Turning The Spotlight On Quality Of Medical Devices

Having access to high quality, affordable medical care is still a dream for India's 1.4 billion people. A crumbling public health infrastructure, acute shortage of doctors, rural-urban disparity in access to healthcare, and absence of health financing mechanisms are all factors that contribute to the poor health status of millions. The lack of public spending in this sector- due to the miniscule allocation of 1.12 percent GDP for health - makes the provision of universal healthcare even more daunting. Today, the country is faced with the challenge of tackling non-communicable diseases (NCDs) such as heart disease, cancers and diabetes, along with infectious communicable diseases such as TB and diarrhea. Averting the crisis that looms on the horizon is the need of the hour.

Medical devices and technologies are critical for the management of NCDs. Devices such as pacemakers and stents have brought down the mortality associated with heart disease dramatically. An estimated 6-lakh patients undergo angioplasty in India every year, with more than half needing two or more stents. This is just a fraction of the number that needs angioplasty and other crucial cardiac treatments: heart disease is on the rise, and lack of access to life-saving critical devices and medical expertise will have a devastating toll.

India is at par with the rest of the developed world when it comes to medical treatments. We have both the expertise and advanced technologies to tackle complicated health conditions. Global devices of the highest quality are in the market. In fact, stent prices have dropped despite a 400 per cent rise in inflation. During 2011-14, stent prices fell steeply as compared to drug and procedure prices. A greater variety of stents are available too- basic metal, drug eluting and bio-absorbable- that can be bought for anything from Rs. 10,000 to Rs 2 lakh. Competition in the arena of medical devices in cardiology is fierce, up gradation is the norm, and only the best options in terms of quality and price have survived. Both doctors and patients have benefitted greatly.

But a new move to put a price cap on some medical devices threatens to reverse this progress. Capping the price of a device is counter-productive, since it will halt research and innovation. Manufacturing high-quality medical devices requires a large investment of capital, R&D, technology transfer and skill development, a long drawn out and costly process. Price control will create hitches and prolong this process further. In addition, it will pose a barrier to the entry of new, advanced devices and technologies from other markets, and India's reputation as a hub of world-class medical destination, will suffer a setback.

Unlike medicines, critical medical devices are not sold over the counter or purchased directly by the public. So fixing a lower price on a device like a stent won't benefit a patient, because the cost of the stent is a mere fraction of the total cost of the procedure required for its implantation, an angioplasty. The fact is that despite the dropping prices of stents, the cost of an angioplasty continues to rise. Patients don't benefit ultimately. In fact, lowering prices raises the risk of use of low quality products. These prolong recovery time for patients, often leading to repeat procedures. In the absence of a mechanism to ensure that the benefit of a price cap is passed onto patients, it's best to focus on quality rather than cost.

Price regulation also doesn't serve any useful purpose also because it doesn't apply to the latest technology. So while it may make obsolete stents more easily available to some, newer and more advanced devices that serve a patient much better, will be harder to attain. That is why the attention needs to be turned away from capping prices of medical devices, and directed at ensuring that every cardiac patient has access to life saving technology and treatment.