The National Pharmaceutical Pricing Authority (NPPA) of India has fixed the ceiling price of drug eluting stents (DES) and bioresorbable stents at Rs29,600 (USD442) and bare metal stents at Rs7,260 - an 85% cut. The prices were effective as on 14 February.

This comes after a three-year long battle against the Indian government by Birender Sangwan, a lawyer in Rohini, New Delhi, who witnessed a friend's brother being overcharged for a stent - Rs 126,000 - by a Metro Hospital, a private hospital in Faridabad.

"The box that carried the stent had no maximum retail price on it. We checked with other doctors and they told us it was because stent prices weren't regulated by the government, so hospitals had a free hand in fixing rates," said 37-year-old Sangwan.

Demanding that stents be included in the NLEM

Sangwan filed a query under the Right to Information Act (RTI) after the episode in 2014. He found that the rates of stents varied between hospitals, so he filed a complaint with India's health ministry a month later. In November 2014, Sangwan filed another RTI to see if stents fell under the category of drugs or metal.

The government responded in December, stating that stents came under the Drug and Cosmetic Act but was not covered by the National List of Essential Medicines (NLEM) - this categorises medicines that must be made affordable for citizens.

30 million people suffer from cardiovascular problems and over two million die of heart attacks and strokes each year in India, making them essential - every year, over 200,000 heart surgeries take place. The government also published data last month, showing that hospitals in India could be selling stents at margins of up to 654%.

In February 2015, Sangwan filed a public interest litigation (PIL) at the Delhi High Court (HC) for coronary stents to be included in the NLEM.

Pushing for a price-cap for stents

After a lack of response for months, Sangwan filed a contempt notice at the HC in October 2015, forcing the Indian government to respond. His efforts were finally recognised in July 2016 when the government notified the addition of stents in the NLEM. But Sangwan was still irked by the exorbitant charges of stents.

He filed another PIL seeking a limit on the maximum retail price of stents in December 2016. The HC agreed and asked the government to fix the rates. With the NPPA’s new price cap, India's Rs3,300 crore (USD531 million) coronary stent industry may finally be stifled, after years of rampant profiteering.

"Our fight isn't against the stent makers," said Sangwan, "It is against the distributors and hospitals who have been extorting patients."

By the time a patient received a stent, the inflated cost was 1,000 to 2,000% of the original cost.

Price-cap opens Pandora's box on India's healthcare ecosystem

NPPA explained that the move was essential as it was found that huge unethical mark-ups were charged at each stage in the supply chain of coronary stents, resulting in a failed market system that has been driven by information asymmetry between patients and doctors.

But industry leaders argue that the singular focus on capping the price of stents, without attempting to correct the inefficiencies in the healthcare ecosystem will just have a short term effect.

Sangwan predicted this, saying that the industry will summon the government to court. "Now hospitals are increasing other costs such as doctor consultation, room rent etc. We suddenly have a bigger issue at hand and I am working towards tackling this problem," he said.

His next target is bringing down the prices of orthopaedic products and has begun filing some RTIs and complaints to the relevant ministries and departments.

International stent makers unlikely to ignore Indian market

International medical device manufacturers such as Abbott and Boston Scientific are expected to take a hit as well, as the pricing has potential to block innovations and limit accessibility to world-class medical care to more affluent or deserving patients.

Many critics also say that the decision does not take into account the evolution of coronary stents over the last four decades as a forecast for future trends. There is also fear that the decision will affect medical tourism in India, driving those away who want fourth or fifth generation stents.

But Indian stent-makers are rejecting the argument, insisting that their stents are just as good as those of multinational-stent makers who boast advancement due to better marketing and financial muscle. However, with 1.2 billion people in the South Asian nation, the international stent makers are unlikely to ignore the sizeable market. MIMS

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