"KIHT to support indigenous research and manufacturing capability to make India self-dependent"
Indian biomedical industry is undergoing a positive transformation over the few years. The change has been felt with Kalam Institute of Health Technologies’ (KIHT) tremendous efforts. India, a country which projects as being extremely import-dependent for medical devices, is no more the same. The efforts of KIHT has changed that paradigm and in just one year since its formation, significant MoUs and agreements have been inked that aim at creating a more indigenous research and manufacturing environment and capability for India. Supporting biomedical startups, skilling India’s young biomedical workforce, nurturing talent, interacting with policy makers and most of all being the face of India’s biomedical industry is serious business for KIHT.
Celebrating its first birth anniversary and its recent agreement with Cuban counterparts has prompted BioSpectrum to interact with Dr Jitendar Sharma, CEO of KIHT. Dr Sharma in an interactive session reveals the goals of KIHT and its accomplishments done so far. Edited excerpts;
With what purpose was KIHT formed and so far how has the institute kept in lines with its objectives?
KIHT was formed to facilitate focused research on critical components pertaining to medical devices by supporting institutions involved with R&D, industry, policy makers and knowledge repositories. KIHT successfully created the world’s first e-auction platform for transfer of Intellectual Property, material and prototypes and bringing strategic and coherent synergy of scientific facilities and institutions to complement efforts on industrial promotion in the medical devices segment.
So far, KIHT has facilitated convergence of available technologies to bring increased access to affordable health products to citizens and a thriving medical devices manufacturing sector in India. The institution has created a knowledge repository for trade information, and has analysed emerging trends in trade and investments and provided policy enabling inputs to the government.
KIHT has been instrumental in launching a pioneer initiative named NIPUN certificate, i.e. Non-regulatory Innovation Potential Utility and Novelty certificate, to act as a single point window for all non-regulatory requirements of the medical technology sector and provide a simplified approach to the current process in the commercialization of a product. It takes care of all the processes relating to regulatory filing for a certified product in hand for gaining market access.
KIHT promulgated Health Technology as one of the core component of market access, which adds value to the product credibility by giving them comparative overview of clinical and economic effectiveness of the innovation with its systematic, transparent and evidence based decision making process.
Following are few achievements in space of Health Technology Assessment (HTA):
1) KIHT got collaborated with The Joanna Briggs Institute (JBI), and Institute of the University of Adelaide as JBI Affiliated group member for applying international standard and methodology to conduct systematic reviews & meta-analysis.
2) KIHT is now regional hub for conducting HTA for Department of Health Research, Ministry of Health and Family Welfare.
3) KIHT has organized two international fellowship programme on HTA and has collaborated with Tata Institute of Social Science (TISS), Mumbai for taking fellowship programme to next level by converting it to Executive programme on Health Technology Policy, assessment and outcomes research. This programme would give holistic approach in understanding public health policies and how to utilize evidence based research for decision making.
4) As part of NIPUN certification, KIHT is well equipped to evaluate technologies with highest
international standards and provide recommendation for innovations on the basis of evidences.
As part of its constant endeavour to cater to the needs of the medical devices industry, KIHT has come out with unique type of dossiers to disseminate information specific to devices in healthcare which are complex in technology and import dependent. These dossiers capture key features of a product like design, technology, market share, etc. and facilitates users like startups, researchers, academicians, manufacturers and other stakeholders in taking decisions on R&D, investment, potential market, innovations etc. KIHT periodically conducts training sessions and workshops on medical devices and their functionality with hands on session by experts on the actual device itself. Such level of close proximity to actual operating medical devices and in depth learning has been unprecedented.
How does the Chandrababu Naidu-headed Andhra Pradesh Government support developments at KIHT?
The land and infrastructural support for KIHT has been provided for within the Andhra Pradesh MedTech Zone, which is an enterprise of AP Government. KIHT was the knowledge partner for AP Health festival in Visakhapatnam and are often consulted for essential decisions in the health department.
What are the significant milestones accomplished by the Institute so far?
KIHT has been recognized by the Principal Scientific Advisor (PSA) to the Government of India as official Project Analysis Unit for all Health Technology Projects in the country. The PSA himself held a consultative meeting at the KIHT campus, where a host of institutions and organizations were called in for an in depth discussion on the status of projects that received government funding in the health technology domain.
Apart from the NIPUN certification and HTA initiative, KIHT takes pride in successfully launching the first ever e-auction for medical technologies on February 15, 2018, by Ananth Kumar, Union Minister for Chemicals & Fertilizers on India Medical Device 2018, the largest exhibition and conference on the Indian Medical Devices Sector Organized by Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India in partnership with Federation of Indian Chambers of Commerce & Industry (FICCI). The e-Auction web portal hosts 22 technologies for technology transfer as on date. KIHT has signed MoU with 12 institutes/ company for the purpose of technology transfer so far and more in progress to bring more technologies to market.
