<b>Debate:</b> Draft medical device rules, 2016

The landscape for the medical devices industry is at an inflection point with the government re-working the regulatory framework

Need to harmonise the rules with the Drugs & Cosmetics Act: Dhvani Mehta

The draft Medical Devices Rules, 2016 have been framed under the existing Drugs and Cosmetics Act, 1940, although the government appears to have intended the passage of a separate Act. In their current form, these rules rely on the regulatory structure under the existing 1940 Act. However, the government has also declared its intention to overhaul the 1940 Act in a much-needed move to strengthen drug regulatory processes. Legislative efficiency demands that these two processes work in harmony. For instance, the draft Medical Devices Rules, in their current form, confer important regulatory functions on the existing Central Licensing Authority and State Drugs Controllers under the 1940 Act. However, the functioning of these authorities has been sharply criticised and any attempt to revamp the 1940 Act ought to make significant changes to their structure.
 

If such changes are made, the Medical Devices Rules will also have to be updated, which seems an unnecessary duplication of legislative work. Notifying the Medical Devices Rules without having in place a new and stronger Drugs and Cosmetics Act is a bit like putting the cart before the horse. 
 

The provisions on clinical investigation and clinical performance evaluation under the draft Medical Devices Rules must also be harmonised with the provisions on clinical trials under the Drugs and Cosmetics Rules, 1945. Currently, there are differences in both sets of rules regarding important provisions, such as the definitions of ‘serious adverse event’ and ‘academic clinical trials’ and the provision of medical management and compensation for an injury or death during such investigations/trials.
 

In any case, the provisions on clinical trials under the Drugs and Cosmetics Rules themselves need to be streamlined and amended. This process ought not to take place independently of the framing of equivalent provisions in the draft Medical Devices Rules. The same standards of safety must be guaranteed for clinical trial participants and users of drugs as well as medical devices. 
 

Frequent amendments to the Drugs and Cosmetics Act and rules have already made for a very confusing regulatory framework, making a dampening effect on clinical research in India. The move to overhaul this framework is welcome, but must take place transparently and in consultation with all stakeholders so that the same mistakes are not repeated.

(The writer is senior resident fellow, Vidhi Centre for Legal Policy)

Govt must build capacity to effectively implement the Rules: Abby Pratt 

We appreciate the efforts made by the government to improve the overall landscape for medical devices in India and the consultative approach that it has adopted to draft the medical device rules. A robust set of medical device rules that offer clarity and predictability to the sector and is aligned with international best practices is critical to influence investment decisions as companies gauge the market’s attractiveness. 
 

The real test, however, lies in the successful implementation of the rules. For this, the government would need to work towards building capacity of the relevant ministries and ensure greater understanding of the sector. Successful enforcement of the rules would require long-term planning and a thorough understanding of the mid- to long-term industry requirements, market potential and the business environment. Currently, even though only 23 categories of devices are regulated by the government, it struggles to accommodate the steady flow of registrations and re-registrations. 
 

With the new device rules, all medical devices marketed in India would eventually come under regulation meaning that the government would have to undertake extreme measures to build capacity as well as capability. This means, hiring and training more medical device reviewers with specific knowledge about medical devices and the various conformity assessment procedures. 
 

The rules in its current form lack harmonisation with international norms of medical device regulation to provide the necessary fillip to the sector, which provides extraordinary growth opportunity for the country through the creation of high-paying jobs, economic value and better patient outcomes. 
 

The current rules address some but not all of the issues that were deliberated upon during several industry consultations while working on this draft. In addition to the device rules, we strongly recommend inclusion of the globally harmonised definition of medical devices into the current Drugs and Cosmetics Act, which is not part of the drug definition. The government should continue consultations with the industry and build on their experience to address reasonable concerns of the med-tech sector while ensuring that India maintains an environment that is welcoming of investment and innovation.  (The writer is vice-president, global strategy and analysis, Advanced Medical Technology Association (AdvaMed) that represents companies producing medical devices, diagnostic products and health information systems)