The Government of India has been systematically increasing its focus on the MedTech sector. The Medical Technology Association of India had cheered the government’s overall effort to boost the medical devices sector in the Budget for 2019–20, which was presented in the Lok Sabha on February 1, 2019.
The medical devices industry in India is presently valued at USD $5.2 billion and contributes 4–5 per cent to the USD 96.7 billion Indian health care industry. Currently, India has about 750–800 medical device manufacturers in the country, with an average investment of Rs 170–200 million and an average turnover of Rs 450–500 million.
“The government is now cognisant of the fact that Medical Devices must be identified as separate from Pharmaceuticals for all purposes relating to Business Policy and Regulations since the Nature of the two industries are different scenario,” said D V Sadananda Gowda, Minister of Chemicals and Fertiliser, Statistical and Programme Implementation, Government of India. “To achieve this, a clear efficient and stable regulatory system is required that would enable ease of doing business as well as help realise Make in India. This shall also give due recognition and acceptance to India’s products. Government also plans to enhance skilled manpower as specialised and inter disciplinary skills are required for a medical device manufacturing setup — such expertise is not readily available as of now.”
Gowda was speaking at the 4th International Conference on Pharmaceuticals and Medical Devices organised by the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India jointly with the Federation of Indian Chambers of Commerce & Industry (FICCI).
The industry has steadily grown and witnessed a surge from USD 2.02 billion in 2009 to USD 3.9 billion in 2015 at a CAGR of 15.8 per cent. As per industry estimates, the Indian medical devices market will grow to USD 50 billion by 2025. Currently, India is counted among the tup 20 global medical devices markets and is the fourth largest medical devices market in Asia after Japan, China and South Korea.
“100% FDI is currently allowed in the Medical Devices sector through the automatic route. An increasing number of MNCs are setting up their manufacturing bases in India in states such as Haryana, Gujarat, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu,” said D V Sadananda Gowda. “To harness the potential of the Medical Devices sector, the Andhra Pradesh MedTech Zone (AMTZ) has been set-up. AMTZ is an enterprise under the Government of Andhra Pradesh, and consists of 270 Acre Zone, dedicated for Medical Device Manufacturing. The zone will allow medial device manufacturers to not only leverage scientific facilities but also reduce manufacturing costs by upto 50%.”
“India is among one of the top 20 global medical device markets and 4th largest in Asia. In India, Medical device sector has registered a growth of 10% and is expected to reach over USD 50 billion by 2025. However, it needs to be noted that, medical devices Industry in India is predominantly import driven accounting for over 65% of the total market,” said K J George, Minister for Large & Medium Scale Industries, Government of Karnataka.
Dr Henk Bekedam, WHO Representative to India, stated that considering the increased involvement of the Micro, Small & Medium Enterprises in the medical devices manufacturing sector, WHO will provide technical support to the sector to upgrade manufacturing standards.
“Indian Med Tech sector, a crucial cog in the wheel to address India’s commitment towards the Sustainable Development Goals — 3 ie ‘ensuring good health and well-being of all’ is traversing a path mixed with opportunities and challenges. The sector now needs a formative resolve to Prioritise, Act & Realise! The interventions needed to steer the sector towards a meaningful growth path needs immediate formation of a long term vision, followed by diligent multi-stakeholder execution,” said D V Sadananda Gowda.
“In the last two decades, the Medical Device Industry has undergone a transformation — from being a domestic-industry- dominated sector prior to 1991 to conversion to import-dependence post — New Economic Policy-1991, to being a non-regulated sector prior to 2006 to regulation of 15 notified devices to the new Medical Device Rules which took effect from 1st January, 2018,” said K J George.
Badhri Iyengar, Chairman, FICCI Medical Device Forum, said that it was important to look at having a unified healthcare regulator which could act as a bridge between the industry and the Government to create one window for facilitating business.
Indian Pharmaceuticals
Mansukh L. Mandaviya, Minister of State for Chemicals & Fertilizers, Road Transport and Highways, Shipping, Government of India, while stressing on the development of infrastructure and affordable healthcare through initiatives like Ayushman Bharat, said that the Government was taking measures to make the Indian pharmaceutical sector a Rs. 3 lakh crore market.
