APPROVAL COMMITTEE FOR M/s. DIVI’S LABORATORIES LIMITED, SPECIAL ECONOMIC ZONE FOR PHARMACEUTICALS AT LINGOJIGUDEM VILLAGE, CHOUTUPPAL MANDAL, NALGONDA DISTRICT, TELANGANA TABLE AGENDA Item No. 1: Proposal of M/s. Divi’s Laboratories Limited – DC SEZ unit in M/s. Divi’s Laboratories Limited, SEZ for Pharmaceuticals at Lingojigudem Village, Choutuppal Mandal, Nalgonda District, Telangana for approval for inclusion of ‘R&D Services’ in their LOA. M/s. Divi’s Laboratories Ltd – DC SEZ unit was issued LOA No. 9/427/SEZ/HYD/2019 dated 28.3.2019 for setting up unit for manufacture and export of “a) Dextromethorphan HBr, b) Levetiracetam, c) Iopromide and d) Iopamidol” in M/s. Divi’s Laboratories Limited, SEZ for Pharma at Lingojigudem Village, Choutuppal Mandal, Yadadri Bhuvanagiri District, Telangana. The unit commenced operations on 5.2.2020 and the LOA is valid upto 4.2.2025. The unit vide its letter dated 11.9.2020 has stated that they wish to submit their application for inclusion of ‘R&D Services (Process Development Services, Pilot & Validation Studies for Active Pharma Ingredients and Fine Chemicals) as they are getting regular requests from MNCs to do these services on their behalf. The inclusion of these services will be very useful to develop technical capabilities of their own employees along with the exposure to the latest developments in the field of Pharmaceutical products. The Contract Research within R&D services are provided under different specializations like process development, Chemical Hazard evaluation, analytical services and the scale up services. They are expecting to earn 10 to 30 Crores worth of Foreign Exchange for R&D Contract Services per year and NFE would be Rs. 100 Crores for the next five years. In this regard, the unit has enclosed the Technical write-up and the details of Capital Goods/Research Equipments available at the R&D for contract research activity. The unit has requested to include the R&D Services in their LOA. The proposal of the unit is placed before UAC, in terms of Rule 19 (2) of SEZ Rules, 2006 **** 1 .