“आपदा में अवसर” – opportunity in disaster, is not a mere slogan. It is a statement of inbuilt positivity, it is a motto, it is an action plan. In India, it is a reality. The biggest disaster mankind has faced in recent times is COVID-19. Right at onset the epidemic exposed the weakness of India depending on imports for the medical devices needed. We were importing 75-80% of our requirements from the US, China and Germany.
From here the situation unfolded into several mutually contributing streams- research, innovation, technology, investment and so on. Soon it gushed beyond the COVID-19 related requirements.
Now, a gigantic medical device park is going to open in Noida, bringing in a total investment of Rs. 5,250 crores by the government, and employing over 20,000 people. By 2022, the Gautam Budh Nagar, Noida, is expected to have Northern India’s first medical tools and system manufacturing park. The park is likely to be developed in Sector 28 of the Yamuna Expressway Industrial Development Authority (YEIDA) Space by the Yamuna Expressway Authority. In March 2021, YEIDA is expected to introduce a mission scheme worth ~Rs. 5,000 crore (US$ 685.35 million), of which Rs. 100 crore (US$ 13.71 million) is likely to be funded by the central authorities.
In February 2021, Punjab’s Industry and Commerce Minister Mr. Sunder Sham Arora announced that a park for medical devices was proposed in Rajpura, Punjab, across an area of 210 acres, with an estimated project cost of ~ Rs. 180 crore (US$ 24.67 million). Still, this is the tip of the iceberg.
India is among the top 20 markets for medical devices worldwide. The market is expected to increase at a 37% annualized compound annual growth rate (CAGR) to reach US$ 50 billion in 2025, from Rs. 75,611 crore (US$ 10.36 billion) in 2020.
Again, the things are not based on a single root. Massive expansion of medical facilities factored in and introduction of the Medical Devices (Amendment) Rules 2020 is also there to boost the demand for medical devices in the market.
In 2022, the Indian market for medical equipment is expected to reach US$ 11.86 billion. By 2025, the medical devices market is predicted to increase from US$ 11 billion to ~US$ 50 billion.
The Indian medical devices sector is estimated to be worth ~US$ 10 billion in 2021.
See the dynamics. To boost the primary healthcare and clinical centers in the country, in July 2021, the government of Uttar Pradesh announced the introduction of automatic medicine dispensing machines. The state health department has been initiated to design an action plan and install ‘Health ATMs’ walk-in medical kiosks with combined medical devices for fundamentals, basic laboratory testing, emergency offerings, cardiology, neurology, pulmonary testing, gynaecology, etc., operated by a medical assistant in all 75 districts of Uttar Pradesh.
The policy and other government initiatives
• The Health Ministry of India has divided medical devices into the following four categories under the medical devices and IVD regulations:
Class A – Low risk devices including surgical dressings, umbilical occlusion devices, bolster sutures, alcohol swabs, nasopharyngeal catheters and Y-connectors.
Class B – Low-moderate risk devices including endoscopic forceps, vial adapters, suction cups and catheters, Sengstaken-Blakemore tube, feeding tubes and gastrointestinal tubes.
Class C – Moderate-high risk devices including anaesthesia conduction filter, introducer sheath, microcatheter, imaging catheter colonic stents and pancreatic instruments.
Class D – High risk devices such as coronary stents, cardiac catherisation kits, cardiovascular, intravascular diagnostic catheters and occlusion catheters.
• Government of India has approved 100% FDIs—under the automatic route for both brownfield and greenfield setups in the sector. Strong FDI inflow also reflects confidence among global players in the Indian medical devices market.
• FDI inflow in the medical and surgical appliances sector stood at US$ 2.19 billion between April 2000 and March 2021.
• The department of pharmaceuticals launched a PLI scheme for domestic manufacturing of medical devices, with a total outlay of funds worth Rs.3,420 crore (US$ 468.78 million) for the period FY21-FY28.
