{"id":52529,"date":"2023-02-16T15:26:24","date_gmt":"2023-02-16T09:56:24","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=52529"},"modified":"2023-02-16T15:26:26","modified_gmt":"2023-02-16T09:56:26","slug":"indian-medical-device-industry-legal-and-tax","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/indian-medical-device-industry-legal-and-tax\/","title":{"rendered":"Indian Medical Device Industry: Legal and Tax Overview"},"content":{"rendered":"\n<p>Drugs,\nvaccines, and medical devices are the three essential industrial foundations of\ncontemporary healthcare technology systems. Bandages and syringes to complex\ngadgets using bioinformatics, nanotechnology, engineered cells, and artificial\nintelligence are all examples of medical devices. These are made to be used by\nprofessionals, patients, and health experts people in a range of locations,\nincluding clinics, surgeries, and private residences. MNCs with a 90% market\nshare dominated the Indian medical device industry in the 1960s. Following the\ngovernment&#8217;s takeover in 1970 with the passage of the Indian Patent Act and the Drug\nPrice Control Order, Indian businesses began to emerge. After the \u2018Make\nin India\u2019 programme, a government initiative that was introduced in 2014, the\nmedical device industry in India gained independence. <\/p>\n\n\n\n<p>India\nhas achieved considerable strides in building its domestic pharmaceutical and\nbiotechnology industries over the past few decades, mostly because of\ncoordinated governmental policy measures and encouraging institutions. The\nIndian healthcare sector has grown to be one of India&#8217;s top industries in terms\nof both income and employment, with an estimated $370 billion in sales by\n2024\u20132025, up from $190 billion in 2020, according to the India Brand Equity\nFoundation.<\/p>\n\n\n\n<p>The\nCOVID-19 pandemic&#8217;s effects on India serve as a reminder of the value of making\ninvestments in the healthcare industry. Healthcare spending in India is\nexpected to rise significantly over the next years, according to industry\nanalysts, in part due to the lessons gained from the epidemic. With a\nparticular focus on poor communities, the Indian government has proposed\nraising public expenditure on healthcare from its current level of barely 1.2%\nof GDP to 2.5 per cent by 2025. The medical equipment market is expected to\nrise in lock step with rising healthcare spending in India.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title ez-toc-toggle\" style=\"cursor:pointer\">Page Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/corpbiz.io\/learning\/indian-medical-device-industry-legal-and-tax\/#Different_Segments_of_Medical_Devices_%E2%80%93_Indian_Medical_Device_Industry\" >Different\nSegments of Medical Devices &#8211; Indian Medical Device Industry<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/corpbiz.io\/learning\/indian-medical-device-industry-legal-and-tax\/#Evolution_of_Medical_Devices_in_India_%E2%80%93_Indian_Medical_Device_Industry\" >Evolution of\nMedical Devices in India &#8211; Indian Medical Device Industry<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/indian-medical-device-industry-legal-and-tax\/#Regulatory_authorities_for_medical_devices_in_India\" >Regulatory authorities for medical devices in India<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/corpbiz.io\/learning\/indian-medical-device-industry-legal-and-tax\/#Legal_framework_applicable_to_the_Indian_Medical_Device_Industry\" >Legal framework\napplicable to the Indian Medical Device Industry<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/corpbiz.io\/learning\/indian-medical-device-industry-legal-and-tax\/#Initiatives_being_taken_by_the_Government\" >Initiatives being taken by the Government<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/corpbiz.io\/learning\/indian-medical-device-industry-legal-and-tax\/#Factors_that_drive_the_growth_of_Indian_medical_device_industry\" >Factors that drive the growth of Indian medical device industry<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/corpbiz.io\/learning\/indian-medical-device-industry-legal-and-tax\/#Tax_policies_for_medical_devices_in_India_%E2%80%93_Indian_Medical_Device_Industry\" >Tax policies for\nmedical devices in India &#8211; Indian Medical Device Industry<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/corpbiz.io\/learning\/indian-medical-device-industry-legal-and-tax\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Different_Segments_of_Medical_Devices_%E2%80%93_Indian_Medical_Device_Industry\"><\/span>Different\nSegments of Medical Devices &#8211; Indian Medical Device Industry<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Based on the kinds of devices produced, the Indian medical\ndevice industry is divided into following segments: <\/p>\n\n\n\n<ol><li><strong>Equipment and instruments: <\/strong>These make up a substantial portion of the\nmarket share and include things like therapeutic breathing equipment, dental\nitems, medical and surgical sterilisers, and ophthalmic tools.