Trade margin rationalisation in In-vitro diagnostic Industry An India perspective October 20181. Executive summary 2. Yirroddictiogs =Executive Summarys W: th ~55 million people getting pushed below the poverty ine annually duet healthcare expenditure, making healthcare more affordable and accessible is the natural priority area for the Indian government. ‘Programmes such as NHM, RSBY. and NHPS have all been concerted efforts in this direction, each with its own success stories and learnings for future programmes. Some other initiatives include the likes of price of medical devices, procedures, drugs and services. The intended end benefit of these measures is to make healthcare more affordable. The most recent initiative in this dit been the release of a consultation paper on ‘Rationalization of trade margins in devices’ by NITI Aayog.” Medical devices consist of a heterogeneous group of equipment, devices, and impla most of which are tangible and easily visualised in the value chain. However, the gro consists of some other devices which are not sold directly to patients but instead fo to the diagnostics and therapeutic services provided to the patient. The most notabl | devices are in vitro diagnostic (IVD) reagents, which have a very different business. 4s around 2% of the overall healthcare cost: ‘but directly influences 198% cost by providing accurate and timely interpretation of medical physicians prepare a treatment plan. Relatively fee and unregulated 1 USD billion and Is growing at ~10-12% annually Unlike the! pushed 55 milion Indians into poverty in aye tnd PHF: Heath spending na ee a ctlnMedicaevice concept pal Rationalization | msl ; 3taflesidocumAcknowledgements Weare grateful forthe efforts ofthe following pioneers and thought leaders for prov fategic direction and immense contribution to this white paper eee "Mr. Badhri lyengar, Chair, FICC! Medical Devices Forum; Ma India, Smi 7 Chair, 's Forum; Managing -Indi F Be irector-India, Smith & h Kumar V, Co-Chair, FICCI Medical Devices Forum; Managing Director, Phoenix (P) Ltd. ndan Bala, Co-Chair, FICC! Medical Devices For President -India, cal Systems India Pvt. Ltd. ubramanyam, Managing Director flarkets, Roche Pvt. Ltd. Advisor, Roche Diagnostics Ind ton Dickinson India Managing Director - India te Limited & GA, Becton Dickinson India Prive rector, Biomeriuex India Pvt Ltd, naging Dii d- Regulatory, Quality & Customer Care, Bic india(rice! ~ . me vivek Kanade, Man20°S pirector Siemens Healthineers site ovo 2 Got fis, Abort Heaknae PV. Ld «4 Diagnostics Siemens Ltd Mr. Amit: ® 2 is, Abbott Healthcare Pvt.Ltd fe Mr.PrabhatJ «Ms. Jayashree Thacker president, Perkinélmer (india) Pvt Ltd ¢ MrsManish Ragtah, Manager egulatory Affairs PerkinElmer (India Pv Ltd “s Me-RaviSinha, Country Director ortho Clinical Diagnostics 4 Mr-Amol Pandit, Marketing Manager ortho Clinical Diagnostics ¢ Mr.Milind Thatte, Managing pirector, Merck Life Science Private Limited mr Akarshit Khare, Regulatory Management specialist, Merck Life Science Privat Limited (Ms, Shobha Mishra Ghosh, Assistant Secretary General, FICC Mr. Prabhat Arora, Senior ‘Assistant Director, FICC Assistant Director, FICC