Tele. No. : 011-23236965Fax No. : 011-23236973

Dy.56975Dated 12.12.11

File No. 4/GSK-58/HXA/08-BD (Part-I)Directorate General of Health Services

Office of Drugs Controller General (India)(Biological Division)

FDA Bhawan, New Delhi.Dated:

To,Mis. GSK Asia Private Ltd.Patiala road, Nabha,Punjab- 147201.

(' I ,aEe 20.1

Subject: Permission for conducting Open label, randomized, multicentre, phase III clinical trial study toevaluate Immunogenicity and Safety of GSK's DTPa-HBV-IPV/Hib (Infanrix hexa) whenadministered to infants ( 224 subjects) according to 6-10-14 weeks and 2-4-6 months schedule as perCT protocol No. (111157) DTPa-HBV-IPV-119 Version no. Final: 17/03/11-regarding.

CT NOC No.: CT/I04/2011

Reference: Your letter No. RA/881120ll dated 9th Dec. 2011.

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

supervision of the investigators mentioned in your letter and as per the protocol forwarded to this Directorate. At thetime of submitting clinical trials reports to this Directorate for evaluation you are required to comply with thefollowing requirements:-

I. Submit complete report of clinical trials as per the approved protocol from the individual investigator dulysigned by him along with his observations/remarks on the drug.

2. Indicating the date of commencement and conclusion of the clinical trial at each centre (in case the study ismulti-centric).

3. Approval of the Ethical Committee of the concerned centre/institution for conducting the clinical trial withthe 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 thisDirectorate. In case any unexpected serious adverse reaction is observed during trial, the same should beimmediately 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 countrywi II automatically be granted to you. .You are also requested to follow Ethical aspects of the clinical trial as described in the booklet "Ethical Guidelinesfor Biomedical Research on Human Subjects" published by Indian Council of Medical Research (ICMR), NewDelhi, and 'GCP' guideline issued by this Department and to obtain Ethical Committee clearance of the Institutebefore initiation of the study. Ethical Committee clearance should be obtained before initiation ofthe study.• It is mandatory to register this clinical trial at ICMR clinical trial registry at www.ctri.in before enrolling first

patient in the study. In future correspondence, you may intimate this Directorate that you have registered thestudy as mentioned above and also mention the registration number in all your correspondences.

• In case of study related injury or death, you will provide complete medical care as well as compensation for theinjury or death and statement to this effect should be incorporated in the Informed Consent Form. Further incase of such injuries or deaths the details of compensation provided should be intimated to this Directorate.

• Only CDL certified batches shall be used in the Clinical trial study.• You are required to amended clinical trial protocol before initiation of the study incorporating the various

commitments including the subset analysis plan for Hep Band OPV, revised rCF and Case report form asgiven in response letter vide dy. No. 56975 dated 12thDe. 2011 to this Directorate.

Yours faithfully,

~.'\~;::-(Dr. V.G.Somani)

Drugs Controller General (India)

F.No. 4/GSK-58/HXAl08 BD (Part-I)Directorate General of Health Services,Office of Drugs Controller General, India

(Biological Division)

Dy. No. 44655 Dt. 22/09/10

s-

To,

FDA Bhawan Kotla Road,New Delhi -110002, India.Dated: _

Mis. GlaxoSmithKline Asia Private Limited,Patiala Road, Nabha,Punjab -147 201.

2 t .~I uEC 20l

Dear Sir,

With reference to your letter No. RAl50S/2010 dated 20/09/2010, please find enclosed

herewith the license for examination, test and analysis" bearing no. T-9910/11 under the provision of

Drugs and Cosmetics Act Rules to import the drug/drugs mentioned therein.

Kindly acknowledge receipt of this letter and its enclosures.

Yours faithfully,iV~<Y

~(Dr. V.G. Somani)

Drugs Controller General (India)

Copy together with a copy of licence Nos. T-9910/11

Forwarded for information to:-

1. The Asstt. Drugs Controller, India, New Customs House, Mumbai.

2. The Asstt. Drugs Controller, India, Custom House, Calcutta.

3. The Asstt. Drugs Controller, India, Custom House, Chennai.

4. The Asstt. Drugs Controller, India, IGI Airport, Air Cargo Unit, New Delhi.

F.No. 4/GSK-58/HXA/08 BD (Part-1)THE DRUGS AND COSMETICS RULES, 1945

FORM-ll(SEE RULE - 33)

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

Number of Licence T·9910/11

Mis. GlaxoSmithKline Asia Private Limited, Patiala Road, Nabha, Punjab 147201 is herebylicenced to, import from Rixensart, Belgium The drugs specified below for purposes of examination,test or analysis at India or in such other places as the licensing authority may from time to timeauthorize.

(1) This licence is subject to the conditions prescribed in the Rules under the Drugs andCosmetics Act, 1940.

(2) This licence shall unless previously suspended or revoked, be in force for period of one yearfrom date specified below:

S.No. NAME OF THE DRUGS QUANTITIES

l. Infanrix hexa: DTPa-HBV-IPV 950 packs(White suspension in a pre-filled syringe)

2. Infanrix hexa: Hib 950 packs(The Lyophilized Hib component presented asa white pellet in a glass vial)

(Items Two (02) only)(Not for Commercial Purposes)

New DelhiDate V<~~

«Dr. V.G. Somani)Drugs Controller General (India)

Licensing AuthorityCondition of License

I. The licensee shall use the substances imported under the licence exclusively for purpose of examination, test or analysisand shall carryon such exam ination, test or analysis in the place specified in the licence, or in such other places as thelicensing 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 which thesubstances 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 the licence,together with the quantities imported, the date of importation and the name of the manufacture4 The licensee shall comply with such further requirements, if any, applicable to the holders of licences for examination,test or analysis as may be specified in any rules subsequently made under Chapter III of the Act and of which the licensingauthority has given to him not less than one month's notice.5. The drugs imported under this licence shall not be used for clinical studies/trials unless specifically permitted so bylicensing 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, Gwaliorfor the import of drugs under Narcotic Drugs and Psychotropic Substances Act and Rules, 1985.

F.No. 4/GSK-58/HXA/08 BD (Part-I)Directorate General of Health Services

Office of Drugs Controller General (India)(Biological Division)

FDA Bhawan, Kotla Road,New Delhi- 110002.Dated:

To,Mis. GlaxoSmithKline Asia Private Limited,Patiala Road, Nabha,Punjab -147 201.

2 9 OtC '20H

Subject: Export of Human Biological samples by Mis GlaxoSmithKline Asia Private Limited,Patiala Road, Nabha, Punjab -147 201 to GSK Biologicals Clinical Immunology, R&DDepartmentl Building 44, Rue de I'Institut 89 B - 1330, Rixensart, Belgium for testingPurpose (CT Protocol No. - 111157) - regarding.

Reference: Letter No. RA/508/2010 dated 20109/2010.

Sir,This directorate has no objection to export the following Human Biological samples by

Mis GlaxoSmithKline Asia Private Limited, Patiala Road, Nabha, Punjab -147 201 for clinicaltrial antibody titre response tests at Mis GSK Biologicals Clinical Immunology, R&DDepartment I Building 44, Rue de I'Institut 89 B - 1330 Rixensart - Belgium.

Serum

Quantity

1568 ml

Biological samples to exported

Yours Faithfully,i(~v,(Dr. V. G. Somani)

Drugs Controller General (I)