The Downside of Indias Protectionist Policy: Dr. B. L. Agarwal – ETHealthworld.com

by Dr. B. L. Agarwal Cardiologist at the Jaypee Hospital in Noida

The ambitious Make in India" initiative, the governments vehicle to boost local manufacturing, has encouraged locally made stents and led to disruption in the market dynamics. Pricing pressure from price controls, forced the global players to halt entry of premium products whereas Indian players utilized the opportunity to increase their market aggression. Two years down the line, has the protectionist policy distanced high quality products from Indian consumers and led to a compromise on patient safety and sidelined innovation?

Recently, Union Minister Mansukh L Mandaviya told the Parliament about price ceiling for cardiac stents, drug-eluting stents, condoms and intrauterine. He added that price capping on stents resulted in price reduction of up to 85% and 69% on knee implants. The move has been hailed to make stents more affordable, strengthen the domestic medical devices manufacturing sector and enable local manufacturers to compete with their global counterparts in a level playing field. While the intent behind capping prices is to make healthcare affordable and accessible to the patient community, hasty decisions do not always make for robust policies. As a cardiologist who has experience in treating several patients with varying symptoms and different needs, I strongly believe that economics should not be given preference over patient health.

Lets understand the downside of the recent directive with the help of similar unsuccessful policies in the past.

Two years ago, the National Pharmaceutical Pricing Authority had capped prices of drug-eluting stents to Rs. 27,890. Aimed to increase the feasibility of angioplasty for millions of patients, the move did not turn out to be successful. Industry reports suggested otherwise. An independent IQVIA study found that despite caps on prices of cardiac stents, amongst Government hospitals surveyed, ~80% hospitals cited no significant increase in the number of angioplasty procedures performed, and even in the remaining 20%, the increase was marginal (2-5% only).

No doubt, the caps on the prices of essential life-saving medical equipment brought both domestic as well global manufacturers at a level playing field, but clearly the aim to make medical technology more accessible did not meet expectations. The very thinking that affordability would mean accessibility was skewed because there are several other factors at play like availability, technological understanding and even procurement protocols. The governments intent to move towards trade margin rationalization may be considered a silver lining.

Are We Compromising on Quality?

The Government has recently directed public hospitals to not keep US and European regulatory certification as a procurement criterion for stents, hence, tacitly saving Indian manufacturers from the mandatory global safety compliance. This has just added to concerns whether Indian public hospitals have become a dumping ground for locally made stents. Meanwhile, the global devices come to India only after safety requirement clearances enlisted by organizations such as the US FDA. So, where on one hand, global stents undergo clinical trials on a much larger patient population, Indian manufacturers, on the other hand, do not have to extensively invest in large-scale patient studies. What does this mean to patients and the medical industry? While the move aims to boost local manufacturing of equipment like heart stents, it looks like we are compromising on quality in the name of accessibility.

The Dire Need to Focus on Quality

Lets understand why affordability alone cannot solve Indias rising heart disease burden. Coronary artery disease, one of the kinds of fatal heart diseases, causes the arteries to clog and affects an astounding 272 people per 100,000 population in India, according to study titled World Heart Day: May the force be with your HEART published in PubMed Central (PMC) managed by NLMs National Center for Biotechnology Information (NCBI).

Increase in the incidence rates can be attributed to change in dietary habits, physical inactivity and increased prevalence of associated comorbidities such as diabetes and hypertension. Sharing the maximum global disease burden, Indias patients require state-of-the heart medical care to even come close to managing the rapidly increasing incidence rates.

In my years of experience, one of the most important factors deciding the clinical route to treat heart diseases has been the varying symptoms of each patient. No two patients can be classified under the same prognosis strategy. For example, the cardiac stent used in a normal angioplasty may not be the same for a patient who is diabetic.

As a cardiologist, I have to assess a patients medical condition and suggest an appropriate device to be implanted. But, if the prices are capped, the choice to suggest a more therapeutically advanced cardiac stent is restricted. And, even a patients freedom to undergo a safe surgery and choose a trusted stent also suffers a blow.

What we must understand is that different patients have different needs. A one-size-fits-all principle will not move the needle in the favour of patient safety. While we must support the domestic industry for its aspirations to compete with the global competitors, I believe the road ahead is a long one. The local cardiac stents have to fill the gaps left open in the hasty ride to compete with trusted names in the industry.

Consider this. The countrys first locally-made bioresorbable cardiac scaffold has been inviting enormous media attention. All set for its launch, the device has been tested in a study on 108 patients only and is being touted as equivalent to gold standard Xience. In a country where heart diseases kills in the millions, the sample size does not make the cut to be credible for safety, efficacy, and quality.

The Way Ahead

A critical medical device such as a cardiac stent must be chosen on the science, research, and technology invested in manufacturing it. An imperative in-patient safety, multiple clinical trials and global safety norms have to be the prerequisite in favouring a stent, not the geography.

While the move may enable local manufacturers to capitalize on the market, but at what cost? The safety of patients is at stake. Can we forget that our medical devices market relies heavily on imports? For us, patient safety has to be inviolable.

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The Downside of Indias Protectionist Policy: Dr. B. L. Agarwal - ETHealthworld.com