Poly Medicure Ltd Management Discussions

The medical device industry is a diverse and dynamic sector. This dynamic nature of the sector stems from continuous technological advancements, evolving healthcare needs, and stringent regulatory frameworks that drive constant innovation. The global market for medical devices is extensive and projected to exhibit substantial growth in the coming years. The market was valued at USD 542.21 billion in 2024 and is projected to grow significantly over the next several years. By 2032, the market is expected to reach USD 883.96 billion, reflecting a compound annual growth rate (CAGR) of 6.3%. As the medical device industry continues to grow, its growth is not only driven by technological innovation but also by increasing global healthcare demands and policy support. With a strong focus on research, localization, and strategic collaborations, the sector is poised to enhance accessibility, affordability, and quality of care across the world. This upward trajectory highlights the industrys vital role in shaping the future of healthcare, ensuring better patient outcomes, and fostering economic development.

Global Medical Device Market Size (in US $ Bn)

The Indian medical device market, currently valued at USD 15.33 billion, is on a strong growth trajectory and is projected to reach approximately USD 50 billion over the next decade. This remarkable expansion is driven by multiple converging factors, including rising healthcare expenditure, increased access to healthcare services, rapid technological advancements, and growing demand for high-quality, affordable medical solutions. Additionally, government-led initiatives such as ‘Make in India and the Production Linked Incentive (PLI) scheme are playing a pivotal role in fostering self-reliance by incentivizing domestic manufacturing and reducing dependency on imports. As a result, India is emerging as a global hub for medical device innovation and production.

Indian Medical Device Market Size ( in US $ bn)

India is undergoing a transformative shift in its medtech landscape, with a strong focus on expanding its presence in global markets. The country is steadily emerging as a key exporter of high-quality, affordable medical devices, backed by robust manufacturing capabilities and a skilled workforce. In FY 2024-25, Indias medical device exports reached USD 4,018 million, reflecting growing international confidence in Indian-made solutions. This momentum is being fueled by supportive government policies, such as the Production Linked Incentive (PLI) , medical devices parks, the new medical devices scheme and strengthening of export promotion councils, which are enabling Indian manufacturers to scale, innovate, and meet global regulatory standards. As the ecosystem matures, India is well-positioned to evolve from a rising player to a global medtech export powerhouse.

Exports & Imports- Segment Wise (FY 2024-25) (in USD million)

Despite being one of the top global markets, Indias medical device industry remains largely import-driven, with imports accounting for nearly 70% of total sales. This reliance stems from the complex and highly regulated nature of medical device manufacturing, where domestic capabilities and regulatory frameworks are still in the process of evolving to meet global standards.

Category-wise Medical Devices Imports

	Category % Share
Category	FY23-24	FY24-25	% Surge	FY2024-25
Electronic Equipment	5399.62	5750.96	6.5%	72.2%
Consumable & Disposable	1185.08	1252.11	5.7%	15.7%
IVD Reagents	802.95	915.431	14.0%	11.5%
Implant	527.69	580.19	9.2%	7.3%
Surgical Instrument	184.54	237.86	28.5%	3.0%
Total Imports	7374.75	7964.22	7.99%	100.0%

To address this gap, the Central Drug Standard Control Organization (CDSCO) released the Indian Medical Device Rules, 2017, which are the new regulations for medical devices in India. These rules were subsequently amended as the Medical Devices (Amendment) Rules, 2020, which came into force in April 2020. The National Medical Device Policy 2023 outlines an accelerated growth strategy for the medical device sector, emphasizing a patient-centric approach in innovation, research, and development. In line with these regulatory advancements, on January 10, 2025, CDSCO issued a memorandum prohibiting the import of refurbished medical devices under the Medical Devices Rules, 2017, due to the absence of clear regulatory guidelines. This decision aims to enhance patient safety and strengthen domestic manufacturing by restricting the entry of unregulated devices into the market. Indias medical device export landscape reveals a strong global presence, with the United States emerging as the dominant market, accounting for USD 782.57 Mn of the total exports. Other key markets include Germany, France, and the Netherlands, contributing USD 208.57 Mn, USD 166.46 Mn and, USD 147.63 Mn, respectively. These nations represent Indias strategic focus on developed markets, with robust demand for high-quality medical devices. Notably, China, Russia, and the UAE also feature prominently, highlighting Indias growing footprint in emerging markets with export values of USD 158.59 Mn, USD 136.99 Mn and, USD 120.15 Mn. This diverse export portfolio underscores Indias competitive positioning across high-value and high-volume markets, reinforcing its reputation as a key global supplier of medical devices.

Top 10 Destinations for Indian Medical Devices Exports

Country	FY23-24	FY24-25	% Growth
U S A	714.3	782.57	9.55%
GERMANY	199.23	208.57	4.68%
FRANCE	159.97	166.46	4.05%
CHINA P RP	166	158.59	-4.46%
NETHERLAND	145.21	147.63	1.66%
SINGAPORE	101.92	130.43	27.97%
RUSSIA	140.19	136.99	-2.28%
U ARAB EMTS	166.56	120.15	-27.86%

INDIAN MEDTECH: A SUNRISE INDUSTRY

The Indian medical device sector holds immense potential to drive innovation and enhance the accessibility of healthcare while also strengthening Indias position in the global market. As a sunrise industry, it requires strategic interventions to accelerate growth, foster research and development, and align with evolving healthcare needs. A collaborative approach involving regulatory bodies, policymakers, and manufacturers will be essential in shaping a self-reliant and globally competitive ecosystem. With initiatives like ‘Make in India reducing import dependency and boosting exports, manufacturers can capitalize on it to expand production capabilities, invest in cutting edge research and strengthen Indias position as a global hub for high-quality medical devices.

Key Findings

1. Indias medical devices sector is currently valued at approximately USD 15.3 billion and is projected to grow to USD 50 billion over the next decade.

2. The Consumables and Disposables segment leads in medical device exports, accounting for USD 1.81 billion - the highest share among all categories.

3. India ranks 39th out of 133 global economies on the Medical Device Innovation Index, with a score of 38.3.

KEY GROWTH DRIVERS

Driving Progress: Three Key Themes Accelerating Indias MedTech Growth Towards 2030

Indias medical devices industry stands at the cusp of transformational growth, propelled by three overarching themes that are shaping its trajectory towards the 2030 ambition.

1) Changing disease patterns and healthcare delivery trends marked by the rising burden of non-communicable diseases, increased focus on preventive care, and the expansion of digital health are reshaping demand for advanced and accessible MedTech solutions.

2) Demographic and socioeconomic factors, including a growing and aging population, rising income levels, expanding health insurance coverage, and increasing health awareness, are driving demand for quality healthcare and diagnostics.