<\/li><li><strong>Diagnostic imaging<\/strong>: This market sector ranks second overall in\nterms of market share and includes items like electro-diagnostic equipment,\nradiation equipment, and imaging components and accessories.<\/li><li><strong>Patient aids: <\/strong>Wheelchairs, portable aids, orthopaedic and\nprosthetic devices, and hospital furnishings are the mainstays of this market\ncategory, which accounts for a tiny portion of the overall market share.<\/li><li><strong>Consumables and implants: <\/strong>These are items that are injected or used internally\nby the patient, such as syringes, needles, catheters, bandages, suturing\nsupplies, etc. These items control a portion of the market share overall.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Evolution_of_Medical_Devices_in_India_%E2%80%93_Indian_Medical_Device_Industry\"><\/span>Evolution of\nMedical Devices in India &#8211; Indian Medical Device Industry<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Since\nIndia&#8217;s independence in 1947, the development of the Indian medical device\nindustry has been examined via the regulatory, industrial, S&amp;T, and\nhealthcare policies. There have been four significant eras.<\/p>\n\n\n\n<ul><li><strong>1947\n\u2013 1991: From Independence to the Pre &#8211; Liberalization Era<\/strong><\/li><\/ul>\n\n\n\n<p>Since\nindependence and before the pre-liberalization era, the major goal of\nindustrial strategies has been self-reliance. With the exception of \u2018lifesaving\u2019 items, which may be\nimported duty-free, medical devices were subject to tariffs of 40% to 60%. The\ndomestic market for medical equipment was quite tiny in the early 1990s. It was\nprojected to be worth INR 1.76 billion (in 1999-2000), of which 15% was\nimported.<\/p>\n\n\n\n<p>Pharmaceuticals\nare governed in India under the Drugs and Cosmetics (D&amp;C) Act of 1940, and\nthe D&amp;C Rules, 1945. Disposable syringes, needles, and perfusion sets were\nofficially declared to constitute pharmaceuticals under the Act by the\ngovernment in 1989.<\/p>\n\n\n\n<p>The\nstandards for other devices were established by the Bureau of Indian Standards,\nwhich is part of the Ministry of Consumer Affairs, Food &amp; Public\nDistribution.<\/p>\n\n\n\n<ul><li><strong>Post-Liberalisation\nEra: 1991 &#8211; 2005<\/strong><\/li><\/ul>\n\n\n\n<p>The\neconomic liberalisation measures adopted by India after 1991 altered the\nrelative functions of the public and private sectors. Medical device imports no\nlonger require a licence, and import duties are now between 15% and 30%. In\n1995, the market for medical devices was worth $680 million and was expanding\nat a rate of 15% to 20% annually. Imports from the US climbed by 19% between\n1994 and 1996, accounting for nearly 40% of the market for medical devices.\nAdditionally, the growing involvement of the private sector in the delivery of\nhealthcare greatly raised the demand for medical equipment.<\/p>\n\n\n\n<p>To\ngovern the manufacturing and import of medical equipment, Schedule MIII was\ninserted into the D &amp; C (2<sup>nd<\/sup> Amendment) Rules of 1994.<\/p>\n\n\n\n<ul><li><strong>2005\n\u2013 2014 <\/strong><\/li><\/ul>\n\n\n\n<p>The\nNational Health Mission was established in 2005 with the goal of reducing\nhealthcare access inequities by giving more money to the states to broaden the\nscope of its programmes.<\/p>\n\n\n\n<p>Ten\nmedical devices were included under the scope of the D&amp;C Act in June 2005,\nincluding cardiac stents, drug-eluting stents, catheters, intraocular lenses,\nI.V. cannulas, bone cement, heart valves, scalp vein sets, orthopaedic sets,\northopaedic implants, and internal prosthetic replacements. Additionally, the\nD&amp;C Act and Rules treated blood or blood component bags, blood grouping\nsera, ligatures, including sutures and staplers, intra uterine devices, condoms,\ntubal rings, surgical dressings, and umbilical tapes as pharmaceuticals.<\/p>\n\n\n\n<p>More\nthan 25 MNCs were granted permission to import medical products through their\nsubsidiaries in 2007. Electronic medical device policy was outlined in the\nNational Policy on Electronics, published in 2012. Collaborations with\ninternational donors, including the Wellcome Trust and Department of\nBiotechnology (DBT), to create the &#8220;Affordable Healthcare Initiative&#8221;\nfurthered these programmes.