14 more med devices may see price regulation soon


Data Being Collected On War Footing
After cardiac stents, around 14 more medical devices that are rampantly sold at inflated rates in hospitals, could see a price regulation in the coming months.The list includes orthopedic implants, intraocular lenses and artificial heart valves to consumables such as syringes, needles and catheters.

The National Pharmaceutical Pricing Authority (NPPA) has begun scrutiny of such devices, even asking makers to log in every detail about their manufacture and cost.NPPA chairman Bhupendra Singh told TOI, “We are collecting data on these devices on a war-footing. It will give us a fair idea about the volume of consumption, cost of manufacturing and price at which they are supplied to a patient.Exorbitant pricing in the health system will be dealt with strongly .“

In terms of steep retail markups, orthopedic implants probably come closest to cardiac stents. The imported hip and knee implants easily see profit margins in the range of 500-1,000%, industry insiders said. Indian implants too are sold at margins of 200500%, though surgeons often prefer imported types. The cost of intraocular lenses also varies widely depending on the hospital and the operating surgeon. Consumables, on the other hand, are not just sold at arbitrary MRPs, but also billed in bulk to make money .

Currently , 14 devices are classified as `drugs' under Section 3 of the Drugs and Cosmetics Act, but none feature in the list of essential medicines.Cardiac stents therefore had to be included in the National List of Essential Medicines (NELM) before their prices could be capped. If a drug is not in the NELM, the NPPA can merely ensure that their MRP is not increased by more than 10% annually .

“It is therefore important for us to see the extent of profiteering in other devices and seek the union health ministry's help to add them to the list of essential medicines before their prices can be capped. In our online platform IPDMS (Integrated Pharmaceutical Database Management System), a tab has been created for information on medical devices and not just stents,“ said Singh.

Singh said the NPPA is undeterred by the medical industry's hue and cry that innovation and research will be throttled by price regulation.“We did an elaborate study before cracking the whip on stents. When an original ma nufacturer sells a product, the cost of innovation, packaging and everything else is built into it. The importer spends nothing on R&D or packaging.Their money is only spent on marketing, paying commissions and distorting the system. With price-capping, affordability will increase,“ Singh said.

A senior cardiologist recently alleged that the NPPA's move was meant to facilitate two Indian stent-makers.Singh said, “Indian stent players were making equal profits as their counterparts who were importing them. Our price calculation was objective and based on research.“

Heart stent price - Stent in heart life expectancy

 Avg stent costs little over Rs 16,000 on import

Angioplasties Resume With Old Models
Manufacturers and distributors have withdrawn the latest generation of cardiac stents from most city hospitals in the name of re-labelling, forcing patients to settle for dated versions. In centres where the stents have not been physically removed, there are verbal orders not to offer the “highend“ varieties to patients.

This is despite the National Pharmaceutical Pricing Authority (NPPA) issuing clear orders that manufacturers, importers and retailers are required to implement the price cap without trying to create any artificial shortage. NPPA had capp ed prices of bare metal stents at Rs 7,260 and that of drug-eluting and bioresorbable stents at Rs 29,600 on Monday . Ithas now written to all chief secretaries to ensure compliance. Cardiologists told TOI on Thursday that the bioresorbable vascular scaffold (BVS)--the most recent version that dissolves into the body after healing the diseased artery--is now practically unavailable after prices were capped. “The companies have taken it away for pasting new rates, our fear is they will not return any time soon,“ said a senior cardiologist from Bombay Hospital, Marine Lines. The latest version of the drug eluting stents (DES) has also been whisked away from centres. Both categories of stents used to be sold for more than Rs 1.5 lakh to Rs 2 lakh before their price was fixed at Rs 29,600.

The National Pharmaceutical Pricing Authority said it is “puzzling“ that none of the 52 imported brands of DES are superior to each other, as per global clinical norms, to justify their wide price variation. It added that the average landed cost of a DES imported by nine companies was only Rs 16,918.

Cardiac surgeon Dr Pavan Kumar said many centres had to postpone angioplasties on Wednesday due to confusion at the stentmakers' and suppliers' end. On average, over 12,000 angioplasties are carried out in Mumbai Metropolitan Region every year.

On Thursday , heart procedures resumed in most hospitals albeit with the older version of stents that had disappeared from catheterisation labs for a while now. “The technology available to patients now is the first and second generation of DES that arrived more than two years ago. It is not that they are ineffective but the newer generation offered certain ease in placing them,“ said interventional cardiologist Dr Dev Pahlanji, who consults at Breach Candy Hospital.

Pahlanji explained the first generation DES were polymerbased, which were found to be slightly toxic. The next generation took care of toxicity repla cing polymer with cobalt and chromium as well as altering the type of catheter required to deliver the device in the artery.“But it can be determined only over time if the treatment outcomes will differ,“ he said. Cardiologist Dr Anand Rao said newer generations have some technical superiority in terms of deployment, make and compatibility with body tissues.“But there is no solid data to compare outcomes between different generations,“ he said.

A spokesperson from Medtronic, a leading stent player said, “We have not taken any decision on withdrawal of any product. As per the requirement, we have initiated relabeling of all products.“



If the stents do not come back to the hospitals in time after the so-called relabelling, the health ministry must step in and ensure that any attempt to create an artificial shortage of these medical devices is thwarted. Any shortage will negatively affect healthcare and make patients suffer for no fault of theirs