Post price cap, Centre to take steps to ease stent shortage

The Department of Pharmaceuticals has taken a serious view on artificial shortages of coronary stents being created.

In letters issued to the Ministry of Health and Family Welfare, Drugs Controller General of India and the National Pharmaceutical Pricing Authority (NPPA), the Pharma Department has asked the concerned agencies to ensure adequate supply of the life-saving devices.

Stents are small wire-mesh tubes that are used to unblock arteries and allow easy flow of blood to prevent heart attacks.

Earlier this week NPPA announced revised capped prices of stents. Given the importance of stents in saving lives, the device was brought under the National List of Essential Medicines (NLEM) in July 2016. It was subsequently added to the Schedule I of the Drug Prices Control Order (DPCO), 2013, in December.

The new capped prices have brought down prices of stents manifold, by as much as 85 per cent in some cases. Now, all manufacturers are expected to keep the prices of drug eluting stents below ₹29,600 and that of bare metal stents under ₹7,260.

However, following the change in prices, the government had received reports of artificially-created shortages of stents across the country.

It is estimated that nearly 3.2 crore people are afflicted with Coronary Atherosclerotic Heart Disease (CAD) every year in India and nearly 16 lakh people die of the disease. Of these patients, at least two per cent or 6.4 lakh heart patients need stents every year.

Meanwhile, the NPPA has also asked all manufacturers to submit price data of stents through the Integrated Pharmaceutical Database Management System as well as to all State Drug Controllers and distributors, dealers or retailers by March 1.

“Necessary action will be initiated as per the provisions of DPCO 2013 read with Essential Commodities Act, 1955, against the company if the requisite information is not submitted within the prescribed date,” the NPPA memorandum issued on Friday reads.

The industry has expressed disappointment with the decision to cap prices of stents and especially with it taking immediate effect.

“The industry was expecting a reasonable price along with rational differentiation in drug eluting stents, to recognize innovation,” said Himanshu Baid, Chairman, Confederation of Indian Industry’s Medical Technology Division.

The industry body added that recalling and relabeling stents posed several logistical challenges, besides “health risks” of effecting sterility of the products in the process of relabeling.

“For inventory of stents already sold, companies would have realised the sales on their books, but the stents may be in distributor or hospital inventory, yet to be used. Industry is confused as to how the sales of these stents to patients would be handled,” Baid said in a statement.

The new price, however, wil take effect for all stents, even those previously sold to hospitals and distributors.

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