Jeevan Scientific Technology Limited Eepeetripemtiy moe irene Ref: JSTL/BSE/MD/2016-17/Dec16 Date: Dec 21, 2016 To: Head - Listing Operations, BSE Limited, P.J. Towers, Dalal Street, Fort, Mumbai — 400 001 Dear Sir/Madam: Sub: Approval of Bioavailability/Bioequivalence Study Centre at B-17, TIE, Phase-Il, Balanagar, Hyderabad — 500 037. Ref: Scrip Code: 538837, Jeevan Scientific Technology Limited With reference to the above subject, we would like to inform that our Clinical Pharmacology Centre to conduct Bioavailability/Bioequivalence studies has been approved by the “Office of Drug Control General, India (DCGI)” on 16-Dec-2016 for a period of Three (3) years. This Centre having four independent clinics having a total capacity of 132 beds will facilitate end-to-end Bioequivalence studies by Jeevan Scientific Technology Limited. A copy of the approval has been attached along with this covering letter. Thanking you. Yours faithfully, For JEEVAN SCIENTIFIC TECHNOLOGY LIMITED ¢ ha ae K. GOPI KRISHNA MANAGING DIRECTOR (DIN: 02376561) Registered Office: Plot No. 162, Sai Krupa Enclave, Near Lanco Hills, Golconda Post, Hyderabad- 500 008, T:S., India. Tel: +91-40-67364700, Fax: +91-40-67364707. Email: info@jeevanscientific.com Web: www.jeevanscientific.com CIN: L72200TG1999PLCO3101614 a Directorate General of Health Services Office of Drug Controller General (India) (Drugs Control Section) FDA Bhawan, Kotla Road, New Delhi-1 10002. ta baed 1§ DEC 2016 ‘Mis Jeevan Scientific Technology Limited., B-17, TIE, Phase Il, Balanagar, Hyderabad- 500 037, Telangana State, Sub:- Approval of Bioavailability/Bioequivalence Study Centre and approval of additional Bioanalytical facility of M/s, Jeevan Scientific Technology Limited. B-17, TIE, Phase I1, Balanagar, Hyderabad- 500 037, Telangana State. Sir, a Please refer to letter no. JST/RA/2016/JUL/001 dated 08/07/2016 received by this Directorate vide diary no. 40135/16 dated 22/07/2016 on the subject stated above, As per documents submitted by you, this Directorate will accept the protocol and Bioavailability / Bioequivatence study reports of New Drugs from your center having Clinical facility with following number of beds: 1) 3" Floor: CPU-1 (42 beds), CPU-2 (24 beds) 2) 2" Floor: CPU-3 (42 beds), CPU-4 (24 beds) ‘at “M/s Jeevan Scientific Technology Limited., B-17, TIE, Phase Il, Balanagar, Hyderabad- 500 037” subject to following conditions:- 1, The study centre should ensure that the whole Informed Consent Process shouild be documented through Audio-Video means maintaining the principle of confidentiality as per GSR 611(E) dated 31.07.2015. 2. Specific protocol for coriducting BE/BA studies with new drug formulation should be cleared by Institutional Ethics Committee and then get approval from this office on case to case basis. 3. This certificate shall remain valid for a period of three years from the date of issite. However, there will be periodical assessment of performance of said study centre for continued acceptance of protocol and reports in this regard. Yours faithfully, (Dr. S, Eswara Reddy) Joint Drugs Controller (India) ‘Copy.to:- Dy. Drugs Controller (1), CDSCO, Zonal Office, CDSCO Bhawan, S. R. Nagar, Hyderabad-500 038, Telangana State.