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The Government has broadened the scope of medical deviceswhich are regulated as a 'drug' under the Drugs andCosmetics Act, 1940. Notably, any software or app used forprevention or monitoring diseases has been classified as a medicaldevice and consequently will be regulated as a'drug'.

For over a decade, software technologies have been bringinginnovative changes and advancements in the healthcare sector, be itin monitoring, diagnosis, prevention or treatment of diseases ordrug manufacturing. On 11 February 2020, the Ministry of Health andFamily Welfare issued a notification(Notification) to broaden the scope of medicaldevices that are to be regulated under the Drugs and Cosmetics Act,1940 (DCA) and Medical Devices Rules, 2017(MDR). Under this Notification, any medicaldevice, including software, will be regulated as a 'drug'under the DCA, effective from 1 April 2020, if they are used forany of the following:

(a) diagnosis, prevention, monitoring, treatment or alleviationof any disease or disorder;

(b) diagnosis, monitoring, treatment, alleviation or assistancefor, any injury or disability;

(c) investigation, replacement or modification or support of theanatomy or of a physiological process;

(d) supporting or sustaining life;

(e) disinfection of medical devices; and

(f) control of conception.

Previously, under the DCA, the definition of a 'drug'included devices intended for internal or external use in thediagnosis, treatment, mitigation or prevention of disease ordisorder in human beings or animals as notified from time to timeby the Central Government. MDR accordingly defined 'medicaldevice' to mean:

(a) substances such as those used for in vitro diagnosis andsurgical dressings, surgical bandages, surgical staples, surgicalsutures, ligatures, blood and blood component collection bag withor without anticoagulant;

(b) substances including mechanical contraceptives (condoms,intrauterine devices, tubal rings), disinfectants and insecticidesetc.; and

(c) devices notified from time to time under DCA.

The Government of India has notified and regulated only 37categories of medical devices so far.

Therefore, prior to this Notification, 'software' wasnot included in the definition of medical device either under theMDR or DCA (except in a limited context of clinical investigationand in relation to in-vitro devices). With this inclusion, anysoftware or app, that is part of or used in conjunction with adevice, that is capable of or assists in the investigation of aphysiological process or in the diagnosis, prevention or monitoringof any disease or disorder would be treated as a medical device andconsequently would be regulated as a 'drug' under DCA.

If a medical device is regulated as a drug under the DCA, itneeds to be registered in accordance with the provisions of DCA forit to be imported, manufactured, sold or distributed in India. Suchregistrations are done by drug regulatory agency- Central DrugStandards Control Organisation, after appropriate quality checks.Further, an entity that imports, manufactures, sells anddistributes these regulated medical devices in India must obtain alicense to do so.

Along with this Notification, the Ministry amended the MDR on 11February 2020. It introduced a new chapter for registration ofmedical devices which fall under the new definition provided in theNotification. This registration allows new medical devices to beexempted from the provisions of MDR, including the requirement ofgetting a license. Manufacturers, importers or sellers of anymedical devices that fall under this new definition are required toregister their medical devices with the Drugs Controller General ofIndia. This registration is on a voluntary basis for a period of 18months from the effective date of the Notification. After 1 October2021, all medical devices that fall under this definition will needto be compulsorily registered. In order to get a registration, amanufacturer will need to provide certificate of ISO compliance forMedical Devices category.

The amendment also exempts the already regulated 37 categoriesof medical devices from the requirement of registration under thisnew chapter. However, this registration-based exemption fromlicensing requirement is also time bound. Medical devicesclassified as low risk and low-moderate risk as per the provisionsof DCA and MDR will cease to have this exemption after a period of30 months from the date of issuance of this amendment notification,i.e. 11 August 2022 and those classified as moderate-high risk andhigh risk devices will cease to have this exemption after a periodof 42 months, i.e. 11 August 2023.

It appears that the intention behind broadening the definitionis to further hold medical device companies accountable for thequality and safety of their product given the sophisticatedfunctions that these devices are able to perform. This is largelyin line with international norms and practices with respect to theregulation of medical devices. In fact, this definition is inaccordance with what has been recommended by the GlobalHarmonisation Task Force (GHTF) framework of theWorld Health Organisation. However, the GHTF also suggested thatcertain medical products may not fit comfortably within thedefinition of medical devices and placed a responsibility onauthorities to clarify the nature of regulatory requirementsapplying to such products. Unlike United States Food and DrugAdministration that puts in a clear mechanism of determination onwhether a product may be classified as a medical device, at thisstage there is not much clarity on the scope of the definitionunder this Notification.

Given the broad nature of the definition, the functioning ofdigital health products and wearables with their new and advancedfeatures would need to be closely assessed to determine whetherthey would fall within the definition of a medical device andconsequently be regulated as a drug. Further, given the extensiveregulatory requirements associated with this classification, itremains to be seen whether this move will impact innovation and theentry of such products in the Indian market.

Originally published 20 April, 2020

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Medical Devices (Including Software Used For Disease Prevention) To Be Regulated As Drugs - Food, Drugs, Healthcare, Life Sciences - India - Mondaq...