3) The evolving MedTech industry ecosystem characterized by policy support, local manufacturing incentives, increased R&D, and greater collaboration between startups, academia, and industry is unlocking new opportunities for innovation and investment. Together, these growth drivers present a compelling opportunity for stakeholders to accelerate progress, enhance self-reliance, and position India as a global hub for medical technology.

CHALLENGES THAT LIE AHEAD

Absence of a supportive infrastructure and supply chain network

Although the government has taken several initiatives in this regard in recent past, for a country with as high a disease burden as India, there is lack of sufficient supportive supply chain network, ancillary manufacturing, and relevant infrastructure for making quality medical devices. This is especially true of high-end devices and in particular those that entail expensive technologies and components. For their part, Indian manufacturers are mostly focused on low-end products for local as well as global markets. Although it is changing in recent years, most multinationals have production (and R&D) facilities outside India from where they import products for the Indian market.

Peculiar nature of domestic market

Even as India has a high population and a high disease burden, from the point of view of manufacturers of high-end and technologically sophisticated medical devices, there is insufficient demand domestically for them to make investments and run full-fledged operations.

Whatever demands that is there, it is limited to hospitals and healthcare facilities as well as individuals and families in the metros and big cities in India. In fact, hospitals in non-metro cities are likely to opt for inexpensive products and devices compared to high-end products stemming from affordability issues. Therefore, besides the usual risks associated with the very nature of a nascent business venture, the long-term sustainability within the country has often played on the minds of the manufacturers within the country.

R&D Limitations

Extensive research and development are important in the medical device manufacturing industry. Lack of advanced infrastructure and specialized testing facilities can hinder research and development efforts. Currently, India needs to focus on developing such facilities to support their researchers. The low innovation is reflected in the number of patents granted to India.

Despite existing challenges, the Indian government has shown strong commitment to nurturing the medtech industry through targeted schemes, progressive policies, and a sustained focus on ease of doing business. These efforts are collectively creating an enabling environment for growth, innovation, and increased global competitiveness. These measures aim to strengthen domestic manufacturing, boost exports, attract investments, and position India as a competitive player in the global medical device ecosystem.

EVOLVING INDIAN MEDTECH INDUSTRY ECOSYSTEM Government Initiatives

The Government of India has implemented a comprehensive set of innovative initiatives and supportive policies to reduce import dependence and boost exports. All these initiatives aim to foster a robust and competitive ecosystem for medical device manufacturing and innovation in India, with initial results already emerging.

The PLI scheme for medical devices was launched in 2020 with the aim of reducing import dependence and enhancing the competitiveness of domestic manufacturers. It proposes financial incentives to boost domestic production and attract significant investment from both national and international companies. The medical device parks are strategically designed to host a suite of world-class, common infrastructure facilities including testing and laboratory facilities, all centralized in one location. This arrangement significantly reduces manufacturing costs and fosters a strong ecosystem for medical device production. The National Medical Device Policy, approved in April 2023, aims at making India a global leader in medical device manufacturing and innovation by achieving a share between 10% and 12% in the expanding global market over the next 25 years. Six components of the policy are - streamlining the regulatory framework, enabling indigenous manufacturing, facilitating R&D and innovation, creating awareness and brand positioning, developing skilled workforce, and attracting investments.

With a total outlay of 500 crores, the comprehensivePromotion of Medical Devices Scheme aims to catalyze the growth of Indias medical device sector by targeting critical gaps across the value chain. It focuses on enabling domestic manufacturing of key components and accessories, building a skilled workforce through dedicated training initiatives, supporting clinical studies to drive innovation and regulatory approvals, and facilitating the development of shared infrastructure such as testing labs and technology centers. Additionally, the scheme includes strong measures for industry promotion, fostering a robust ecosystem that supports self-reliance, quality enhancement, and global competitiveness.

PRIP (Promotion of Research and Innovation in Pharma MedTech Sector) scheme can further help promote innovation and research.

Launched by the Department of Pharmaceuticals, it has a financial outlay of 5,000 crores, with a significant portion ( 4,250 crores) dedicated to accelerating R&D investments. The scheme focuses on supporting the development of innovative, cost-effective, and affordable healthcare solutions. It encourages collaboration between industries and academic institutions to foster innovation and knowledge sharing. The National Single Window System (NSWS) is a digital platform designed to streamline the process of licensing of Medical Devices.

It acts as a one-stop solution, bringing together all the stakeholder departments / organizations such as AERB, MeitY, DAHD, etc., enhancing the Role of Indian Standards like BIS and designing a coherent pricing regulation.

Medtech Mitra is an initiative for innovators and startups to help them navigate the complex journey from ideation to product being used in clinical settings and to get timely and comprehensive guidance/facilitation. The difficulties faced by them are related to their lack of understanding and opportunities for regulatory requirements, testing and validation, industry grade production, animal studies, clinical evaluation/trials, technology assessment imperatives, among others.

WAY FORWARD: CHARTING THE COURSE FOR REALIZING THE POTENTIAL

Strengthening Research & Development Through Increased Allocation

To foster innovation and accelerate technological advancements, the government can consider a range of initiatives. These include increasing funding and incentives for research and development (R&D) in the science and technology sector, and promoting greater collaboration between government, industry, and academia. Establishing platforms for knowledge exchange, technology licensing, and joint R&D projects can help leverage collective strengths. Additionally, offering tax benefits and incentives for companies investing in technology infrastructure, equipment, and talent development will further drive progress. Targeted support for startups and SMEs in tech-driven sectors—through grants, subsidies, and incubation programs—can play a vital role in nurturing breakthrough innovations and building a robust innovation ecosystem.

Industry-Academia Collaboration

Academia, with its deep research expertise, serves as a cradle for groundbreaking ideas, while industry provides the resources, scalability, and real-world testing environments necessary to translate those ideas into tangible solutions. Their collaboration accelerates innovation, shortens time to market, and addresses unmet medical needs. Establishing incubation centers in partnership with global institutes will play a pivotal role in advancing cutting-edge medical technologies. Equally important is building a skilled workforce by promoting career opportunities in the MedTech sector and working closely with academic institutions to design industry-relevant curricula that align with evolving sector demands.

Public and Private Partnership

Public-private partnerships (PPPs) are crucial for advancing Indias MedTech sector by combining public resources with private sector innovation and efficiency. PPPs help bridge the gap in healthcare infrastructure by leveraging private sector investments and expertise to build and modernize hospitals, diagnostic centers, and other essential facilities. Private sector involvement can accelerate the adoption of cutting-edge medical technologies, such as telemedicine, digital health solutions, and advanced medical equipment, making them more accessible to the public. PPPs can extend healthcare services to remote and underserved areas by establishing clinics, diagnostic centers, and telemedicine networks in partnership with local communities. Private sector partners bring their expertise in operational management, supply chain optimization, and process improvement, leading to more efficient and cost-effective healthcare delivery.

