siliconindia | | January 20189ers currently operating in the Indian healthcare market. While the costs of securing a license to manufacture for sale or for distribution for a medical device in India is expected to be nom-inal, the fee (under the new regula-tion) is expected to be more expensive than an import license fee.Digital India makes way for `On-line Application' for Medical Device License ApplicationsFrom 2018, the Ministry of Health and Family Welfare is expected to facilitate the online application for a license to manufacture for sale or for distribution for medical devices of any class. The details can be found, com-pleted and submitted on the ministry's website. Manufacturing sites that are outside India may require inspection by the Central Licensing Authority or a federally appointed and registered entity of the Government of India. All such inspection shall be subject to a $6,000 inspection fee per visit.Affordable Healthcare shall remain a distant dream for Indians in 2018As India celebrated its 70th Independence Day this year, Bengal reported numerous cases of Dengue, Uttar Pradesh reported death of 400 young children due to lack of care, and Jharkhand reported deaths more than 800 children in two state-run hospitals. There is one government doctor for every 10,189 people, one hospital bed for every 2,046 people, and one government-run hospital for every 90,343 people. And if this is not enough, then we have some horror stories from private hospitals too, where a Dengue patient is charged Rs.18 lakhs for quality care in a private tertiary care hospital, while another big player shamelessly declared twin baby dead which was later found to be alive. Our healthcare system is going through a difficult phase. While the cost of hospitalisation (public) has gone up more than 10 percent between 2004 and 2014, the Rashtriya Swasthya Bima Yojana's insurance coverage has remained unchanged.As the 2017 published reports in Social Science Magazine, programs such as Rashtriya Swasthya Bima Yojana (RSBY) have not led to any reduction in out-of-pocket expen-diture or personal spending by the patients under BPL (Below poverty line beneficiaries are approximately 150 Million in India). India's Poor Are Still Paying for Healthcare de-spite the National Health Insurance Scheme and affordable care shall remain a dream.Final WordWith hopes and hypes in the Indian healthcare market, the medical devices market will foresee price fluctuations, just like the drug capping last year. Patients may get access to affordable devices and IVD devices and kits. It will be interesting to watch the market, as many foreign players may delay the launch of new products in the Indian market. Since the days of unregulated market are gone, foreign players will have to re-strategize before investing in India. The nation shall remain attractive due to its high domestic consumption.The public healthcare system shall continue to struggle between government budgets, policies and directions and the vision to offer quality & affordable care to all Indians. The private healthcare market will however see growth, AI may enter the Indian market through healthcare and connected health may become one of the lucrative areas. Cost optimization will remain the prime focus for the healthcare services industry and new business models will be tried & tested in 2018Dr.Siddharth Dutta
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