How is Lotus Surgicals placed to meet the increase in demand for medical devices in healthcare?

Lotus Surgicals has a profound understanding of the healthcare domain and the legacy of supporting the demand of such a diverse and vast country with our surgical product lineup. We always strive to give our best service to increase patient outcomes. Our surgical sutures and devices are blended with advanced and future challenge-ready technology with a proven history of transforming and improving business efficiency.

We have an ultra-modern and robust 60,000 square feet manufacturing unit, a world-class facility capable of delivering superior quality surgical devices and sutures to domestic and international markets. It is situated in Dehradun, India, which is at par with the world's best medical device manufacturing facilities. Our manufacturing unit has enough capacity to meet the increased demand in the market without compromising the world-class quality standards.

Since our inception, we have played a crucial role in developing and empowering the healthcare industry and making a robust supply chain. Our business model with powerful supply chain management ensures streaming of our surgical products to address healthcare disparity in each regional market because it democratizes the availability and accessibility of cost-efficient quality healthcare.

Lotus Surgicals is progressively moving towards innovating healthcare and patient care experience with an abiding concern for human life. We have great regard for human values and creating a global presence by manufacturing high-quality medical devices with persistent innovation, research and development. It goes beyond medical devices, surgical sutures and kits, offering a patient-centric solution through cross-industry and enterprise collaboration.

What are the regulatory changes that need to be made to make Indian medical devices competitive in the global marketplace?

In India, the healthcare industry contributes 3% to the nation's GDP and is an employment provider to over 10 million people. The Indian medical devices market stood at Rs. 77,539 crore (US$ 11 billion) in 2020. The market is expected to increase at a CAGR of 35.4% from 2020 to 2025, reaching Rs. 352,450 crore (US$ 50 billion). Though this sector is contributing well, the healthcare sector is facing many productivity and demand challenges.

Considering the importance of this sector, the government over the years has relaxed rules and regulations. Still, many areas are left untapped, which creates a hindrance in making Indian medical devices competitive in the global marketplace. Multiple clearances from concerned authorities, licenses required for import, sale and manufacture, export-import restrictions, anti-competitive practices, exaggerated loan process, patent protection, pricing, penalties on advertising and sales promotion are significant areas. There must be ease of import registration and licensing, import procedure, approval of the new medical device, market authorization on multiple levels.

The pandemic has compounded many problems that highlighted the critical gap between required and existing services and medical devices in the nation's healthcare system. Also, it has evoked the need to adopt technological-based infrastructure for seamless production of medical devices and profitable business operations.

The absence of robust manufacturing infrastructure units and developers clinging onto the traditional production process leads to a higher scope of inefficiency in medical devices. Lack of technological-based infrastructure, compelling production management insights and skilled workforce are some of the significant challenges.

The Indian regulatory system needs to be aligned to the global systems prevalent in developed countries like the USA and EU. These systems are time-tested and enjoy the confidence of international buyers. The regulations need to follow global best practices so that Indian made products can also equally compete with international brands, domestically and globally.

Many Indian healthcare providers rely on refurbished equipment that's imported. What needs to be done to change this practice?

The aim of any healthcare provider is to add value to human health and deliver better patient outcomes. We must stick to our objective. Due to cost-effectiveness and restrictions on budget on multiple fronts, the Indian healthcare sector especially the unorganized sector has been using refurbished medical devices. Also, this practice has led to the establishment of a separate second-hand market which is booming in India. But, some issues have been raised by domestic manufacturers and demand a total ban on such devices. Though there is a ban on the usages of refurbished medical devices, refurbished medical devices have been used in healthcare services.

The refurbished medical goods involve utilization rehauling a product with genuine spares for an additional run and the equipment comes with safety and quality guarantees of an original product. Importing non-OEM products is done by traders, unsupported by guarantees, and hence poses a safety threat to patients. The medical devices sector in India is dominated by multinational overseas players and is highly dependent on imported goods. The Medical Electronics and Equipment India's import crossed ? 15,000 Crore last year, and over 50 percent is estimated to be pre-owned equipment. Due to the absence of records, it is difficult to tell how widespread the use of pre-owned equipment is. Only 20 percent of India's labs are in the organized sector, and many use second-hand units.

