medical device rules
The Indian healthcare industry has been growing at double-digit rates and has evolved significantly in the last decade. However, a number of challenges need to be addressed in providing access to quality, affordable healthcare in the country. The new medical device rules which came into force from January 2018 has finally given the medical devices and in-vitro diagnostic devices(IVD) industry a distinctive regulatory identity. By delinking devices from drugs, the multitudes of devices used in the country today, from the humble to the complex have potential to come under the ambit of rules to ensure patient safety, quality and performance parameters of devices sold within the country.
While the present regulation is still an amendment to the Drugs and Cosmetics Act, 1940, the Parliamentary Standing Committee for Health and Family Welfare has actively sought comments and concerns to revive the bill for a stand-alone legislation for medical devices, which has been under discussion for a couple of years now. Widely anticipated to be tabled in the Parliament this year, the singular act of medical devices, if passed, will host India’s regulatory framework for the sector on par with mature global economies.
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With a phased approach in the works, the rules in the present form give scope for introducing new products as the implementation continues. In a few years, it is expected that the regulation will span the entire medtech devices and IVD manufactured in the country.The success of the legislation, however, hinges on addressing a few implementation bottlenecks, as voiced by the industry.
The obstacles to successful implementation of the regulation:
Creating The Right Ecosystem:
The primary concern in implementation is the establishment of an ecosystem for the notified bodies, which will shoulder the burden of evaluating regulatory compliance. The process so far is not going as speedily as expected.
The State Vs. The Center Debate:
Like in the sister industry of pharmaceuticals, the efficacy of any legislation laid down by the central government depends on the involvement and co-operation of the state governments.
The present legislation is based on the licensing model with a one-time audit and no in-built surveillance mechanism to measure continued compliance. Sampling is also expected to be conducted by the central licensing authority (The Central Drugs Standard Control Organization) or the respective state licensing authority (the state Food and Drug Administrations) themselves.
There are still on-going debates among stakeholders if this is the right approach for implementing the legislation, as this is unlike any other regulatory model in the world. The CE mark, for instance, is earned after a rigorous surveillance every year, along with surprise inspections and audits by accredited third-party organizations to ensure non-partisanship.
- Infrastructure Issues:
The “Make in India” program has spurred the founding of medtech parks around the country, with the promise of the government support in the form of land allocation and subsidies to encourage the growth of the domestic medtech industry. However, the relatively slow pace of infrastructure development of these parks is delaying the domestic industry from setting shop. In the face of the anticipated withdrawal of large players as an effect of price control, this may have larger implication on the availability of devices in the country.
- Industry Awareness:
While dominated by large players and multinational corporations, the domestic medtech landscape also comprises small and medium players and startups vying for bigger market shares. While these players have a birds-eye perspective of the regulation and the compliance requirements, there is a general lack of in-depth understanding of the rules.
This creates a problem – the scope of the regulation is automatically limited to the 22 device types that were already under mandatory control. To advance further to higher levels of manufacturing, domestic players must comprehend the scope of requirements in Schedule 4 and 5, which pertain to the manufacturing of medium to high-risk devices.
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