• In July 2021, the government announced plans to build a medical park in Uttar Pradesh, which is expected to generate an estimated Rs. 500 crore (US$ 67.13 million) business in the state.
• In May 2021, with joint efforts of the Defence Research and Development Organisation and Dr. Reddy’s Laboratories an anti-COVID-19 drug called 2-deoxy-D-glucose (2-DG) was developed. This drug is to expedite recovery.
• On March 25, 2021, the Department of Pharmaceuticals (DoP) released a revised notice on the Public Procurement Order (PPO), incorporating 19 medical devices in the revised guidelines of the PPO, which is expected to improve domestic medical devices manufacturing (and strengthen ‘Make in India’) and reduce import bills by ~Rs. 4,000 crore (US$ 538.62 million).
• In order to expedite the clearance of medical devices such as nebulisers, oxygen concentrators and oxygen cannisters in April 2021, the government made it easier to import critical medical devices by easing the requirements for clearance under the Legal Metrology Act (Packaging Rules 2011).
• Over the last five years (2015-20), India received US$ 600 million with key investments from countries such as Singapore, the US, Europe and Japan. Categories such as equipment & instruments and consumables & implants have attracted the most FDIs.
• The government also approved nine eligible projects that are expected to lead to a total committed investment of ~Rs. 729.63 crore (US$ 100.01 million) by the companies (e.g., Siemens Healthcare Private Limited, Allengers Medical Systems Limited (AMSL), Allengers OEM Private Limited (AOPL), Wipro GE Healthcare Private Limited, Nipro India Corporation Private Limited, Sahajanand Medical Technologies Private Limited, Innvolution Healthcare Private Limited, Integris Health Private Limited) and generate ~2,304 jobs.
• In February 2021, Siemens Healthineers introduced Corindus, a robotic system, to drive cardiovascular interventions with robotic assistance in India.
• The Medical Devices Virtual Expo 2021 will showcase Indian products and enable direct interaction between Indian suppliers and buyers/importers from participating countries. Also, 300 foreign buyers from the healthcare sector are expected to participate in this event.
• In July 2021, Abbott announced that it has launched a pea-sized, life-saving device for babies with hole-in-the-heart malformations. The company has launched the device in India with emphasis on centres having an active neonatal intensive care unit (NICU).
• In June 2021, AstraZeneca India signed a memorandum of understanding with Docon Technologies, a Bengaluru-based health start-up, to digitise 1,000 clinics across India by implementing customised Electronic Medical Record (EMR) systems in clinics to offer doctors access to complete patient history.
• In July 2021, Blackfrog Technologies, a start-up backed by the Biotechnology Industry Research Assistance Council (BIRAC), developed Emvólio, a portable, battery-powered refrigeration device to provide efficient and safe transportation of vaccines.
• In June 2021, the National Anti-profiteering Authority’s (NAA) directed tax officials to ensure rate cut on Goods and Services Tax (GST) for COVID-19-related medical supplies to offer consumers tax relief on supplies.
• In June 2021, Trivitron Healthcare announced the launch of two innovation-driven products for HbA1c (Hemoglobin A1c) and Hb variant detection. These HbA1c analysers will be used for monitoring diabetes, thalassemia and hemoglobin variants.
• In June 2021, Medtronic India Private Limited announced the launch of Micra AV – a miniaturised, fully self-contained pacemaker that delivers advanced pacing technology to atrioventricular (AV) block patients via a minimally invasive approach.
• In June 2021, Wipro GE Healthcare announced that it has commenced local production of its Versana Ultrasound range in India.
• In March 2021, Transasia Bio-Medical Ltd., a Mumbai-based in-vitro diagnostic company, announced plans to invest Rs. 150 crore ($21 million) to set up a manufacturing unit at the Medical Devices Park in Sultanpur, Telangana. The company plans to manufacture state-of-the-art high-technology analysers in the unit to address biochemistry, immunology, hematology, molecular testing in addition to COVID-19, HIV, dengue, and TB testing for domestic and export markets.