The baton has been handed to the National Pharmaceutical Pricing Authority to fix the price on stents.

In July this year, the Health Ministry had made it clear that stents would come under price control as it was brought into the National List of Essential Medicines (2015). All products on this list have their prices controlled by the NPPA. The Department of Pharmaceuticals' notification on Wednesday took this discussion to the next level by giving the NPPA the mandate to fix stent prices as well. The NPPA now has to lay out the criteria to fix stent prices, expected in the next two months.

The directive has health advocacy groups celebrating the move that they believe is in the patient’s interest as it would help bring down stent prices. But the medical device industry is divided with domestic players welcoming price control, even as foreign companies remain unhappy with a move they say does not recognise innovation even within a category.

The real worry in this high-decibel discussion on stent pricing is whether the safety aspect is being lost in the din.

Safety first

Stents are thin, flexible wire meshs that are inserted into blood vessels to remove blockages largely in the heart. Its price varies depending on whether it is a bare metal stent (about Rs 25,000), a drug-eluting one (between Rs 80,000 to a lakh-plus) or an absorbable stent (shy of Rs 2 lakh).

The mistrust that many patients have towards this device stems from the fact that the procedure is not transparent in terms of whether a patient does indeed require a stent, what type of stent is necessary for the patient’s condition (a bare metal one or a drug-coated one), and is the patient paying a realistic or inflated price on the stent?

The Government also needs to review safety studies. An institution like the ICMR (Indian Council for Medical Research) could be called in to look at comparative safety data from the stent-makers, Indian and foreign, to study the occurrence of restenosis (where the artery becomes narrow again, despite a stent being inserted). Doctors point out that a high degree of restenosis results in increased trauma for the patient, who would have to go in for another procedure.

Layered discussion

Pateint families also complain of having to pay for more than the stent used in the body, a practice that contributes to inflated pricing. Stent makers explain this saying that more than one stent is tried out before the right one is deployed.

Cardiologists that BusinessLine spoke to point out that many of these unhealthy market practices can be curbed if the Government brings in standard guidelines under which a stent can be used in a patient. Patients will then feel satisfied that a stent is being used after adequate scientific deliberation and not because of a possible collusion between doctors, hospitals and the drug or medical device company.

In fact, industry experts constantly point out that doctors and hospitals also need to be brought under this regulatory watch. Patient families have in the past complained of getting the stent at a reduced price from a registered distributor, only to be denied by the hospital that insists they buy it from them at a higher cost.

If the Government intends to truly benefit the patient, it needs to take into account the many layers of this discussion, even as the NPPA sets about its task of setting criteria for stent price control.