Medical devices whether syringes and swabs, implantable devices, or technologically advanced solutions like software-driven devices, play a key role in the monitoring, prevention, and management of various diseases. A robust and dynamic regulatory system to oversee the development of safe and efficacious medical devices is needed. This is always a work in progress, as innovation pushes beyond the boundaries of the existing regulatory framework.

This article will help readers understand the regulators approach to medical device in India. All interested stakeholders can use this understanding to plan their business operations and to effectively engage with the regulators. Through such engagement it may be possible to implement the desired regulatory framework for medical devices in India. One that makes devices made in India reliable and trustworthy, globally.

This article is the first in a series of articles that examine the regulatory issues faced by the medical devices industry in India. It traces the evolution of medical devices regulation.

Key regulatory developments:

Date Event
November 13, 1982 The definition of "drugs" under the Drugs and Cosmetics Act, 1940 (DCA, 1940) was amended to include such medical devices as may be notified by the Government from time-to-time. Post notification these devices would then be governed by the DCA's regulatory framework.1 Interestingly, to this day, to be recognised as a medical device, a device must first be notified as a "drug" under DCA and thereafter be governed by the regulatory framework meant for drugs. Till as late as 2017, India did not have a single regulation that dealt specifically with the approval of medical devices.
March 17, 1989 The Health Ministry notified the following devices: 2 Disposable Hypodermic Syringes;Disposable Hypodermic needles;Disposable Perfusion sets.
February 22, 1994 Rules laying down the requirements of factory premises for manufacture of Medical Devices were notified.3
January 20, 2005 The Health Ministry notified the requirements and guidelines to be followed for obtaining permission to import or manufacture new drugs and for conducting clinical trial. Medical devices are technically covered within the ambit of these rules as well (because medical devices are classified as "drugs"). However, a bare reading of these rules makes it clear that they were drafted for the benefit of drugs and not medical devices. In fact, medical devices are mentioned only once in the entire text of these rules.
October 06, 2005 The Health Ministry notified 10 sterile devices:4 Cardiac Stents; Drug-Eluting Stents; Catheters; Intra Ocular Lenses; I.V. Cannulae; Bone Cement; Heart Valves; Scalp Vein Set; Orthopaedic Implants; Internal Prosthetic replacements. Thus till 2005, only 12 medical devices in India were recognised.
It is important to note that at this time, many devices were not regulated. For example, insulin pens, voice prosthetics, and diagnostic tools like biopsy kits were not notified as medical devices. Some of these devices are invasive and could even pose health risks if not tested, scrutinized, and if used without proper guidance.
October 07, 2005 The Health Ministry placed the decisions of sale, manufacture, and import of the 10 notified devices under the control of the Drugs Controller of India ('DCGI').5 Subsequently, guidelines for the import of these 10 devices were brought into effect from March 01, 2006.6
2006 The Science and Technology Ministry released a draft of the "Medical Devices Regulation Bill, 2006", for comments.7 This Bill proposed creating a Medical Device Regulatory Authority of India and introducing a risk-based classification of medical devices. It recognized certain shortcomings of housing devices under the definition of 'drugs' and thus regulation under the DCA, 1940 and DCR, 1945, highlighting that the then definition did not include all devices.
October 31, 2012 The Central Drugs Standard Control Organisation ('CDSCO'), released a guidance document for the import of medical devices,8 listing 21 products that would fall under it.
January 31, 2017 The Health Ministry notified the Medical Device Rules, 2017 (MDR, 2017).9 Some of the key changes brought in include: Single window for registration, review, and submission through an online portal called 'SUGAM';Manufacturing and import licenses will remain valid in perpetuity or till surrendered;10Risk-based classification of devices with 4 classes in increasing order of risk (Class A, Class B, Class C, and Class D) was introduced. Regulatory requirements and the appropriate licensing authorities are based on the risk class of the device;The work of regulators within these rules are largely time-bound.Clinical Trials related compliances and oversight for medical devices were separated from Schedule Y of the DCR, 1945. The MDR, 2017 lists the same under its Seventh Schedule, with numbered tables housing the format for each document being submitted.A "Unique Device Identification" will be introduced for each medical device in January 2022.11
November 07, 2017 The DCGI released a list of 247 devices classified based on their risk and detailing their intended use.12
October 18, 2019 The Health Ministry released a draft notification that proposed the mechanism for registering certain medical devices, whether locally manufactured or imported.13 It listed 36 devices that would need registration with CDSCO through the online portal.
December 03, 2018 The Health Ministry notified the following devices:14 Nebulizer; Blood Pressure Monitoring Devices; Digital Thermometer; Glucometer.
December 18, 2019 The Niti Aayog organized a stakeholder meeting on its draft Medical Devices (Safety, Effectiveness, and Innovation) Bill, 2019, where it proposed creating the Medical Devices Administration, to work parallel to the CDSCO, under the Directorate General of Health Services ('DGHS').15 One of the reasons cited by Niti Aayog was that the CDSCO and DCGI may not have the relevant expertise to exercise oversight in this realm.16
February 11, 2020 The Health Ministry expanded the definition of "drugs" in Section 3(b) to include all devices intended for– diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; investigation, replacement or modification or support of the anatomy or of a physiological process; supporting or sustaining life; disinfection of medical devices; and control of conception.17 The expanded definition included software and accessories as well. This potentially means that all wearables boasting health features can be classified as a medical device.

