28191113107112

F. No. CT/83/12-DCG (I)Directorate General of Health Services

Office of Drues Controller General (Indial(New Drug Divisionl

FDA Bhawan New DelhiDated: 3l_i. -f {

ToM/s. Klinera Corporation India,40 1, Hill View Indl. Estate, Amrut Nagar,L.B.S. Marg, Ghatkopar (W), Mumbai-4OO 086.

Subiect: Clinical trial with Ranolazine 500 mg film coated tablets (Protocol No: GS-US-259-

0 147 dated 19-Mar-20 1 2)-regarding.

CT No: CT/Drugs/ 75612012

Reference: Your letter no nil dated 1I l07 I 12.

Sir,Permission is hereby granted to you under the provisions of Rule 122 DA of Drugs and

Cosmetics Rules to conduct Phase III clinibal trial with the said drug at the sites and under thesupervision of the investigators as mentioned below and as per the protocol forwarded to thisDirectorate.

1. Dr. Badgandi Mohan Manipal Hospital, Airport Road, Bangalore'2. Dr. Mala Darmalingam Endocrinolog' & Diabetes Research Centre, Bangalore,

Malleshwaram, Karnataka.3. Dr. Abhay Mutha, Diabetes Care and Research Centre, Pune.4. Dr. Ramanathan Balamurgan, Kovai Diabetes Speciality Centre & Hospital,

Ramnagar, Coimbatore.5. Dr. Chittaranjan S Yajnik, KEM Hospital, Rastha Peth, Pune.6. Dr. Kiran Pal Singh, Fortis Hospital, Mohali, Fortis City Center, Punjab.7. Dr. Sivagnanam Nallaperumal, Swamy Diabetes Centre, R.K. Mutt Road,

Mandaveli, Chennai.8. Dr. K. M. Prasanna, The Bangalore Diabetes Hospital, 16lM, Thimmainah Road,

Vasanthnagar, Bangalore.g. Dr. Sanjeev Ratnakar Phatak, DHL Research Centre, 2nd Floor, Ahmedabad.10. Dr. Darshan Banker, Banker's Heart Institute, Vadodara.11. Dr" Bansi Saboo, Dia Care- A Complete Diabetes Care Center, 1 & 2, Gandhi Park,

Near Nehrunagar Cross Roadsn Ambawadi, Ahmedabad.12.Dr. Rakesh Kumar Sahay, Osmania General Hospital, Afzalgunj, Hyderabad'13. Dr" S. Srikanta, Jnana Sanjeevani Medical Center, J.P. Nagar Bangalore"

14. Dr. Ardhanareeshwaran Sharda, Endocrinolory Diabetes Centre, 640, 1st stage

Indiranagar Karnataka, Bangalore-560078.15. Dr, eshGh Saxena, Diabetes and Heart Centre, Main Sunder Nagar Road,

Ludhiana16. Dr. Padmalatha Devi, Diabetomics India, Banjara Hills, Hyderabad.17.Dr. Hansraj Alva, Vinaya Hospital and Research Centre, Karangalpady,

Mangalore,18. Dr. Sanjay Reddy, Bangalore Diabetes Hospital, Bangalore, Karnataka.19. Dr. Subhankar Choudhury, IPGME & It and SSKM Hospital, Kolkatta.20. Dr. Jayashri Shembatkar, Getwell Hospital and Research Institute, Nagpur-

440012.2l.Dr. Sunil Ambulkar, Institue of Clinical Endocrinolory (I.C.E) and Diabetes Care

' Unit (D.C.U), NagPur.22.Dr. Tushar Bandgar, Seth G.S. Medical college and KEM Hospital, Mumbai

Department of Endocrinolory, Mumbai.

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23' Dr- Johny Johe Kannampilly, Lakeshore Hospital, Mardu, Nettoor Kochi, Kerala.24. Dt. Mahendra Parmar, SSG Hospital & Medical College, Vadodara, Gujarat.25. Dr. Viswanathan Mohan, Madras Diabetes Research Foundation, Gopalapuram,

Chennai.

This clinical trial permission is subject to the condition that age limit of subjectsto be included in the study should be 18 to 65 years.

At the time of submitting clinical trials reports to this Directorate for evaluation vou arerequired to comply with the following requirements:-

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

2. Indicating the date of commencement and conclusion of the clinical trial at eachcenter (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 clinicalttial viz. ongoing, completed or terminated. in case the trial is terminatedthe 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 withthe drug does not convey or 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 thebooklet "Ethical Guidelines for Biomedical Research on Human Subjects" published by IndianCouncil of Medical Research (ICMR), New Delhi, and 'GCP'guideline issuedby this Departmentand to obtain Ethical Committee clearance of the Institute before initiation of the study.Ethical Committee clearance should be obtained before initiation of the study.

It is mandatory to register this clinical trial at ICMR clinical trial registry at3ygw.-ggge.{}e before enrolling lirst patient in the study.

In future correspondence, you may 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 deathsthe details of compensation provided should be intimated to this Dlrectorate.

vourflfaithfully,

\P(Dr. G"lN. Singh)

Drugs Controller cental (India)