<\/p>\n\n\n\n<ul><li><strong>2015\nonwards <\/strong><\/li><\/ul>\n\n\n\n<p>The\n&#8220;Make in India&#8221; campaign was introduced in 2014. It named the sector\nof medical devices as a major one. The same year, the Ministry of Chemicals and\nFertilizers&#8217; Department of Pharmaceuticals established a multi-stakeholder task\ngroup to address issues and offer policy suggestions for the reasonably priced\nproduction of secure and effective medical devices.<\/p>\n\n\n\n<p>Schedule\nMIII for medical devices under the D&amp;C Act of 1940 was changed and\nseparated from Schedule M for medicines in January 2015. This confirmed that\nthe Quality Management System for the manufacturing and import of medical\nequipment, ISO 13485, is in conformity. Additionally, both greenfield and\nbrownfield medical device enterprises were eligible for 100% FDI through the\nautomated route. The government has also taken steps to develop a manufacturing\ninfrastructure for medical devices. Three industrial parks were intended to be\nbuilt by the government for Gujarat, Maharashtra, and Andhra Pradesh in 2015.\nIn 2016, the Andhra Pradesh MedTech Zone (AMTZ) was created. The Department of\nBiotechnology provided money in 2017 for the establishment of the Kalam\nInstitute of Health Technology (KIHT) at AMTZ.<\/p>\n\n\n\n<p>A\n$125 million deal was inked in 2018 between the Indian government and the World\nBank to assist India in creating a cutting-edge biopharmaceutical and medical\ndevice sector.<\/p>\n\n\n\n<p>The\nNational Policy on Electronics, 2019, also included many plans to aid in the\nproduction of electronic medical equipment.<\/p>\n\n\n\n<p>A\nrequired quality certification system for medical devices supplied in India didn&#8217;t\nexist until 2016. A voluntary quality certification programme for medical\ndevices called Indian Certification for Medical Devices was launched by the\nAssociation of Indian Medical Device Industry (AIMED) in conjunction with the\nNational Accreditation Board for Certification Bodies (NABCB) under the Quality\nCouncil of India to fill the regulatory gap.<\/p>\n\n\n\n<p>The\nmuch-needed regulatory framework for medical devices was made available with\nthe introduction of the Medical Device Rules of 2017. These regulations become\noperative on January 1<sup>st,<\/sup> 2018. For the first time, regulations\nparticularly addressing the production and import of medical equipment were\nreleased as a result of this endeavour. The new Rules were developed in\naccordance with the Global Harmonisation Task Force (GHTF) framework, which\ndivides devices into four categories (A, B, C, and D) based on the level of\ndanger they pose, from low risk to high risk. The Rules were revised in\nFebruary 2020, adding 14 more devices for a total of 37 devices must be\nregistered.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Regulatory_authorities_for_medical_devices_in_India\"><\/span>Regulatory authorities for medical devices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Medical\nDevice Regulation, which were established by the Indian government to control\nthe production and marketing of Indian medical device industry, is governed by\nthe following bodies:<\/p>\n\n\n\n<ol><li>Central Drug Standards Control Organization:\nThe primary authority in charge of regulating drugs and medical equipment<\/li><li>In India, the CDSCO&#8217;s most important\nrepresentative is the Drug Controller General.<\/li><li>The manufacturing, import, sales, and\ndistribution of medical equipment are governed by the Drugs &amp; Cosmetic Act\nand Rules.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Legal_framework_applicable_to_the_Indian_Medical_Device_Industry\"><\/span>Legal framework\napplicable to the Indian Medical Device Industry <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Indian\nmedical device industry is controlled and regulated by the legal framework:<\/p>\n\n\n\n<ul><li><strong>Drugs and Cosmetics Act of 1945 and Rules (DCA)<\/strong><\/li><\/ul>\n\n\n\n<p>The\nact controls the production, importation, distribution, and sale of medications\n(including medical equipment) and cosmetics. With that it also set rules for\nproducts and labels and controls drug advertisements<\/p>\n\n\n\n<ul><li><strong>Medical Devices Rules of\n2017 (MDR)<\/strong><\/li><\/ul>\n\n\n\n<p>It\nserves as India&#8217;s main regulatory framework for medical devices and is issued\nunder the DCA. On February 11, 2020, the Ministry of Health &amp; Family\nWelfare (the &#8220;Health Ministry&#8221;) released a notice that essentially\nsubjected all <strong><a class=\"text-primary\" href=\"https:\/\/corpbiz.io\/medical-device-registration\">medical devices in India<\/a><\/strong> to MDR regulation.