A single platform to connect dots of investor, innovator, regulator and government: Dr S Eswara Reddy, Joint Drugs Controller, CDSCO

New Delhi: Health committee, PHDCCI in association with Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Govt. of India recently organized the second series of Self Sufficiency in Medical Technology on “Innovation & Incentivisation of Indigenous MedTech Manufacturing”.

The Guest of Honour of the session was Dr. S. Eswara Reddy, Joint Drugs Controller General of India, CDSCO. He complemented the MedTech industry for doing an excellent job in last decade, yet Accessibility needs to improve significantly. Dr. Reddy said that Govt provides many schemes to promote innovation and pooling of the R & D funds which are offered by the various ministries could significantly give an impetus to the medtech ecosystem.
 
The webinar was graced with the presence of Mr. Pradeep Multani, Sr. Vice President, PHDCCI, Dr. N. Subramanian, Chair, Health Committee, PHDCCI & Director, Medical Services, Indraprastha Apollo Hospitals, Dr. Sameer Gupta, Co-Chair, Health Committee, PHDCCI & Director, Cardiac Cath Lab, Metro Group of Hospitals and Prof. (Dr.) Harvinder Popli, Co-Chair, Health Committee, PHDCCI & Director, SPS, Delhi Pharmaceutical Sciences and Research University, Govt. of NCT of Delhi.
 
The other eminent panelists present were Dr. Jitender Sharma, MD & CEO, AMTZ, Dr. Manish Diwan, Head - Strategic  Partnership & Entrepreneurship Development , BIRAC, Mr. Pavan Choudary, Chairman & Director General, MTaI & Managing Director, Vygon India, Mr. Sunil Khurana, CEO, BPL Medical Technologies, Mr. Saurabh Arora, Head of Tax, Asia Pacific, Siemens Healthineers Mr. Atantra Das Gupta, Director, South West Asia Head for Samsung HME (Health & Medical Device), Mr. Peeyush Kaushik, Head-Healthcare Innovation Center & Business Leader, Philips India Ltd. and Mr. Sanjay Gupta, President, ASIMA India & MD, Mars Edpal Instruments Pvt. Ltd.
 
While giving the welcome remarks, Mr. Multani said that MedTech Industry has evolved significantly in the last decade witnessing a high growth trajectory, but due to a number of ecosystem constrains, this industry sector has not been able to achieve its full potential. While talking about the innovation n MedTech, Mr. Multani said; to foster any medical device innovation, we need market push and technology generators such as trained manpower to generate ideas; funding opportunities for nurturing the idea; intellectual property (IP) protection; infrastructure to seed the IP or technology into a company set-up; and tax incentives policies for ease of doing business.
 
Mr. Multani hailed the PLI and Promotion of Medical Devices Parks scheme and said that these initiatives have the potential to contribute significantly to achieving higher objectives of affordable healthcare in the country and globally on a sustained basis.
 
Dr. Jitendar Sharma said that Medical device industry is very unique and diverse which makes the entire spectrum complex because of too many categories. Dr. Sharma emphasized on 3 major portfolios to be approached. He said that we should not discriminate research by nature of institutions as Government or Private and we must have national R & D fund which does not discriminate between Government and Private institutions. He suggested to have a 1000 cr R&D budget under the Principal Scientific officer. Dr. Sharma also mentioned that there should be a scientific regulatory pathway to converge to common regulatory filling platform where traceability can be done clearly and duplicity can be avoided without disturbing the current performance.

Dr. Manish Diwan said that there are gaps in the ecosystem which needs to be addressed and simultaneously opportunity is also sitting along with that. The first gap identified is that there is only 10% of population which is able to take & adopt the technology whereas most of the other people are yet to receive similar kind of technology. He further mentioned that hospital industry has taken a huge leap during Covid era because of the dependency on in-person healthcare delivery and remote consultation got Government recognition which has transformed the healthcare delivery in post covid era. The idea is as soon as we recognize the gap, the ecosystem needs to respond very fast where an idea needs to be scaled up to POC to early manufacturing stage.

Dr. Diwan mentioned about the creation of Technology Clusters in the country which provide support for POC where an entrepreneur comes with his talent and technology and walks away with the product.

Dr. N. Subramanian said that from conducting 1,000 tests per day to nine lakh tests per day to detect symptoms of COVID-19, India has showcased immense potential to become the global producer and supplier for quality indigenous medical equipment and technologies. He further said that strategic alignment and adoption is the key to success and can be done with adoption of innovation in complete life cycle of medical device to achieve the value-based medical device and healthcare solutions. Dr. Subramanian mentioned that the industry should have the approach to produce minimal invasive and preventive healthcare.
Dr. Sameer Gupta talked about ongoing challenges in the medical device sector about Doc to patient ratio, infrastructure, technology, affordability & accessibility and said new advance technologies could play a pivotal role in developing Health care sector. He mentioned that India is emerging with lot of new startups in the technology sector with new innovative products.  He said technology also plays a significant role in Health care delivery. He said that current pandemic has also created various new opportunities for medical device sector.

Dr. Gupta also stated about that life expectancy has been doubled in last few years due to adoption and innovations in Medtech sector. He also said that improvements come at a cost and schemes like Ayushman Bharat going to take country to new heights. He further said that India is the pharmacy of the world and now the time to come for being a MedTech capital of the world. 

