The Ministry of Chemicals and Fertilizers’ Department of Pharmaceuticals (DoP) recently unveiled an Approach Paper for the Draft National Policy for the Medical Devices, 2022. The proposed policy aims to streamline regulations, bolster competitiveness, create infrastructure, encourage research and development (R&D), and foster human resource development in order to advance India’s medical device industry.
Key Features of the Draft Policy
The draft policy presents several strategies aimed at bolstering India’s medical device industry.
Regulatory Streamlining
The policy proposes the optimisation of regulatory processes and a reduction in the number of agencies involved in the oversight of the industry. This is designed to enhance the ease of conducting business and align Indian standards with those practiced globally for improved safety of devices.
Building Competitiveness
The draft policy plans to stimulate the growth of local manufacturing through financial encouragement and investment from the private sector.
Infrastructure Development
Additionally, the policy suggests the provision of top-tier physical infrastructure, including medical device parks equipped with common facilities such as testing centres. This would enhance cost competitiveness and the attractiveness of domestic manufacturers.
Facilitating R&D and Innovation
The policy emphasizes the need for increased cooperation in innovation and R&D projects, as well as global partnerships and joint ventures among key stakeholders. This approach is intended to bridge the gap between academic education and industry requirements.
Human Resource Development
The draft policy also highlights the need for relevant higher education curriculum, skilling of stakeholders, and the creation of a future-ready HR force with required skill sets across the innovation value chain.
Awareness Creation and Brand Positioning
To promote India as a global manufacturing hub for medical devices, the policy articulates strategies for raising awareness and positioning India under the “Make in India, Make for the World” initiative.
Objective of the Policy
The policy addresses core objectives such as accessibility, affordability, safety, and quality. Moreover, it emphasizes self-sustainability and innovation. By 2047, the policy envisions India will establish multiple National Institutes of Medical Devices Education and Research (NIMERs), be the originator of 25 advanced futuristic technologies in medical technology, and possess a MedTech industry valued between USD 100-300 billion.
Current State of the Medical Device Industry in India
The Indian medical device market is predominated by multinational companies, with about 80% of the sales generated from imported devices. Despite being one of the top twenty markets for medical devices globally and the fourth-largest in Asia, the Indian medical device industry remains relatively small. The medical devices sector has remained mostly unregulated until 2017 when the Central Drugs Standard Control Organisation (CDSCO) introduced the Medical Device Rules, 2017.
Issues within the Medical Devices Sector in India
Challenges in manufacturing medical devices in India include inadequate infrastructure and logistics, concentrated supply chains, and a high cost of finance. Also, despite efforts to simplify regulations, the landscape remains complex with numerous government bodies at the state and central levels.
A Way Forward
For the Indian medical device industry to thrive, increased coordination and communication among industry stakeholders are needed. The emphasis should be on competency enhancement through skilling, upskilling, and reskilling, in sync with medical and technological advancements. Furthermore, both the demand and supply sides of the medical devices industry need collaborative policy support to expand access and opportunities.
