India Medical Device Sector Overview

Indian Healthcare industry is close to USD 100 Bn industry and in terms of both employment and revenues, it has grown to be one of the biggest sectors in the country and has attracted a lot of foreign players. The medical devices market in India is a technology driven innovative sector & contributes to about 5% of total healthcare industry. Presently, the medical devices industry has a market size that is worth $5.2 billion and about 1000+ medical device producers in the country.

The Medical Device sector in India has seen a significant churn in the past three years, with multiple attempts being undertaken to promote local manufacturing in India, expand the ambit of Regulations and Price Control, develop standards, and define procurement policies.

The launch of MDR 2017 and its subsequent implementation in January 2018 was a significant milestone in giving medical devices and in-vitro diagnostic devices (IVD) industry a distinctive regulatory identity. The government’s recent notification to regulate all medical devices in a phase wise manner has also been a welcome move as this will promote international regulatory convergence and harmonization as guided by WHO and shall encourage to adopt internationally harmonized principles and technical guidance benefitting both domestic producers, exporters and importers. Manufacturing will get more organized and international companies will assess plans to manufacture in India in selected segments due to harmonized global standards. Increase in R&D investments will also lead to customized product development for the Indian market.

While the net impact of these policies remains to be seen, an overarching policy framework, which defines the long term vision and policy architecture, remains reclusive. In the absence of the same, these efforts are seen more as short term reactions. Considering the time taken for the pharma industry to mature to its current level from the time of process and product patents in India, it is recommended that a suitable policy be designed with consultation and inputs from all stakeholders (Industry, Regulators, Ministerial Bodies, Advisory Bodies, etc.).