Over the years, the government has initiated to look upon the usage and ban of refurbished medical devices. Sadly, no substantial decision or ban has been imposed till date. The Association of Indian Medical Device Manufacturers (AiMeD) wants a complete ban on importing pre-owned and refurbished medical equipment. Even the Inter-Ministerial Committee of the Government of India has sought feedback from various stakeholders for restricting the import of refurbished medical equipment. The nation needs to increase the expenditure on the healthcare sector. The government must come up with clear regulations on the import and usages of refurbished medical devices. However, the scope of imported refurbished medical devices will be a severe threat to the "Make in India" initiative in the medical device sector, which has recently started to bloom.

Do we need a PLI scheme for the medical devices industry in India to promote manufacturing?

Yes, we need a PLI scheme and other related schemes which aim to attract large investment, financial incentives to boost manufacturing, encourage domestic and empower local companies to set up or expand existing manufacturing units in the medical device sector.

The PLI scheme is crucial for ramping up manufacturing since the government makes little investment in this sector as they require a longer time to provide the return. Inviting the global companies with adequate capital to set up capacities in India. Since this sector is labor intensive and possesses numerous opportunities for empowering the nation's economy and making India a leader in the medical devices market globally.

The Indian government has undertaken deep structural and sustained reforms to strengthen the healthcare sector and announced conducive policies for encouraging FDI. The Atma Nirbhar Bharat Abhiyaan package includes several short-term and longer-term measures for the health system, including Production-Linked Incentive (PLI) schemes for boosting domestic manufacturing of pharmaceuticals and medical devices.

The Covid-19 pandemic has presented not only challenges but also considerable opportunities for India to grow. The crisis has opened ways for Indian start-ups, many of whom have risen to the occasion and accelerated the development of low-cost, scalable, and quick solutions. Further, the pandemic is providing an impetus to the expansion of telemedicine and the home healthcare market in the country.

Which are the areas that need to be improved to make the Indian medical devices industry more competitive globally?

The healthcare and medical device sectors have grown significantly in the last decade and are considered the backbone of a nation's economy. The medical device sector is considered a predominant and crucial factor. It has been growing at a CAGR of 22% since 2016, employing 4.7 million people directly. Hence, any possibility of elevating and expanding an economy is rooted in the healthcare sector.

The Indian medical device industry needs to increase the accessibility of healthcare services on multiple levels, collaborate with various stakeholders to make the medical device industry globally competitive, and adopt advanced technology to bring innovation. The Government must emphasize ensuring product quality, regulatory compliance with administrative support, embracement of technology, reduction of excise duty and all taxes and localization of medical devices to boost the Make in India and Atma Nirbhar Bharat Abhiyan.

The government needs to ensure access to medical diagnostic and treatment devices for patients by working in tandem with regulators, manufacturers, healthcare providers, and players. An information exchange platform must be created for knowledge exchange and engagement with stakeholders to develop solutions that meet growing healthcare demand. Promoting a cost-effective and value-based approach with an increased emphasis on public-private partnerships and accelerated adoption of digital technologies for future challenge-ready and advanced healthcare solutions.

What are your expansion plans in India and overseas?

The Healthcare industry is proliferating, banking on increasing health consciousness among people and rising demand for medical devices followed by the covid outbreak. The healthcare market is enormous; at the same time, it's exceptionally complex, primarily because of its fragmented nature.

We have an ultra-modern 60,000 square feet robust manufacturing capacity in Dehradun, India, which can meet the growing market demand and is at par with the best Medical Device manufacturing facilities in the world. The infrastructure complies with the specifications, testing and validation norms of International Regulatory Agencies such as COPP(WHO/GMP), ISO, CE, USFDA and EU.

As we have already started developing our operations for upcoming city launches, we plan to have a strong brand presence pan India, focusing more on Tier-II and III cities. While even introducing other specialized manufacturing units rather than only particular production, we should be able to empower the nation's healthcare infrastructure and supply chain with our reliable, reasonable product cost and highly effective medical products.

With some debottlenecking capacity of our Dehradun plan would be sufficient to take us to the next phase of growth. Our focus is now to ensure full capacity utilization of the manufacturing facility. So, we don't have any immediate plan to set up a new manufacturing facility. In the global market, we constantly explore market expansion and customer acquisition opportunities. Thanks to our enhanced manufacturing capacity, we are better placed to grow our international market aggressively.