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PLI scheme for medical devices seems to be taking off, albeit only for large players
The PLI scheme for medical devices has resulted in a ₹1206-crore investment commitment from 14 players, so far; they comprise only large players is its Achilles heel.
Under the Production Linked Incentive (PLI) scheme for medical devices, till now, a total of 26 projects have been approved, with a committed investment of ₹1206 crore and out of this, so far, an investment of ₹714 crore has been achieved. A total of 14 projects producing 37 products have been commissioned and domestic manufacturing of high-end medical devices has started.
Having said that, it has completely eluded the MSME (micro, small, and medium enterprises) segment. The scheme allows for a 5-percent incentive on incremental sales of medical devices over the base year 2010–2020, and the minimum incremental sale under the scheme has to be ₹60 crore in the first year, ₹120 crore in the second, and gradually ₹280 crore by the fifth year. A micro enterprise has a total annual turnover of up to ₹5 crore, small enterprise up to ₹50 crore and a medium enterprise up to ₹250 crore. While micro and small-scale industries cannot manage incremental sales of ₹60 crore, the medium-scale industries may apply, but this is not a profitable scheme for them.
The criteria also require the company to manufacture in India, invest in R&D, and set up a greenfield project, that is, manufacture a new product from scratch in the country at a new or existing facility. The medium enterprises find it a challenge to generate funds for a greenfield project. The scheme also requires a bank guarantee, equivalent to the cost of the project, which is another financial constraint. Of course, these players do not manufacture high-end devices.
The PLI manufacturers
Latest entrants. Five projects out of total 26 projects have been approved recently, under Category B, for domestic manufacturing of 87 products/product components. The new players are Neurovasive, Samvardhana Motherson Maadhyam, Indovasive, Meril Endo-Surgery, and Omron Healthcare.
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Approved applicants under PLI scheme March 15, 2023 |
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COMPANY ELIGIBLE PRODUCTS |
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| Target segment 1 – Cancer care/radiotherapy medical devices | |
| Panacea Medical Technologies Private Limited | LINAC; rotational cobalt machine |
| Target segment 2 – Radiology & imaging medical devices (both ionizing & non-ionizing radiation products) and nuclear imaging devices | |
| Siemens Healthcare Private Limited | CT scan and MRI |
| Allengers Medical Systems Limited (AMSL) | CT scan, MRI, ultrasonography, x-ray, cath lab, PET systems, SPECT, mammography and C-arm. |
| Allengers OEM Private Limited (AOPL) | X-ray tubes, collimators, flat panel detector and monitors |
| Wipro GE Healthcare Private Limited (WGHPL) | CT scan, cath lab and ultrasonography |
| BPL Medical Technologies Private Limited | Surgical x-ray, C-arm, fixed LF and HF x-ray products, x-ray panels and ultrasound products |
| Trivitron Healthcare Private Limited | CT scan, MRI, ultrasonography, x-ray equipment, mammography, C-arm and cath lab |
| Philips Global Business Services LLP | MRI coils |
| Target segment 3 – Anaesthetics & cardio-respiratory medical devices including catheters of cardio respiratory category & renal care medical devices | |
| Nipro India Corporation Private Limited | Dialyzer |
| Wipro GE Healthcare Pvt. Ltd. | Anesthesia unit ventilators, patient monitoring system, connectivity hub |
| BPL Medical Technologies Private Limited | Anesthesia workstation, anesthesia unit vaporizers, anesthesia unit ventilators, AEDs, ECG, patient monitoring, syringe pump, defibrillators, stress test system and oxygen concentrator |
| Poly Medicure Limited | Dialyzer, dialysis machine, peritoneal dialysis kits, fistula, blood Line, haemodialysis catheter and transducer protector |
| Allied Medical Limited | Anesthesia workstation, anesthesia unit gas scavengers, anesthesia kits, masks —anesthesia, anesthesia unit vaporizers, anesthesia unit ventilators, AEDs, oxygen concentrator and other products bi- phasic defibrillators, infusion pumps – syringe and volumetric, intensive care ventilators, emergency ventilators, high flow oxygen devices, multi-parameter monitor and suction machine |
| Deck Mount Electronics Limited | Anesthesia unit ventilators, dialyzer and oxygen concentrators |
| Microtek New Technologies Private Limited | Oxygen concentrators |
| Target segment 4 – All implants including implantable electronic devices | |
| Sahajanand Medical Technologies Private Limited (SMTPL) | Heart valves, stents, PTCA balloon, dilatation catheter and heart occluders |
| Innvolution Healthcare Pvt. Ltd. | Stents, PTCA catheter |
| Meril Healthcare Private Limited | Hip implants, knee implants and other product trauma implant |
| Meril Life Sciences Private Limited | Heart valves, stents and ‘PTCA balloon catheter |
| Envision Scientific Private Limited | Stents, and PTCA balloon catheter |
| Bio India Interventional Technologies Private Limited | Drug eluting stents, and drug eluting balloon |
| List of approved category –B applicants | |
| Samvardhana Motherson Maadhyam International Limited, Indovasive Private Limited, Omron Healthcare Manufacturing India Private Limited, Meril Endo Surgery Private Limited, Neurovasive Private Limited, and Indovasive Private Limited | |
Samvardhana Motherson Maadhyam International Ltd. has received approval for housing diamond Emerald Metric 90 DEG, housing/center section sapphire, anode outer sealing ring, ring sealing cathode inner, sealing ring, shield, and cathode.
