A new group of regulators at various levels should be established,\naccording to the Parliamentary Standing Committee on Health and Family Welfare,\nto oversee the medical device sector. The Standing Committee stated that this\naction would substantially assist the manufacturers and minimize the time\nrequired to launch a production unit, hence improving ease of doing business,\nin its one hundred thirty-eighth (138th) report on the medical devices:\nRegulation and Control. In this article, we will discuss some\nparliamentary recommendations for Medical Device Sector.<\/p>\n\n\n\n
Medical devices and IVDs are regulated by the Drug Controller\nGeneral of India (DCGI) within the Central Drugs Standard Control Organization\n(CDSCO), part of the Ministry of Health and Family Welfare. Manufacturers of\nspecific medical devices must adhere to Indian medical device rules in order to\nmarket their products in India. With the release of the Medical Device Rules in\n2017, Indian authorities completely revised the regulatory framework for\nmedical devices. Devices are governed by the Central Drugs Standard Control\nOrganization (CDSCO), a division of the Ministry of Health and Family Welfare,\nunder the laws that went into effect in January 2018.<\/p>\n\n\n\n
In the current times, in India predominantly the following\nregulatory authorities have control and jurisdiction over medical devices in\nIndia: – <\/p>\n\n\n\n
Unlike the current structure, the proposed regulator should grant\nmanufacturing licenses for all classes of medical devices, including Class A,\nB, C, and D. As distinct regulating techniques used by different States would\nbe eliminated, this would assist in harmonizing the regulation process across\nthe nation. It is estimated that India\u2019s medical device sector is currently\nworth 11 billion dollars, and that country\u2019s share of the worldwide medical\ndevice market is 1.5 percent. India ranks in the top 20 markets in the world\nand is the fourth-largest market in Asia for medical devices after Japan,\nChina, and South Korea. It further suggested that all three pillars of the\nmedical devices sector\u2014Government, Business, and Academics, work\ncollaboratively in order to achieve the aim of making India a USD 50 billion\nmarket by 2025.<\/p>\n\n\n\n
The industry has grown at a CAGR of 15% during the last three\nyears. Imports supply over 80% (by value) of the needs of the domestic market.\nCostly medical gadgets are imported to meet the population\u2019s demand because the\nmajority of products created in India are disposables and consumables.<\/p>\n\n\n\n
To undertake the regulation for all medical device classes throughout the country, the proposed regulator should be adequately staffed with workforce which is technically skilled & well-versed with the functioning of the medical devices industry.<\/p>\n\n\n\n