Nanomedicine, an interdisciplinary technology domain is attracting worldwide attention owing to its perceived advantages such as efficacy and efficiency . Varied aspects of the subject have been suitably covered earlier . Interestingly, the Indian nanomedicine market is expected to grow to a value of USD 1.6 Billion in another 10–15 years . It is anticipated that India would rank among the top three healthcare markets by 2020 . The Indian government has been funding research and development (R&D) in the area of nanomedicine with the intention to address specific societal needs and to be a forerunner in this area. In the year 2007, the Department of Science and Technology (DST) established a Nanomission program to foster basic research, establish research infrastructure, nurture human capital, strike international collaborations, and strengthen the capacity for creating nanoenabled technologies. Other government organizations, such as the Council of Scientific and Industrial Research (CSIR), Defence Research and Development Organization (DRDO), Department of Biotechnology (DBT), and Indian Council of Medical Research (ICMR), also followed suit in funding nanomedicine projects. Although research in India on nanomedicine has progressed, a comprehensive landscape on Indian nanomedicine innovation activities is currently unavailable to assess the impact of India’s engagement in the field of nanomedicine.
There have been some studies in the past to understand the area of nanomedicine or nanotechnology in healthcare in India. Jain (2006) has elaborated on the status of nanomedicine research in India by exemplifying the research activities in numerous institutes across India, but the study was limited to the academic institutions . Although Kumar and Desai (2014) have illustrated the initiatives taken by the Indian government in promoting nanobiotechnology and conducted a strength, weakness, opportunity, and threat (SWOT) analysis to identify the strengths and weaknesses in this area, they have, however, not considered various other determinants such as the patent filing trends in India and the number of commercial products or startups in this field , , . Further, the SWOT analysis focused on nanobiotechnology, an amalgamation of nanotechnology and biotechnology, whereas, nanomedicine is multidisciplinary and connotes convergence of different disciplines. Hence, the study does not reveal a complete picture of development of nanomedicine in India. Ali and Sinha (2014) have highlighted a bibliographic output of nanobiotechnology, but there is no detailed assessment of the research indicators . They have also analyzed nanotechnology applications in the healthcare sector in India and have attempted to identify the various stakeholders , . Bhattacharya and Shilpa (2011), Anand (2014), and Shefali et al. (2016) have cited a few nanotechnology-based products in medicine , , . All of the above publications have evaluated funding schemes, bibliographic indicators, and products from the year 2000 onward and illustrated a growth trend of nanotechnology, in general, and nanotechnology in healthcare, in particular. It has also been established that the major source of research is academics. However, none of these publications portray a complete picture of nanomedicine innovation in India. There is, thus, a case for adequately surveying the level of nanomedicine innovations in India.
Innovation leads to development; therefore, indicators that convey information on the inputs and outputs contributing to the development need to be assessed for innovation mapping . A national innovation system is characterized by institutions that support and foster knowledge creation and its exploitation . Bibliographic indicators are frequently used as output indicators, but the major drawback is that these do not give a complete picture , . To illustrate the contemporary status of nanomedicine in India, it is essential to use multiple indicators to map the entire innovation value chain. As defined by Kaplinsky and Morris (2001), “The value chain describes the full range of activities which are required to bring a product or service from conception, through the different phases of production (involving a combination of physical transformation and the input of various producer services), delivery to final consumers, and final disposal after use” . Funding agencies, academia, industrial units, contract research organizations (CROs), and regulators are important stakeholders in the value chain. The present study tried to map the nanomedicine innovation landscape from the year 2010 to 2015 based on five parameters – financial ecosystem, technology source, research translation, bibliometric indicators, and regulation (Figure 1). As the focus of the paper is to provide the status of nanomedicine in India, a comparison of the status of nanomedicine with other countries is beyond the scope of this study and has not been discussed. However, it is noteworthy that similar studies to understand the status of nanomedicine in Europe and South Africa have been carried out , . The present paper has been structured along the methodology adopted, results, and discussion.
