Introduction
The Medical Device industry is highly capital intensive with a long gestation period and requires development and induction of new technologies. It also requires continuous training of health providers to adapt to new technologies. Most of the hi-tech innovative products originate from a well-developed eco-system and innovation cycle which is yet to be fully developed in India. The industry depends on imports up to an extent of 86%.
This “Policy to Catalyze R&D and Innovation in the Pharma- MedTech Sector in India” is a commitment to encourage Research & Development (R&D) in pharmaceuticals and medical devices and to create an ecosystem for innovation in the sector in order for India to become a leader in drug discovery and innovative medical devices through incubating an entrepreneurial environment. It acknowledges the need for greater emphasis on encouraging R&D, through indigenously developed cutting-edge products and technologies across the value chain.
Background
India is the largest provider of generic drugs globally. Indian pharmaceutical sector supplies over 50% of global demand for various vaccines, 40% of generic demand in the US and 25% of all medicine in the UK. Globally, India ranks 3rd in terms of pharmaceutical production by volume and 14th by value. The domestic pharmaceutical industry includes a network of 3,000 drug companies and ~10,500 manufacturing units.
India enjoys an important position in the global pharmaceuticals sector. The country also has a large pool of scientists and engineers with a potential to steer the industry ahead to greater heights. Presently, over 80% of the antiretroviral drugs used globally to combat AIDS (Acquired Immune Deficiency Syndrome) are supplied by Indian pharmaceutical firms. There are about 100 biosimilar approved in the Indian market till October 2020 and Industry reports another 40+ biosimilars in the clinical development stage. In the response to the pandemic, Indian industry has come forward to develop and manufacture bio-specific antibodies with some companies developing expertise in Antibody Drug Conjugate (ADC) and Monoclonal antibodies (MAB). The Vaccine sector in India with proven capacity for manufacturing at scale, (catering to 62% of global vaccine demand) is also benefitted by talented vaccine developers that have been at the forefront of the fight against COVID 19. Innovation and R&D will be key to retaining global leadership in vaccine sector and growing the biopharmaceuticals segment.
The medical devices sector, is a sunrise segment in Indian manufacturing sector, with over 750-800 domestic medical devices manufacturers having an average investment of $2.3–2.7 M and turnover of $6.2-6.9 M. The sector itself is highly diversified as it covers a range of products from reagents to radiotherapy equipment. The Indian medical device Industry is heterogeneous, consisting of large multinationals as well as small and medium enterprises (SMEs) and is growing at an unprecedented scale. Around 65% of the medical device manufacturers in India are domestic players operating in the consumables segment and catering to local consumption with limited exports. In addition, there are notable private sector firms manufacturing stents, dialyzers, x ray machines etc.
While giving a clarion call for ‘Atmanirbhar Bharat’, the Hon’ble Prime Minister highlighted that India can only achieve self-reliance in pharmaceuticals and medical devices by strengthening its R&D infrastructure that would drive expansion of access to life-saving medicines and help India become a global pharmaceuticals and medical devices exports hub. Also, the Parliamentary Standing Committee in its 46th Report on ‘Promotion and coordination of basic, applied and other research in areas related to the Pharmaceutical Sector’ in July, 2018 recommended for institutionalizing inter-departmental coordination mechanism, enhancing academia-industry linkage, boosting infrastructure, enhancing budget allocation for Pharmaceuticals and medical devices Research & Development, concentrating on future areas of research, like biologics and re-adjusting policy, rules & regulations. In pursuance to the recommendations of the Committee, an Inter Departmental Committee (IDC) was set up by the Department of Pharmaceuticals in January, 2019 to institutionalize a robust mechanism to ensure efficiency, effectiveness and transparency and coordinate research in a collaborative, synchronized and synergized way for optimum utilization of funds and to ensure no overlapping and duplication of efforts and resources.
The Scheme has been notified vide Gazette notification no. – 50020/5/2021 dated – 25/10/2021.
Opportunity
The COVID 19 pandemic has brought to the forefront the role of innovation in expanding scale, access and affordability of healthcare products
At a global level, Pharma and Medtech innovators are moving towards application of telemedicine, Artificial Intelligence (AI) & Machine Learning (ML), Virtual Reality (VR), Internet of Medical Things (IoMTs), Nanotechnology, Robotics & 3D printing, Big data & advanced analytics for aided diagnosis, green technology, additive manufacturing, flexible production, mobile applications for chronic disease management, digital therapeutics, precision medicine, and Medical records etc.
The Pandemic showed that Advancing research and innovation are top priorities for the industry. To enable an ecosystem of innovation and growth the industry will continue to invest in skill development, infrastructure enhancement to transform the country into a life sciences innovation hub. Regulatory simplification, industry-academia collaboration and funding will be the pillars for innovation.
