Another year has arrived and with it another immensely successful India Medical Device Expo. In addition to shedding some light on the progress that has been made in the Indian medtech sector and the future potential of this space, many speakers also underscored some of the most substantial recent health care developments that have taken place across India.
Fortunately, our DRG Medtech analysts were in attendance and took to Twitter to share their thoughts on the various presentations. Below is our analysis of some of the major highlights from the conference, presented against the backdrop of real-time reactions.
- Pradhan Mantri Jan Arogya Yojana (PM-JAY)
Perhaps the biggest story at India Medical Device 2019 was PM-JAY. Professionals from across the industry highlighted the progress made since the enactment of the legislation, as well as the challenges facing the program and steps that are being taken to address these challenges and further improve the implementation of PM-JAY (see our post on Ayushman Bharat and PM-JAY for more background information).
All stakeholders in India—including medtech and pharma manufacturers, health care providers, and regulatory and administrative government bodies—have expressed profound enthusiasm for PM-JAY, and results from the first 5 months have been strong; the program has already served around 1.2 million patients at a cost of nearly $140M (Rs. 960 crores).
Many speakers at the conference also highlighted a number of challenges facing PM-JAY. The pricing of procedures, for instance, emerged as a major concern that may reduce the effectiveness of PM-JAY in the long run.
Our DRG Medtech analysts believe that current pricing has yielded very limited margins for both hospitals and industry players in both the pharma and medical devices sectors, but as the scale of PM-JAY continues to grow and more data from the initial phase of the program becomes available, the government’s understanding of the nuances of this program will also increase, which is expected to lead to some price rationalization to bolster stakeholder confidence.
- Implementation of Standards and Regulatory Updates
To ensure the continued successful implementation of PM-JAY, the Indian government has been tightening its regulatory framework for medical devices; for instance, the government continues to implement the Medical Device Rules, 2017, which came into force in January 2018 and has better aligned the Indian medical sector with international standards by providing a risk-based device classification system, more stringent requirements for device registration and certification, and increased alignment with GHTF standards and guidelines. In addition, the Bureau of Indian Standards (BIS) has created a set of standards dedicated exclusively for the regulation of manufacturing practices, sales, and distribution for all medical devices in the country.
DRG Medtech believes that the government has to ensure the safety of a rapidly expanding patient population; as the implementation of PM-JAY moves forward, the number of patients receiving medical treatment will also increase, and the risk inherently associated with such treatments (namely medical procedures) will rise in tandem. Therefore, creating a strong regulatory framework for medical devices is extremely important and the efforts being made in this direction are highly commendable.
- Implementation of Health Technology Assessment in India
It is important to emphasize that streamlining the implementation of PM-JAY will require the government to make sure that the empanelled hospitals in the country follow the most suitable diagnostic and treatment protocols and utilize available drugs and devices at prices with rational trade margins. As a result, the government has created HTAIn, a health technology assessment body reporting to the Department of Health Research under the Ministry of Health and Family Welfare.
The organization will be responsible for evaluating the effectiveness of different procedures and suggesting suitable drugs or medical devices. Additionally, the authority has the power to make pricing recommendations to the National Pharma Pricing Authority (NPPA), which regulates the prices of both drugs and a set of devices. In July 2018, the body conducted a landmark evaluation of intraocular lenses for the treatment of age-related cataracts in India. The results have been met with diverse feedback from different stakeholders, but the effort has been highly praised by everyone across the board.
Our DRG Medtech experts believe that the creation of HTAIn, although a very progressive step, will have a limiting impact on the health care environment because of two reasons—firstly, there is a lack of data in the Indian health care system for the proper evaluation of drugs/medical devices; secondly, this is a very resource-intensive process and can be a huge burden on India’s already overburdened health care system. In fact, health care in India could benefit more from accessing international HTA data during the initial phase of PM-JAY.
- Artificial Intelligence (AI) in the Indian Health Care System:
Another key topic that was discussed at the conference was AI and the potential for using this technology to further improve health care provision in India. For instance, IBM Watson was floated as a potential solution to assist Indian oncologists—who, unlike their counterparts in the US and Europe, may not specialize in a specific cancer—to keep up with the latest oncological research. Additionally, technology heads of major medical device companies such as GE Healthcare and Novartis also highlighted the importance of big data.
DRG Medtech’s perspective is that the Indian health care system could benefit from prioritizing the development of technology platforms that store data in a structured manner to improve patient monitoring and analysis of health outcomes in the country. Also, pricing/sales data can help in the rationalization of trade margins for drugs and medical devices in the future.
For more information on DRG’s insights into Indian medical device markets, check out the nearly 40 Medtech 360 reports that cover India as part of our Asia Pacific geographical coverage. Visit Marketrack’s homepage to learn more about our brand-level pricing and market share tool. For any questions or to request a demo, contact us at firstname.lastname@example.org.