Indovasive Pvt. Ltd. has received the approval for incentives to manufacture biopsy kits – renal, dialyzer reprocessing system, PCN catheter/kit, ureteral catheter malecot catheter/kit, re-entry malecot catheter/kit, suprapubic catheter/kit, dual lumen ureteral catheter, IUI catheter/kit, braided shaft catheter (ureteral access sheath), cysto catheter/kit, urethral stent, double J stent/kit.
Omron Healthcare Manufacturing India Pvt. Ltd. has received the approval for manufacturing automatic blood pressure monitors.
Meril Endo Surgery Pvt. Ltd. has been awarded the approval to manufacture hernia surgical mesh implants, endocuters, linear staplers, linear cutters, trocars, litigation clips, and hemostats.
For Neurovasive Pvt. Ltd., the PLI scheme will be applicable for cerebrospinal fluid shunt systems (CSF), flow diverter implants, embolic liquids, peripheral stents, carotid stents, intracranial stents, and intravascular devices.
Technology advancements in fluid balance monitoring
Amrith Rangan
CMO,
AKAS Infusions
Fluid balance monitoring is an essential part of healthcare management. Maintaining homeostasis, and preventing adverse health outcomes, depend on accurate monitoring recent technological advancements have led to the development of fluid balance monitors that offer accurate and efficient monitoring of fluid levels in patients. This article briefs the technical trends in fluid balance monitors and their impact on healthcare management.
Primary technological advancements in fluid balance monitors is the development of electronic monitoring systems. These systems use sensors to detect changes in fluid levels through urine output and transmit this information to healthcare providers advantages including increased accuracy, real-time data analysis, and automatic alerts for healthcare providers.
Another technical advancement in fluid balance monitors is the use of smart pumps. Smart pumps use advanced algorithms to monitor and regulate fluid intake and output. They can also detect and prevent potential complications, such as fluid overload or dehydration. Smart pumps offer several benefits, including reduced nursing workload, increased patient safety, and improved patient outcomes.
Smart pumps with fluid balance typically include features, such as real-time monitoring of infusion rates, automatic adjustments of infusion rates based on patient weight and other factors, and alerts for potential medication errors or fluid imbalances. Additionally, smart pumps with fluid balance incorporate advanced software can help healthcare providers identify trends and patterns in fluid balance data, enabling more informed decision making.
Another potential benefit of smart pumps with fluid balance is their ability to improve efficiency and reduce healthcare costs.
In conclusion, technological advancements in fluid balance monitoring system have revolutionized healthcare management. Electronic monitoring systems, smart pumps, and improved algorithms offer accurate and efficient monitoring of fluid levels improved patient outcomes, reduced nursing workload, and increased patient comfort.
Towards such technical advancement, AKAS is working predominantly in introducing the smart pumps, urine monitoring system called AKAS UROMON™ and specialized standalone web application for fluid balance monitoring AKAS FBM.
Putting into perspective
In 2021, under the Atmanirbhar Bharat initiative of the government, the department of pharmaceuticals launched the PLI scheme for pharmaceuticals, the financial commitment being ₹15,000 crore over a period of six years. Along with that, the PLI scheme for medical devices was launched with a financial outlay of ₹3420 crore. A total of 21 applicants are selected.