Future Outlook

While India is currently a significant importer of medical devices, it has the potential to emerge as a key exporter and a global MedTech industry leader. This shift would be driven by Indias strategic strengths, which include a skilled workforce, cost competitiveness, technology edge, and government initiatives that promote domestic manufacturing and innovation. With these strengths harmoniously converging, India stands on the cusp of redefining its role in the international MedTech arena, not merely as a market participant but as a frontrunner steering the industrys future direction.

Overview of the Company

Poly Medicure Ltd. (POLYMED) is a leading player in the organized medical disposable devices market with strong brand positioning due to high quality products used in infusion therapy, blood management, surgery, dialysis, and other segments. The quality of products is maintained through automation and high degree of engineering in manufacturing process, skilled labor force and high technical expertise.

We manufacture and supply, in India and internationally, a diverse portfolio of medical devices in the product verticals of infusion therapy, oncology, anesthesia and respiratory care, urology, gastroenterology, vascular access, surgery and wound drainage, dialysis and renal care, diagnostics, transfusion system, veterinary medical devices and others. POLYMED is the largest exporter of medical devices from India, 70% of the sales are from exports to the highly regulated developed markets like EU, LATAM, SE Asia etc., which is a testament to POLYMEDs superior quality products. POLYMED is among the top three IV Cannula manufacturers in the world and the first indigenous dialyzer manufacturer.

We focus on research and development ("R&D") for developing more effective, safe to use, and user-friendly products. Our R&D activities are also aimed at improving existing processes and production cost efficiency and developing processes for sustainable manufacturing practices and environmental friendly products. We operate one in-house R&D facility at Faridabad (Haryana) ("R&D Center"), which has been approved by the Department of Scientific and Industrial

Research, Ministry of Science and Technology, Government of India ("DSIR"). We have developed a number of safety medical devices across product lines, including safety I.V. cannula and safety scalp vein sets within the infusion therapy vertical, safety blood collection sets within the transfusion system vertical, safety fistula needles within the dialysis and renal care vertical, and safety huber needles and safety closed I.V. catether system in our critical care vertical. Our Company is led by Mr. Himanshu Baid, our Managing Director and Mr. Rishi Baid, our Joint Managing Director, each of who have over two decades of experience in the medical devices industry and are first generation entrepreneurs. Our Managing Director, Mr.

Himanshu Baid, received the HEALTHCARE ENTREPRENEUR OF

THE YEAR 2025 by Financial Express and EY Entrepreneur of the year award in 2024.

We have been recognized as the "BEST HEALTHCARE BRANDS 2024" by ET Edge. We have also been awarded by CII "TOP 75

INDUSTRIAL INNOVATIVE COMPANY OF THE YEAR 2024" and "INDUSTRIAL INTELLECTUAL PROPERTY AWARDS 2024", "INDIAS

500 MOST VALUABLE COMPANIES LIST 2024" by Hurun India,

"MEDICAL DEVICES PROVIDER OF THE YEAR 2025" by Financial

Express. We also received "EXCELLENCE IN MEDICAL EQUIPMENT INNOVATION" by India Health Next Awards, "LEADING BRAND IN MEDICAL DEVICES" by ELETS.

Business Operations and Manufacturing Facilities

The company currently operates 12 manufacturing facilities across India, China, Egypt, and Italy. In India, there are nine facilities: six in Faridabad (Haryana), two in Jaipur (Rajasthan) including a SEZ unit, and one in Haridwar (Uttarakhand). Internationally, there are facilities in China (through the wholly-owned Poly Medicure Laiyang Company Limited), Egypt (through associate Ultra For Medical Company), and Italy (through step-down subsidiary Plan1 Health s.r.l.), as well as a newly established subsidiary in England and Wales named POLYHEALTH LTD in FY25.

All facilities are equipped with infrastructure for injection molding, extrusion, insert molding, blow molding, ultrasonic welding, UV bonding, and laser welding. Additionally, each facility features effluent treatment plants that process industrial wastewater for recycling or safe disposal.

To take advantage of growth prospects in the medical devices sector, the company plans to invest in enhancing its physical and operational infrastructure and diversify its product portfolio. It is set to open three new manufacturing facilities dedicated to medical device production in Jaipur (Rajasthan), Palwal (Haryana) and Haridwar (Uttarakhand).

Global manufacturing capabilities with a focus on automation

With a global footprint spanning India, China, Egypt, and Italy, and bolstered by its R&D Center, the company operates nine strategically located facilities in India. These include six facilities in Faridabad, Haryana; two in Jaipur, Rajasthan (with one unit in a Special Economic Zone); and one in Haridwar, Uttarakhand. These facilities cater to both the domestic market and international regions, including Europe, Africa, South America, Australia, and Asia. Alongside these, Ultra for Medical Products, an associate company, runs a manufacturing facility in Assuit, Egypt focused on disposable medical devices. Facility operations in China, via a wholly-owned subsidiary, and in Italy, through a step-down subsidiary, further supply both local and global markets for disposable medical products.

Manufacturing operations are vertically integrated, enabling in-house design and development. Core capabilities include injection moulding, extrusion, insert moulding, blow moulding, ultrasonic welding, UV bonding, and laser welding, with production processes fully automated through robotics and proprietary technologies.

Assembly lines utilize automated arms programmed for specific functions, supported by ‘Servo systems to ensure precision and minimize waste. Advanced vision systems enable stringent quality control by identifying and removing defective products, while colour sensors and internet ports further enhance accuracy and operational oversight. These efficiencies translate into significant operational and cost advantages.

All Indian manufacturing facilities hold EC certificates for quality assurance and EN ISO 13485:2016 accreditation, with select sites also certified for ISO 9001:2015 compliance. The facilities in China,

Italy, and Egypt possess multiple international quality credentials, contributing to the companys ability to consistently deliver high-quality products and maintain a strong competitive position in both Indian and international markets.

Sales and distribution network and strong customer relationships

The companys operations span international markets, supplying products to Europe, Africa, the Americas, Australia, and Asia through a robust distributor network. Many distributors benefit from local or regional exclusivity, allowing them to be the sole authorized providers of the companys medical devices within specific territories, subject to set conditions.

The sales division actively promotes products in both private and government hospitals, often organizing ongoing medical education programs at various facilities. Products are distributed to more than 8,000 private and government hospitals and nursing homes across

India, reflecting the companys commitment to building sustained relationships with the majority of its distributors.

Over the years, the distribution network has expanded steadily, both domestically and globally, with all international sales managed via distributor partnerships. For the past decade, the company has earned the distinction of being the leading exporter of plastic medical disposables and surgical items, including syringes, as recognized by the Plastics Export Promotion Council, Ministry of Commerce and Industry, Government of India.

