Opportunities for India’s medical devices sector

In the post pandemic era there are significant opportunities for the continued expansion of telemedicine. Virtual consultations also create opportunities for remote monitoring of patients’ health status. The latter could become an important avenue of growth for the medical devices sector. The rising burden of chronic, non-communicable diseases as well as an increase in the population of senior citizens bolsters the need for continuous monitoring of patients’ vitals and key health parameters.

The post-Covid era has also brought about increased public awareness of health issues and a greater emphasis on wellness. This means that individuals are increasingly becoming conscious of their health and fitness levels. Opportunities to track health status and provide inputs for individuals to adopt more healthy lifestyle choices through wearables and smart sensors is likely to become another important growth avenue for the medical devices sector going forward. Artificial Intelligence based diagnostics present an additional area of opportunity as they can not only help to enhance the accuracy and timeliness of diagnosis but also save time and effort for clinicians.

Further, the government’s flagship health programs create opportunities for expansion of the medical devices sector. For instance, over 1.2 lakh Health and Wellness Centres (HWCs) are currently operational across the country and it is envisaged that by end December, 2022 there will be 1.5 lakh such centres functional in India. The HWCs are being equipped with medical devices required for the delivery of diagnostic services at the primary healthcare level. HWCs are mandated to conduct screening for various non-communicable diseases which also creates an important opportunity for the deployment of medical devices. Additionally, the government is promoting the expansion of hospitals across the country, including in tier II and III locations. Various hospitals in the public and private sectors are being empanelled under the Pradhan Mantri Jan Arogya Yojana. This is yet another key growth avenue for the medical devices sector. Under the Ayushman Bharat Health Infrastructure Mission as well, Rs. 64,000 crore are being spent on creating modern health facilities at the district level.

Over the last few years, the government has prioritised the medical devices sector with several regulatory and policy measures, including some critical ones in the pipeline. Recently, the government has reconstituted the National Medical Devices Promotion Council to serve as a facilitating body for the medical devices industry. The Council is headed by Secretary, Department of Pharmaceuticals and key industry associations have been included in it. The government has also placed an approach paper to the National Medical Device Policy, 2022 in the public domain. The Policy proposes to catalyse a comprehensive set of measures for enabling the sustained development of the sector. It also seeks to integrate the regulatory, trade and promotion initiatives spread across multiple government agencies and departments at the central and state levels into a coherent policy framework. Further, the proposed Policy is focused on facilitating the transition from the partial regulation of selected medical devices to the complete regulation and licensing of all medical devices. This necessitates an unambiguous articulation of device certification and quality assurance.

Additionally, the government has released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022. The proposed Bill seeks to replace the existing Drugs and Cosmetics Act, 1940 and regulate medical devices as a distinct entity. Historically, devices have been regulated together with drugs. The draft Bill specifies various types of medical devices within its ambit including diagnostics, implants, life support machines, instruments for disinfection, reagents and devices providing assistance with disabilities.