‘Govt must build capacity to effectively implement the Rules’
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 longterm 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.
ABBY PRATT