<\/p>\n\n\n\n<p>Specific\nequipment intended for internal or exterior use in the diagnosis, treatment,\nmitigation\/prevention of disease or disorder in humans or animals that are\nperiodically reported by the government under the DCA are governed by the MDR\nas medical devices. The government notifies some compounds under the DCA that\nare intended to alter the structure or any function of the human body. The\nsubstances that have currently been notified are surgical dressings, surgical\nsutures, surgical bandages, surgical staples, ligatures, blood &amp; blood\ncomponent collection bags with or without anticoagulant, and substances used\nfor in vitro diagnosis. Mechanical contraceptives (such as condoms,\nintrauterine devices and tubal rings), insecticides, and disinfectants have\nalso been notified.<\/p>\n\n\n\n<ul><li><strong>The Legal Metrology\n(Packaged Commodity) Rules of 2011<\/strong><\/li><\/ul>\n\n\n\n<p><strong>The Legal Metrology Act of 2009<\/strong><sup><a class=\"text-primary\" href=\"https:\/\/www.indiacode.nic.in\/bitstream\/123456789\/2102\/1\/a201001.pdf\"><strong>[1]<\/strong><\/a><\/sup> was notified, which governs the packaging and\nlabelling of pre-packaged goods in India.<\/p>\n\n\n\n<ul><li><strong>The Drugs &amp; Magic\nRemedies (Objectionable Advertisements) Act of 1954<\/strong><\/li><\/ul>\n\n\n\n<p>Regulates\ndrug ads for the diagnosis, cure, mitigation, treatment, and prevention of\nspecific prescribed illnesses and disorders. AIDS, Asthma, Cancer, and other\ndiseases and conditions are some of the examples.<\/p>\n\n\n\n<ul><li><strong>Indian Patent Act of 1970<\/strong><\/li><\/ul>\n\n\n\n<p>The\nact talks about the mandatory licencing and the control of ever-greening. Under\nthe act patent is given for a period of 20 years for a new product or a process that involves an\ninventive step and capable of industrial application. &nbsp;It\ngrants the owner an exclusive right and forbids others from using the patented\ninnovation in their products or processes or from manufacturing, marketing, or\nimporting them without the inventor&#8217;s consent.<\/p>\n\n\n\n<ul><li><strong>Trade Marks Act of 1999<\/strong><\/li><\/ul>\n\n\n\n<p>A trademark can be a word, sign, symbol, or\neven graphic applied to a company&#8217;s goods or services to distinguish them from\ncompetitors. Under the act registered marks are given the protection from being\ncopied. Under the act, trademark registration is valid for a period of 10 years.\nIn case of infringement, the owner can claim his rights thought passing of\nlawsuit.\n<\/p>\n\n\n\n<ul><li><strong>Indian Medical Council\n(Professional Conduct, Etiquette &amp; Ethics) Regulations of 2002 (MCI Code)<\/strong><\/li><\/ul>\n\n\n\n<p>Controls\nthe professional conduct of licenced medical professionals in India. The code\nprohibits qualified medical professionals from accepting gifts from the\npharmaceutical or allied healthcare sector or their sales representatives and\nfrom publicly endorsing any drugs or products.<\/p>\n\n\n\n<p>Makes\nsuggestions to organisations (like hospitals) on the unethical nature of\npatient soliciting. Over and beyond any other civil or criminal action that may\noccur under applicable law, a violation of the MCI Code may constitute\nprofessional misconduct and result in penalties and includes permanent\ndisqualification from practising.<\/p>\n\n\n\n<ul><li><strong>Drugs Price Control Order of\n1995 (DPCO)<\/strong><\/li><\/ul>\n\n\n\n<p>Controls\nthe cost of notified medical equipment, formulations, and regulated bulk\npharmaceuticals.<\/p>\n\n\n\n<p>It\nalso controls the margins given to merchants and dealers. Imposes a need to sell\nnotified medical devices, formulations, and bulk pharmaceuticals to consumers\nand dealers. <\/p>\n\n\n\n<ul><li><strong>Uniform Code for\nPharmaceutical Marketing Practices (UCPMP)<\/strong><\/li><\/ul>\n\n\n\n<p>Regulates the pharmaceutical\nindustry&#8217;s marketing methods. It Establishes criteria for comparing products in\na competitive market. Specifies that any exchange of presents during a\npromotion is prohibited. This is a voluntary rule, but non-compliance with it\nmight cause it to become law.&nbsp; Manufacturers\nor distributors require prior approval from the Indian Drugs Controller General\nfor promotion. Promotion must be truthful, unbiased, verifiable, and not\ndeceptive.