Through direct engagement, the company has fostered longstanding relationships with third-party distributors, many of whom enjoy regional or local exclusivity as the sole authorized distributors for medical devices in designated areas, contingent on specified criteria.

Research and Development

ThecompanysR&D operationsarecentraltoadvancingtechnological innovation and maintaining competitiveness. Its DSIR-approved R&D Centre, based in Faridabad, Haryana, focuses on developing new products within existing verticals, entering new segments—particularly fluid management solutions for non-communicable diseases such as oncology, nephrology, and cardiology—and enhancing process efficiency and cost management. Through these initiatives, the company has been granted 334 patents worldwide. Robust in-house R&D capabilities have enabled the development of a diverse and innovative product portfolio, as well as improvements to manufacturing processes. In fiscal 2025, R&D expenses accounted for 1.47% of operational revenue, reflecting ongoing investment in automation and new technologies that support high-quality manufacturing and advanced process control. The company places special emphasis on R&D for fluid management in non-communicable diseases, encompassing areas such as oncology, nephrology, infusion therapy, and cardiology. Recent product launches stemming from these efforts include dialyzers, dialysis machines, safety Huber needles, PICC catheters, arterial and diagnostic catheters, guidewires, and pre-filled syringes, making it the first Indian company to indigenously manufacture dialyzers.

As a result of intensive R&D, the company has been granted 334 patents globally, including in markets such as the USA, Europe, Brazil, Thailand, Japan, and Australia. The R&D Centre is equipped to conduct rapid prototyping with 3D printers, process validation, and product customization. Recognition of the companys R&D achievements includes being named "India Medical Device Leader of the Year" at the India Medical Device Awards 2022 and one of the

Best Healthcare Brands 2024 by ET Edge.

Manufacturing Process

The company employs a variety of advanced technologies for manufacturing its medical devices, including injection molding, extrusion, insert molding, blow molding, ultrasonic welding, UV bonding, and laser welding, along with expertise in handling specialized plastic materials. Component manufacturing is performed using state-of-the-art PLC-controlled plastic injection molding machines that utilize hot runner or runner-less mold technology, a clean method that minimizes scrap production. Tubes are produced on highly precise extruders that ensure excellent yield. Our assembly lines feature poka-yoke designs and vision inspection systems to ensure error-proofing and rigorous quality control.

Our facilities are also equipped with CNC-controlled machines for precise and efficient mold fabrication. Furthermore, we implement lean manufacturing principles, including Kaizen, to optimize production processes and minimize cycle times.

Our manufacturing process involves transforming raw materials into molded or extruded components, which are then assembled and sample-tested. The finished products are packaged using blister packing machines in duplex or correlated boxes, followed by sterilization and rigorous quality inspections before being cleared for release.

Manufacturing Technology and Automation

The companys manufacturing processes are highly automated, utilizing robotics and proprietary technologies developed and programmed in-house. Automated arms integrated into assembly machines are specifically designed and programmed to perform precise assembly tasks across different product variants. Additionally, ‘Servo systems support the manufacturing equipment, enabling precise machine movements that enhance process accuracy and reduce scrap generation.

For quality control, advanced vision systems have been implemented to detect manufacturing defects, with automated arms removing faulty products from the assembly line. Further enhancing automation, machines are equipped with colour sensors and internet ports, which improve accuracy and facilitate easier operational intervention and control.

Financial Performance (Consolidated) Income

The Companys total revenues comprise revenue from operations and other income. Total income increased by 22.61% from 1,43,454.44 lakh in Fiscal 2024 to 1,75,895.92 lakh in Fiscal 2025. Revenue from operations increased by 21.37% from 1,37,579.63 lakh in Fiscal 2024 to

1,66,983.16 lakh in Fiscal 2025, and our other income increased by 51.71% from 5,874.81 lakh in Fiscal 2024 to 8,912.76 lakh in Fiscal 2025 and this increase is primarily due to growth in our revenue from operations, for reasons described below.

Revenue from Operations

Revenues from operations increased by 21.37% from 1,37,579.63 lakh in Fiscal 2024 to 1,66,983.16 lakh in Fiscal 2025, due to an increase in sale of products by 21.19% from 1,36,569.37 lakh in Fiscal 2024 to 1,65,502.27 lakh in Fiscal 2025, particularly medical devices such as intravenous cannula, prefilled syringes and blood bags, both in the domestic and export markets and an increase in other operating revenues by 46.59% from 1,010.26 lakh in Fiscal 2024 to 1,480.89 lakh in Fiscal 2025.

The increase in sale of products was driven by an increase in revenue from sale of manufactured products, such as intravenous cannula, prefilled syringes and blood bags by 21.57% from 1,35,654.01 lakh in Fiscal 2024 to 1,64,915.22 lakh in Fiscal 2025.

Other Income

Other income increased by 51.71% from 5,874.81 lakh in Fiscal 2024 to 8,912.76 lakh in Fiscal 2025, primarily due to increase in market gain on mutual fund.

Expenses

The Companys total expenses increased by 20.02% from

109,280.21 lakh in Fiscal 2024 to 131,162.42 lakh in Fiscal 2025 due to the reasons set forth below.

Cost of raw materials consumed

Cost of raw materials including packaging materials consumed increased by 22.93% from 46,478.45 lakh in Fiscal 2024 to

57,136.26 lakh in Fiscal 2025, due to an increase in raw materials consumed such as PVC compound and plastic granules by 23.50% from 37,548.67 lakh in Fiscal 2024 to 46,373.84 lakh in Fiscal 2025, and an increase in packaging material consumed by 20.52% from 8,929.78 lakh in Fiscal 2024 to 10,762.42 lakh in Fiscal 2025 on account of increase in production at our facilities.

Employee Benefit Expenses

Employee benefit expenses increased by 22.62% from 24,591.17 lakh in Fiscal 2024 to 30,153.20 lakh in Fiscal 2025 due to an increase in the salaries, wages and bonus by 23.18% from

22,612.75 lakh in Fiscal 2024 to 27,854.59 lakh in Fiscal 2025 on account of an increase in the number of full time employees, production workers and annual increment.

Research and development expenses

Research and development expenses increased by 26.38% from 1,944.23 lakh in Fiscal 2024 to 2,457.11 lakh in Fiscal 2025, primarily on account of increase in (i) cost of components and material consumed (net) for R&D, which increased by 2.42% from 1,232.85 lakh in Fiscal 2024 to 1,262.66 lakh in Fiscal 2025 on account of materials used in research and development activities, and (ii) employee benefit expenses in respect of the research and development professionals by 81.57% from 559.76 lakh in Fiscal 2024 to 1016.38 lakh in Fiscal 2025 driven by new technical hires, including engineers.

