Fitness Wearables and the Law Part III: India

Recap

In Parts I and II of our series on fitness wearables and the law, we examined how the COVID-19 Pandemic accelerated the adoption of technology in the life sciences sector at an unprecedented rate, occasionally bringing what may once have been dismissed as science fiction within the reach of reality. Today, in a world where watches and rings can continuously monitor essential human biomarkers, the distinction between a patient and a consumer, or a fitness wearable and a medical instrument, has blurred. While new wearable devices continue to be launched at an exhausting pace, the regulatory framework struggles to keep up with the market.Do these devices require unique categorisation for regulatory ease, or can they be accommodated within the current regulatory frameworks?

In Parts I and II, we looked at how smart wearables are regulated in the United States and European Union respectively. Here in Part III, we attempt to analyse the regulatory and legal issues surrounding smart wearables in India.

A. Regulation of smart wearables as medical devices in India

Background

The Drugs and Cosmetics Act, 1940 (DCA) read along with the Medical Device Rules, 2017 (MDR), and other allied rules regulate the standards of quality and safety of medical devices in India. The scope of the DCA and MDR was, until recently, restricted only to 37 categories of medical devices which were notified as “drugs” by the Central Government (also referred to as “notified medical devices”).

The foundation of the regulatory framework applicable to medical devices changed unexpectedly on 11-2-2020, when the Government, in consultation with the Drugs Technical Advisory Board (DTAB), issued two notifications simultaneously — the first expanded the scope of medical devices to any device that came within an expansive definition¹, and the other notified the Medical Device (Amendment) Rules, 2020 (MDR-20)². The effect of these two notifications, read together, was that all medical devices were brought under the purview of the DCA with effect from 1-4-2020, and that the universe of regulated medical devices expanded overnight from thirty-seven to an indeterminate number, as manufacturers scrambled to understand whether devices already being marketed by them came within the new definition and therefore, now required a licence. Eventually, the authorities allowed extended compliance periods, that varied for different classes of medical devices, within which manufacturers could secure licences for devices that were not hitherto regulated.

When is a smart wearable a “medical device”?

Unlike the US FDA which provides detailed guidance on the regulation of smart wearables, the Central Drugs Standard Control Organisation (CDSCO) in India has generally been silent on this aspect, leaving the matter to interpretation.

Section 3(b)(iv) of the DCA defines a medical device as

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; or ….

(ii) investigation, replacement or modification or support of the anatomy or of a physiological process;”

The words “used alone or in combination, including a software or an accessory,” indicate that under the MDR, a medical device includes software. In addition, the MDR includes “investigation of the anatomy or a physiological process” within the definition of a medical device. Arguably, this means that if a smart wearable constantly tracks a physiological process such as blood circulation by measuring one’s heart rate, as is common for several smartwatches these days, they can, in principle, be classified as a medical device.

The qualifying words “intended by the manufacturer”are crucial for they mean that the manufacturer’s intention is key to determining the nature of a medical device.

Can smart marketing make all the difference?

In this context, it becomes pertinent to circle back to the concept of intended use and function of a medical device. We have previously seen that in the US, the FDA gives as much importance to function, as it does to the intended use stated by the manufacturer. Thus, where the intended use may be for general wellness purposes, but where such device functions as a medical device, the US FDA, in line with its guidance document, encourages manufacturers to obtain regulatory approval for the same.

In the absence of a similar guidance document in India, and with only the definition of a medical device provided under the MDR to rely upon, it means that only the intention of the manufacturer determines whether a smart wearable is a medical device. If that is the case, a smart wearable capable of monitoring heart rate, oxygen levels, and even physiological processes such as menstruation, will not be classified as a medical device if its intended purpose is general fitness or wellness, as opposed to one whose intended purpose is to monitor or prevent cardiac disease or investigate ovulation in women. For instance, there are several smartwatch manufacturers in India today (such as Fire-Boltt, Noise, GOQii, etc.) which track essential biomarkers such as heartbeat, sleep, stress, activity, and oxygen levels. Except for GOQii, which is registered as a medical device and a fitness tracker in India³, most other smart watch companies only market their products for use in health and fitness and disclaim any reliability or accuracy which has allowed them to dodge the requirements under MDR.

Therefore, it can be argued that in India the functionality of the device has little bearing if the manufacturer markets the smart wearable to be used solely for fitness or wellness purposes. This is similar to the EU which also places more importance on the intended use of a device as opposed to the functionality of a smart wearable. Thus, in combination with the view taken by European Court of Justice (ECJ), that if the manufacturer does not intend for a wearable to be a medical device, then the function is of little bearing further substantiates our argument, that marketing and promotional materials surrounding a smart wearable make a significant difference while determining its classification in India and EU. This is especially problematic since people are increasingly relying on smart wearables to make medical decisions.

Conclusion

Given that the line between smart wearables and medical devices is blurring as technological capabilities advance, and while smart wearables offer a multitude of features and an insight into one’s health like never before, the question surrounding its accuracy repeatedly pop ups. Inaccuracy of the number of steps one has walked in a day may have little impact, but inaccuracy in calculating one’s blood sugar levels or heart rate may have a significant impact on one’s health if the need for medical intervention becomes necessary.

While it is understood that imposing compliance requirements applicable to medical devices on these smart wearables might act as an entry barrier to accessibility and technological advancement, the absence of proper guidelines or regulations may end up doing more harm than good. There is an increasing need to periodically evaluate legislations to incorporate a well-rounded medically accurate and consumer-welfare-centric approach while keeping up with the pace of the industry.