<\/p>\n\n\n\n<ul><li><strong>Information Technology Act of 2000 (IT Act) and Information Technology (Reasonable security practices &amp; procedures &amp; sensitive personal data or information) Rules of 2011 (Data Protection Rules)<\/strong><\/li><\/ul>\n\n\n\n<p>Imposes\nresponsibility for negligence in the implementation and upkeep of adequate\nsecurity and procedures for the securitization of such data on the body\ncorporate or person handling such sensitive personal data or information, if\nsuch carelessness results in unjust gain or loss to any person.<\/p>\n\n\n\n<p>Penalises\nthe disclosure of personal data to a third party without the owner&#8217;s consent,\nin violation of a valid contract, and with the aim or knowledge that the revelation\nmay result in unjust gain or wrongful loss.<\/p>\n\n\n\n<p>Technology\nInformation (Reasonable security practises and procedures and sensitive\npersonal data\/information) Sensitive personal data\/information is defined by\nRules, 2011 to include medical records and histories, as well as personal data\npertaining to physical, physiological, and mental health conditions. Impose\ncertain requirements on corporate bodies dealing with sensitive personal data\nor information and personal information. Violation of Data Privacy Rules may\nresult in penalties under the IT Act.<\/p>\n\n\n\n<ul><li><strong>National List of Essential Medicines (NLEM)<\/strong><\/li><\/ul>\n\n\n\n<p>The\nMinistry of Health &amp; Family Welfare (MoHFW) released a list. Each\nmedication or medical gadget on the list is regarded as necessary, and it is\noffered or made available at a reasonable price with guaranteed quality. The\nmost recent list, which was released in 2022. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Initiatives_being_taken_by_the_Government\"><\/span>Initiatives being taken by the Government<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The following initiatives\nare taken by the Central government to promote the Indian medical device\nindustry: <\/p>\n\n\n\n<ul><li>Through\nprogrammes like <em>Make in India, the creation of medical device parks, and testing labs<\/em>, the Indian government has supported\nthe production of gadgets. To control Notified Medical Devices, the Indian\ngovernment has established the <em>Medical Device Regulation<\/em>.<\/li><li>With a\nfocus on <em>100% FDI for medical devices to expand the market<\/em>, the\nGovernment of India has started a number of efforts to enhance the medical\ndevices sector.<\/li><li><em>The National\nMedical Devices Promotion Council (NMDPC)<\/em> was reconstituted by the Department of Pharmaceuticals\nin August 2022, with the Secretary of the Department of Pharmaceuticals serving\nas its chairman.<\/li><li>To\nguarantee and provide comprehensive legal safeguards to ensure that the medical\nproducts marketed in India are dependable, effective, and up to needed\nstandards, the government introduced a draught of the new <em>Drugs, Medical Devices, and\nCosmetics Bill 2022 in July 2022.<\/em><\/li><li>The Union\nBudget 2022\u201323 had a budget of Rupees. 86,200 crore (US$ 11.3 billion) for the\npharmaceutical and healthcare industry.<\/li><li>To boost\nthe acceptance of Indian medical products in the international market, the\ngovernment announced plans to create a <em>New Medicines, Cosmetics, and Medical Devices\nBill in October 2021<\/em>.<\/li><li>The\ngovernment stated in October 2021 that 13 businesses had been given the\ngo-ahead under the <em>PLI plan for medical equipment<\/em>, which is anticipated to increase\ndomestic production in the nation.<\/li><li>In\nSeptember 2021, the government approved a plan to build a <em>medical devices park in\nHimachal Pradesh&#8217;s industrial township of Nalagarh in the Solan district<\/em>\nfor a cost of Rs. 5,000 crore (US$ 674.36 million). A <em>medical devices park in Oragadam,\nTamil Nadu<\/em><em>,<\/em> which the\ngovernment authorised in September 2021, is anticipated to provide direct and\nindirect employment for 10,000 people.<\/li><li>To\nconduct verification of the quality, safety, and efficacy of medical devices,\nthe <em>Quality Council of India (QCI)<\/em>\n&amp; the <em>Association of Indian\nManufacturers of Medical Devices (AiMeD)<\/em> introduced the <em>Indian\nCertification of Medical Devices (ICMED) Plus programme in June 2021<\/em>.<\/li><li>The\ndepartment of pharmaceuticals introduced a <em>PLI plan for domestic production of medical\ndevices<\/em>, with a total expenditure of funds of INR 3,420 crore for\nthe period FY 2021 &#8211; 2028, in order to increase domestic manufacturing of\nmedical devices and attract significant investments in India.