Introduction
Since the advancements in healthcare services and medicinal sciences, medical devices in India have become part and parcel of the existing healthcare delivery services framework. Medical devices, in essence, are tools, instruments and even software which inter alia enable healthcare service providers to diagnose, monitor, mitigate and treat illnesses and health conditions.
With the advent of technology and advancement of healthcare delivery, the demand for medical devices of various categories has increased manifold. In India, the surge in demand for such devices is currently met through a combination of imports from foreign countries and indigenous production. Generally, it is observed that to sell a medical device in the Indian market, a manufacturer /importer/ distributor must mandatorily adhere to the procedural and documentation requirements for conducting clinical investigations.
In straightforward terms, clinical investigation is a procedure to establish the safety and efficacy of a medical device before it is approved to be marketed and distributed in India. The regulatory framework around clinical investigation of medical devices have undergone transformative change in the preceding three decades beginning with the inclusion of the definition of ‘medical devices’ under the Drugs and Cosmetics Act, 1940 (“D&C Act”), the subsequent promulgation of the Medical Devices Rules, 2017 (“MD Rules”) and the latest being the Drugs, Cosmetics and Medical Devices Draft Bill, 2022 (“Bill”). The Bill is scheduled to be considered by the Indian parliament in the upcoming monsoon parliamentary session of 2023.
Prior to the MD Rules, the regulatory framework for undertaking clinical investigation of medical devices was ambiguous and inefficient. The lacuna in the previous regulatory framework resulted in flooding the Indian market with medical devices that escaped the requisite clinical investigation. .
Development of the Regulatory Framework
Medical devices proposed to be marketed and sold in the Indian markets are regulated by the Central Drugs Standard Control Organization (“CDSCO”). We have provided hereinbelow a timeline of the regulatory developments which shaped the creation of the current regulatory regime:
- Post the inclusion of the definition of medical devices in the D&C Act, in 2005, the Ministry of Health and Family Welfare (“MOHFW”) notified the requirements and guidelines for obtaining permission to import or manufacture new drugs and for conducting clinical trials ( the notified medical devices were technically covered in the ambit of drugs). As of 2005, only 12 medical devices were notified and regulated, leaving most of them unregulated.
- The Science and Technology Ministry published a draft of the Medical Device Regulation Bill, 2006 to create a medical device regulatory authority of India and to introduce a risk-based classification of medical devices.
- In 2017, the MOHFW notified the MD Rules, 2017, which brought forth a single window for: (i) registration of medical devices; (ii) review and submission of medical device applications through an online portal called ‘SUGAM’. Furthermore, under the MD Rules, manufacturing and import licenses issued to the applicants were to remain perpetually valid or until surrendered. Lastly, the procedure for clinical investigation of medical devices was clearly stipulated under Chapter VII of the MD Rules. Most importantly, the MD Rules defined the term ‘medical device’ to include inter alia substances used for in vitro diagnosis and surgical dressings, bandages, staples, sutures, ligatures, blood and blood component collection bag; substances including mechanical contraceptives, disinfectants and insecticides. The MD Rules also introduced ‘medical device grouping’ which meant a set of devices having the same or similar intended use or commonality of technology allowing them to be classified in a group not relating to specific characteristics.
- In 2019, Niti Ayog proposed the draft Medical Devices (Safety, Effectiveness, and Innovation) Bill, 2019, envisioning the creation of the ‘Medical Devices Administration’ that would function alongside the CDSCO.
- In 2020, the MOHFW expanded the definition of ‘drugs’ in terms of Section 3(b) of the D&C Act to include all devices intended for inter alia : (i) the diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life; disinfection of medical devices; and (v) control of conception. Most importantly, the definition extended the ambit of ‘medical devices’ to include software.
- In 2020, the Government issued a notification stipulating that any software or app used for the diagnosis, prevention or monitoring of any disorder or disease, whether forms a part of or used in conjunction with a device or is capable or assists in the investigation of any physiological process are included in the meaning of ‘medical device’ and thus regulated as a ‘drug’ under the D&C Act.