Observations:

The sequence of events illustrated in the above table shows that medical device regulations have largely evolved in a piece meal manner. Changes have been brought into redress needs as they arise. They have not been pre-planned. Consequently, there hasn't been a logical progression leading to some dangerous gaps. Many devices, both for external use and invasive use, whether for therapeutic or for diagnostic purposes remained unregulated for the longest time.18

The notification of Medical Device Rules in 2017 was a first step in reversing this trend of ad-hoc regulation making. These rules gave the regulators greater ability to regulate devices on a stand-alone basis. It recognised that medical devices and drugs are different, and hence a separate criterion needs to be laid down for determining their use, testing for safety and efficacy, and risks posed to the human body. The MDR, 2017, however, carried forward that piece-meal approach of notifying devices.

This was partly remedied by the February 2020 notification that expanded the definition of medical devices. The effect of this notification is that nearly all health-related devices are recognised as medical devices and no longer exist in a legal vacuum. This opens the door for regulators to set standards for software components of medical devices and for creating robust mechanisms to clinically evaluate innovations that may come in this field. The cumulative effect of the MDR, 2017 and the February 2020 notification is that together they have the potential to bring India's regulations on par with various international jurisdictions; furthering India's standing as the pharmacy of the world by providing quality products.

Conclusion:

Indian regulators have made a conscious effort to change their approach to regulating medical devices – from one that is piece meal and need based to one that is systematic and pre-planned. Consequently, an attempt is being made to anticipate developments in this field and to put in place a regulatory framework that is competent enough to test the effectiveness of these developments and can lay down standards to be adopted for their safe deployment. This trend has been welcomed by stakeholders.19 To further this process, stakeholders need to engage in an effective dialogue with the regulators. The aim for such dialogue being – to help develop a framework regulatory framework that would make medical devices developed and approved in India, reliable and trustworthy globally.

This piece has been authored by Shambhavi Ravishankar with inputs from Tanya Sadana and Anirudh Rastogi.

Footnotes

1. Act 68 of 1982, https://www.casemine.com/act/in/5a979db54a93263ca60b72d0#1001_1_FN0001

2. G.S.R. 365(E), Ministry of Health and Family Welfare, https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjA0

3. Schedule M-III in Drugs and Cosmetics Rules, 1945 By GOI Notification No. G.S.R. 109(E), w.e.f. 22.2.1994. http://www.egazette.nic.in/WriteReadData/1994/E-0395-1994-0082-15199.pdf

4. S. O. 1468(E), (October 06, 2005) http://www.egazette.nic.in/WriteReadData/2005/E_1077_2012_007.pdf

5.GSR 627 (E) dated 7/10/2005 https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI3Mw==

6. GUIDELINES FOR IMPORT AND MANUFACTURE OF MEDICAL DEVICES https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadImmunization/11GUIDELINES1.pdf

7. https://www.prsindia.org/uploads/media/vikas_doc/docs/1241499654~~madra_act.pdf

8. Guidance Document on Common Submission Format for Import License in Form-10 of Notified Medical Devices in India, CDSCO/MD/GD/IL/01/00, available at: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadImmunization/FinalGuidance_Doc_Import_Licence_31dec12.pdf

9. G. S. R. 78(E), January 31, 2017, https://www.emergobyul.com/sites/default/files/india-medical-devices-rules-2017.pdf

10. Rule13(7), Medical Devices Rules, 2017

11. Rule 46, Medical Device Rules, 2017, https://www.emergobyul.com/sites/default/files/india-medical-devices-rules-2017.pdf

12. Classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017 -Reg., File No: 29/Misc.l3/2017-DC(292), November 07, 2017 available at: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/Classificationg1.pdf

13. G.S.R. 797 (E), https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadGazette_NotificationsFiles/gsr797(E.pdf

14.S.O. 5980(E), 3rd December, 2018 https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjM1NA==

15. https://www.business-standard.com/article/economy-policy/niti-aayog-plans-to-bring-all-medical-devices-under-one-regulatory-regime-119121900025_1.html

16. https://www.healthissuesindia.com/2019/12/20/the-medical-devices-bill-explained/#:~:text=
The%20Bill%20%E2%80%93%20in%20full%2C%20the,an%20estimated%20Rs%2039%2C000%20crore.&text=
The%20Government%20would%20also%20establish%20a%20National%20Register%20of%20Medical%20Devices.

17. S.O. E. 648(E), February 11, 2020, https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTU0OA==

18. Telangana Today, 'Radiation risks in using medical devices neglected' (December 16, 2018) https://telanganatoday.com/radiation-risks-in-using-medical-devices-neglected

19. Industry perspectives can be found here: https://www.youtube.com/watch?v=5BDkJbEF0gM&ab_channel=ETHealthWorld; https://www.outlookindia.com/newsscroll/aimed-amp-bcil-seek-regulatory-framework-on-medical-devices/1634729 ; https://www.expresshealthcare.in/news/aimed-welcomes-dtabs-move-of-considering-to-regulate-all-medical-devices/410959/

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