Currently, there is no universally accepted definition of nanomedicine ; therefore, we have considered nanomedicine as an intervention at the level of nanoscale in human beings for medical diagnosis, prevention, and treatment of disease (Box 1). A scientometric analysis has been carried out to assess nanomedicine innovation in India by deploying a two-step strategy involving quantitative and qualitative analysis for a period of 5 years from 2010 to 2015. The methodology adopted is illustrated in Figure 2. The quantitative analysis was conducted through keyword-based primary and secondary searches to identify different stakeholders, trend in market, and patent filing. In order to capture all alternative phrases that are used for nanomedicine, we used “nano” and “India” as keywords. The various keywords and websites used for data collection are listed (Box 2). The information on the funding schemes of the government was mined from the respective agency’s website and their annual reports. Google search was used to gather information on the venture capital (VC) firms and angel investors who are supporting nanomedicine-based companies. The authors also relied on their survey to solicit response from various firms that may have funded any nanomedicine-based venture.
The universities, institutes, and companies carrying out nanomedicine-based projects were identified from the data collected from websites of funding agencies, Indian Patent Database, Pubmed, and Scopus. Further, the academia was categorized as universities (public and private), CSIR Institutes, Higher Education Institutes (HEIs, other than CSIR Institutes), medical colleges, pharmacy colleges, and others. Special centers established at different universities and institutes were also studied. A short survey was conducted to determine the CROs in India providing translation support. Bibliographic analysis of publications and patents was conducted using Pubmed, Scopus, and the Indian Patent Database. Publications were retrieved from Pubmed and Scopus using the keyword “nano”, keeping it broad, and the results obtained were further screened. In Pubmed, the results were limited to human beings, while in the case of Scopus, veterinary articles were also found, which were then manually screened. To maintain uniformity, only article type publications were searched for the period 2010–2015. To identify the key players and patent filing trends in India, patent applications were searched from the database of the Indian patent office. The patent applications and the granted patents were retrieved on the basis of filing date and were manually screened. Some of the data were not available due to the lag of up to 18 months in the publication of patent information by various patent offices. To identify products in the market, Google search was used, while to ascertain the products undergoing clinical trials in India, the Clinical Trials Registry-India was used. As a second step, a qualitative analysis was carried out to map various laws, policies, and proposed amendments applicable for nanomedicine in India. Google search for “nano” and “India” was also carried out.
In the following sections, we present the results related to funding, patenting, and the number of products in the Indian market. The section on discussion details out the funding ecosystem, stakeholders, and regulation of nanomedicine in India.
A landscape view of nanomedicine innovation in India has been mapped highlighting the contribution of different stakeholders to nanomedicine innovation, level of investment, and policies applicable for nanomedicine. Figure 3 illustrates the category of various stakeholders, products, bibliographic indicators, and relevant laws. Each of these factors are discussed in detail in the following sections.
3.1 Financial ecosystem
We have used the term “financial ecosystem” to elucidate the funding systems covering both public and private sources. The government of India’s DST launched a program on Nanoscience and Technology (Nanomission) in the year 2007. Since then, Nanomission has been promoting nanotechnology-based research and development in India. Similarly, the DBT, established by the Ministry of Science and Technology, Government of India, supports the development of nanomedicine and toxicity testing. The ICMR that falls under the Department of Health Research, Ministry of Health and Family Welfare is also investing in the promotion of nanomedicine. It has been observed that the ICMR has funded a higher number of projects in the years 2011, 2012, and 2015, while the DBT was the leader in the years 2010, 2013, and 2014 (Figure 4A). Compared to other areas, projects on drug delivery and drug development have received more funding (Figure 4B–D). It is noteworthy, that toxicological and mechanistic studies have also been funded. Besides the above projects, eight industry-academia collaborative projects have been supported by the DBT under various schemes of its enterprise, Biotechnology Industrial Research Assistance Council (BIRAC) (Table 1). The authors have noted, through data mining and a survey, that in the past few years, angel investors and VC firms such as the Karnataka State Industrial Investment and Development Corporation Limited, Accel India Partners, Navam Capital, Aarin Capital, Nadathur Group, Priaas Investments, ICICI Ventures, and India Science Venture Fund have actively invested in nanomedicine-based ventures in India.
