F. No. 4-126/CADILA/12-BDDirectorate General of Health Services

Central Drugs Standard Control Organization(Biological Division)

To,

~

M/S Cadila Healthcare Limited\.~ 'Zydus Tower' Satellite Cross Roads

f\J" Ahmedabad-380015, INDIA

FDA Bhawan, New Delhi-ll0002

Dated: 2 1 MAR 2013

Subject: Permission to carryout a Phase I clinical trial entitled "Arandomized controlledstudy to evaluate pharmacokinetic, pharmacodynamics (efficacy) and safety ofRituximab (Zydus) and Rituximab (Roche) in patients with Rheumatoid Arthritis" videProtocol No. RIT.11.001.01, version 1.1 dated 06/11/2012-reg.

Reference: Your letter No. CHL/BT/RA/06.1l.2012/01 dated 06/11/2012 (Diary No. 46001dated 08/11 /20 12).

Sir,This Directorate has no objection to your conducting subject mentioned study: under the

rovisions d: 1e-122-QA -f-Qr-tl~~~ -' sues on y under the supervision of theinvestigators mentioned below as per Protocol No. RIT.11.001.01, version 1.1 dated06/11/2012 forwarded to this Directorate.

1. Dr. Atchuta Ramaiah, Department of Orthopaedics, Andhra Hospital, CVRComplex, Prakasham Road, Vijaywada - 520002.

2. Dr. Aman Sharma, Department of Rheumatology (Internal medicine), PGIMER,Chandigarh.

3. Dr. Ashok V. Bangarashettar, Manvi Multispeciality Hospital, Hubli-580029.4. Dr. Ateet B. Sharma, Satellite Orthopaedic Hospital and Research Centre PVt.

Ltd., 302, Vraj Complex, Dhananjay Towers, 100 Feet Road, Nr. Shyamal CrossRoads, Ahmedabad-380015.

5. Dr. Gattani Atul Krishnakumari, Sterling Wockhardt Hospital, Sector 1, Vashi,Navi Mumbai-400703.

6. Dr. Gaurav Rathi, Rathi Orthopaedic & Research Centre, Nr. Anupam ShoppingCentre, Opp. Mahabaleshwar Society, Jodhpur Cross Roads, Satellite,Ahmedabad-3800 15.

7. Dr. H.M. Prasana, Pristine Hospital and Research Centre Pvt. Ltd., #1877, ModiHospital Road, 2nd Stage Extension, West of Chord Road, Bangalore-560086.

8. Dr. Hemant Gopal, Pushpawati Singhania Research Institute For Liver, Renal &Digestive Diseases, Press Enclave Marg.-Sheikh-Sar:ai-P-hase-I-I-~---New-E)~lh7-i-----

------'11110-017.9. Dr. Kaushik S Bhojani, Kennisha Rheumatology Care & Diagnostics, Bhandup,

Mumbai10.Dr. Jadhav Praveen Pratap, Omkar Heart Institute & Nursing Home &

Rheumatology Clinic, Behind Regimental Plaza, Gaikwad Mala, Nasik Road,Nasik - 42210l.

l1.Dr. Puttakemparaju K V, Sushruta Orthopaedic and Eye Care Centre, 1/1, 1st

temple road, 15 Cross, Bangalore12.Dr. Ramachandra Kamath, Dept. of Orthopaedics, Kasturba Medical College

Hospital, Attavar, Mangalore - 57500113.Dr. Ravindra Gauda Patil, Vijaya Ortho & Trauma Centre, Opp M.G. Bhawan,

Behind Sanman Hotel, CollegeRoad, Belgaum14.Dr. Ravindra Kumar Nagula, Gandhi Hospital, Secunderabad-50000315.Dr. Renu Saigal, Department of Medicine, SMS Medical College & Hospital,

Jaipur.

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16.Dr. Saurabh Agarwal, Lucknow Hospital, B-1, Sindhu Nagar, Behind KrishnaNagar, Thana, Kanpur Road, Lucknow-226023

17.Dr. Shashank Akrekar, Mumbai Arthritis Clinic & Research Centre, Bhandup(West).

1S.Dr. Somnath, Hyderabad Medical Centre, Erragadda, Hyderabad.19.Dr. T. Ramakrishna, Orthopaedic Clinic, Chikkadapally, Hyderabad - 500020.20. Dr. Vikram Haridas, Sushruta Multispeciality Hospital & Research Center Pvt.

Ltd., Vidyan agar , P.B. Road, Hubli-580021

At the time of submitting study reports to this Directorate for evaluation you are requiredto 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 on thedrug.

2. Indicating the date of commencement and conclusion of the clinical trial at each center(in case the study is multicentric).

3. Approval of the Ethical Committee of the concerned centre/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 unusual, unexpected or seriousadverse 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 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 you.

Yours faithfully,/j!:(Dr. .N. Singh)

Dru~s Controlle General (I)0IvbJ-~ ~

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 theproposed trial registered at ICMR clinical 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 Rule1220AB, compensation matters etc., vide GSR 53 (E)dated 30.01.2013 and inclusion ofRule 12200 vide GSR no. 72 (E) dated 08-02-2013 under the provisions of Drugs &Cosmetics Act 1940 are all mandatory and binding.

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