Other Expenses

Other expenses increased by 24.47% from 27,009.52 lakh in Fiscal 2024 to 33,619.84 lakh in Fiscal 2025.

Earnings before Interest, Taxes, Depreciation and Amortization

(EBITDA)

EBITDA was 41,648.76 lakh in Fiscal 2024 compared to EBITDA of 54,196.75 lakh in Fiscal 2025, while EBITDA margin (EBITDA as a percentage of our revenue from operations) was 30.27% in Fiscal 2024 compared to 32.46% in Fiscal 2025.

Depreciation and amortization expenses

The Companys depreciation expenses increased from 6344.44 lacs in fiscal 2024 to 8263.60 lacs in fiscal 2025 due to more capitalization in existing plant as well as new plant.

Finance costs

Finance costs increased by 6.16 % from 1,130.09 lakh in Fiscal 2024 to 1,199.65 lakh in Fiscal 2025 primarily due to an increase in borrowings.

Profit Before Tax

The Companys profit before tax increased from 34,426.91 lacs in fiscal 2024 to 45,251.51 lacs in fiscal 2025.

Tax Expenses

Current tax expenses increased from 7,693.19 in Fiscal 2024 to

9,560.27 lakh in Fiscal 2025, primarily on account of increase in profit before tax. Deferred tax also increased from 898.41 lakh in Fiscal 2024 to 1,825.33 lakh in Fiscal 2025 on account of additional depreciation claimed in income tax and unrealised gain on mutual funds. However, tax adjustment for earlier years (net) increased from 9.34 lakh in Fiscal 2024 to 10.19 lakh in Fiscal 2025, as a result of tax assessment of earlier years. As a result, the total tax expenses amounted to 11,395.79 lakh in Fiscal 2025 compared with 8,600.94 lakh in Fiscal 2024.

Profit for the Year

For the various reasons discussed above, we recorded a profit after tax of 33,855.72 lakh in Fiscal 2025 compared to 25,825.97 lakh in Fiscal 2024.

RISK AND CONCERN

As a Medical Device Manufacturing Company, we faces risks, both internal and external, in the undertaking of its day-to-day operations and in pursuit of its longer-term objectives. A detailed policy drawn up and dedicated risk workshops are conducted for each business vertical and key support functions wherein risks are identified, assessed, analyzed and accepted / mitigated to an acceptable level within the risk appetite of the organization.

The Company faces the following Risks and Concerns

Economic risk for a manufacturing company refers to the potential negative impact of macroeconomic factors that are largely beyond the companys control. These include fluctuations in market demand, which can lead to reduced sales and excess inventory, as well as rising input costs for raw materials, energy, and labour that can squeeze profit margins.

Economic growth has received major boost by the governments push for digital transformation, financial inclusion and ease of doing business. There has been substantial rise in foreign direct investment (FDI) due to the production-linked incentive (PLI) schemes aimed at boosting domestic manufacturing.

To Mitigating Economic Risk, We proactively manage economic risks through strategic diversification, operational efficiency, and supply chain management. To address market demand fluctuations and cost pressures, we invest in lean manufacturing, automation, and energy-efficient technologies. We diversify our customer base and product portfolio to ensure revenue stability, while also leveraging financial instruments to hedge against raw material and currency volatility. By aligning with government initiatives such as PLI schemes and embracing digital transformation, we enhance our competitiveness and resilience in a dynamic economic environment. Foreign Exchange rate can affect the cost of imports and revenue from exports, while changes in interest rates may increase borrowing costs, limiting capital investments. Inflation poses another risk by raising overall operational expenses and reducing purchasing power.

To Mitigating Foreign Exchange Risk, We actively monitor currency trends and use appropriate hedging instruments. Rising interest rates can affect our cost of borrowing; hence, we maintain a balanced capital structure and explore fixed-rate financing options to ensure investment continuity. Inflationary pressures are managed through cost optimization, value engineering, and strategic supplier partnerships, helping us maintain operational efficiency and protect margins.

Technological risk for a company manufacturing medical devices refers to the potential negative impact arising from rapid technological changes, innovation gaps, or failure to adapt to evolving industry standards. This risk is particularly critical in the Medical Device sector, where innovation, precision, and regulatory compliance are vital. That involves the danger of becoming outdated due to rapid advancements in medical technology and innovation by competitors. If the company fails to invest in research and development or delays adopting emerging technologies such as AI-driven diagnostics, minimally invasive surgical tools, or smart wearable health devices, it may lose market relevance and competitiveness.

Additionally, integrating outdated technology could compromise product safety, performance, and regulatory compliance, leading to product recalls or rejection by healthcare providers.

To Mitigating the Technological Risk, we prioritize continuous investment in research and development, enabling us to innovate in line with evolving industry trends and regulatory standards. We actively monitor advancements in medical technology, such as AI- driven diagnostics and smart health devices, and update our product roadmap accordingly. Strategic partnerships, regular technology audits, and upskilling of our workforce ensure that our capabilities remain current and competitive. By fostering agility in product development and leveraging market intelligence, we safeguard against obsolescence and reinforce our commitment to delivering safe, effective, and future-ready medical solutions.

Credit risk for a company involved in manufacturing medical devices and selling internationally refers to the potential financial loss due to the inability of customers particularly international buyers to full fill their payment obligations on time or at all.

In the case of a medical device manufacturer engaged in international sales, credit risk arises when hospitals, distributors, or government agencies in foreign markets delay or default on payments. This risk is heightened in regions with weaker financial systems, political instability, or currency volatility. of

Extended credit terms offered to penetrate new markets can further strain cash flow. Additionally, reliance on a few large international customers increases vulnerability to non-payment. Differences in legal systems and challenges in cross-border debt recovery make it difficult to enforce contracts or recover dues. To manage this risk, agile companies often perform rigorous credit assessments, use export credit insurance, set credit limits, and include strong payment terms and guarantees in contracts. Proactive credit management is essential to maintaining financial stability and ensuring smooth international operations.

To mitigating the Credit Risk, Asaglobalmedicaldevicemanufacturer, we recognize the credit risk associated with international operations . particularly from delayed or defaulted payments by hospitals, distributors, or government entities in certain regions. This risk is more pronounced in markets with unstable financial systems, currency volatility, or legal enforcement challenges. To mitigate exposure, we conduct thorough credit evaluations, set prudent credit limits, and secure export credit insurance where applicable. Our contracts include clear payment terms, advance payment clauses, and where possible, bank guarantees. We also maintain a diversified customer base to avoid overdependence on a few large buyers. Proactive credit monitoring and disciplined receivables management are central to ensuring strong cash flow and financial resilience.