Clinical Investigation Framework
As per the MD Rules, ‘Clinical investigation’ refers to the systemic study of an investigational medical device in or on human participants to assess its safety and performance for its intended use. An ‘investigational medical device’ refers to medical devices excluding in vitro diagnostic medical devices which lack ‘predicate devices’ or are licensed under the provisions of the MD Rules with claims for new intended use/ new population/ new material/ major design change, and are being assessed for safety, performance or effectiveness in a clinical investigation. The MD Rules provide for a compensation clause wherein any injury caused to a participant in a clinical investigation of a medical device and the injury is attributable to the use of the device thereto, the sponsor of the clinical investigation is mandated to provide medical management and compensation (in terms of the Drugs Rules, 1945) to the participant. The procedure for application of a grant of licence to conduct clinical investigations under the MD is primarily divided into two broad categories:
- Pilot Clinical Investigations, wherein an investigation is conducted amongst humans for the first time, usually amongst a small group of patients, for specific information relating to a medical device, typically before initiating a clinical study in human participants; and
- Pivotal Clinical Investigations, which is the final study providing information about the safety and standard of the medical device. These are often carried out on a large population having conditions or diseases that are under scrutiny.
It is interesting to note that the Central Licensing Authority may in public interest choose to defer or waive certain requirements/ pre-requisites for conducting clinical investigations. This discretionary power of the authority is particularly useful during emergency situations when it is imperative that the clinical investigation of new medical devices (having no predicate devices) must be fast-tracked.
Role of Predicate Medical Devices
A ‘predicate medical device’ is defined under the MD Rules as a device, first time and first of its kind, approved for manufacture for sale or for import by the Central Licensing Authority and has the similar intended use, material of construction, and design characteristics as the device which is proposed for license in India. For most manufacturers and importers of medical devices, it is extremely beneficial if a medical device has been approved by the Central Licensing Authority because a medical device which claims substantial equivalence[1] to a predicate device may be allowed to bypass the MD Rules’ requirements for clinical investigation. However, the MD Rules further provide that a claim of substantial equivalence does not mean that the proposed medical device and predicate device are identical. It further states that substantial equivalence must be established on the basis of a number of factors including manufacturing process, safety, effectiveness, labelling and bio-compatibility.
European Regulatory Framework for Clinical Investigation of Medical Devices
It is interesting to note that the regulatory framework of investigational medical devices in foreign jurisdictions, most notably, ‘Article 77(6) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices’ read with the Commission Guidance document[2], require a structured and detailed clinical investigation report, including information about the design, conduct, analysis and results of the clinical investigation, in a format that is easily understandable to the intended user of the medical device. Such compliances, if incorporated by the Indian regulators, may ensure further accountability and transparency on the part of medical device manufacturers and importers.
Concluding Thoughts
India’s healthcare industry has witnessed a substantial surge in the adoption and development of medical devices, which has significantly contributed to improving patient outcomes and revolutionising healthcare delivery. Indian medical device manufacturers have begun submitting applications for clinical investigation to gain approval of their products. It has given a much-needed boost to the indigenous medical device industry, evident from the surging number of clinical investigation studies being registered on Clinical Trials Registry – India website. The National Medical Devices Policy, 2023 notified by the Department of Pharmaceuticals on May 2, 2023[3] read with the strategy document[4] aims to accelerate growth in the medical devices sector while promoting safety and quality. The policy is demonstrative of the continuing objective of the government to fructify its ‘make in India’ goals, thereby giving further fillip to indigenous manufacturers of medical devices. However, it is observed that even though Indian manufacturers are now actively involved in the R&D and clinical investigation of new medical devices, the industry at large remains highly dependent on identifying and referencing predicate devices when a product is being proposed to be introduced in the Indian markets.
Despite the challenges surrounding the development of a robust framework focusing on the safety and efficacy of medical devices, the growth of medical devices in India is expected to reach new heights on the back of sustained efforts and collaboration from various stakeholders of the industry.
For further information, please contact:
Biplab Lenin, Partner, Cyril Amarchand Mangaldas
biplab.lenin@cyrilshroff.com
[1] A device shall be deemed to be substantially equivalent in comparison to a predicate device, if it has: (i) the same intended use and technological characteristics; or (ii) the same intended use and different technological characteristics, and demonstrate that the device is as safe and effective as the predicate device.
[2] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52023XC0508(01)
[3] Department of Pharmaceuticals, Gazette Notification bearing F. No. 31026/91/2015-PI-II dated May 2, 2023, available at https://egazette.nic.in/WriteReadData/2023/245630.pdf.
[4] Department of Pharmaceuticals, ‘Strategy Document on National Medical Devices Policy 2023’, available at https://pharmaceuticals.gov.in/sites/default/files/Strategy%20Document%20on%20NMDP%20