<\/li><li>About 300\nglobal buyers from the healthcare industry attended the <em>Medical Devices Virtual Expo\n2021<\/em>, which featured Indian goods and allowed for direct\ncommunication between Indian suppliers &amp; buyers\/importers from\nparticipating nations.<\/li><li>On March\n25, 2021, the Department of Pharmaceuticals released an updated notice on the <em>Public\nProcurement Order (PPO<\/em>) that\nincluded 19 medical devices in the updated PPO guidelines. This is\nexpected to improve domestic medical device manufacturing (and support\n&#8220;Make in India&#8221;) and lower import costs by INR 4,000 crore (US$\n538.62 million).<\/li><li>In April\n2021, the government made it simpler to import essential medical devices by\nrelaxing the procedures for clearance under the <em>Legal Metrology Act (Packaging\nRules 2011).<\/em> Examples of these medical devices include nebulizers, oxygen concentrators, and oxygen\ncanisters. <strong>&nbsp;<\/strong><\/li><li>About 300\nglobal buyers from the healthcare industry attended the Medical Devices Virtual\nExpo 2021, which featured Indian goods and allowed for direct communication\nbetween Indian suppliers &amp; buyers\/importers from participating nations.<\/li><\/ul>\n\n\n\n<p>Along\nwith the above initiatives the Ministry of Health and Family Welfare (MoHFW)\n&amp; Central Drugs Standard Control Organization (CDSCO) adopted the following\nsteps to enhance the export of medical devices in the nation:<\/p>\n\n\n\n<ol><li>A review and application of Schedule MIII (a\ndraught guidance on good manufacturing practises and facility requirements)<\/li><li>Export labelling system<\/li><li>Clarification of clinical assessment and\nadverse reporting<\/li><li>The state licencing authority will increase\nthe validity of free sales certificates from two to five years in order to\npermit exports.<\/li><li>Compile a list of export-licensed producers\nfor quick access to regulatory bodies throughout the world.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Factors_that_drive_the_growth_of_Indian_medical_device_industry\"><\/span>Factors that drive the growth of Indian medical device industry<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Mentioned below is the list\nof factors that drive the growth of the Indian medical device industry:<\/p>\n\n\n\n<ol><li>Increased population<\/li><li>The population is getting older<\/li><li>A rise in the prevalence of chronic illnesses<\/li><li>Increasing patient advantages from health\ninsurance.<\/li><li>International travellers seeking medical\ntreatment.<\/li><li>Rapidly increasing need for healthcare infrastructure.<\/li><li>Indian hospitals have followed international\nquality norms.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tax_policies_for_medical_devices_in_India_%E2%80%93_Indian_Medical_Device_Industry\"><\/span>Tax policies for\nmedical devices in India &#8211; Indian Medical Device Industry<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The COVID-19 pandemic&#8217;s effects on India serve as a reminder\nof the value of making investments in the healthcare industry. Healthcare\nspending in India is expected to rise significantly over the coming years,\naccording to industry analysts, in part due to the lessons gained from the\npandemic. With a particular focus on poor communities, the Indian government\nhas proposed raising public spending on healthcare from its current level of\njust 1.2 percent of GDP to 2.5 percent by 2025.<\/p>\n\n\n\n<p>In an interview with ABP, Dr Shravan Subramanyam, managing\ndirector, Wipro GE Healthcare said, \u201c<em>Exemption\nof customs duty on the import of high-end MedTech equipment will help in\nreducing the cost of healthcare for the end customers i.e., the patients. We\nexpect a tweak in the customs duties and taxes levied on medical devices<\/em>.\u201d<\/p>\n\n\n\n<p><strong>The implementation of the GST\non Indian medical device industry <\/strong><\/p>\n\n\n\n<p>The establishment of the Goods and Services Tax (GST) has had\na significant influence on the Indian Medical device industry. It resulted in\nthe abolition of a number of interstate indirect taxes and increased uniformity\nacross the nation with a single uniform tax structure.<\/p>\n\n\n\n<ul><li><strong>Medical devices attracting per cent GST<\/strong><ul><li>Coronary stents &amp; coronary stent systems for use with cardiac catheters.