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(Photo: Mint )

Opinion | Why doctors worry about locally made medical devices

The big question is: What is the quality of care we are offering our patients?

When Prime Minister Narendra Modi’s “Make in India" initiative, part of his economic vision, was extended to medical devices, it was hailed as a move to strengthen the domestic medical devices manufacturing sector. What followed was a host of manufacturers claiming to be on a par with global brands under the Make in India banner. For instance, many Indian brands launched cardiac stents that were compared to some of the gold-standard ones in the global market. While I support the domestic players entering the market, for us, as doctors, geography does not decide the safety and reliability of a heart stent. Robust clinical trials do.

Let me explain this with one of my recent cases. An elderly diabetic woman with a single kidney was planning knee replacement surgery for both knees. She also had repeated and painful episodes of angina on minimal movement. We did a pre-operative angiogram that showed a critical blockage with a lot of calcification in a major artery. We decided to postpone the elective major surgery, as, after angioplasty, we would have to put her on double blood thinner medications for a year. However, as she was suffering from acute pain in the knees, she insisted on an early surgery.

I discussed the options with her family and we decided to go ahead with the angioplasty. Now, in this situation, we had to choose a stent that is not only strong enough to be implanted in a calcified artery at high pressures, but has enough data in support of a shorter duration of double blood thinners, as was needed. We opted for an international brand that was approved by the US Food and Drug Association (FDA).

The point I am trying to make here is that different patients have different needs. We cannot choose a domestic stent only because of the geography of its manufacture. The big question is: What is the quality of care we are offering our patients?

In the recent past, we have seen some domestic brands claiming to be on par with their global counterparts. These promise to be revolutionary and, thus, the claims make for perfect headlines. The facts, however, are different.

Let’s understand this with the example of another brand that claims to be the country’s first locally-made bioresorbable cardiac scaffold, which is reportedly in a dialogue with the government for an exemption from price caps. Not in the market currently, this stent seems to be all set for launch. The device has shown superior outcomes in clinical trials in a study on 108 patients. In a country where heart disease is the leading cause of death, killing 1.7 million Indians in 2016, is this sample size enough to approve a product that will eventually cater to millions? With 150 research and development (R&D) engineers and a sample of 108, is its research backed by large clinical data with long-term follow-ups? If it were to get the government’s nod on the exemption, this would seem like a case of preferential treatment.

This may sound like a favourable time for domestic manufacturers to prove their worth by capitalizing on opportunities and launching newer products, but at what cost? We cannot lose lives in the process. The safety of patients is at risk.

It is important to give people the real picture before making these claims. The need of the hour is to use the best available external clinical evidence from systematic research before such decisions are made. Until domestic players meet global standards in all aspects, their entry into the market is likely to put patients at risk.

It is laudable that the government has taken steps to strengthen the regulatory and policy framework, and encourage local R&D and skill development. However, what India needs most of all are medical companies with high-quality infrastructure and a strong product pipeline of research-based products.

A bioresorbable stent needs to follow thousands of patients for multiple years, before it can be stated that the device is better than existing technologies or stents. In the absence of robust clinical data, tall claims by brands fall flat. Blatantly claiming that a stent is better than its foreign counterpart will only hurt the healthcare system in India.

When we choose a stent for a patient, it depends on the science, research, and technology invested in manufacturing it. The first significant step in this direction is clinical data. Clinical trials must be conducted on a significant number of patients—an imperative to establishing the success rate of a stent. Trials need to be both extensive and exhaustive to achieve the required credibility. Further, within the category of stents, with no significant difference in cost, there is no strong reason for not choosing FDA-approved brands.

Today, we are a country with an ageing population, rising income levels and an increased prevalence of lifestyle-related diseases. With changing times, we will only require better and better healthcare facilities, as also a wide range of sophisticated devices and equipment.

Let’s not forget that our medical devices market relies heavily on imports, and there is a reason why this is so. As a doctor, for me, patient safety is first and foremost. If I know that a stent has not been tested extensively, I would not risk my patient’s life by using it, and the geography of its manufacture would not matter.

Dr Bharat Rawat is associate director, cardiology, Medanta Super Speciality Hospital, Indore

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