Objective
- Creation of world class infrastructure facilities in order to make Indian medical device industry a global leader.
- To simplify regulatory processes to enable rapid drug discovery and development and innovation in medical devices;
- To explore mechanisms to incentivize private sector investment in research and evaluate various funding mechanisms – Budgetary support, Venture capital, CSR funding etc. and fiscal incentives to support innovation;
- To identify mechanisms to strengthen the R&D ecosystem through increased collaboration between Industry and Academia; and
- Easy access to standard testing and infrastructure facilities through creation of world class Common Infrastructure Facilities for increased competitiveness will result into significant reduction of the cost of production of medical devices leading to better availability and affordability of medical devices in the domestic market.
- To enable integration of the existing policies and programs of various departments/ agencies/ institutes in order to develop mechanisms to dovetail research as per requirement of the Industry.
Focus Area
- The first is to create a regulatory environment that facilitates innovation and research in product development, expanding the traditional regulatory objectives of safety and quality.
- The second focus area would be to incentivize private and public investment in Innovation through a mix of fiscal and non-fiscal measures, thereby matching risks with remunerative financing options.
- The third area of focus will be to build an enabling ecosystem designed to support innovation and cross sectoral research as a strong institutional foundation for sustainable growth in the sector.
Regulatory Framework: Streamlining Processes/Approvals
The Drug Controller General of India in the CDSCO is the licensing authority, but there are multiple agencies with different mandates and expertise that an Innovator firm has to navigate. In the case of bio-pharmaceuticals, the regulatory scrutiny of manipulation of the genetic material is an additional procedure. In the case of medical technology, a number of existing standards and licensing approvals apply to specific components especially in the electronic and radioactive spheres. As a result, clear processes to deal with new products and innovations that fall outside the existing standards may be absent. The Clinical Trial Rules have been modified in 2020 to deal with some of these issues and the Medical Devices Rules have been notified by MOHFW to guide the transition to a fully regulated regime. Another major challenge lies in building regulatory capacity within government to keep up with the latest advances in science and technology and reduce dependence on ad-hoc external inputs. All of this contributes to long timelines for grant of approval to innovative products, which has been identified as an area of concern.
Measures
- Process optimization: All regulators will be mandated to work together to reduce process overlapping and establish timelines for requisite approvals. A Common Specific Procedure Pathway (CSPP) would be provided for each class of product, which would include checklists, prescribed timelines, parallel processing, joint inspections, automatic / deemed approvals, and sharing of data across regulators. It shall be the aim to bring down the current time taken for regulatory approvals for innovative products by at least 50% within the next two years.
- Technology based platform: Creation of a single end to end digital portal is proposed, which would be used by different departments/ regulators. The Portal (single window) to be hosted by CDSCO will offer a single interface between Innovator and Regulator. It will function through an interconnected system with automated transfer of data across departments and agencies and enable upload of all documents on the integrated portal. Artificial intelligence backed dossier review and deficiency identification using natural language processing (NLP) and automated document management workflows will be deployed to enhance efficiency and reduce human interface.
- Regulatory Capacity: The strengthening of the regulator’s capabilities would include building in-house expertise in Biopharmaceuticals and high end medical devices. Specialization will have to be created or in-sourced to handle oversight of regulatory functions in respect of New Biological Entities and New Chemical Entities, Biologics, Imaging medical technologies, New Materials, tele-diagnostics, AI/ML based innovations, Sensors, etc. NPPA will be supported to develop greater expertise in pricing of new innovative products, while pursuing affordability as an overall objective. The policy advocates collaboration with relevant international regulatory agencies to enhance expertise of Indian regulators for approval of new drugs and medical devices and ensure a globally harmonized regulatory system; existing MoUs available with CDSCO will be reactivated and expanded for this purpose
Legislative
- Products that are cultured and cultivated artificially under controlled conditions are essentially not impacting natural resources and effectively the biodiversity of the country and hence should be exempted from the Biological Diversity Act.
- Institutional bodies need to be empowered for approving pre-clinical protocols, e.g., Institutional Animal Ethics Committee (IAEC) to be on par with Institutional Bio- Safety Committee (IBSC) to permit regulatory approvals for pre-clinical activities. o Enable joint inspection by CDSCO and State FDA (which should be conducted only once), in parallel, in case of vaccines and biologics for a particular class of product, for marketing authorization
- Review legislation enabling regulation of all medical devices in a phased manner with lead time of 12 months to manufacture for each category of medical device – Class A, B, C & D.
- Create dedicated licensing provisions for Ayurveda, Siddha & Unani (ASU) drugs. Explore providing Ayurveda WHO licensing authority to have the power to issue WHO GMP certificate.