Mr. Pavan Choudary said that medical technology today affects domains outside healthcare too; it even has the potential to affect geopolitics. An electronic implant can be potentially cyber attacked, forcing countries to reimagine their cyber security apparatus. India has the unique advantage of having a stable democratic system, a shared history of peace with most of the world and the ability to hold its own against any misadventurous power. These additional factors make our country a reassuring location in Asia for Western companies to manufacture their quality medical devices here. The recently introduced government incentive programs such as the PLI scheme which is available to global companies too, also add to the attractiveness of India as a preferred investment destination for manufacturing.

Mr. Saurabh Arora said that Government has done remarkably well in boosting investment & local manufacturing of medical devices.  Be it rationalizing CIT rates or abolishing Dividend distribution tax or introduction of PLI schemes. Having said that, we should not miss sight of fact that similar measures are introduced by other competing economies as well since localization of medical devices is very high on radar of all major economies, especially after the pandemic. Therefore, it is important for India to exploit its USP of potentially being biggest market for medical devices globally and should take measures to stimulate demand. Here, enhancing both “affordability” and “accessibility” to health services and infrastructure would play a critical role and this may call for significant increase in Government spending as well (from current 3% of GDP).

In addition, Mr. Arora mentioned that development of local quality eco-system would is imperative in making investments decision in the sector simpler (like it happened for automobile and mobile sector). Besides this, R&D incentives should be re-introduced not only towards hardware components & design but also towards developing digital competencies in the field of AI, data analytics and machine learning etc. India has huge potential to lead digital transformation in health space globally and therefore it is imperative to remain attractive to fight stiff competition both internally (amongst captive set-ups) as well as with external players.  Govt. may look at incentivizing R&D on similar levels as was being done in SEIS earlier”.

Mr. Atantra Das Gupta mentioned that Samsung is committed to build up the ecosystem with digital health as well as with traditional medical system. Today bridging the gap between doctors and patients to improve the preventive and primary healthcare is the need of the hour. Our country primary healthcare expenditure accounts only 6% of the total spend. 56% accounts for secondary and Tertiary health therefore we are not able to harness demographic dividend and also lacked in our preparations when pandemic like COVID sets in. In order to improve primary healthcare digital intervention is an absolute necessity not only for urban population but for the remote and far-flung areas.

With the increase of life expectancy we need to also look into HALE-Healthy life expectancy to avoid the burden of aging population in our economy hence connected health can play a very important role. Most of the healthcare budget gets drained and large of people suffer from malnutrition and diarrhea which is a lack of proper hygiene where proper information and relevant treatment can be meted out through digital interventions. Last but not the least traditional healthcare system comprising MRI , CT ,Ultrasound, Digital X-Ray can be manufactured by leveraging the knowledge capital of IIT and other engineering colleges. We need to explore the opportunity of considering software as the medicine as it will be the fuel of healthcare going forward.

Mr. Peeyush Kaushik said that the Innovation and Manufacturing industry is making progress in India through incentive policies. However, these policies are not sufficient in terms of size and coverage. For example we stopped MEIS (Merchandise Exports from India Scheme for Manufacturing) in January 2021 and SEIS (Service Exports from India Scheme for Services) in April 2020 and stopped the benefit. The new policy RoDTEP (Remission of Duties and Taxes on Exported Products) is still being launched with many clarifications to be solved. The incentives provided to Core Component Manufacturers should also be extended to assembly operations in healthcare field to make end-to-end product for customers. Additionally, the high policy threshold for Investment and Sales is on a much higher side and in a way disqualifying many companies. India has to take big steps to attract Innovation and manufacturing development for Indigenous and export.

Mr. Sunil Khurana said that China is $100bn market where as India stood at $10bn only and the motivation to set up more manufacturing units is more important here. Mr. Khurana said that we need to redefine the PLI scheme to make it more attractive from small scale manufacturers and start ups. The infrastructure can only be developed with the help of Government where as regulatory body will also play a major role. As the size of the regulatory body is small, we should work with speed and can impart the knowledge also from the foreign regulatory bodies. The regulators should have to be enablers and supportive and all should work on a framework. Mr. Khurana also mentioned about the export policy of China as they are giving 50% export incentive and India needs to work on this. There are more than 100 ultrasound manufacturers in China whereas India has none; here we need right motivating policy for the industry. Mr. Khurana further mentioned that abundance of technology is available for innovation so there is no need to start from scratch.

Mr. Sanjay Gupta said that India is a hub of software Inventions, we should have more technological innovations, which will help the medical device industry to grow further. He further mentioned that we need to develop a medical infrastructure in large scale and innovate in optical technologies. Mr. Gupta said there’s a need for a good medical system in medical device sector.
Dr. Harvinder Popli gave a formal vote of thanks to the Guest of Honour and all the panelists for sparing their valuable time and sharing their views on this platform. Dr. Popli agreed with the points shared by Dr. Reddy and mentioned to formalize training programs with the industry & academia. She further talked about standards and compliances in the manufacturing, lack of trained manpower & told to have right framework for the same.

The session was moderated by Mr. Vivek Seigell, Assistant Secretary General, PHDCCI and attended by more than 100 delegates.