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India’s regulatory framework for medtech is still evolving. | Representational Photo
Despite India’s $10 billion medtech market and the country’s potential to become a global manufacturing hub, scaling businesses in the sector remains challenging. Experts attribute it to hurdles such as an underdeveloped supply chain, regulatory complexities, and talent gaps.
One of the key issues is the lack of a robust local supply chain, which was highlighted at this year’s annual health conference ‘Scale-Up Health 2024’. Indian medtech companies struggle with a shortage of component suppliers, which limits their ability to scale operations and compete on pricing.
Anish Bafna, MD and CEO of Healthium Medtech, emphasised that the country needed more component suppliers to support its growing manufacturing needs.
He said without a developed ecosystem, importing components increases costs which in turn makes it challenging for companies to price competitively.
“At Healthium, we would like to make more products but would need around 200 component suppliers. The component suppliers do not exist in India because the ecosystem is not developed. If we import these components, we would not be able to competitively price them in the market” Bafna said.
Regulatory hurdles are also a significant obstacle. India’s regulatory framework for medtech is still evolving, leading to a complex and often shifting landscape. Companies must navigate multiple government agencies and ensure compliance with varying standards, which can be time-consuming and costly.
While India’s regulatory environment for pharma is well-established, medtech regulations are still developing, noted Anu Moturi, CEO and founder of Kriya Medical Technologies, asserting that there is a need for more clarity and industry involvement in the formulation of such norms.
The auditors from the regulatory bodies in India are also trying to do their best, as they learn and implement the changing norms and standards, she said.
“While it is a challenge, I am personally encouraged that India should take strong steps towards recognising medtech as a key sector of the healthcare ecosystem, putting rigorous regulations in place to ensure the stringent quality of the devices and diagnostics to ensure successful patient outcomes,” Moturi said.
The medtech industry faces talent shortages, particularly in research and development. The lack of specialised training programmes and research facilities means that companies must invest heavily in internal training to upskill their workforce.
Kriya Medical Technologies addresses this challenge through internal training programmes and international exposure for its employees.
However, there are some promising developments. The government’s initiatives like the Production Linked Incentive (PLI) scheme and the establishment of medical device parks have been designed to support the growth of the medtech sector.
These policies aim to enhance infrastructure, facilitate research and development, and attract foreign direct investment. Such measures are expected to bolster domestic manufacturing capabilities and help medtech companies scale faster.
The shifting landscape of global manufacturing also presents an opportunity for India. As multinational companies diversify their supply chains away from China, India is expected to benefit from this realignment.
The country’s medtech sector can leverage this shift to expand its manufacturing base and improve its global market presence. The increasing recognition of medical devices as a crucial sector under the ‘Make in India’ campaign further supports this potential.
“The wealth of knowledge from our own literature and the world-class manufacturing facilities give us a strong competitive advantage. The cost-effectiveness and flexibility of Indian companies also play a crucial role in challenging multinationals,” Prabhat Maheshwari, Co-founder and Director of Amocare, said on competing with multinationals.
Indian companies are not just facing challenges, they are also making strides. Innovations in product development and distribution are disrupting traditional channels. Companies are focusing on producing high-quality, cost-effective products and exploring new distribution models to reach a broader market.
Despite the hurdles, Indian medtech firms are well-positioned to challenge multinational corporations by leveraging their cost efficiencies, technical expertise, and innovative capabilities.
As the industry continues to grow and evolve, there is a strong possibility that India will establish itself as a key player in the global medtech landscape.
First Published: Sep 15 2024 | 1:46 PM IST
