosures.

Yours faithfully,

(Dr.K.Ba~Dy. Drugs Controller (I)

Copy together with a copy of license No. 202/CT -BE/11Forwarded for information to:-

The Asstt. Drugs Controller, India, New Customs House, MumbaiThe Asstt. Drugs Controller, India, Custom House, CalcuttaThe Asstt. Drugs Controller, India, custom House, ChennaiThe Asstt. Drugs Controller, India, IGI Airport, Air Cargo Unit, New Delhi

THE DRUGS AND COSMETICS RULES, 1945

(SEE RULE - 33)

FORM-11

LICENCE TO IMPORT DRUGS FOR THE PURPOSE OF EXAMINATION, TEST

OR ANALYSIS

Number of License: 202/CT -BE/11

M/s.Parexel Internatinal Synchron Pvt. Ltd., Plot # 180, 3rd Floor, MFARSilverline Tech Park, EPIP II Phase, Whitefield, Bangalore 560 066, is herebylicensed to import from UK the drugs specified below for purposes of examination,test or analysis for clinical trial (Protocol No: 130-00) in India or in such otherplaces as the licensing authority may from time to time authorize.• The license is subject to the conditions prescribed in the Rules under the Drugs

and Cosmetics Act, 1940.

• This license shall unless previously suspended or revoked, be In force for a

period of one year from date specified below:-

Name of Drug QuantitySitagliptin matching placebo (21 tablets/bottle) 1761 tablets t

Sitagliptin 100 mg or matching placebo tablet 1434 tablets(49 tablets/ bottle)

(Items Two (2) Only)

New DelhiDate ' i··1 AU (: ·l011

~~(Dr. K. B~r\garurajan)

Dy. Drugs Controller (I)Licensing Authority

Condition of License1. The Licensee shall use the substances imported under the license exclusively for purpose of examination, test or

analysis and shall carry on such examination, test or analysis in the place specified in the license, or in such otherplaces as the Licensing Authority may from time to time authorize.

2. The Licensee shall allow any inspector authorized by the Licensing Authority in this behalf to enter, with or without priornotice, the premises where the substances are kept, and to inspect the premises, and investigate the manner in whichthe substances are being used to take samples thereof.

3. The Licensee shall keep a record of, and shall report to the Licensing Authority, the substances imported under thelicense, together with the quantities imported, the date of importation and the name of the manufacturer.

4. The Licensee shall comply with such further requirements, if any, applicable to the holders of licenses for examination,test or analysis as may be specified in any rules subsequently made under Chapter III of the Act and of which theLicensing Authority has given to him not less than one month's notice.

5. The drugs imported under this license shall not be used for clinical studies/trials unless specifically if permitted so underthe Rules and / or by Licensing Authority.

6. The drugs imported under this license shall not be directed to or for Commercial Marketing including export purposes.7. The Firm shall obtain No Objection Certificate from the Narcotics Commissioner of India, 19, The Mall Morar, Gwalior

for the import of drugs under Narcotic Drugs and Psychotropic Substances Act and Rules,1985.




(New Drug Division)

ToMIs. Parexellnternational Synchron Pvt. Ltd.,Plot # 180, 3rd Floor, MFAR Silverline Tech Park,EPIP II Phase, Whitefield, Bangalore - 560 066.

Dear Sir I Sirs,

FDA BhawanKotla Road, New Delhi,Dated: :.::-~;:-

1 1 AU G2011With reference to your letter no. nil dated 26/05/11. I am to forward herewith

Import License No. 210/CT-BE/11 For the drug I drugs mentioned in yourapplication.


Yours faithfully,


Copy together with a copy of license No. 210/CT-BE/11Forwarded for information to:-



(SEE RULE - 33)

FORM-11


OR ANALYSIS

Number of License: 210/CT-BE/11

M/s.Parexel Internatinal Synchron Pvt. Ltd., Plot # 180, 3rd Floor, MFARSilverline Tech Park, EPIP II Phase, Whitefield, Bangalore 560 066, is herebylicensed to import from USA the drugs specified below for purposes of examination,test or analysis for clinical trial (Protocol No: 130-00) in India or in such otherplaces as the licensing authority may from time to time authorize.• The license is subject to the conditions prescribed in the Rules under the Drugs


• This license shall unless previously suspended or revoked, be in force for a


Name of Drug QuantitySitagliptin matching placebo (21 tablets/bottle) 1761 tabletsSitagliptin 100 mg or matching placebo tablet 1434 tablets(49 tablets/ bottle)

(Items Two (2) Only)

New Delhi'~ .y1\ ~iDate -------------------


Licensing Authority

Condition of License1. The Licensee shall use the substances imported under the license exclusively for purpose of examination, test or




4. The Licensee shall comply with such further requirements, if any, applicable to the holders of licenses for examination,test or analysis as may be specified in any rules subsequently made under Chapter III of the Act and of which theLicensing Authority has given to him not less than one month's notice.


6. The drugs imported under this license shall not be directed to or for Commercial Marketing including export purposes.7. The Firm shall obtain No Objection Certificate from the Narcotics Commissioner of India, 19, The Mall Morar, Gwalior





(New Drug Division)

ToMIs. Parexel International Synchron Pvt. Ltd.,Plot # 180, 3rd Floor, MFAR Silverline Tech Park,EPIP II Phase, Whitefield, Bangalore - 560 066.

Dear Sir I Sirs,

FDA BhawanKotla Road, New Delhi,Dated: Ii -1 i U" ,

! ! ~"I.' ?flUv I 1 \v, ••••J L. VI 'f

With reference to your letter no. nil dated 26/05/11. I am to forward herewithImport License No. 211/CT-BE/11 For the drug I drugs mentioned in yourapplication.


