Indian Healthcare industry is growing rapidly however the provisions related to healthcare remains inadequate and there are challenges pertaining to accessibility, reliability and affordability in the country
With the increasing demand of medical facilities in India, the market of medical devices is growing rapidly. The medical devices Industry in India is 4th largest in Asia and is amongst the top 20 players in the world. It can easily be said that this industry is highly capital intensive and there is immense potential in terms of skilled manpower and Research & Development. The government has come up with few schemes to promote market of #medical #devices in India. As per the Indian Brand Equity Foundation (IBEF) report the market of medical devices in India is expected to grow at Compound Annual growth rate (GAGR) of 37% to reach US$ 50 billion in 2025, from US$ 10.36 billion in ear 2020.
Recent initiatives by Government
• The government of India took various initiatives recently to enhance medical devices industry. The medical device industry not only offers great opportunities in terms of #growth but the government is also coming up with new schemes and policies to encourage this industry.
• In the Union Budget 2022-23, Rs 86,200 Crores was allocated to pharmaceutical and healthcare sector. In November 2021, Centre of Excellence (CoE) for Make-in –India Product development and commercialisation in the medical devices and diagnostic space was established by The Indian Council of Medical Research (ICMR) collaborated with Indian Institute of Technology.
• In order to increase acceptability of Indian Devices in the global market the Government of India announced plan to draft a new drugs, cosmetics and medical devices bill in October 2021.
• The major announcement was made in October 2021 that under the PLI scheme 13 companies have got the approval for manufacturing medical devices in country which will turn is expected to bring major expansion in medical devices sector in India.
• The government of India recognised this sector as a sunrise sector under the ‘Make in India ‘campaign in 2014.
• The proposal of Rs 5000 crore was sanctioned in year 2021 to build a medical device park in Himachal Pradesh’s industrial township, Nalagarh in the solan district.
• In the same year government announced medical devices park in Oragadam (Tamil Nadu) and in Uttar Pradesh as well , with estimated investment of Rs. 3,500 crore and Rs. 500 crore respectively . These investment in medical device industry is also expected to offer direct and indirect employment to many.
Medical device Industry and market share
As stated above Medical devices market in India is expected to grow by 37% and touch 50 billion dollar by 2025. There are multiple reason responsible for growth of medical device industry in India. Most importantly there has been tremendous increase in spending of people in healthcare as they have now more disposable income, there have been improvement in healthcare infrastructure, there is a visible increase in affordability, lifestyle changes are also leading to more ailments than before, and there is a tremendous growth in ‘Medical Tourism’ as well. The foreign direct investment (FDI) is also increasing every year in medical device sector which clearly shows the confidence of foreign players in Indian Market. Export is also rising, as export stood at 2.51 billion US $ in 2019 -20 and are expected to rise at US$ 10 billion by 2025.
Manufacturing of Notified Medical Device in India
The manufacturing of notified medical devices of category A&B is regulated by state Licensing authority whereas License to manufacture C&D is issued by Central Licensing authoring. It is to be noted the License is required for each manufacturing location and for each Notified Medical Device at such manufacturing location.
Import of Notified Medical Device
Import of Medical devices in India are very common. There are few more legal requirements in notified medical device import as compared to manufacturing of medical devices. The import of medical devices are completely regulated by central licensing authority. Like all other export import, the import of medical device is also governed under the provision of Export Import policy (“EXIM policy). Before initiating import of Notified medical device in India Importer need to obtain Importer and exporter code (IEC) from the office of director general. The IEC number is an important number required at the time of getting clearance from custom for imported goods.
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