New Delhi, May 4

India’s National Medical Devices Policy 2023, notified by the Centre earlier this week, has proposed the establishment and strengthening of large parks and medium sized medical device clusters, with these being located close to economic zones.

The policy envisages logistics connectivity for better convergence and backward integration.

The policy documents say, testing and certification facilities for medical devices are available “to some extent” across institutions like National Institutes of Pharmaceutical Education and Research (NIPERs), Department of Biotechnology centres, at the Indian Council of Medical Research and so on. While existing institutions will be strengthened, the policy has also called for establishment of “required number of testing laboratories”.

Such testing facilities will “ensure quality, safety and efficacy of the medical devices marketed in the country”, it said. In order to boost domestic manufacturing, it is also required that phase-wise manufacturing of critical components “to ensure continuous access and availability of medical devices without supply chain disruptions” is required.

“There are some micro-details that need clarity. We have been told they are work-in-process. So we are meeting the government soon,” Rajiv Nath, Forum Coordinator of Association of Indian Medical Device India, said.

According to him, there is also a need to have separate laws governing medical device segment, rathern than tweaking existing provisions of different laws. “Decriminalisation of certain provoisions in laws gives assurance to foreign investors and entreprenuers about the regulatory environment. These aid investment decisions,” he said.

Regulatory issues

The policy document identifies the need “to bring further regulatory streamlining” so that there is a balance between patient safety and product innovation. Reduction of compliance burden and enhancing ease of doing research and business are two points that the policy intends to take -up too.

Options in this regard include a single window clearance system’ for licensing of medical devices in alignment with National Single Window System (NSWS) to avoid duplication.

India’s standard setting-bodies such as Bureau of Indian Standards (BIS) and sectoral standards development organizations “shall gradually expand the standards” - to include processes, products, wireless technologies and performances – so that a particular level of standardization and quality is obtained. These standards will also enable indigenous industry to gain global competitiveness.

“A framework for a coherent pricing regulation will be developed,” it said adding that due alignment of existing provisions of Drugs (Prices Control) Order (DPCO), 2013 through National Pharmaceutical Pricing Authority (NPPA) will be carried out and this will “make available quality and effective medical devices” at affordable prices.

Guidelines and framework for researchers, innovators & entrepreneurs will be designed too, with there being a push towards market-ready products “from the design phase” and for testing purposes.

“An institutional arrangement for aligning National Medical Commission (NMC) Regulations, Code of ethics followed by Industry associations is envisaged to ensure ethical marketing of medical devices.,” it said.

According to Dr GSK Velu, MD, Trivitron Healthcare, India needs to have a separate department focussed on medical devices - that include its manufacture, sale, export and so on -within the Ministry rather than clubbing it under Pharmaceuticals.

“Pharma by itself is a huge segment. But having a dedicated department on medical devices, with the right personnel, would help get the segment more focus,” he said. Some nations in Europe, Singapore, Brazil, Japan, Korea and others already follow such a practice.

Monitoring and Evaluation

In order “to measure the impact” a quantitative output or outcome metrics will be developed in due consultation with NITI Aayog. And these will measure factors like affordability of devices, self-reliance in manufacturing, improvement of overall healthcare index and reduced disease burden, creation of high-value jobs in R&D and innovation in due consultation.

Economic indicators such as market size, exports and Foreign Direct Investments (FDIs) will be tracked by regular monitoring.