In the last three years, during the COVID-19 pandemic, the Pharmaceutical, healthcare, life sciences, and medical devices industries faced new challenges and adaptations. However, as we enter 2023, there is a sense of renewed optimism and focus on growth. The healthcare crisis caused by the pandemic has led to an increased emphasis on the pharmaceutical sector, reflected in higher budgetary allocations over the past three years. In this bog post, the authors have discussed the healthcare infrastructure in India – its growth, current status, and prospects.
The Indian pharmaceutical sector has emerged as a major global player, particularly in the generic and affordable vaccine segments. Over the past two decades, there have been substantial investments in the industry, both foreign and domestic. In 2021, the global pharmaceutical industry revenue reached an impressiveUSD 1.42 trillion. India’s feat of administering over 200 crore vaccine doses has not only eased pandemic-induced restrictions but also revitalized the demand for healthcare services across the sector.
The COVID-19 pandemic has brought the importance of digital health to the forefront of global healthcare. In response to the crisis, digital health technologies have played a vital role in enabling remote patient monitoring, telemedicine consultations, and contact tracing efforts. These innovations have helped bridge the gap between patients and healthcare providers, ensuring access to essential healthcare services while minimizing the risk of infection. The pandemic has accelerated the adoption of digital health solutions, highlighting their potential to revolutionize healthcare delivery and improving overall patient outcomes.
The COVID-19 pandemic brought attention to the importance of virtual technology in accessing medical experts, diagnostic services, disease treatment, and pharmaceutical distribution, further emphasizing the existing term ‘Digital Health’ in India. This increased emphasis is expected to drive significant changes in the healthcare industry in the near future. However, alongside these changes, there will also be challenges related to the lack of regulations or difficulties in implementing them. The digital health industry has grown rapidly since the pandemic, and a few of the reforms that transformed healthcare in India in the last five years include telemedicine, e-pharmacies, wearables, e-diagnostics, remote care, newly notified medical devices, technology relating to medical devices, QR codes in drug or API products, healthcare platforms, integration of new technologies, and theNational Health Digital Mission.
The COVID-19 pandemic has shown how data-driven, digitally enabled business models can be adopted in the healthcare sector to enhance the quality of care in India. Currently, there aremore than 7500 health tech startups in India, and the last few years saw some major investments in such health tech companies. By 2025, it is anticipated that India’s healthcare sector will increase in sizeto $50 billion. The future of the healthcare system ecosystem will be about how healthcare delivery will change efficiently and effectively over the next decade and what it means for both patients and healthcare providers. This will maximize the clinical, financial, and operational value of these new digital offerings and services. Organizations operating in the space may need to realign their goals by creating new business models to ensure the delivery of services is not only efficient and secure but also legally compliant. From a regulator’s point of view, an efficient, risk-based approach to regulating digital health technology will foster innovation of digital health products.
Moreover, the Indian Government iscurrently evaluating e-pharmacies, expressing concerns about potential data breaches and misuse of information through these digital platforms. The Government is deliberating on whether online sales of medicines should be permitted by e-pharmacies. As part of this process, the Drugs Controller General of India (“DCGI”) hasissued show-cause notices to more than 20 e-pharmacies, allowing these organizations to clarify their operational practices and compliance with existing regulations. There are multiple petitions which are pending in several High Courts across the country as well.
B. Digitalizing India’s Healthcare: The Journey of Integrating Digital Health Ecosystem
The World Health Assembly (“WHA”) the foremost authority in terms of setting health policy on a global scale urged its member states, vide itsresolution on Health in 2005, to consider developing a long-term strategic plan for developing and implementing Health services and building the infrastructure for health-related information and communication technologies to encourage equitable, low-cost, and universal access to their benefits. Subsequently, in 2013, the WHA adopted aresolution on Health standardization and interoperability that urged member states to consider developing policies and legislative mechanisms linked to an overall national Health strategy. In May 2018, the WHA adopted a resolution on digital health to develop aglobal strategy on digital health, identifying priority areas in close consultation with member states and inputs from stakeholders. In India, the concept of digital health and its integration into the folds of the domestic healthcare sector has grown exponentially in the last five years.