S Sridhar, Chairman, FICCI Pharma Committee said that industry believed in universal healthcare at affordable price for all Indian citizens, adding that this is a long term plan and requires a joint effort of the Government, industry and other stakeholders to collectively own this vision.
“The pharmaceutical industry in India was valued at over USD 34 Billion in FY 18 with an almost 50–50 share of domestic and export markets. It is expected to grow at a CAGR of 15% in the near future. The Indian biotech industry holds about 2 per cent share of the global biotech industry. The biotechnology industry in India, comprising about 800 companies, is expected to be valued at US$ 12 billion. Several global companies have aggressively joined hands with Indian companies due to India’s strong biotechnology potential. The Department of Biotechnology (DBT), the National Biotechnology Board (NBIB) and many other autonomous bodies representing the biotechnology sector are working together in order fo project India as a hub for biotech research and business excellence,” said D V Sadananda Gowda.
“Karnataka a vibrant pharmaceutical manufacturing hub currently ranks 5th in Pharma exports and contributes 10% to the country’s revenue and 12.37% to the country’s exports in the pharmaceutical sector,” said K J George. “The state has exclusive Pharma SEZs in Hassan and Yadgir. The Government will soon be setting up a Pharma and MedTech Zone in Bangalore and establish a Pharma Park at Mangalore which will give much needed fillip for manufacture and also woo the potential investors into the state. At present more than 230 Pharma and Bio-tech Companies are housed in the State. State Government has set up a dedicated Pharma Venture Capital Fund for active participation of pharmaceutical industries, financial institutions and private investors. State Government has proposal to develop Medical Devices Park with comprehensive infrastructure facilities like common facilities, calibration, testing, quality control, waste management, etc. We have a well-developed research base with presence of 35 Clinical Research Organisations (CROs) and 12 Adverse Drug Reaction Reporting Centres (ADR) assisting the industry with clinical trials and research.”
Indian pharmaceutical sector industry supplies over 50 per cent of global demand for various vaccines. By 2020, India is likely to be among the top three pharmaceutical markets by incremental growth and is expected to grow to US$100 billion by 2025.
AI and Advanced Analytics in Pharma
In the Budget for 2019–20, which was presented in the Lok Sabha on February 1, 2019, Piyush Goyal had stated that the government plans to launch a national programme on Artificial Intelligence (AI) and will set up a national AI portal for the purpose. “By bringing health and AI together on the agenda, the government has set a very progressive human resource tone. The national programme on AI should be unfolded by Co-opting knowledgeable stakeholders from the nine domains that are being targeted,” said Pavan Choudary, Chairman and Director General, Medical Technology Association of India (MTaI) while commenting on the budget initiatives in the healthcare sector.
A FICCI-KPMG Knowledge Paper “Evolution to revolution: by use of Artificial Intelligence and Advanced Analytics in pharma” was also released at the event. Highlights of FICCI-KPMG Knowledge Paper :
- Catalyzed by an exciting range of new, disruptive technologies, the pharmaceutical industry needs to reimagine its future. And the need to reimagine is being driven by shifts which are disturbing the industry’s status quo — pressure to reduce costs and demonstrate greater value, swing from treatment to prevention, and personalised treatments. These shifts are challenging the overall business model of the pharmaceutical companies.
- Emerging technologies, AI and advanced analytics are being increasingly adopted by the pharmaceutical industry in many diverse and interesting ways.
- The value of technologies come from their ability to process large amount of complex, both structured and unstructured data, at a rapid pace to generate actionable insights and thereby reduce costs, improve time to market and gain competitive strength in the market place.
- While lot of interesting applications are in areas related to drug discovery, applications in other areas such as drug dosage and safety, manufacturing and supply chain and commercialisation is being further explored.
- As far as technologies are concerned, pharmaceutical companies are choosing their fields of play and also who they play with, with a growing emphasis on collaboration and partnership. Accordingly, the industry is witnessing many such partnerships and quite often with technology start-ups.