3.2 Technology sources
The academia, research organizations, and industry are the usual sources of technology solutions. It has been observed that in India, both public and private universities have ventured into the field of nanomedicine. Then, there are other HEIs, like the Indian Institutes of Technology (IITs), CSIR institutes, medical colleges, and pharmacy colleges (Figure 5A, Table 2). Special nanoscience and nanotechnology centers with strong focus on nanomedicine have also been established in India (Figure 5B, Table 3). Some of these centers are outcomes of joint industry-academic collaborations: for instance, the Nano Functional Materials Centre, established by the Indian Institute of Technology Madras in partnership with Orchid Pharma, a Nano Technology Centre setup at the University of Hyderabad in collaboration with Dr. Reddy’s Labs, while the Centre for Pharmaceutical Nanotechnology at the National Institute of Pharmaceutical Research and Education (NIPER), is also in collaboration with a pharmaceutical company (www.nanomission.gov.in). The Department of Electronics and Information Technology (DEITY) has also sponsored two facilities to promote prototyping and fabrication at IIT Delhi and IIT Bombay (Table 3). Besides the DST and DEITY, the Ministry of Human Resource Development (MHRD) has also taken up steps toward supporting initiatives in the area of nanomedicine research. The Indian academia and companies have collaborated on nanomedicine research with foreign organizations under different funding schemes between India and other countries for instance, USA, UK, Russia, Australia, and European countries (Table 4). Interestingly, pharmaceutical and medical device companies such as Dabur, Lifecare Innovations, and Concept Medical are also working in this domain (Table 5) for some time now.
3.3 Research translation
The CROs are important entities that assist in translational research. The authors conducted a short survey to identify the CROs in India working in the field of nanomedicine. It was observed that some organizations, such as Quintiles Technologies (India) Pvt. Ltd, were already working in this field, while Sristek and Cadila had indicated interest to work in the future (Table 6). Interestingly, non-governmental organizations such as industry associations, societies, and advocacy agencies like The Energy and Resources Institute, India, have taken up policy-related issues in the context of nanomedicine (Figure 6).
3.4 Policies and regulations
The tremendous potential of nanomedicines has generally been accepted, but there are concerns regarding their safety and toxicity. Therefore, the regulation for use is called for. At present, no laws specific to nanomedicine exist in India , ; therefore, the existing relevant Indian regulatory laws in context of nanomedicine were examined (Figure 7). Scholars have already assessed and found the Indian Factory Act, Environment Protection Act, and Biomedical Waste Disposal Act to be applicable in the context of nanomedicine; thereby, these were not reevaluated in the present study , . The Indian Patent (Amendment) Act was also not assessed in detail in this manuscript (discussed elsewhere). We have assessed the Drugs and Cosmetic Act 1940, Drug Price Control Order, 2013, The Essential Commodities Act, Consumer Protection Bill, 2015, and Guidelines on Similar Biologics, 2012. In India, the Drugs and Cosmetic Act 1940 regulates drugs, medical devices, and diagnostics. Although the Act does not specify nanomaterial, nanomedicine can still be regulated. However, in the case of diagnostics, only in vitro diagnostics that are classified as critical can be regulated. Drug pricing in India is controlled through the Drug Price Control Order, 2013, and The Essential Commodities Act, and these two acts will influence to ensure access to nanomedicine as well. The proposed Consumer Protection Bill, 2015, which will replace the Consumer Protection Act, 1986, confers protection to the consumer by putting the liability of safety of the product on the manufacturer.
The Central Drugs Standard Control Organization (CDSCO) and DBT have laid down the “Guidelines on Similar Biologics” for their manufacturing process and quality aspects. These guidelines also address the pre-market regulatory requirements including comparability exercise for quality, preclinical and clinical studies and post market regulatory requirements for similar biologics.
The Drugs and Cosmetics (Amendment) Bill, 2013, proposes to include all vaccines, recombinant deoxyribonucleic acid-derived products, living modified organisms, stem cells, gene therapeutic products, etc., which are to be used as drugs. The medical devices were proposed to be regulated separately from drugs under the proposed bill. However, these amendments still do not address the concerns in the regulation of the newer generation of nanomedicine such as combination products or those with multiple functions, for example, imaging and drug delivery as in the case of quantum dots. It is noteworthy that this uncertainty would also arise in the case of nanobiosimilars or nanosimilars or nanogeneric drugs. The innovation quotient of nanomedicine in India may be affected by the uncertainty in the regulatory pathway.