Maintaining accuracy and precision is critical for a company manufacturing medical devices, as it directly affects patient safety, product performance, regulatory compliance, and brand reputation. In the medical device industry, maintaining accuracy and precision means ensuring that every product consistently performs its intended function within exact tolerances and specifications. This is vital because even minor deviations can lead to incorrect diagnoses, ineffective treatments, or serious health risks. To Mitigating Ensuring Accuracy and Precision Risk, We follow validated manufacturing protocols, enforce rigorous quality control at every stage, and conduct regular equipment calibration. Our commitment to precision engineering ensures consistent product reliability, strengthens our regulatory compliance, and reinforces trust in our brand across global healthcare markets.

Manufacturing Facility Risk Management, We operate 12 manufacturing facilities across four countries, including 9 in India and 1 each in China, Egypt, and Italy, producing critical disposable medical devices such as IV cannulas, blood bags, and infusion sets. The uninterrupted functioning of these facilities is vital to our supply chain and customer commitments. However, operations may be impacted by risks such as natural disasters, fuel shortages, mechanical failures, geopolitical disruptions, regulatory changes, or loss of key licenses and certifications.

To mitigate these risks, we maintain comprehensive business continuity plans, invest in preventive maintenance, ensure redundancy in critical operations, and comply rigorously with local and international regulatory standards. Regular risk assessments and insurance coverage further enhance our operational resilience.

Cybersecurity and Data Protection Measures

Poly Medicure Ltd. is committed to protecting data as a core element of operational excellence, regulatory compliance, and stakeholder trust. Guided by ISO 27001 and GDPR standards, the companys

Privacy and Data Security Policy ensures the confidentiality, integrity, and availability of all critical information—including personal data, production records, intellectual property, and vendor information—across its systems and operations.

This policy covers all personnel and platforms, including ERP (SAP S/4HANA), MES, IoT devices, and cloud infrastructure. Key security controls include Role-Based Access Control (RBAC), Multi-Factor Authentication (MFA), AES-256 encryption, and disaster recovery protocols. The IT infrastructure is fortified with firewalls, IDS/IPS, and VPN-secured access.

Poly Med conducts quarterly access reviews, internal/external audits, and implements data classification for effective data governance. Regular employee training programs reinforce cybersecurity awareness, data privacy obligations, and phishing prevention.

A structured Incident Response Procedure governs data breach handling, including root cause analysis and disciplinary action. The company also ensures lawful and transparent data collection, control, auditing, and deletion.

By embedding information security into its digital governance framework, Poly Medicure ensures cyber resilience and safe stewardship of sensitive data—critical for sustainable, secure growth in the healthcare sector.

Internal Control Systems & Adequacy

In a medical device manufacturing company, internal control systems are essential to monitor and manage operational, financial, and compliance-related risks.

Poly Medicure Limited implemented proper and adequate systems of internal control to ensure that all assets are safeguarded and protected against loss from any unauthorized use or disposition and all transactions are authorized, recorded and reported correctly. The systems ensure that all activities from procurement of raw materials and production processes to inventory management, quality control, sales, and accounting are carried out with transparency and accountability.

The Internal control system aims at improvement in financial management and the investments of the Company. The System ensures appropriate information flow to facilitate effective monitoring. The internal audit system also ensures formation and implementation of corporate policies for financial reporting, accounting, information security, project appraisal, and corporate governance.

The Company also implemented effective systems for achieving highest level of efficiency in operations, to achieve optimum and effective utilization of resources, monitoring thereof and the compliance with provisions all laws including the Companies Act, 2013, Listing Agreement, directions issued by the Securities and Exchange Board of India, drugs and cosmetics laws, Medical and Pharma Laws, labour laws, tax laws etc.

The company ensure internal controls prevent fraud, detect errors, and safeguard company assets such as proprietary technology, sensitive patient data, and financial resources. They also ensure that regulatory requirements, such as those imposed by the US FDA, EU MDR, or ISO standards, are strictly followed.

Key components of an adequate internal control system include segregation of duties, authorization protocols, regular audits, risk assessments, IT security measures, and timely financial reconciliations. An effective system is regularly reviewed and updated to respond to changes in operations, regulations, or external threats. Overall, the adequacy of internal controls is crucial for ensuring business integrity, operational efficiency, and long-term sustainability. A qualified and independent Audit Committee of the Board of

Directors also reviews the internal control system and its impacts on improvement of overall performance of the Company.

Internal Control System & Adequacy

The Company implemented proper and adequate systems of internal control to ensure that all assets are safeguarded and protected against loss from any unauthorized use or disposition and all transactions are authorized, recorded and reported correctly. The Company also implemented effective systems for achieving highest level of efficiency in operations, to achieve optimum and effective utilization of resources, monitoring thereof and the compliance with provisions all laws including the Companies Act, 2013, Listing Agreement, directions issued by the Securities and Exchange Board of India, drugs and cosmetics laws, Medical and Pharma Laws, labour laws, tax laws etc.

The Internal control system also aims at improvement in financial management and the investments of the Company. The System ensures appropriate information flow to facilitate effective monitoring. The internal audit system also ensures formation and implementation of corporate policies for financial reporting, accounting, information security, project appraisal, and corporate governance. A qualified and independent Audit Committee of the

Board of Directors also reviews the internal control system and its impacts on improvement of overall performance of the Company.

Related party transactions

The Company has formulated a Policy on Related Party Transactions and manner of dealing with related party transactions which is available on the Companys website at the link: www.polymedicure. com.

All related party transactions entered into during FY 2024-25 were on an arms length basis and in the ordinary course of business. Accordingly, the disclosure of related party transactions as required under Section 134(3)(h) of the Act in Form AOC-2 is not applicable to the Company for FY 2024-25.

All transactions with related parties were reviewed and approved by the Audit Committee. Prior omnibus approval is obtained for related party transactions which are of repetitive nature and entered in the ordinary course of business and on an arms length basis. The transactions entered into pursuant to the omnibus approval so granted are reviewed by the internal audit team. Thereafter, a statement giving details of all related party transactions, entered pursuant to omnibus approval so granted, is placed before the Audit Committee on a quarterly basis for its review. Details of the transactions with Related Parties during the FY 2024-25 are provided in the accompanying financial statements.

