In April of this year, the Drugs Technical Advisory Board (“DTAB”) deliberated on the issue of creating a roadmap for the regulation of medical devices and allocating the necessary human resources to regulate the medical device industry.

The DTAB eventually took the view that all medical devices, including those that are outside the purview of the currently regulated 23 categories of devices (and another 12 more), should, in a phased manner, be regulated under the Drugs & Cosmetics Act 1940.

The outright challenge that this approach creates is that it continues to subject the ecosystem of medical device manufacturers to the regulatory regime of the pharmaceutical industry (comprised in the Drugs & Cosmetics Act 1940 – though the recent Medical Device Rules 2017 offer some solace).

Before examining the view taken by the DTAB, it would be useful to outline some of the reasons that many in the medical device industry believe should warrant the creation of an independent legal and regulatory framework for medical devices in India.

The first is having a regulatory regime that understands the enormous impact that technology has had and continues to have in the growth and development of medical devices. Medical devices, as an industry, has seen a tremendous growth in the past forty years, owing to scientific advancement in imaging capabilities, implant technology, artificial organ development, prosthetics and more recently, in the use of big data in disease treatment. To put it in a more vivid context, this is an industry whose participants are developing 3D printing capabilities of their goods, using AI centric imaging techniques to offer diagnosis of diseases afflicting patients across the globe and making real time assessments on suitable health norms for human beings across geographies. Therefore, any regulatory regime that works towards regulating such a technology centric industry would need a framework that is well suited towards reviewing and responding to constant scientific developments. The regime that therefore seeks to regulate this industry hence needs to be on the same page as this ecosystem.

The second is to address the trend of harmonization of nomenclature and capabilities of medical devices globally. Those working in the medical device industry will often encounter references to the Global Harmonisation Task Force (“GHTF”), a World Health Organisation backed initiative to harmonise nomenclature, standards and regulatory practices associated with medical devices across the globe. Regulations surrounding the medical device industry have been internationally undergoing a great deal of changes, to come in line with such global norms. In this regard, it is hence important that a separate regulatory regime be created for medical devices in India.

The third is to address the increasing scrutiny that the medical device industry is facing in India, especially in light of the recent hip implant controversy, inclusion of stents and kneecaps under price control and further expansion of the national list of essential medicines to cover various medical devices. There is a clear and visible interest of the industry and the current regulatory framework that governs it.

In evaluating the above considerations, it ought to have been a clear imperative to ensure that the medical device industry be given a specific legal and regulatory framework that would deal with the regulation of medical devices, independent of drugs and pharmaceutical products.

However, the DTAB in its wisdom has chosen to continue regulating medical devices under the Drugs & Cosmetics Act 1940 (through suitable exemptions under Rule 90 of the Medical Device Rules 2017). This approach brings about the following challenges.

Firstly, in creating a regulatory framework, a great deal of emphasis has to be placed on the allocation of risk and responsibility. This is something that has to necessarily vary in accordance with the industry that’s sought to be regulated and the entity that participates in such an industry. For example, should the supplier or distributor face the same level of risk and responsibility as that of the manufacturer? What would define the role and consequent commitment of the supplier in a given industry? What should be the rules and regulations that govern the sales of such products and should sales be allowed to end users? These are specific questions that will necessarily vary based on the industry involved. The Medical Device Rules 2017 themselves are silent on this aspect, along with many others. To simply impose the norms that apply to the pharmaceutical industry on the medical devices industry may not be the way forward.

Secondly, the current regulatory framework that deals with the drug and pharmaceutical industry, itself needs evolution. We need fresh ideas on pricing control and improvement of access; and more modern ideas on labelling and distribution requirements that should apply to drugs. We have to better understand the practical risks and challenges that face industry players that operate in this space. Consequently, to impose a regulatory framework that itself needs further reform on a completely different industry is difficult to accept.

Thirdly, the use of the current regulatory framework will not be suitable towards appreciating all of the industry nuances and capabilities that exist in the medical device industry; and hence, the ability to regulate an industry whose contours cannot even be fathomed in the first place seems all the more unlikely. A simple scenario here could be dissected in this regard; how should data saved on an MRI, X-Ray machine, retina scanner be saved or stored or handled by the hospital or doctor? What would the norms for the use of such data be? Who would be responsible for ensuring security of such data? Would manufacturers be responsible for creating tools to anonymise the data?

Lastly, to consider the adequacy of the Medical Device Rules 2017 (framed under the Drug & Cosmetics Act 1940), these rules remain silent on a range of relevant issues that affect the medical device industry, such as quality control, reporting of adverse events, norms on compensation, relevant training, advertising and promotional restrictions and sale channels. These are the issues that need regulations backed by clear and considered guiding principles.

Among the various issues to note in this recent decision of the DTAB, it is particularly interesting to see how there is no reference made to the recommendations of the Expert Committee constituted by the Ministry of Health & Family Welfare, Government of India in respect of the compensation for patients who were using faulty hip implants. These recommendations, among others, dealt with tracking of usage of high risk medical devices, strengthening the materiovigilance programme, creating a registry for noting adverse reactions and including regulations for compensation to patients. The fact that such siloed thinking continues to exist is itself suggestive of the need for a fresh start in regulating medical devices. And presumably a new paradigm is thus crucial.