Introduction: Manufacturing Medical Devices in India
During the COVID-19 Pandemic, there was a surge in global demand for medical equipment like ventilators, RT-PCR kits, infrared thermometers, PPE kits, and N-95 masks. In March 2020, at the onset of the pandemic, the Indian medical devices sector was not equipped to manufacture these products at a large scale. In fact, the sector was almost completely dependent on imports. Due to government intervention, the medical devices sector, in a matter of just nine months, was not only able to meet domestic demand for COVID-19 medical equipment, but had also started exporting these goods. This demonstrates the manufacturing potential of the Indian medical devices sector.
Using Industry 4.0 technologies, the medical devices sector can offer high-quality and affordable medical equipment that will bolster the healthcare industry. The Production-Linked Incentive (PLI) Scheme launched in May 2020 can help here. The PLI Scheme for Manufacturing of Medical Devices provides financial incentives to manufacturers to boost domestic manufacturing and attract large investment in various medical devices segments. The scheme has a total outlay of funds worth Rs. 3,420 crore (US$ 468.78 million) for the period 2020-21 to 2027-28. Companies registering for the scheme will be given incentives based on annual incremental sales.
Medical Devices Produced in India
A wide range of medical devices are produced in India. Majority of medical devices manufactured in India are disposables like catheters, perfusion sets, extension lines, cannulas, feeding tubes, needles, and syringes, as well as implants like cardiac stents, drug-eluting stents, intraocular lenses, and orthopaedic implants. These devices are segregated into five segments, as shown in the following figure:
The above figure indicates the five key product segments in medical devices. These segments are Consumable & Disposables, Equipment & Instruments, Patient Aid, Orthopaedics & Prosthetics, and Dental Products. Following these segments are examples of products manufactured in each segment.
It is estimated that over 6000 medical devices are manufactured in India by over 700 manufacturers. These products include catheters, heart valves, ligatures, sutures and staplers, blood pressure monitors, X-Ray machines, CT Scan equipment, defibrillators, dialysis machines, ultrasound devices, and many more. These products along with many others have been notified in the Medical Device Rules, 2017. These Rules seek to remove regulatory bottlenecks, facilitate ease of doing business while ensuring availability of better medical devices for patient care and safety.
The PLI Scheme is meant for medical devices falling under the following categories:
- Cancer care / Radiotherapy medical devices.
- Radiology and Imaging medical devices (both ionising & non-ionising radiation products) and Nuclear Imaging Devices.
- Anaesthetics, Cardio-Respiratory and Renal Care Medical Devices; and,
- All implants including implantable electronic devices.
Medical Devices Manufacturing States
In the past decade, medical device clusters have come up in India. These clusters include states of Haryana, Gujarat, Maharashtra, Karnataka, Andhra Pradesh, and Tamil Nadu. Of these, Maharashtra and Tamil Nadu are leading examples of states that have developed a holistic ecosystem to boost the indigenous medical devices sector.
Haryana is proficient in the manufacturing of low-end consumables like needles and syringes, and dental equipment. Gujarat and Maharashtra largely manufacture pharmaceutical machineries like dryers and cooling towers, while Andhra Pradesh and Tamil Nadu manufacture medical electronics like digital thermometers, and Karnataka manufactures devices like cardiac stents and implants.
National Industrial Classification (NIC) of Medical Devices
The National Industrial Classification Code (NIC Code) is a statistical standard for developing and maintaining a comparable data base for various economic activities. It has been developed to ascertain and analyse how each economic activity contributes towards national wealth. For medical devices, the NIC has two divisions, namely, Division 26 and Division 32.
Division 26 is for ‘Manufacturer of Computer, Electronic and Optical Products’. This division includes the manufacture of computers, computer peripherals, and similar electronic products. It also includes the manufacture of irradiation, electro medical and electrotherapeutic equipment, among others. Manufacture of Irradiation, electro medical and electrotherapeutic equipment constitutes a separate group, Group 266, under the division.
This group includes manufacture of electromedical and electrotherapeutic apparatus, such as MRI scanner, CT scanner, medical ultrasound equipment, electrocardiographs, and irradiation apparatus.
Division 32 is for ‘Other Manufacturing’. This division includes the manufacture of a variety of goods not covered in other parts of the classification. Similar to Group 266, under this division Group 325 deals with the manufacture of medical and dental instruments and supplies.
Under this group, various devices like laboratory sterilisers, dental fillings and cements, operating tables, bone plates and screws, orthopaedic and prosthetic devices, ophthalmic goods, and other such equipment are manufactured.
Raw Materials for Medical Devices
As observed above, a wide range of medical devices are produced in India. To produce a range this wide, diverse types of raw materials are required. The materials used to make medical devices depend on how the products will be used. They are chosen based on factors like mechanical requirements, cost, compatibility to manufacturing process, availability of the material, patient safety, and ease of maintenance.
There are primarily four categories of raw materials used for manufacturing of medical devices. These categories are:
Polymers include materials like polythene and natural polymers like latex. These materials are used to make devices like sutures, arteries, veins, artificial tendons, and implants.
Metals include metals like stainless steel, chromium-cobalt alloys, titanium and its alloys, iron, zinc, and magnesium to make devices like implants, pacemaker casings, joint prostheses, dental implants, and cranial plaques.
Ceramics include materials like alumina, zirconia, bio-glass, and vitro-ceramic to produce devices like coatings, medical equipment and tools, and bone filling.
Composites are made from combining two or more materials to obtain a material having properties greater than one of its singular constituents. They are used to make heart valves, implants, and artificial joints.
Infrastructure for Production
Availability of infrastructure is essential to scale domestic production. Specific to medical devices, infrastructure like warehousing and packaging facilities, quality testing facilities are required. Public infrastructure like roads, waste management, electricity and water supply are also essential for the production process.
However, these facilities are not all that is required. For India to be truly competitive, state-of-the-art facilities are required too. Such facilities include component testing centres, biomaterial/biocompatibility testing centres, medical grade moulding and tooling centres, 3D printers, radiation testing centres and others. These are highly capital-intensive and have a long gestation period. Moreover, these are not affordable for small and medium scale businesses. For this reason, along with the PLI Scheme, complementary schemes like the National Biopharma Mission and the Scheme for “Promotion of Medical Device Parks” have been implemented. Both these schemes aid in the creation of state-of-the-art infrastructure the sector needs, thereby creating a robust ecosystem for the sector and reduce manufacturing costs significantly.
Challenges faced by the Sector
A Parliamentary Standing-Committee on Health and Family Welfare, in its report, has found that the medical devices sector is currently facing the following challenges:
- Inadequacy of indigenous research and development (R&D) in high end technology, including lack of adequate funding.
- Unavailability of adequate, trained, and qualified workforce in innovative technology, with entrepreneurial skills.
- Failure to undertake research in academic institutions in innovative technologies and establishing clear pathways for translation from lab to manufacturing facilities.
- Unavailability of adequate finances at concessional rates and other fiscal incentives
- Higher cost of development of indigenous technology and failure to ensure transfer of technology from other countries to set up manufacturing facilities in the country.
- With the introduction of modern technologies like robotics, the manufacturing process has become easier, however, the sector now also faces the challenge of cyber security threats.
India has demonstrated its manufacturing potential of medical devices to the world. While it ranks 4th in Asia and is in the top 20 markets globally, given the challenges, India has a long road ahead to truly become competitive in the global market.
Ms. Purvi Patil is a Research Assistant at Tatvita. She has pursued her graduation from the Liberal Arts Department of Savitribai Phule Pune University. Her areas of interest include International Relations, Data Protection and Privacy, and Sustainability.