Strengthen MedTech in India through R n D Policy
December 13, 2021:
Recently, the Ministry of Pharmaceutical Sciences (DoP) has published a draft guideline aimed at facilitating research and development (R & D) in the pharmaceutical and medical device sectors. With the implementation of this document, India aims to become a leader in drug discovery and innovative medical devices by fostering an entrepreneurial environment. This policy also plans to address the current flaws in the Medtech space, especially the domestic manufacturing capacity underdeveloped in high-end scanning and imaging equipment.
India’s medical device sector, which is currently the fourth largest in Asia, is growing by encouraging R & D investment in diagnostics, promoting a startup ecosystem, increasing exports and attracting more medical tourism. The purpose is to provide an opportunity. The three main areas the policy focuses on are strengthening regulatory frameworks, encouraging investment, and realizing an ecosystem for innovation.
What is a roadmap?
This document sets out several steps aimed at achieving that goal, with a focus on the following priority areas:
Strengthening the regulatory framework: This policy aims to achieve this by optimizing the process, reducing duplication, and approving the timeline. We also plan to create a single technology-based portal hosted by CDSCO. Another aspect is by building in-house expertise in areas such as new biological and new chemical entities, biologics, imaging medical technologies, new materials, remote diagnostics, AI / ML-based innovations, sensors and more. The focus is on strengthening regulatory capacity. Greater cooperation with international regulatory agencies. In addition, the current law will be reviewed to eliminate redundancy and contradictions.
Encouragement of investment with financial and non-financial support: This policy plans to create and promote a vision of “discovery in India”. It will boost national R & D investment by providing financing schemes and tax refund policies for innovative products and improving ROI through redemption. It also seeks to mitigate industry challenges by considering tax and financing issues, reducing the burden of compliance, and harmonizing multiple regulations on single-window clearance. This policy may also introduce special grants, receive support from existing funds as needed, and partner with research and funding agencies.
Creating a facilitating ecosystem for innovation: One of the most important areas of R & D policy is to strengthen industry-academia collaboration between sectors. We plan to build the infrastructure, set up an innovation hub, and create more incubation centers and center of excellence. This document also addresses the need to implement strong intellectual property policies.
Why now?
Through the pandemic, the country has witnessed trends in better treatment outcomes, home care, personalized diagnostics, wearables, telemedicine, etc., leaving room for differentiated products and services. Therefore, this required policies that would likewise evolve, welcome and promote India’s current health care trends to the next level.
As a result, this policy was introduced. It’s a competitive regulatory environment that accelerates R & D, drives targeted financing, builds strong industry-academia collaboration in line with global best practices, and provides best-in-class infrastructure for innovation. The purpose is to create. Pharmaceuticals-Medtech Sector. The specific purposes of the policy are:
a) Simplify regulatory process to enable rapid drug discovery, development and innovation of medical devices
b) Explore mechanisms that encourage private sector investment in research, evaluate various financing mechanisms (budget support, venture capital, CSR financing, etc.), and financial incentives to support innovation.
c) Identify mechanisms for strengthening the R & D ecosystem through strengthening industry-academia collaboration.When
d) Integrate existing policies and programs from different departments / institutions / institutions to enable the development of mechanisms for dubtailing research according to industry requirements.
What is the timeline?
This policy describes a step-by-step implementation with a five-year action plan and a total of ten-year annual plan. This time, a task force is set up, actions are determined, responsibilities are assigned, and finally decisions for implementation are made. All of these tasks are constantly monitored and evaluated with the help of a high level task force.
Where are we now?
The Department of Pharmaceutical Sciences (DoP) and Invest India are presenting policies and seeking feedback from all stakeholders. Industry representatives also developed skills, infrastructure development, and “joint inventions” from developing clear clinical research guidelines, IP protection policies with faster turnaround times, and health economics-based reimbursement policies. And “Co-innovation” between industry and academia. If policies are deployed in a timely manner and implemented successfully, India will quickly rise its rank in the ease of executing business indicators and begin to rise to become a global hub for the healthcare sector.
Anjali Singh, Manager, Indian Medical Technology Association.