Medical Devices Sector: Prerogatives and Regulatory Reforms post COVID-19

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 OVERVIEW
India is the 4th Largest Medical Devices Market in the world after Japan, China and South Korea. The present Government is also trying to harness and stabilize the medical devices market in India, by allowing 100% FDI in the Medical Devices Sector.

Through a recent notification, the Union Health Ministry has proposed to bring all medical devices including contraceptives and implants under the regulatory framework of the apex drug regulatory body, Central Drugs and Standard Control Organisation (CDSCO), mandating all medical devices to get CDSCO certification[1]

India’s Ministry of Health and Family Welfare (MoHFW) and the Central Drugs Standard Control Organization (CDSCO) are the main regulatory bodies that are responsible for overseeing pharmaceuticals and medical devices within India. The CDSCO exercises regulatory control over the import of drugs and devices, and approves new medical products and clinical trials.[2]

THE GOVERNANCE MECHANISM
Medical Devices and InVitro Diagnostics (IVDs) are governed by the Medical Devices Rules, 2017 which were notified in 2018. They are further classified into four major categories:
·         Class A (low risk)
·         Class B (low moderate risk)
·         Class C (moderate risk)
·         Class D (high risk)[3]
As of now, the premier agency which control and check the efficacy and quality of manufactured and imported medical devices in India is Central Drugs Standard Control Organization (CDSCO). To create a separate regulator for medical devices and pharmaceuticals, the Union Government has sent a draft to the cabinet, for establishing Medical Devices Administration (MDA), to regulate only medical devices, and to improve overall efficacy and quality.[4]
Before dealing with the specifics, it is relevant to discuss the key functions of CDSCO under the Drugs and Cosmetics Act of 1940.
Firstly, CDSCO is responsible for approving new drugs, which are manufactured or imported, and to ascertain whether they meet the twin requirements of quality and efficacy.
Secondly, CDSCO is also responsible for import licensing and registration procedures of pharmaceuticals and medical devices.
Thirdly, one complex nature of work that CDSCO performs, is to make sure that Blood Banks, LVPs, Vaccines and r-DNA products are licenses as per the existing policy framework.
Lastly, other functions of the organization include but not limited to, are banning of certain drugs, granting of test licenses, testing of drugs etc.
From the diverse nature of tasks and duties that CDSCO performs, there arises an urgent need to make sure a separate regulator for medical devices in India, particularly in view of the fact that our medical devices industry has grown from $2.2 billion in 2009 to $5.5 billion in 2018, with a substantial increase in both imports and exports.
However, there is still no particular mechanism for reporting malfunctioning of non-notified medical devices. The Union Government has taken a proactive step by notifying medical devices as drugs under Section 3(b) of Drugs and Cosmetics Act of 1940. However, this is just a temporary solution, as there is a dire of efficient and skilled health care regulators and scientists to check the quality of imported/manufactured medical device.

REGULATORY POSITION OF MEDICAL DEVICES:
Unfortunately, till February 2020, only 23 medical devices had been notified as drugs, and therefore were capable of being regulated. However, the Union Government now has expanded the scope to include 37 devices, all of which are used on humans, in the list of notified medical devices.
Furthermore, a time limit of 2.5-3.5 years, has been given to importers/manufactures, to get their respective devices notified with the Organization if the same are being used to treat human beings.
The genesis of this step, arises from a recommendation given by Drug Technical Advisory Board, that came in April 2019, to regulate such devices.
It is also relevant to state here Section 3(b) (iv) of Drugs and Cosmetics Act, 1940 clearly mentions that
“3(b) drug includes-
(iv) such devices* intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board;]”
Using such powers as mentioned in the above said provision, the Ministry of Health and Family Welfare came up with a notification dated 11th February 2020, by which it expanded the definition of ‘drugs’ under D&C Act, 1940.  The key extract of the same is as under:
“In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board,hereby specifies the following devices intended for use in human beings or animals as drugs with effect from the 1 st day of April, 2020, namely:―
All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
(i) 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;
(v) disinfection of medical devices; and
(vi) control of conception.”[5]
Careful reading and analysis of the gazette notification, allows us to ascertain the intent and purpose of such an amendment. It can be said to be two fold, firstly, to include all such devices, used for the purpose of overall diagnosis, treatment and treatment under the net of the said definition, so as to make sure, that the quality and efficacy of such devices is maintained at all time.
Secondly, other intent which could be gauged from the above is, that person or organization who are using devices without proper regulatory permissions, are brought to task and their accountability is fixed.

INDUSTRY CONCERNS AND THE WAY AHEAD:
First and foremost, what the medical devices industry needs at the moment is some confidence from the Government by creating a separate regulatory body consisting of eminent experts, who are assigned specific tasks of policy formation, and driving the agenda that they set forth.

At the infrastructure level, especially post COVID-19, we would require manufacturing cluster to be set up in PPP Mode. Looking at the financial constraints post this event, and also the high lending rates of some nationalized banks, it would be suggested that low cost funding to MSMEs who are willing to set up manufacturing hubs, should be done by the respective State Governments. [6]

Policy prerogatives on the efficacy and testing sphere should now be followed up by developing adequate infrastructure for efficacy and safety testing. This could be done by:
Ø    Setting up Medical Devices Testing Centres in PPP Mode.
Ø  Creating Institutes of Eminence (IoE) for supporting product development and validation.
     Creation of BIS or a similar marking system for medical devices in sync with international certifications.

On the research and development front, we urgently need to set up a system for IP Exchange with several developing and developed nation, with whom we can do regular trade in medical devices sector. Further one more way forth, could be setting up specified and accredited healthcare incubators on cost sharing basis.

A proactive policy formulation to regulate medical devices should permit free market dynamics to succeed. The regulations should be simple which will help in protecting consumers and incentivizing Make in India.

Synchronizing the expertise from various agencies, including NITI Aayog, to formulate the policy will be essential steps in this regard.

Aditya Jain is Advocate on Record at Supreme Court of India and Partner at J&G Advocates
Neha Gyamlani is an Advocate at Rajasthan HC/Supreme Court and Partner at J&G Advocates


[3] 2016. Growth Opportunities For The Global Medical Device Market. Texas, USA: Lucintel.
[4] Collins, S., 2015. A Must-Read Overview Of The Medical Device Industry - Market Realist. [online] Marketrealist.com. Available at: <http://marketrealist.com/2015/11/must-read-overview-medical-device-industry/> [Accessed 4 May 2020].
[6] Emergo. 2017. INDIA – Overview Of Medical Device Industry And Healthcare Statistics. [online] Available at: <https://www.emergogroup.com/resources/market-india> [Accessed 7 May 2020].

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