India takes pride for being known as ‘Pharmacy of the world’. The country has made it possible by becoming one of the largest suppliers in providing affordable and high-quality generic drugs. As we become self-reliant for necessary infrastructure, skills and domestic production, there is also a need to strengthen the ecosystem to fulfil unmet needs and to maintain global relevance in the Pharma-MedTech sector. The ‘Make in India’ mission has given birth to newer opportunities to start-ups, incubation centers and domestic manufacturers to establish self-reliance.
The proposed national policy on ‘R&D and innovation in the Pharma-MedTech sector in India’ helps lay out the right foundation to achieve self-reliance and become one of the leaders in the healthcare industry in all aspects. With the proposal of a national policy, the country aims to wear another crown of ‘Innovation hub’, and encourages industry partners to discover and innovate drugs, biologics, biosimilars and medical devices in the country.
The Indian government’s vision of ‘Aatmanirbhar Bharat’ is tied to various missions and schemes at domestic and international level. The proposed policy does not fail to demonstrate such linkages:
The proposed policy recognizes telemedicine, artificial intelligence, machine learning, virtual reality, the internet of medical things, nanotechnology, 3D printing, robotics, and advanced analytics for aided diagnosis as innovative fields at the global level. These are some areas where industry partners are encouraged to strategize and develop their business modules. The policy also estimates a positive impact on the animal healthcare industry with the development of R&D in the pharmaceutical sector.
The proposal focuses on three critical areas and identifies various needs for their fulfillment to promote R&D and Innovation in Pharma-MedTech Sector:
Special insights for medical devices:
It is certainly good news for the MedTech stakeholders that the ‘medical device industry’ is finally getting its own recognition when it comes to proposals and regulations from the Indian government. The recent success of MedTech Expo 2023 is a classic example of how India aims to become a leader in manufacturing affordable and high-quality medical devices. The G20 Summit is another step forward!
However, apart from bringing innovation in the medical device world, ensuring a common understanding of the existing regulatory requirements, its harmonized implementation, development of guidelines in technical and regulatory areas, and ways to continuously educate industry partners can make a significant impact in the current system.
Though regulatory mechanisms for medical devices are now separate from pharmaceuticals, there is still a huge void in adapting a harmonized approach to regulating the devices.
Simply put, the engineering behind designing a medical device, bringing it to production, and the regulatory market need different skillsets and expertise compared to developing a pharmaceutical ingredient. Nonetheless, special attention must be paid to the nitty-gritty of developing the right foundation for medical devices if we have to go toe-to-toe with the regulatory systems of the developed nations.
Alceon Medtech Consulting can help you unriddle the complexities behind regulatory compliance and its continuous maintenance. Our in-house experts can also train your resources on a large variety of topics, adapting to the customizations for your needs and product portfolio. We offer annual contracts, consultancy support for regulatory challenges and approvals, and prepare high-quality documents for regulatory, clinical, and medical affairs.
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