Although it is mandatory to label active ingredients as per the Drugs and Cosmetics Act, 1940; this provision may not be applicable to encapsulated drugs, wherein the delivery mechanism comprises nanomaterials not the drugs. Similarly, the Drug Price Control Order 1995 defines “active pharmaceutical ingredients or bulk drug” as any pharmaceutical, chemical, biological, or plant product including its salts, esters, isomers, analogs, and derivatives, conforming to the standards specified in the Drugs and Cosmetics Act, 1940 (23 of 1940), and which is used as such or as an ingredient in any formulation. In light of this definition, nanoscale medicines may be excluded. Thus, the Act may further need revision to include the definition of “nano” and nanomedicine, provisions for appropriate labeling of nanomaterial-based products. Regulatory clarity would give a strong fillip to innovation programs in the domain of nanomedicine.
3.5 Bibliographic analysis
The expanse of deep research activities finds its echo in the publications’ record particularly in the refereed technical journals. In the present study, articles from Scopus and Pubmed with authors and institutions from India were analyzed to assess research growth in the subject domain. The Scopus database covers more articles on nanomedicine work compared to Pubmed (Figure 8A). Since the year 2010, there has been a consistent increase in the number of publications, which reflects the growth of nanomedicine research in India (Figure 8B). It is interesting to note that the total publications collated from both the sources remained constant from the year 2013 to 2015.
In general, the intellectual property (IP) position of an institution or country can reflect its innovation capacity/strength. Patenting in a technical domain is, thus, an important determinant of the development efforts in that space. The filing trend of patent applications in the field of nanomedicine in India was examined by the assessment of patent applications and granted patents. It has been observed that in the year 2012, more patent applications were filed followed by the year 2013 (Figure 9A). Less number of filings in the year 2015 can be attributed to the lag of 18 months from the date of filing after which the patent applications are published. The key players have also been identified. The Indian Institute of Technology Bombay leads in the filing of patent applications in nanomedicine followed by Amrita Viswa Vidhypetham (Figure 9B). The applicants were classified into individuals, funding agencies, companies, and academia (Figure 9C). A greater number of patent applications have been observed in the domain of delivery system followed by drugs and therapy (Figure 9D and E). It was interesting to observe that patent applications on multi-feature nanomedicine have also been filed.
3.6 Technology-driven entrepreneurship
Technology-driven entrepreneurship connotes innovation movement to the market place. Such commercialization efforts through startup companies are a good indicator of the overall maturity of the innovation ecosystem. In the present context, startup companies and entrepreneurs were identified to map nanomedicine innovation levels in India. For example, under the Biotechnology Ignition Grant (BIG) scheme of BIRAC until the year 2015, eight companies and three projects in the area of nanomedicine have been supported. Besides these BIG funded startups, there are 12 more startup companies in nanomedicine in India (Figure 10, Table 7).
3.7 Products in market and under clinical trials
A number of products have been introduced in the market for pain relief, anti-inflammatory, and cancer treatment. Volini®, a Ranbaxy Laboratories product for pain relief, is claimed to contain diclofenac entrapped in nanoparticles due to which there is a deeper penetration of ingredients to the site of pain in the joints and muscles giving quick and long-lasting relief. A generic version of Abraxane® and Albupax® that was introduced by Natco® for the treatment of breast cancer contains paclitaxel in an albumin-bound nanoparticle form. Table 8 highlights the compiled list of some of the products that have been developed in India and are available in the Indian market. The products have been divided into different categories such as pain management, antimicrobials, cancer treatment, ayurvedic nanoformulations, and biomaterials. In order to identify nanomedicine-based products undergoing clinical trials in India, a search was conducted in the Indian clinical trial database. It was observed that 19 products are currently in various phases of clinical trials in India (Table 9).
