The invitro diagnostics (IVD) market in India is growing at a phenomenal pace and the country has the potential to emerge as a global manufacturing hub in the medical devices space. India is the fourth largest market for IVD devices in Asia after China, Japan and South Korea. Demand for personalized medicines, innovations in diagnostic techniques, increasing preference for point-of-care testing among the general population, a growing geriatric population base and increase in disposable incomes is driving the growth of the IVD sector in India. The medical devices industry in India is still in a nascent stage and its efficacies are largely restrained by a fragmented structure and its import centric nature. The Indian government has taken positive steps to boost the capacities of the domestic IVD sector. The formulation of the Medical Devices Rule 2017, which will come into effect from January 1, 2018, is a key measure which will direct investment inflows in the sector and reduce the production cost of devices, whose benefits, in turn, can be passed on to the end user. The healthcare sector is likely to receive a flurry of investments with the government considering coming out with a new FDI policy. The government needs to provide a level-playing field to domestic IVD manufacturers’ vis-à-vis their global peers by removing the anomalies in inverted duty structure and reducing the tariff on raw materials. The right mix of pro-industry policy initiatives and investment strategies can position India as a global IVD manufacturing power and leverage its latent competencies to scale the next level of growth trajectory.