India has established a robust framework to establish a national digital health ecosystem, aiming to provide universal health coverage in an efficient, accessible, inclusive, affordable, timely, and secure manner. Since 2018, India has been an active member of theGlobal Digital Health Partnership (“GDHP”), an international collaboration of governments, government agencies, and multinational organizations, including the World Health Organization. The GDHP aims to facilitate the effective implementation of digital health services. To bridge the gap between stakeholders in the healthcare ecosystem and integrate the country’s digital infrastructure, the Government launched theAyushman Bharat Digital Mission (“ABDM”). The ABDM focuses on creating four essential registries for doctors, health infrastructure, health IDs, and patient personal health information. Currently, over21.9 crores of health IDs have been issued under the ABDM. In January 2022, theABDM Unified Health Interface was launched, granting digital health companies and other participating entities permission to develop their services on top of it. This initiative enables instant consultations with doctors, medicine delivery, and other health services, leading to increased efficiency for organizations and improved affordability for patients.
TheGovernment’s National Health Policy, 2017, aimed to establish a Digital Health Ecosystem in India by proposing the creation of a National Digital Health Authority and advocating for the integration of Aadhaar with individual health records. TheDraft Digital Information on Security in Healthcare Act, 2018 (“DISHA”) further proposed the establishment of the National Digital Health Authority and Health Information Exchanges to ensure the privacy, confidentiality, security, and standardization of electronic health data. DISHA, which complements thePersonal Data Protection Bill (“PDP Bill”), is similar to theHealth Insurance Portability and Accountability Act (“HIPAA”) of 1996 in the United States. It distinguishes between Digital Health Data (“DHD”) and personally identifiable information (PI) that it regulates. However, some provisions in DISHA, such as the prohibition of commercializing health data, may conflict with the PDP Bill, which allows for data processing under specific circumstances.
The committee constituted by the Health Ministry released the National Digital Health Blueprint in 2019 to implement the National Health Stack through the streamlinedNational Digital Health Mission (“NDHM”) in 2020. The blueprint recommended several key components, including the creation of Aadhaar-linked Health IDs, a federated architecture for data analytics based on aggregated health data from Health Information Providers (“HIPs”), registries for healthcare professionals and health facilities, a Consent Manager, a Gateway for seamless data flow with patient consent. The data is stored in theNational Health Stack, which was established in 2018 to enable the “portability” of healthcare by creating a centralized health record for all citizens, facilitating the efficient collection and management of health information. This data can be accessed not only by patients but also by various stakeholders in the healthcare industry, including hospitals, laboratories, and insurance companies. The blueprint also proposed the creation of master health data, personal health records, digital health IDs, health data directories, and a platform for integrating health insurance programs into the system.
Although the National Digital Health Blueprint acknowledges the need for a federated architecture to establish a digital healthcare ecosystem, it primarily focuses on prioritizing data protection and privacy while neglecting other regulatory considerations that may arise due to the evolving definition of medical devices. The current laws pertaining to drugs are inadequate for effectively regulating intangible software and other emerging technologies in the healthcare industry. For instance, theDrugs and Cosmetics Act of 1940 defines “import” as “bringing anything into India,” which means that any software developed outside India may be considered imported once it is used within the country. Consequently, the software owner becomes subject to Indian laws, discouraging the cross-border flow of innovative technologies. It is crucial to ensure that domestic regulatory scrutiny aligns with global trends and avoids unnecessary and disproportionate regulations that may hinder the growth of innovative healthcare solutions.
C. Digital Health: Paving the Way for Improved Healthcare Infrastructure and Outcomes
Digital health has emerged as a transformative alternative in terms of healthcare infrastructure. With advancements in technology, digital health solutions offer a range of benefits, including improved access to healthcare services, enhanced patient engagement, and streamlined healthcare delivery. By leveraging telemedicine, remote patient monitoring, electronic health records, and mobile health applications, digital health enables healthcare providers to reach patients in remote areas, provide timely interventions, and monitor patients’ health remotely. This alternative infrastructure reduces the need for physical infrastructure and enables healthcare to be delivered beyond traditional healthcare settings, making healthcare more accessible, efficient, and patient-centered. However, it is important to note here that implementation of digital health in India needs to bolster the supporting infrastructure to ensure effective implementation.
From a practical point of view, the success of digital health initiatives relies heavily on robust infrastructure, including a reliable internet connection, secure data networks, and interoperable systems. To fully harness the benefits of digital health, healthcare facilities must invest in upgrading their technological infrastructure, ensuring seamless connectivity, and establishing a strong foundation for data management and security. Adequate training and resources should also be provided to healthcare professionals to effectively utilize digital health tools. By strengthening the infrastructure, healthcare systems can overcome barriers to digital health adoption and ensure the smooth integration of these technologies, ultimately improving patient care, enhancing efficiency, and driving innovation in the healthcare sector.