The commercial growth of any technology is dependent upon numerous factors and stakeholders. Therefore, to ascertain the levels of innovation, it is essential to examine the role of different contributing factors. One of the most important factors for spurring innovation outcomes is investment. The Indian government has provided funding for development projects and establishment of research centers with focus on nanomedicine. Indian agencies that are supporting nanomedicine R&D in the area of include DST, DBT, ICMR, CSIR, and DRDO. The Nanomission has funded nearly 76 nanomedicine-based projects from the year 2010 to 2015, while DBT has funded 127 projects for the development of nanomedicine products and toxicity testing. The ICMR is responsible for the promotion of biomedical research in India and has funded 154 projects on studies related to nanomedicine (Figure 4A). Besides governmental funding, other sources of funding are by VCs and angel groups. It has been observed that non-governmental funding for nanomedicine is comparatively less than that by governmental agencies. This seems normal as it is the government agencies that take upon themselves much of the development risk in the early stages. The risk capital (VC and angel funding) flows in where there are strong commercialization prospects, and the projects have been sufficiently de-risked.
The academia and the industry are sources of knowledge, and both contribute to technology development. More than 27 universities and most of the premium institutions are conducting research in the field of nanomedicine. It is interesting to note that research institutes with a mandate in other areas are also conducting research in nanomedicine; examples include the Bombay Veterinary College, CSIR’s Central Leather Research Institute, Central Scientific Instruments Organisation and National Metallurgical Laboratory, and Indian Association of Cultivation of Science. Companies such as Dabur Pharma and Lifecare Innovations are also working toward developing nanotechnology-based drug delivery systems for controlled release. One of the drug delivery systems developed by Dabur Pharma is Nanoxel that enables specific targeting of the cancerous cells and directly interacts with the tumor-causing agents. Other than drug delivery systems, devices with nanocoatings, such as the Relisys’s drug-eluting stent, are also in the process of being introduced in the market. Nanoforms of ayurvedic medicines are also available in the market.
Technology development and transfer finds an important onward avenue in technology-driven entrepreneurship, which has emerged as an important innovation indicator. Technology-based entrepreneurship can be regarded as recognizing, creating, and exploiting opportunities, and assembling resources around a technological solution to address gaps in the market . Therefore, identifying the startup companies in nanomedicine in India is a useful dataset in mapping innovation levels. Interestingly, NSTEDB (National Science & Technology Entrepreneurship Development Board, DST) has supported the setting up of the Nanotechnology Research Innovation and Incubation Centre (NRIIC) at PSG-STEP, PSG College of Technology at Coimbatore . The state government of Karnataka has also proposed a nano park and nano incubation center in Bangaluru . The DST has supported the establishment of a Nanotechnology Business Incubator at National Chemical Laboratory, Pune . However, the various facilities for incubation, testing, and manufacturing need to be augmented.
Both CROs and Contract Research and Manufacturing (CRAM) are crucial stakeholders in the development of therapeutics. In the case of nanomedicine, they also act as the interface between knowledge source and industry participants. They play a key role in development/improvement of innovative products including nanomedicine entities by providing needful access to R&D and test facilities that a company or an academic setup may lack. These organizations, thus, reduce the time for transition of product from laboratory to market. However, the number of CROs and CRAMS involved with nanomedicine in India are limited even though they are required to bridge the gap in translational research. Universally accepted or recognized standards are required for material manufacturing, product development, and clinical testing for enhanced compatibility and interoperability. Pal et al. have emphasized the importance of standards in nanoforms of ayurvedic medicine . However, in the case of nanomedicine, these are currently under development. The Bureau of Indian Standards (BIS) is responsible for evolving standards, while the Indian Institute of Toxicology Research (IITR), Lucknow, is working on the development of standard testing methods.
Policies and regulations assist in enhancing competencies and establishment of innovation networks. There are three major regulatory issues pertaining to nanomedicine – biosafety, biosecurity, and accessibility. Biosafety relates to the impact of nanomedicine on ecology and humans, while biosecurity addresses the inappropriate use of nanomedicine. Also, accessibility is a principle that ensures the availability of nanomedicines at affordable prices. Interestingly, the Indian Patent Laws take care of all the three issues. The Indian Patent Act prohibits patenting of inventions, which may harm human, animal, or plant health or the environment, while compulsory licensing ensures accessibility to the public in matters of absolute public good.