Industry-academia linkages: Strengthen academic talent and infrastructure
The academic infrastructure will be strengthened and integrated into a coherent framework for building skilled manpower for the Pharma and Medtech sectors. Currently Pharmaceutical education is governed by Pharmacy Council of India. In addition, NIPERs work as Institutes of national excellence for post graduate and doctoral study. The multidisciplinary nature of the medical devices sector covering material science, electronics, sensors, biochemistry etc. requires the sector to draw upon talent from a wide range of academic institutions including the Indian Institutes of technology.
- Strengthening academic curriculum to make it dynamic and contemporary to meet current needs of pharmaceutical and Medtech sector, with increased focus on future ready technologies
- Institutionalize Industry representation in NIPERs and provide channels for varying degree of financial and managerial involvement
- Integrate pharmaceutical education at graduate, post graduate and doctoral levels under NIPERs and enhance expertise in Biopharmaceutical education
- Attract global educational institutions of eminence to create centers in India, leveraging the provision in the National Education Policy (NEP) allowing foreign universities to open campuses in India
- Purposeful investment in few priority institutes to build ‘Centres of excellence’ focused on med-tech innovation and R&D in the country
- Encouraging industry to fund research in academic institutions; Provision for companies to setup “research fund” for supporting research programs at academic institutions and laboratories with tax incentives
- Setup of entrepreneurship incubation centers in academic institutions
- Setup a strong governance framework to build trust and accountability;
Collaborating across institutions and sectors
Apart from the NIPERs, the rest of them fall within the Council for Scientific and Industrial Research, Department of Biotechnology, Department of Health Research and Department of Higher education. There is scope to increase collaboration across institutions so as to encourage innovation at scale and integrate research work across sectors and institutions. Collaboration is also required across the entire product development cycle covering drug discovery, drug delivery, device design, clinical trials, therapeutic and incremental innovations etc.
- Identification of Partner Institutions / organizations that would adopt the policy through a formal mechanism; these Partner institutions may include Research Institutions under various Government departments, CoEs set up under various Programs, and Private Research Labs. Institutions operating in a wide range of subjects of research would be eligible including electronics, instrumentation, Sensors and IoT, Material Science, AI/ML, Pharmacology, Biotechnology, Human Genetics etc.
- Setting up of an Inter-Departmental Research Council on Pharma and MedTech to catalyze, facilitate and promote collaboration across industry, academia and research institutions across Departments for domestic and international collaboration in R&D in Pharma Medtech sectors.
- Building an ecosystem model to strengthen R&D establishments, that acts as a unique platform for innovation, integrates diverse skill sets, and brings together stakeholders of pharmaceuticals/ bio-pharmaceutical / biomedical innovation landscape, while ensuring synergy between stakeholders across the product innovation pipeline.
- Taking forward the compelling lesson learnt from Covid-19 to showcase India’s strength and prowess in recent times, the policy will promote the concept of “Innovate in India”. To achieve this and to promote India as an “innovation hub”, the following interventions will be undertaken to build a strong brand along with effective dissemination of the same among target investors looking at making R&D investments in India in this Pharma-Medtech sector
Implementation Framework
A High-level Task Force will be set up in Department of Pharmaceuticals under the Minister for Chemicals and Fertilizers to guide and review the implementation of the Policy. The Task Force will draw upon resource persons from Departments and Organizations related to the implementation as the success of the policy requires coordinated action by several agencies. The Implementation will be designed in the form of an Action Plan defining roles, responsibilities, activities, targets, and timelines. The Policy has a ten-year perspective, and the Action Plan will be broken down to five year and annual activities for ease of implementation including spending decisions. The Action Plan will list activities in four categories namely Policy decisions, Program execution, Collaboration and Communications. The Policy Action Plan will cover a Five-year period with Annual Plans with attendant Financing framework.
Monitoring and Evaluation
Evaluation
- Identification of Priority areas and Research problems measured in Share of Research by Identified Institutions in priority areas
- R&D spending by Industry
- New Drug Discovery (including Biopharmaceuticals) measured in number of NCE and NBE in the pipeline and approved.
- Domestic manufacturing share in identified high end medical equipment
- Degree of Backward Integration in API, consumables and Components in domestic startups,
- Number of Orphan Drugs introduced in Indian market
- Increased availability of quality Research manpower in priority areas
- Start Ups in Pharma Medtech space incubated by Partner Institutions
- Share of Global exports in non-generics
- Share of imports in selected product segments of medical devices
A Monitoring and Evaluation Framework would be designed with the help of IEO NITI with rational Target setting, resource optimization, portal based reporting mechanism
