Pharma authority probes spike in price of cardiac stents

Alarmed by unusual spikes in prices of medical devices such as cardiac stents, drug-eluting stents and orthopaedic implants, the National Pharmaceutical Pricing Authority (NPPA) has sought pricing data from manufacturers, importers and distributors of these devices.

The drug regulator has shot letters to companies including Abbott Healthcare, Boston Scientific India, Zimmer India, Edwards Life Sciences, Johnson & Johnson, India Medtronic Corporate, B Braun Medical India, Roche Products India, Harsoria Healthcare and 3M India seeking specifications of devices and price revisions in the last two years. The replies are to be furnished in three days.

In the letter, the regulator has reminded the companies that since such medical devices are under non-scheduled drug category, their prices can be increased only up to 10% of MRP annually.

Those who have charged beyond this have to reduce it to the level of 10% of MRP for the next 12 months.

The move comes in the wake of is in light of the reports that prices of medical devices regulated as "drugs" under Drug & Cosmetics Act & Rules, particularly cardiac stents, drug-eluting stents and orthopedic implants, are sold at exorbitant price fetching a huge profit or trade margin. Some reports mentioned that prices of such medical devices notified as "drugs" have increased significantly in the recent past.

Due to a lack of price control or a fair price mechanism, most medical device companies overcharge patients, who are sometimes forced to pay over Rs 1.25 lakh to Rs 1.5 lakh for cardiac drug-eluting stents (DES) whereas the imported price is at least 30% less, experts said. Some stents cost upward of Rs 90,000-1,00,000 whereas, the government's bill of entry at a price at which they are imported is around Rs 40,000-50,000. Besides, these devices also get custom duty concessions.

Shivkumar Utture, senior surgeon and office bearer, Indian Medical Association, Maharashtra, said "Majority of these are imported, especially DES. So as far as these are concerned, no MRP is printed on the device. The difference in the import price and what is charged to the patient is huge. If there is a price control on these devices like essential drugs, it will be advantageous for patients."

He said the prices should be printed on the devices in rupees as it will empower and help the patients.

At present, the actual manufacturer does not print the price on the device, but the companies that import and sell them in India put stickers.

"We should get rid of this putting stickers on the devices as the price of same device varies with different companies who import it," said Utture.

The NPPA has, therefore, sought information or documents in order to examine price violation in respect of notified medical device manufactured or imported or marketed by a company.

"Further, Para 25 of DPCO, 2013 provides that every manufacturer/importer shall issue a price list and supplementary price list in Form V to the dealer, State Drugs Controller and the Government from time to time. As provided in Para 26 of the said order, no person is authorised to sell any formulation including medical devices regulated as drugs to any consumer at a price exceeding the price specified in the current price list or price indicated on the label of the container or pack thereof, whichever is less."

The information/document sought by NPPA includes product specification with brief description/ literature of different types of notified medical devices manufactured/ imported by the company, a copy of current price list in Form-V under provision of DPCO, 2013 and details of price revision carried out during the last two years for each type of medical device.

"The above information/ document may be furnished urgently, not later than three days from the date of issue of this letter as it is required in connection with issues raised during the ongoing parliament session," the notice said.

"Para 20 of the Drug Price Control Order (DPCO), 2013, provides for monitoring the prices of non-scheduled formulations and to ensure that no manufacturer/ importer/ distributor is allowed to increase the MRP of a non-scheduled drug more than 10% of MRP during preceding 12 months and where the increase is beyond 10%, it shall reduce the same to the level of 10% of maximum retail price for next 12 months," the NPPA said in a recent notification.

It has said manufacturers/ importer/ distributor shall be liable to deposit the overcharged amount along with interest thereon, from the date of increase in price in addition to the penalty.