Yours faithfully,

(Dr.K.B~Dy. Drugs Controller (I)

Copy together with a copy of license No. 211/CT -BE/11Forwarded for information to:- '



. (SEE' RULE - 33)

FORM-11


OR ANALYSIS

Number of License: 211/CT -BE/11

M/s.Parexel Internatinal Synchron Pvt. Ltd., Plot # 180, 3rd Floor, MFARSilverline Tech Park, EPIP II Phase, Whitefield, Bangalore 560 066, is herebylicensed to import from Germany the drugs specified below for purposes ofexamination, test or analysis for clinical trial (Protocol No: 130-00) in India or insuch other places as the licensing authority may from time to time authorize .• The license is subject to the conditions prescribed in the Rules under the Drugs


• This license shall unless previously suspended or revoked, be in force for a


Name of Drug QuantityGlucose Meters 168

Control Solution 285

Test Strips (50 ct) 1153 boxes

Lancets (50 ct) 1153 boxes

Rice Lake Scale 3

10 Kg Calibration Weight 3Universal Adapter Plug Model #: LP-PTC 3

Anthropometric DVD 3Stadiometer 3Calibration Rod, Aluminium, 90 cm 3

(Items Ten (10) Only)

New Delhi

Date ---+~r-ft++T~~HMr(Dr.K.Ba~

Dy. Drugs Controller (I)Licensing Authority

Condition of License1. The Licensee shall use the substances imported under the license exclusively for purpose of examination. test or




4. The Licensee shall comply with such further requirements, if any, applicable to the holders of licenses for examination,test or analysis as may be specifled in any rules subsequently made under Chapter III of the Act and of which theLicensing Authority has given to him not less than one month's notice.


6. The drugs imported under this license shall not be directed to or for Commercial Marketing including export purposes.7. The Firm shall obtain No Objection Certificate from the Narcotics Commissioner of India, 19, The Mall Morar, Gwaiior





(New Drug Division)

ToMis. Parexel International Synchron Pvt. Ltd.,Plot # 180, 3rd Floor, MFAR Silverline Tech Park,EPIP II Phase, Whitefield, Bangalore - 560 066.

FDA BhawanKotla Road, New Delhi,Dated:

Dear Sir I Sirs, 1 'f AU G 2011With reference to your letter no. nil dated 26/05/11. I am to forward herewith

Import License No. 212/CT -BE/11 For the drug / drugs mentioned in yourapplication.


Yours faithfully,

(Dr. K. Ba garurajan)Dy. Drugs Controller (I)

Copy together with a copy of license No. 212/CT -BE/11Forwarded for information to:-



1 (SEE- RULE - 33)

FORM-11

LICENCE TO IMPORT DRUGS FOR THE PURPOSE OF EXAMINATION, TEST OR

ANALYSIS

Number of License: 212/CT-BE/11

M/s.Parexel Internatinal Synchron Pvt. Ltd., Plot # 180, 3rd Floor, MFAR SilverlineTech Park, EPIP II Phase, Whitefield, Bangalore 560 066, is hereby licensed to importfrom Belgium the drugs specified below for purposes of examination, test or analysis forclinical trial (Protocol No: 130-00) in India or in such other places as the licensingauthority may from time to time authorize.• The license is subject to the conditions prescribed in the Rules under the Drugs and

Cosmetics Act, 1940.

• This license shall unless previously suspended or revoked, be in force for a period of

one year from date specified below:-

Name of Druq QuantityKit A 335Kit B 335Kit c 168Kit D 168Kit E 234Kit F 176

Kit X 293Kit Y 117

Kit z 176

Serology kit 59Genetic kit 5921 G Eclipse Needle W/Holder 2059

(Items Twelve (12) Only)

New Delhi

Date 1 1, ,t.\U G 7011_

(Dr. K.Ba~Dy. Drugs Controller (I)

Licensing Authority

Condition of License1. The Licensee shall use the substances imported under the license exclusively for purpose of examination. test or

analysis and shall carryon such examination, test or analysis in the place specified in the license, or in such otherplaces as the Licensing Authority may from time to time authorize.



4, The Licens~e shall comply with such further requirements, if any, rPplicabl~to ~heholders~flicenses_for e~arrlin~ti?n,Licensing Authority has given to him not less than one month's notice.


6. The drugs imported under this license shall not be directed to or fo Commercial Marketing including export purposes.7. The Firm shall obtain No Objection Certificate from the Narcotics ICommissioner of India, 19, The Mall Morar, Gwalior

for the import of drugs under Narcotic Drugs and Psychotropic SUbftances Act and Rules,1985.

F. No. CT/21/11-DCG (I)Directorate General of Health Services

Office of Drugs Controilier General (India)(New Drug Diivision)

FDA BhawanKotla Road, New Delhi,Dated: f1 ;:::-:.

" 1 AUe 2011ToMis. Parexel International Synchron Pvt. Ltd.,Plot # 180, 3rd Floor, MFAR Silverline Tech Par,EPIP" Phase, Whitefield, Bangalore - 560 066

Subject: NOC for export license for biological sanjples (Protocol No: 130-00) -regarding.

Ref: Your letter no nil dated 26.05.11 on the subject mentioned above.

Sir,Your application has been scrutinized by this office. You are requested to furnish

clarification regarding the total volume of blood to be withdrawn from each subject toconsider the matter further.

Yours faithfully,

Documents

F. No. CT/21/11-DCG (I) Directorate General of Health ...ctri.nic.in/Clinicaltrials/WriteReadData/dcgi/1225562245...F.No.CT/21/11-DCG (I) Directorate General ofHealth Services Office