Sustainability Approach

Poly Medicure Ltd. embeds sustainability at the heart of its operations, recognizing its responsibility to deliver healthcare solutions that positively impact the environment, society, and future generations. The company has outlined ambitious sustainability targets, including achieving Net Zero emissions by 2050, reducing

Scope 1 and Scope 2 emissions by 2030, and transitioning 30% of energy to renewable sources. It also aims to develop PVC-free medical devices and improve gender diversity to 33% by 2035. In action, Poly Med signed a 9.9 MWp solar power purchase agreement, projected to reduce Scope 2 emissions by ~ 28% upon commissioning in 2025. In FY 2024 25, the company achieved a 4% reduction in Scope 2 emission intensity, increased on-site solar power generation by 42%, and avoided 120 tCO2e emissions through digital transformation aligned with SDG 7 (Clean Energy) and SDG 15 (Life on Land). Rainwater harvesting efforts also grew, with a 27% increase in rainwater pits, supporting SDG 6 (Clean Water and Sanitation). Additionally, 50% of facilities are ISO 14001:2015 certified, with more sites under certification. Notably, Poly Med became the first and only Indian member of ZEMBA, advancing its commitment to Scope 3 emission reduction through sustainable ocean freight.

Aligned with the UN Sustainable Development Goals, the companys approach reflects a deep integration of ESG principles into every layer of its operations.

In terms of performance, Poly Med manufactured1.27 billion medical devices, achieved an annual turnover of 1601.8 Cr. ($192.22 million USD), and secured 334 patents. With a global footprint in

125+ countries, the company operates 12 manufacturing facilities across 4 nations, employs 3,000+ people, collaborates with 900+ distributors, and maintains a portfolio of 200+ medical devices—demonstrating its continued leadership in sustainable, innovation-driven healthcare.

Energy and Emission

At Poly Medicure Ltd., tracking emissions and energy usage simultaneously is central to improving operational efficiency achieving our Net Zero target by 2050. We have adopted dual-fuel generator systems and CNG vehicles, with a planned transition to green mobility. Digital energy management solutions have enabled us to avoid approximately

120 tCO2e in emissions, highlighting the

impact of smart technology on sustainability.

In FY 2025, our on-site solar energy generation increased by 42%, reaching 2,391.17 MWh. Strengthening our green energy shift, we signed a Power Purchase Agreement (PPA) for a 9.9 MWp solar power plant, in collaboration with AMPIN C&I Power Pvt. Ltd., a key player in Indias renewable energy transition. This initiative is projected to reduce Scope 2 emissions by 28%, supporting our 2030 climate goals.

Together, these efforts—spanning on-site solar generation, off-site renewable energy procurement, and smart energy systems—form the backbone of our climate action strategy. They reflect our strong alignment with GRI 305-5 disclosures on greenhouse gas emissions and reinforce our long-term commitment to energy transition and environmental sustainability.

Waste Management

In FY 2024 25, Poly Medicure Ltd. strengthened its commitment to responsible waste management by maintaining detailed records of all waste streams plastic, biomedical, hazardous, and general across its manufacturing sites, in alignment with GRI 306 (Waste) standards. Waste segregation at source and disposal through authorized vendors ensured full compliance with national regulations, including the Hazardous and Other Wastes Rules, 2016 and Plastic Waste Management Rules, 2016. Biomedical waste was processed via licensed facilities, while packaging waste reporting was done through the official EPR portal.

Plastic waste generation increased to ~1,038.09 MT, a rise driven by production growth. However, waste intensity per unit of turnover declined, reflecting better resource efficiency and control. Under its Extended Producer Responsibility (EPR) obligations, Poly Med recycled 719 MT of plastic waste in FY 2024 25 under its Brand

Owner category. In the previous year, it recycled 869 MT under BO and 30 MT under Importer obligations, maintaining consistent environmental accountability.

To foster a circular economy, the company also launched employee-led "Best Out of Waste" campaigns, promoting creativity, reuse of process waste, and sustainability awareness across facilities. These initiatives underscore Poly Med commitment to environmental stewardship, compliance, and resource-conscious growth.

Water Conservation

Recognizing the critical importance of water efficiency, Poly

Medicure Ltd. has implemented structured initiatives to reduce freshwater consumption, recharge groundwater, and recycle water through advanced treatment systems. In FY 2024 25, the company expanded its rainwater harvesting (RWH) infrastructure by 27%, bringing the total to 33 RWH pits across its facilities. These systems directly support groundwater recharge, especially in water-stressed areas.

To further reduce dependency on freshwater sources, the sewage treatment plant (STP) capacity was increased by 40%, reaching a total of 380 KLD. Treated water from STPs is reused for non-potable applications such as landscaping and DG cooling, contributing significantly to water conservation.

These efforts align with GRI 303-3 (reducing freshwater withdrawals) and GRI 303-4 (managing water discharge through reuse), reinforcing the companys commitment to sustainable water management and long-term environmental stewardship.

Sustainable product

Poly Medicure, is committed to designing medical devices that balance patient safety with environmental responsibility. Recognizing the environmental concerns associated with PVC (polyvinyl chloride)—due to its high lifecycle emissions and disposal challenges—the company has initiated a phased transition toward

PVC-free medical devices.

In FY 2024 25, Poly Med achieved a significant milestone by selling 965.3 million PVC-free products, accounting for 75% of total finished goods sold (excluding packaging). This marks substantial progress toward the companys long-term material innovation goals.

Looking ahead, Poly Med aims to develop PVC-free alternatives for 15% of its product portfolio by 2035. This will be driven by enhanced R&D, sustainable material sourcing, and continued restructuring of product lines to support an eco-friendlier and safer healthcare ecosystem.

Human Resource

At Poly Medicure Ltd., employee well-being, engagement, and continuous development are central to building a high-performing and future-ready organization. In FY 2024 25, the company implemented a holistic strategy focused on health, skill development, recognition, and cultural inclusion—strengthening organizational resilience and supporting sustainable growth.

With a workforce of 6,300 employees (including 300 engineers), Poly Med conducted ~26 formal safety training sessions, ensured 100% health insurance coverage, and held regular on-site health check-ups.

Over 500 employees underwent general health screenings, 200 availed eye examinations, and 300+ accessed annual medical check-ups. A Nutrition Consultancy Program, extended to families, promoted healthy living, while yoga, fitness, and mental wellness sessions were attended by 150+ employees.

Employee development was driven by robust learning and upskilling programs, supported by quarterly publications like "Seekh". A new recognition system, RISE, led to a 90% increase in employee recognitions.

Emotional and psychological wellness was addressed through the

‘1 to 1 Help Employee Assistance Programme.

Cultural and team engagement remained a key focus, with 1,700+ employees participating in festivals like Diwali, Holi, and Womens Day across units. 1,300+ employees received Diwali gift coupons, fostering celebration and inclusion.

Team-building initiatives such as quizzes, "best out of waste" challenges, and games saw 250+ employees actively involved, encouraging collaboration and camaraderie.

The company experienced no industrial disruptions or disputes, with a non-unionized workforce and full compliance with labour and safety laws, including the Factories Act, 1948. These initiatives align with GRI 403 and GRI 405, reinforcing Poly Meds commitment to a safe, inclusive, and performance-driven workplace.