KIHT also participated in International Technology Transfer Convention 2017, Beijing, China. China’s largest technology transfer forum to streamline the innovative healthcare technologies to India.
NIPUN Certification came as a boon to start-ups, innovators and MSMEs of medical device industry for commercializing their products. Since the industry is still in its infancy stage, the exposure towards standardization is limited and therefore the innovators are finding difficulty in putting their product in the market. Soon after the official launch of NIPUN by PSA on April 30, 2018, an overwhelming response from various people have been observed. The services of NIPUN include: conformity testing, HTA, Market Research, Patenting, Rapid Prototyping and other related services in order for the product to conform to a particular standard. As a part of the continuous growth phase, KIHT has entered into 22 associations with several institutions and organizations pan India and have offered trainings, workshops, conference speech at many events in order to bring more open-ended discussions in the MedTech space.
What is the USP of KIHT and how it is different from other institutes?
No other organization, in any realm of any discipline of science, has accomplished what KIHT has in this short span of time. KIHT has mapped the core health technology space, offered solutions and various aspects of policy support, along with the parent organization, Andhra Pradesh MedTech Zone Ltd (AMTZ) has created a bandwidth of bench to bedside transition and has opened up medical technology as a formidable discipline to contribute to the Indian dream.
The institute has been instrumental in shaping the biomedical skill sector of India. How, according
to you, has this been accomplished?
KIHT along with AMTZ, National Accreditation Board for Certification Bodies (NABCB), Quality Council of India (QCI) and Association of Indian Manufacturers of Medical Devices (AIMED) joined hands to form the Indian Biomedical Skill Consortium on February 16, 2018 with an objective to reinforce biomedical skill sector in the country. Institutional Bio Safety Committee (IBSC) brings an equivalence system of value-based assessment covering educational qualification, work experience and competency possessed by practitioners of biomedical engineering skills. To facilitate this, 50 assessment centres with a total testing capacity of 14,000 to take load of certification of more than 2 lakh biomedical engineering practitioners is planned across several states in India.
Could you elaborate on the recent collaboration with BioCubaFarma? How is this collaboration benefitting India and its relationship with Cuba?
The President of India visited Cuba from June 2123, 2018. An MoU on collaboration in the field of Biotechnology was signed between the two countries on June 22, 2018. It is to be emphasized that this is a great opportunity for Indian startups and industries in the field of Biotechnology to collaborate with their Cuban counterparts and vice versa.
A delegation comprising experts from the Biotechnology Industry Research Assistance Council (BIRAC) and KIHT, participated in discussions with ‘BioCubaFarma’, the Cuban Industry promotion institute for health sector for further potential collaboration in areas of mutually interest.
It has been observed that owing to its limited domestic production, Cuba is highly dependent on medical device imports. More than 40 per cent of medical devices are imported from Europe, primarily Germany and nearly 30 per cent come from China and Japan collectively. Indian startups/companies can play a major role in providing better and cost-effective solutions through mutual collaborations in the field of medical devices and other biotechnology related technologies/products. In view of the above a tripartite MoU between KIHT, BIRAC and ‘BioCubaFarma’ was signed to facilitate several stakeholders, including industry, R&D Institutes and Technology Transfer offices and pave the way for technological & industrial progress in Biotechnology sector. Some of the companies have been identified to interact with Cuban technology enterprises for licensing, manufacturing, R&D and program uptakes.
What is KIHT’s vision/goal for the next five years?
KIHT has few set goals to accomplish in the next five years.
a) Create a self-dependency module for Medical Technologies.
b) Consolidate all government funded health technology projects and facilitate their successful completion.
c) Enable more and more health technology innovations to reach out to their industry partners.
d) Create testing and validation bandwidth for all innovators so that they can take their prototypes to the next phase, thus enabling start-up’s in this technology driven segment.
e) Make HTA a mandatory module for procurement for medical devices.
f) Enable early researchers’ access to medical devices so that further innovations can be carried out.
How do you see accomplishing those goals as a boost to India’s biomedical industry?
The Indian biomedical industry is extremely import dependent. The efforts of KIHT can potentially motivate more indigenous research and manufacturing capability and in turn make the nation come out of this import dependency.
Besides BioCubaFarma are there any other partnerships KIHT has entered into? If yes, how have those partnerships supported the growth of KIHT?
KIHT has so far partnered with 22 institutions through which innovations can reach out to market place for possible health and market access avenues. The disease burden and trade deficit amalgamated model by KIHT created the National Priority List which was the first-ofits-kind need and trade-based grant released for R&D in any sector of science.