Maharashtra Food and Drug Administration (FDA) Commissioner Dr Harshadeep Kamble has written letters to the parliamentarians recently following a probe on the overpricing of stents conducted over a period of six months. The letters are aimed at addressing the menace of overpricing compounded further with the growing nexus of distributors and hospitals. "State FDA Minister Girish Bapat is also taking up the issue with the Union health ministry," Dr Kamble informed while discussing about an FDA inquiry into the rampant malpractice.

Through the inquiry, it revealed that cardiac stents were exorbitantly priced across seven hospitals from Mumbai, Pune and Nashik involving five such distributors. Dr Kamble while speaking to Pharmabiz on the matter has stressed on greater transparency and accountability in matters concerning patient care.

The maximum retail price (MRP) of the imported stents is being usually jacked up by 300 per cent to 700 per cent of the actual cost of import. This is an exploitative practice and fails to address the concept of patient care, says Dr Kamble.

Inquiry by the Maharashtra FDA revealed that patients were being forced to pay double or even triple the price for cardiac stents at hospitals. As most of these are not available in the open market, patients can't check prices and are held hostage by the hospitals, which force them to buy at the price they quote. However, experts opine that having an MRP has not prevented profiteering in medicines, with the MRP being fixed high enough to accommodate commissions since there is no limit on what the MRP can be.

Medical devices including cardiac stents and drug eluting stents (DES) are notified as drugs under the Drugs and Cosmetics Act, 1940 but is not included under the Drug Price Control Order (DPCO-2013). Therefore, the prices of medical devices cannot be monitored and controlled as of today.

The FDA has therefore urged NPPA to bring coronary stents under the ambit of National List of Essential Medicines to control its prices.

The recommendation comes in the wake of studies conducted by the FDA which has revealed that manufacturers in connivance with importers, distributors and hospitals are fixing the MRP of cardiac stents arbitrarily which is then passed on to the patients. It was observed from the studies that the MRP of the imported drug eluting stents is exorbitantly high and patients have no option to bargain.

The MRP of a drug eluting stent is fixed by the importing company. As the manufacturers of these devices are located overseas, it is difficult to study the manufacturing cost and export prices of these devices. Besides this, the startling fact is that the cost of DES is immediately recovered from the patients but payments to the distributors are made after a period of 60 to 120 days. The payments of applicable taxes of the concerned sale transactions, to the state government are made only within 51 days by the distributors.

Dr Kamble says the price of stents could be drastically brought down if NPPA intervenes. Cardiac stents have been categorised as drugs under the Drugs and Cosmetics Act, 1940, and therefore NPPA could issue directions to control its prices.

"Since cardiac stents are considered as life saving  products, a fixed profit margin on cardiac stents also need to be stipulated for importers, distributors and hospitals to make it affordable to the patients," recommended Dr Kamble to NPPA.

A senior FDA official explained, "Overpricing of stents can be prevented if the drug pricing regulator draws out a policy to fix the prices so that any violation in terms of evading the law related to ceiling price of stents can be treated as an 'offence'."