Even though the government has taken a positive step in boosting capacity of domestic invitro diagnostics (IVD) industry through formulation of Medical Devices Rule 2017, a lot more needs to be done to ramp up growth of domestic manufacturing of IVD products, said Khushroo A Pastakia, chief executive officer & executive director of Voxtur Bio Ltd.

The Medical Devices Rule, once implemented in January 2018 will facilitate investment flow in IVD sector as well as lead to a decline in manufacturing cost of IVD products. The government needs to come up with a policy to encourage domestic manufacturing. The policy should aim at providing a level-playing field to Indian IVD players by eliminating shortcomings in inverted duty structure and lowering tariff on raw materials. This will enable domestic manufacturers to compete with global players. Certain incentives need to be provided by the government at par with China to encourage domestic IVD industry, said Pastakia.

He stressed the need for putting in place incentive structure to facilitate investment in the IVD sector and boost innovation and technical advancement. Greenfield manufacturing units and startups should be given tax holidays to increase their capacity, he opined.

The domestic IVD sector consists of small and medium players who lack adequate R&D fund and have capacity to make low-cost high-volume products like medical disposables. The country depends on import to cater to demand for high-end diagnostic kits and tubes. The government should focus on increasing capability of the domestic IVD industry through Make in India initiative. These steps will help provide IVD products to vast section of population at affordable prices, he added.

Over the past few years, domestic manufacturing of IVD products has witnessed double digit growth. Earlier, the ratio of domestic manufacturing to imports was merely 5 per cent. Now a number of Indian companies are manufacturing kits for blood grouping, serology, clinical chemistry, pregnancy detection, HIV detection and other rapid tests that are exported globally. Currently, these products are hardly imported.

Being second largest country in the world, India's IVD market is next to USA, China and Japan. There is lot of potential for the IVD market with growing evidence based treatment, increasing health consciousness, rising acceptance of personalised medicine, ageing population. Rise in lifestyle diseases has also driven IVD market. Existing market is valued at USD 500 million. The market is estimated to grow a CAGR of 20 per cent annually by 2020.