Indian Medical Device Industry is projected to reach $50 billion by 2030 and further could witness a fivefold increase to reach $250 billion by 2047 with the diagnostics segment could emerge as the highest contributor, however the current trends reflect the growing emphasis on eco-friendly manufacturing processes and supply chain solutions, offering new ways to enhance patient care and streamline healthcare delivery.
The medical disposable manufacturing industry in India has seen significant growth in recent years. With increasing demand for high-quality, single-use medical products, medical disposable manufacturers in India are faced with both challenges and opportunities as they navigate the future landscape of healthcare.
Major Challenges Faced by Medical Device Manufacturers
Regulatory Compliances
When dealing with medical devices, industry manufacturers must comply with stringent regulations. Since people’s lives are at stake, the government has laid down certain safety standards regarding the manufacturing of medical devices.
Supply Chain Issues
As is the case with most manufacturing sectors, the medical device manufacturing industry is also plagued with supply chain issues. However, the issues extend beyond vendor selection, procurement of raw materials, and inventory visibility. The lack of distributors and shipping networks also contributes to delays and damages during medical device shipment. This ultimately causes problems for those in need of these crucial devices.
Main temperature ranges to be considered along supply chains.
R&D Limitations
Extensive research and development are important in the medical device manufacturing industry. Lack of advanced infrastructure and specialised testing facilities can hinder research and development efforts. Currently, India needs to focus on developing such facilities to support their researchers. Government is taking lot of initiative for the research and development sector of medical devices to become resilient.
Lack of Investments
The manufacturing sector requires a significant and steady source of investment. It requires substantial funds to procure raw materials, machinery, and labour. The situation is much more complicated for medical device manufacturers, requiring higher investments in quality research and development. Maintaining a manufacturing unit becomes extremely challenging without adequate financing in a competitive market with margins being towards the lower end.
One of the primary challenges faced by the industry is maintaining quality standards while keeping costs competitive. With global competition, local manufacturers must balance affordability with stringent regulations and safety protocols. The growing emphasis on sustainability also adds pressure to develop eco-friendly materials and processes, a task that requires investment in research and innovation.
Additionally, the COVID-19 pandemic highlighted the need for a robust supply chain. Disruptions in raw material availability and logistics continue to affect manufacturing timelines, making it essential for Indian manufacturers to establish resilient, localized supply chains that can withstand global fluctuations.
Opportunities
Despite these challenges, the industry is ripe with opportunity. The rising demand for healthcare services, both domestically and internationally, presents a vast market for Indian manufacturers. India’s capacity for cost-effective production gives it a competitive edge in the global market.
The growing opportunities are resulting from a combination of the following:
- Increasing population and demand: India is set to become the most populous country in the world, which equates to being the home to one of the biggest demand areas for medical devices and equipment in the world.
- Changing health preferences and behaviour of Indian consumers: With more health awareness and changing preferences, Indians are becoming more health conscious, which is increasing the demand for medical manufacturing.
- Increase in medical tourism: India is an attractive destination for medical tourism owing to the low cost of treatment and a large pool of talented doctors.
- Increasing health insurance coverage: With more and more people opting for health insurance, medical spending in India is increasing overall.
- Favourable conditions created by the Government: The Government is taking various steps to expedite growth in the sector;
Government initiatives in the Indian medical manufacturing sector
- Production Linked Incentive (PLI) scheme for medical devices manufacturing: To boost the Make in India initiative, the Government has launched the production-linked incentive scheme for promoting domestic manufacturing of medical devices. The scheme covers incentives of about Rs. 3,420 crores that will collectively increase domestic production and attract investments in the medical devices sector.
- Medical device parks in India: The medical device parks initiative in India, with a total financial outlay of Rs. 400 crores, is aimed at boosting the domestic infrastructure for medical manufacturing in India. This will help create manufacturing clusters that will reduce manufacturing costs and create a competitive advantage for large-scale manufacturing with a streamlined supply chain.
- National Medical Device Policy 2022: The Government is also working on other initiatives like the National Medical Devices Policy, which, if implemented, would further smoothen the process of medical devices manufacturing for companies in India. It will be aimed at removing various friction points that stop companies from growing globally.
- Indian Certification of Medical Devices (ICMED) 13485 Plus scheme: Quality Council of India (QCI) and the Association of Indian Manufacturers of Medical Devices (AiMeD) launched the scheme to undertake verification of the quality, safety and efficacy of medical devices.
While challenges remain, the future looks promising for medical disposable manufacturers in India. By embracing innovation, quality control, and sustainability, the industry is well-positioned to lead in the global healthcare market.