Digital health has undoubtedly emerged as a transformative force in India’s healthcare landscape. The rapid advancements in technology and the increasing penetration of mobile devices have opened new avenues for delivering healthcare services, improving access, and empowering patients. From telemedicine consultations to remote patient monitoring and health apps, digital health solutions are revolutionizing healthcare delivery and bridging the gap between patients and healthcare providers. While challenges remain, such as infrastructure gaps and regulatory frameworks, the potential for digital health to positively impact healthcare outcomes in India is immense. As the nation continues to embrace and invest in digital health initiatives, it is crucial to prioritize collaboration among stakeholders, encourage innovation, and ensure inclusivity to maximize the benefits for all citizens. With continued efforts and a patient-centred approach, digital health has the potential to revolutionize healthcare, making it more accessible, efficient, and patient-centric for the people of India.
D. Stakeholder Expectations and Next Steps
Ensuring access to high-quality healthcare is essential, and while digital health has been adopted in Tier-I cities, there is limited access and integration of healthcare services in Tier-II and Tier-III cities, as well as rural and remote areas that are on the disadvantaged side of India’s digital, economic, and literacy divide. Therefore, it is necessary to develop infrastructure that caters to the diverse needs of the Indian population, considering the country’s demographic realities. The Government should focus on bridging the digital divide in India, enabling a smooth transition from traditional healthcare delivery to technology-driven solutions that optimize costs, save time, and include more people in the healthcare system.
Although challenging, a strategy must be adopted to include the adoption of appropriate digital health technology, particularly targeting Tier-II cities, Tier-III cities and rural areas by adopting shared services and technologies. If the system provides high-quality and affordable healthcare that strengthens and scales up diagnosis, management, health promotion, and disease prevention in a system that understands the needs of the patients and values their privacy, it will be valued and adopted.
Virtual care, telemedicine, remote monitoring, artificial intelligence, Internet of Things (“IoT”), big data analytics, blockchain, smart wearables, digital tech or enabled platforms, tools enabling data exchange and storage, and tools enabling remote data capture and the exchange of data and the sharing of relevant information are creating an ecosystem to improve the health of individuals. The cornerstones of the digital health sector must include ethics, security, reliability, safety, equitability and sustainability vis-à-vis the use of digital health. Furthermore, digital health providers must consider other important factors such as transparency, accessibility, scalability, replication, interoperability, privacy, and, crucially, legal compliance while developing mass consumer digital health services. In order to empower patients and realize the goal of ‘health for ‘all’, digital health technology may be adopted by consumers, healthcare providers, and the industry at large. It is predicted that in the coming years, sustainable health systems and universal health coverage may rely heavily on the incorporation of digital technologies in the healthcare system.
It is also crucial to note that the sale of medicines and drugs from online e-pharmacies has resulted in large-scale benefits to the public at large, especially patients that are based in remote locations and Tier-Il/Tier-III cities where the accessibility to authentic and affordable medicines remains limited. Through e-pharmacies, consumers can instantly know about the availability of a product, including drugs for rare medical conditions, instead of physically reaching out to multiple ‘brick and ‘mortar’ pharmacies spread across a large area. The advancements in the telecom infrastructure and ‘Digital ‘India’ initiatives across the country have directly resulted in increased and affordable internet coverage, which in turn has resulted in an increased number of areas being covered under the ambit of services provided by e-pharmacies. Consequently, an increasingly larger section of the population is benefitting from access to quality medicines. Furthermore, e-pharmacies proved their mettle during the COVID-19 lockdown periods when access to medicines, medical devices and drugs was severely impacted, and the home delivery of medicines to patients proved to be of significant importance.
In conclusion, regulators should adopt a less interventionist approach when it comes to lower-risk digital health technologies, including software. Adhering to traditional premarket requirements can hinder or slow down patient access to important advancements in software technology, especially those that pose minimal risks to patients. It is essential to enhance the global regulatory landscape for digital health products to promote innovation within the country and expand the availability of products that contribute to the overall improvement of human health.
Any views or opinions represented in this blog post are personal and belong solely to the authors and do not represent those of people, institutions, or organizations that the authors may or may not be associated with in professional or personal capacity.
About the Authors
Mr. Biplab Lenin is a Partner (Healthcare, Pharmaceuticals and Life-sciences) at Cyril Amarchand Mangaldas; and Mr. Priyam Raj Kumar is an Associate (Healthcare, Pharmaceuticals and Life-sciences) at Cyril Amarchand Mangaldas.
Managing Editor: Naman Anand
Editors-in-Chief: Jhalak Srivastav and Muskaan Singh
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Preferred Method of Citation
Biplab Lenin and Priyam Raj Kumar, “From Crisis to Opportunity: Revolutionizing India’s Healthcare Landscape” (IJPIEL, 5 June 2023)