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Maharashtra FDA detects 5 distributors involved in overpricing of cardiac stents
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Shardul Nautiyal, Mumbai
May 29 , 2015
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Maharashtra Food and Drug Administration (FDA) has detected five such
distributors involved in overpricing stents based on a probe conducted
over a period of six months. An inquiry into the rampant malpractice,
according to the FDA Commissioner Dr Harshadeep Kamble has further
revealed that cardiac stents were exorbitantly priced across seven
hospitals from Mumbai, Pune and Nashik.
The 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
maximum retail price (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'."
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