The Medical Technology Association of India (MtaI) has called for the need for creating an ecosystem that fully supports technology in medical technology, from the perspectives of engineering design, human application, clinical validation and delivering the product in the hospital setting. Wider adoption of the medical devices which are developed in India is a necessary prerequisite in order for the industry to leverage the ‘Make in India’ initiative.

“The development of an expert decision-making system suitable for the manufacturing of medical devices in the country will need to be supplemented by a series of enabling policy initiatives by the government of India. To start with, regulations specific to medical devices must be laid out, which recognize the difference between medical devices and drugs. The real benefits to the sector will only become available when the creation of a different Act, and regular review and amendment of the respective rules are carried out in tandem with each other. Key to achieving the ideal ecosystem is the establishment of significant academic-industry partnership to support high-end technology manufacturing, and the development of technical know-how and skills. A tie-up with clinicians, on the other hand, will be important in the design as well as testing phases, when the industry can learn the medical needs for addressing a disease space, and can utilize the space for testing the medical devices before rolling out large-scale manufacturing,” MTaI said.

Pavan Choudary, Director General, MTaI said, “The Government needs to recognize that the MedTech sector is capital intensive with a long gestation period requiring continual infusion of technology and accordingly take a nuanced approach in its policy-making mechanisms. Given that the global medical device industry has the technology legacy, the spectrum of understanding, and strong manufacturing footprint in India, it should be included in the ‘Make in India’ policy-drawing-board.”

MTaI firmly believes that the MedTech sector is in dire need of support, in terms of policies that can be oriented towards facilitating ‘ease-of-doing’ business. Post the FDI coming on automatic route, the FDI has multiplied as was anticipated. Taxation benefits, infrastructural support, skill development, single window clearance, higher expense on healthcare, a holistic understanding of the nuanced sector and reducing the overlap between different ministries are some recommendations to help boost the performance of the MedTech sector in the country.

On the taxation front for example, in the recent GST roll-out, a large range of products came under the 12% bracket of GST, a figure that is quite high (especially after the custom duties on most devices having gone up from 11.6% to 18.9% in 2016) and will inadvertently result in a higher tax burden on patients.

“Three issues need to be immediately addressed to generate interest and actions on ‘Make in India’,” added Varun Khanna, Director, MTaI. “First, we need globally harmonized regulatory policies providing safe and effective products for patients in India and abroad. Beyond product regulatory policy, policies around investments, infrastructure, research and development add to the appeal of manufacturing in India. Secondly, companies need to gain financial viability for making in India through various tax waivers or incentives. And thirdly, we need more impetus on healthcare infrastructure.” said Khanna.