The uncertainty of regulatory pathway influences the dynamics of R&D collaborations and future research by companies. Several groups have emphasized the relevance of governance of research and commercialization of nanotechnology by a regulatory body , , . The DST has set up a working group to develop a National Regulatory Authority Framework Roadmap for Nanotechnology , , . Guidelines and best practices for safe handling of nanomaterials with a separate section on healthcare applications of nanotechnology have been framed by Nanomission . However, these are not mandatory for an organization to follow nor have the issues of misuse been addressed. In order to frame the regulation of nanodrugs and devices, a national center for pharmaceutical nanotechnology has been proposed to be established by the Department of Pharmaceuticals (DoP), Government of India, at NIPER Kolkata , . However, no framework or mechanism has been devised so far. Various authors have proposed the framework for governance of nanotechnology and its applications in India, but these are yet to be adopted by the government , , , , , . Thus, regulatory pathway is one of the key challenges to be addressed in order to further promote nanomedicine research in India.
5 Conclusion and future perspectives
It is anticipated that more nanomedicine products would be released in the Indian market in the next 5–10 years. The earlier studies have adequately captured the dynamics of nanomedicine in India. In the present paper, a landscape of nanomedicine innovations in India has been mapped highlighting the contribution of different stakeholders to innovation, kind of investment, and the policies applicable for nanomedicine. At present, the number of nanomedicine-based products, compared to pharmaceuticals and medical devices, is much less. Currently, there are 17 products in the market, and 19 products are at different stages of clinical trials. Filing patent applications and publishing nanomedicine research is also on the increase. Compared to the academia, companies are more proactive in filing patent applications in India. However, the major stimulus for nanomedicine innovation is through government funding, whereas private investments are still low. The rate of commercialization is low in the absence of credible value chain pathway, facilities, standards, and regulatory framework. In India, nanomedicine is still at a technology level slowly progressing, with major research concentrated in the academia. Appropriate policies and coordination between different stakeholders is required to increase the development activities and commercialization prospects. Nanomedicine, being an interdisciplinary field, can trigger an open innovation model for sharing knowledge and resources. There is scope for fostering strategic partnerships and also address issues of patent thickets and unnecessary monopolism. Evidently, a multidisciplinary field like nanomedicine needs a multifaceted IP and commercialization strategy for its growth. This landscape analysis intends to assist the policy makers and R&D community to decide on suitable ways forward.
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About the article
Ms. Pooja Bhatia has a Masters in Biotechnology and Masters in Business Administration. She has worked in the field of IP Management and Technology Transfer for the last 11 years and is also the Consultant Licensing at the Foundation for Innovation and Technology Transfer. Her current areas of interest are governance of nanomedicine, synthetic biology, and marine bioprospecting.
Suhas Vasaikar has a PhD in Systems Biology of Neurodegenerative Diseases from the Indian Institute of Technology Delhi and is currently working as a research associate at Baylor College of Medicine, USA, in the area of cancer multi-omics analysis. He has a combination of computational research experience in multi-omics, pan-cancer analysis. His interests lie in bioinformatics, systems biology, neuroinformatics, biomedical informatics, and cell signaling research.
Anil Wali is an IIT Delhi Doctorate and has years of experience in specialty chemicals and clean processes. He has worked in the chemical industry for 19 years and has several proprietary reports, patents, and publications to his credit. Since 2006, Dr. Wali is the Managing Director at the Foundation for Innovation and Technology Transfer (FITT) – an autonomous industry-interface organization at IIT Delhi. Besides having strategic customer and quality orientation, Anil Wali has multifaceted experience with respect to R&D management, training, entrepreneurship, IPR policy and strategy, open innovation, etc. Dr. Wali has been a member of the Board of Management, Indira Gandhi National Open University, N. Delhi, in 2013–2016. He is actively associated with the major industry associations (CII, FICCI, and ASSOCHAM) in India as an invited expert. Besides looking at issues of concern to SMEs, Anil Wali is overseeing technology transfer, enabling partnerships, capacity building programs, and driving innovations and incubation in the academia. Currently, he is organizing the establishment of Research Parks. Dr. Wali has piloted several industry partnership models at/from the academia. He is a part of several expert committees in the government and academia, and lectures widely.
Published Online: 2018-02-14
Published in Print: 2018-04-25