<\/li><li>Artificial kidney<\/li><li>Disposable sterilized dialyzer\/micro barrier of artificial kidney<\/li><li>Parts of the following goods, namely:<\/li><li>Crutches<\/li><li>Wheelchairs<\/li><li>Walking frames<\/li><li>Tricycles<\/li><li>Braillers<\/li><li>Artificial limbs<\/li><li>Assistive devices, rehabilitation aids &amp; other goods for disabled<\/li><\/ul><\/li><\/ul>\n\n\n\n<ul><li><strong>Medical\ndevices attracting 12 per cent GST<\/strong><ul><li>Blood glucose\nmonitoring device called Glucometer along with the test strips<\/li><li>Apparatus &amp;\nequipment employed in medical, dental care or veterinary services,<\/li><li>Other electro-medical\ndevices<\/li><li>Eyesight testing\ndevice<\/li><li>Mechanical treatment\nmachines;<\/li><li>Cerebral curve\ntesting device;<\/li><li>ozone treatment apparatus,<\/li><li>oxygen pump,<\/li><li>vaporized treatment,<\/li><li>Other types of\nbreathing equipment and gas masks<\/li><li>Orthopedic devices\nsuch as knee braces, sauna belts<\/li><li>Artificial limbs;<\/li><li>Amplifiers<\/li><li>Other forms of\ndifferent apparatuses which are worn or conveyed, on the body, in case of a\ndisability &nbsp;<\/li><li>Devices using the\nX-rays\/alpha, beta\/gamma radiations, for medical\/veterinary uses. This also\nincludes radiography X-ray tubes &amp; other X-ray generators (high-pressure <\/li><\/ul><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Over the past five years, the Indian government has taken a number of measures to support the development of a thriving ecosystem for the manufacture of medical devices in India. The competent legal system in India is a major factor in the medical device industry&#8217;s continued upward expansion. In order to service both the Indian and international markets, several MNCs have been expanding their industrial presence and setting up research facilities in India. Other supply-side changes in healthcare delivery in India, such as the expansion of the healthcare infrastructure following the pandemic, rising recognition for healthcare providers, and a focus on the accessibility and distribution of medical devices, have also been influenced by increased funding and investments. There is no doubt that, despite the challenges, the Indian market for medical devices continues to present investors and other stakeholders with unmatched opportunity. The medical device business in our nation has tremendous development potential as a result of growing investments in the sector, and this growth is being aided by the government&#8217;s proactive measures, such as the implementation of Make in India programmes and online registration for medical devices. The Make in India strategy is crucial for leveraging efforts to promote home grown manufacturing and achieve India&#8217;s dual goals of accessibility and affordability.<\/p>\n\n\n\n<p class=\"text-left\"><b>Read Our Article<\/b>: <mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/registration-process-for-medical-devices-in-india\/\">A Step By Step Guide For Registration Process For Medical Devices In India<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Drugs, vaccines, and medical devices are the three essential industrial foundations of contemporary healthcare technology systems. Bandages and syringes to complex gadgets using bioinformatics, nanotechnology, engineered cells, and artificial intelligence are all examples of medical devices. These are made to be used by professionals, patients, and health experts people in a range of locations, including [&hellip;]<\/p>\n","protected":false},"author":48,"featured_media":52530,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[3101],"acf":{"service_id":"385"},"authorName":"Astitva Kumar","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/12\/MicrosoftTeams-image-27.jpg","authorDescription":"Astitva Kumar is an advocate by profession and has completed her BBA. LLB from IP University. She is an avid reader, researcher, and legal writer. Her areas of interest include mediation, conflict resolution, finance, cyber laws, and taxation.","postViews":4337,"readingTime":12,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/52529"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/48"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=52529"}],"version-history":[{"count":2,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/52529\/revisions"}],"predecessor-version":[{"id":52532,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/52529\/revisions\/52532"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/52530"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=52529"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=52529"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=52529"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}