Under the scheme, 5-percent incentive will be provided on incremental sales (over base year, FY20) of medical devices manufactured in India. The incentives under the scheme will be offered for a period of 5 years from FY21 to FY28. The applicant companies will be required to meet minimum thresholds of investment and production and meet the eligibility criteria to receive incentives under the scheme. The total maximum incentive per applicant is ₹121 crore. In case an applicant does not meet the minimum threshold criteria for any given year, the applicant shall not be eligible for disbursement of incentive for that particular year. However, the applicant will not be restricted from claiming incentive for subsequent years during the tenure of the scheme, provided eligibility criteria are met for such subsequent years.
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Eligibility threshold criteria for Category A applicant |
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| Segment | Rate of incentive on incremental sales of manufactured goods for respective FY | Threshold minimum incremental sales of manufactured goods | Maximum incentive per applicant per target segment |
| All 4 segments of medical devices |
FY 2022-23: 5% FY 2023-24: 5% FY 2024-25: 5% FY 2025-26: 5% FY 2026-27: 5% |
FY 2022-23: FY 2023-24: FY 2024-25: FY 2025-26: FY 2026-27: |
FY 2022-23: FY 2023-24: FY 2024-25: FY 2025-26: FY 2026-27: Total ₹ 121 crore |
The objective of this scheme is to encourage manufacture of high-end medical devices in four segments – cancer care and radiotherapy; radiology and nuclear imaging; anesthetics, cardio-respiratory, and renal care; and implantable electronic devices.
The scheme has enabled the successful manufacturing of high-end medical devices, such as MRI coils; linear accelerators (LINAC); CT, C-Arm, mammogram, ultrasonography, and dialysis machines; intensive care ventilators, knee and hip implants; heart valves and stents; MRI coils, and high-end X-ray tubes, and dialyzers. Some of these devices are being domestically manufactured for the first time in India.
Guided by six broad areas of policy interventions
A regulatory streamlining measure monitors research on patient safety and product innovation by creating a single-window clearance system for the licensing of medical devices. This co-opts all the stakeholders, such as Atomic Energy Regulatory Board (AERB), the Ministry of Electronics and Information Technology (MeitY), and the Department of Animal Husbandry and Dairying (DAHD), and enhances the role of Indian standards like the Bureau of Indian Standards (BIS). The design of a coherent pricing regulation is being followed.
The policy facilitates R&D and innovation, and aims at establishing Centers of Excellence in academic and research institutions, innovation hubs, and plug-and-play infrastructures. It will also give support to startups in the field.
Along with recent schemes and interventions like Make in India, Ayushman Bharat program, Heal in India, and the Start-up Mission, the policy supports private investments, funding from venture capitalists, and also public-private partnerships (PPP).
For producing futuristic medical technologies and high-end manufacturing and research, MedTech human resources will be needed. To ensure a steady supply of skilled workers like scientists, health experts, and technicians, the policy will encourage multidisciplinary courses for medical devices in the existing institutions.
Some of the medical devices are being domestically manufactured for the first time in the country. Thus, the PLI scheme has paved the way for an ecosystem for domestic manufacturing of these high-end medical devices.
Support is also being extended for setting up of four Medical Devices Parks in the states of Himachal Pradesh, Madhya Pradesh, Tamil Nadu, and Uttar Pradesh.
Research-linked incentive scheme
The Parliamentary Panel has recommended to the central government to start a research-linked incentive (RLI) scheme on the lines of production-linked incentive (PLI) scheme in order to promote research and development (R&D) and innovation in the medical devices sector in the country. In its latest report on the Medical Devices: Regulation & Control, the Parliamentary Standing Committee of the Union Ministry of Health and Family Welfare stated that to invigorate the culture of research and development in medical devices in institutions like IITs, NITs, and other academic institutions, the government should start an RLI scheme in line with the PLI scheme.
A robust funding mechanism could be prioritized to nurture an ecosystem for innovation for the medical devices industry, a dedicated corpus to fund startups and small and medium enterprises (SMEs) undertaking research projects that aim for improving quality, efficiency of existing devices, and other healthcare outcomes. Preferential purchase for domestically manufactured products in government procurement could also be encouraged for Indian-manufactured medical devices having domestic content of at least 50 percent.
No doubt a good beginning, but it cannot remain just that. Access to capital in this capital intensive industry, a single-window clearance for multiple government department approvals, allowing for competitive disadvantage when pitched against the more advanced infrastructure, lower costs, and more supportive regulatory environments from China and Taiwan will require more than a nudge in the form of a PLI scheme.
