F. No. 4-164/QUINTILES/12-BDDirectorate General of Health Services

Central Drugs Standard Control Organization(Biological Division)

To,

FDA Bhawan, New Delhi-I 10002

Dated: '6 APR l~'~MIs Quintiles Phase One Clinical Trials Pvt. Ltd.,7th & 8th Floor, Apollo Health Street BuildingApollo Health City, Jubilee HillsHyderabad - 500033

Subject: Permission for grant of permission to participate in "Pharmacokinetic andPharmacodynamic Bioequivalence of Single Dose Zydus Pegfilgrastim to NeulastaPegfilgrastim from US and EU source" vide Protocol No. QHYD- 0001, version 1.0 dated31/05/2012-reg.

Reference: Your letter No. QHYD-001/01/08/2012 dated 01/08/2012 (Diary No. 32145 dated08/08/2012).

-Sir,This Directorate has no objection to your conducting subject mentioned Bioequivalence

study under the provisions of Rule 122 DA of Drugs and Cosmetics Rules only under thesupervision of the investigator mentioned below as per Protocol No. QHYD - 0001, version1.0 dated 31/05/2012 forwarded to this Directorate.

l. Dr. Manoj K.Bose, Quintiles Phase One Clinical Trials Pvt. Ltd., 7th & 8th Floor, ApolloHealth Street Building, ApolloHealth City, Jubilee Hills, Hyderabad - 500033

At the time of submitting study reports to this Directorate for evaluation you are required tocomply with the followingrequirements:

1. Submit complete report of Bioequivalence study 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 bioequivalence study ateach center (in case the study is multicentric).

3. Approval of the Ethical Committee of the concerned centre/institution for conductingthe bioequivalence study with the said drug.

You are requested to submit to this Directorate an annual status report on eachbioequivalence study viz. ongoing, completed or terminated. In case the study is terminated thereasons for the same should be communicated to this Directorate. In case any unusual,unexpected or serious adverse reaction is observed during trial, the same should beimmediately communicated.

It may kindly be noted that merely granting permission to conduct Bioequivalence studywith the drug does not conveyor imply that based on the clinical trial data generated with thedrug, permission to market this drug in the country will automatically be granted to you.

You are 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 Councilof Medical Research (ICMR),New Delhi, and GCP guideline issued by this Directorate, get the

proposed trial registered at ICMRclinical trial registry at www.ctri.in and also obtain EthicalCommittee clearance of the Institute before initiation of the study.

It may also be noted that registration of clinical trial as mentioned above, is mandatoryw.e.f 15th June 2009. In future correspondence, you may initiate this Directorate that you haveregistered the study as mentioned above.

Also, it is informed that the amendments to Rule 122DAA, inclusion of Rule122DAB, compensation matters etc., vide GSR 53 (E) dated 30.01.2013 and inclusion ofRule 122DD vide GSR no. 72 (E) dated 08-02-2013 under the provisions of Drugs &Cosmetics Act 1940 are all mandatory and binding.

Yours faithfully,

(Dr.G • Singh)Drugs Controller eneral (I)