Rajeev Nath, Managing Director, Hindustan Syringes & Medical Device Ltd and forum coordinator, The Association of Indian Medical Device Industry (AiMeD), while speaking to Health Pioneer, rues that the domestic medical devices sector is being given step-motherly treatment and suggests ways to boost the segment which played a pivotal role during Covid pandemic

India imported medical devices worth Rs 63,200 crore in 2021-22, up 41 per cent from Rs 44,708 crore in 2020-21 and this is not a good sign for Indian manufacturers. Even Budget 2023 didn’t provide much relief to the sector. There seems to be a stalemate in this regard. Whereas, globally, other countries are doing better with their own consortiums/ groups in the MedTech sector.

With the majority of the devices being imported, the way out for Indian manufacturers is very limited. We are seeking policy clarity because if the government really has no wish to provide tariff protection or to make it profitable for manufacturing of medical devices in the country then the people who are importing will keep on importing then there is no point in trying to invest money in putting up factories.

What we noticed is that post Covid the imports have come down for the covid critical medical devices as demand fell , not for all but quite a few of them, at the same time there's been a steep increase of the import of non-covid medical devices.

There have been many cases where the imports have gone up from 25% to 152% which is extremely alarming and the government needs to seriously consider tariff and non-tariff barriers to address this particular issue as a tit for tat policy otherwise India will always be 80% import dependent. We've seen the gains done in the toy industry using non-tariff barriers, we've seen the gains done in the mobile phone industry and consumer electronics for using tariff barriers, a mix of both I would say are required in case of medical devices.

The Indian medical devices factories are audited  by the Indian Certification bodies and then inspected by SLA but there is no Indian Regulators or Certification Body doing inspection or audit of the companies in China or the other countries and it’s easier and faster to get an import License than a manufacturing License from CDSCO. That is not a level playing field, the domestic manufacturers do need a level playing field.

However, if the government starts implementing what parliament health committee has suggested and that’s what AiMeD has also been recommending then there is definitely hope that what is 80% import dependency can convert into 60% market share for Indian manufacturers with even 70% of the recommendations of Parliament being implemented. The most important strategic recommendations made by the Parliamentary committee on Health are:

• To have a separate law for Medical Devices separate from Drugs Act
• Have a separate medical devices department considering these are engineering products not chemicals like in the case of pharmaceuticals
• The third area is the issue of review of tariff structure
• The area of review of the trade margins and the price control mechanisms to protect consumers and to support ethical marketing
• Another area which the parliament has recommended is the case of having a research linked incentive scheme and they've also recommended widening the scope of PLI scheme to cover more medical devices, lower investments as well as to cover critical components and raw materials which are key to manufacturing certain medical devices in the country

The Medical Device policy by itself has been on the anvil under discussion since 2014, multiple drafts have been made but the strong imports lobby manages to get the announcement delayed.

In the area of public procurement also it's important that the government needs to incentivize procurement by quality-based selection criteria rather than just the lowest price criteria, so to have an objective quality certification like ICMED ( Indian Certification for Medical Devices by QCI) as a criteria or  Design India certification from DPITT as a criteria to promote R&D and indigenisation.

We are unaware of the reasons why the government is shying away from providing the much-needed nominal custom duty protection to support investments in the medical devices sector to address the 80% import dependency. While it is understandable that the government seeks to protect consumers and would like to ensure that they access medical devices at a low nominal cost then capping of MRP over the imports landed price is more impactful for consumers, also equally important is the issue of healthcare security of the country which was shown when Covid came and the government had to resort to lockdowns so that manufacturing of medical devices could be done to provide support to the healthcare infrastructure and the healthcare facilities in the country as supply chains internationally got disrupted.

We request kind consideration of the government for encouraging domestic manufacturing to be sustainable and as an attractive proposition in long term for becoming AtmaNirbhar to address national healthcare security needs exposed at the onset of Covid and for Ease of Doing business.