Insurance

Wemaintainrobustinsurancecoveragethroughreputedindependent insurers to safeguard our business operations, assets, inventory, and human capital. Our policies include standard fire and special peril insurance across all manufacturing facilities, product liability insurance, marine cargo coverage for exports, and separate policies for stocks and receivables. To ensure responsible governance, we also maintain Directors and Officers (D&O) liability insurance.

Equally, we place a strong emphasis on employee well-being and security. 100% of our employees are covered under comprehensive health insurance. All eligible shop-floor employees are enrolled in the Employees State Insurance Corporation (ESIC) scheme, while other employees are covered through a Group Mediclaim policy, depending on their roles. Additionally, every employee is protected under a Group Personal Accident Insurance policy. These measures ensure financial protection for our workforce during medical emergencies, workplace injuries, and unforeseen events, contributing to a safe and secure work environment.

Health and Safety

At Poly Medicure Ltd., ensuring employee health, safety, and regulatory compliance is central to operational excellence and long-term sustainability. In line with GRI 403: Occupational Health and Safety, the company maintains a robust framework focused on hazard prevention, employee training, and emergency preparedness across all facilities.

In FY 2024 25, the company conducted ~26 formal safety training sessions covering PPE use, fire safety, machinery operations, chemical handling, and emergency response. All new site-based employees undergo safety orientation to ensure awareness from day one.

Workplace safety is reinforced through clearly marked evacuation zones, fire extinguishers, emergency signage, and strict PPE compliance. Risk-eliminating engineering controls—including machine interlocks, emergency stop switches, and guard systems—are installed, and regular equipment maintenance ensures operational safety.

Emergency preparedness is enhanced by mock drills, fire drills, and trained emergency responders stationed at all sites, supported by coordination with nearby hospitals for medical emergencies.

Poly Med complies fully with the Factories Act, 1948, and conducts internal safety audits annually. Monthly safety committee meetings promote accountability, transparency, and continuous improvement through incident tracking and resolution.

As a result of these efforts, Poly Medicure reported zero lost time injuries and no fatalities in FY 2024 25, highlighting its strong safety culture and commitment to employee well-being.

Our Strengths

Our core purpose is in our motto, "We care as we cure". We are one of the leading Indian companies in the disposable medical devices industry with a diversified product portfolio manufacturing a wide range of products also enables us to generate pricing advantages, which has strengthened our relationship with our primary customers, hospitals and clinics. We consistently innovate to develop new products and improve existing products. We have Global manufacturing capabilities with a focus on automation. Our manufacturing capabilities are vertically integrated with design and development being carried out inhouse. Our capabilities include injection moulding, extrusion, insert moulding, blow moulding, ultrasonic welding, UV bonding and laser welding. We have wide geographic reach through our extensive sales and distribution network and strong customer relationships. We have integrated capabilities to market and distribute our products. We also have team of experienced, highly professional and skilled personnel. We understand the customer needs, market trends and work closely with health care professionals to make further advancements to our products. Our diversified product portfolio enables us to cater a wide range of market segments.

Weakness

Poly Medicure Limited faces several inherent weaknesses that may impact its long-term performance. The company is exposed to complex and evolving regulatory requirements across multiple jurisdictions, which can delay product approvals and market entry. A heavy reliance on export markets, contributing nearly 69% of total revenue, increases vulnerability to foreign exchange fluctuations and geopolitical risks.

Opportunity and future Prospects

The medical device industry is witnessing rapid evolution, presenting significant opportunities for companies that invest in innovation, digital transformation, and global expansion. Growing healthcare awareness, an aging global population, and the increasing prevalence of chronic diseases are driving demand for advanced diagnostic and therapeutic devices. Technological advancements such as AI-powered imaging, wearable health monitors, minimally invasive surgical tools, and smart implants open new avenues for product development. Additionally, the shift toward personalized and remote healthcare creates opportunities for connected and data-driven devices. Emerging markets like India, Southeast Asia, Africa, and Latin America offer untapped potential due to rising healthcare investments and improving infrastructure. Companies that prioritize R&D, form strategic partnerships, and align with global regulatory and sustainability standards will be better positioned to capture these opportunities. The future prospects remain strong, particularly for firms that focus on patient-centric solutions, digital health integration, and efficient distribution models, enabling sustainable and scalable growth in a rapidly transforming healthcare landscape.

Threat

The company faces several external and internal threats that could impact its operations and growth. Regulatory changes across global markets may increase compliance burdens and delay product approvals. Volatility in raw material prices and currency exchange rates can affect cost structures and profitability. Global supply chain disruptions, geopolitical instability, and dependence on key international customers heighten business risks. Rising competition from low-cost manufacturers and the risk of technological obsolescence require continuous innovation. Additionally, product liability risks, skilled labor shortages, and growing cybersecurity concerns present ongoing operational challenges. Addressing these threats requires proactive risk management and strategic planning.

Competition

The medical device industry is in a transformative phase with technological advancements and newer manufacturers entering the market. One of the biggest industries in healthcare, the medical device industry is driven by innovation and technology but currently witnesses strong competition in the market. The medical device manufacturers compete on the basis of product offerings to serve different market segments.

We sell our products in competitive markets, and face competition at the domestic and international level. We continue to invest in brandbuilding activities across various geographies to maintain our market position in the medical devices industry. Certain competitors may be larger than us and may have significantly greater financial resources than us. As a result, to remain competitive in our markets, we continuously strive to innovate products, improve existing products, reduce our costs of production and distribution and improve our operating efficiencies. Some of the key players in the Indian medical devices industry consist mainly of multi-national companies. Other than multi-national companies and Indian companies, the disposable medical devices industry in India also has various fragmented local players catering to regional or local markets.

Intellectual Property

We have applied for 616 patent applications in India and worldwide including and not limited to United States, United Kingdom, South Africa, Russia, China and Australia, wherein we have successfully been granted with 116 patents in India and 334 patents across the globe. Additionally, we have applied for a total of 397 trademark applications in India and worldwide, wherein we have successfully registered 307 trademarks in India and across the globe.

Further to this we also have146 registered designs and 16 registered copyrights in India and worldwide.

Cautionary Statement

Statements in this report on Management Discussion and Analysis, describing the Companys objectives, projections, estimates, expectations or predictions may be "forward-looking statements" within the meaning of applicable laws and regulations. These statements are based on certain assumptions and expectations of future events. Actual results could differ materially from those expressed or implied since the Companys operations are influenced by many external and internal factors beyond its control. The Company assumes no responsibility to publicly amend, modify or revise any forward-looking statements, based on any subsequent developments, information or events. Readers are cautioned that the risks outlined here are not exhaustive. Readers are requested to exercise their judgment in assessing the risks associated with the Company.