Orthopedic implant makers, including Zimmer India, Johnson & Johnson, India Medtronic Corporate, Braun Medical India and others have been asked to produce a “slew of documents” by the Indian National Pharmaceutical Pricing Authority (NPPA).
According to a December 8, 2014 Pharmabiz.com posting by Ramesh Shankar, the request comes under the NPPA’s authority to monitor price movement of medical devices. The agency reportedly wants to examine the extent of price variations of devices in the Indian market.
“Exorbitant Prices – High Profit Margins”
Shankar wrote that the agency’s “knee-jerk action” comes after recent media reports that the prices of devices “regulated as drugs under the Drugs and Cosmetics Act and Rules, ” have been sold at “exorbitant prices with high profit or trade margins, particularly the prices of cardiac stents, drug eluting stents, orthopaedic implants, etc.” He also wrote that there have been reports that the prices of the devices have increased “significantly” in the recent past.
Overcharging Information Sought
“In this regard it has been decided to seek the following information/documents in order to examine price variation, if any, in respect of notified medical device manufactured/imported/marketed by the company”, the NPPA said. Shankar reports the documents include “product specification with brief description/literature for different types of notified medical devices manufactured/imported by the company; a copy of the 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.”
On September 15, 2014, The Times of India (TOI) ran a story titled, “Patients pay three times import price for stents”. The story said Indian patients pay more for some devices than Europeans because the country has no regulator “to ensure that medical device companies do not overcharge patients. The result is loot.”
India FDA Report
India’s Food and Drug Administration (FDA), according to the story, had submitted a report after investigating “overcharging” for various medical devices to the NPPA. The agency recommended that devices “be brought under price control.” The FDA’s report included pricing details devices such as “cochlear implant, bone cement and orthopaedic implants and pointed out that the price of most devices was hiked by over 100% at least.”
Orthopedic implants, among other devices, “are notified as drugs under the Drugs and Cosmetics Act, 1940 but not included under the Drug Price Control Order (DPCO). Hence, their prices are neither monitored nor controlled. The multinational companies that dominate the market import the devices and mark MRP at whatever level they think the market can bear in the absence of any regulation. These devices even get customs duty concessions, ” stated the TOI story.
At the time of the September 15 story, the NPPA had not replied to the Indian FDA a year after the report was submitted, nor had it taken any action on pricing. “When contacted, NPPA chairperson Injeti Srinivas told TOI that he was not aware of the FDA report as he had joined recently (in June this year) and that he would look into it.”
It now appears Mr. Srinivas has looked and asked for documents. Looks like device companies will have some explaining to do.
Each and every doctor in India who are performing angioplasty and using drug eluting stents are taking cash as bribe from the supplier to use their stents. There are USA based companies and Indian companies who manufacture and supply Drug Eluting Stents in India through distributors. Each Doctor decide which company’s stent he or she will use and it depends on who pays them maximum cash as bribe. Big private hospitals in big cities can charge high because they have patients who are financially strong. In big private hospitals, USA based companies stents are sold at Rs 90,000 to Rs 120,000 per stent and doctors get Rs 40,000 to Rs 50,000 from distributor. Cath lab technician gets Rs 2000 to Rs 4000 for using each stent. Distributor buys at Rs 25,000 to Rs 28,000. But they sell at Rs 90,000 to Rs 120,000 as they have to pay half of the price to doctors. Distributor can-not sell any stent without bribing doctors who are using stent.
In government hospitals since price is fixed by government at near Rs 25,000 per drug eluting stent the USA based companies are not ready to supply there, though they have some type of drug eluting stents which they are supplying to distributors at less than Rs 20,000. In government hospitals Indian companies are strong supplier. Different company sell to distributor at different price and it range from Rs 10,000 or Rs 12,000 or Rs 15,000 per drug eluting stent. In government hospitals distributor pays Rs 4,000 to Rs 7,000 to doctor and pays 1500 to Rs 2,000 to Cath lab technician to sale each stent.
In smaller cities and big towns, Indian manufacturer are selling Drug Eluting Stents at Rs 50,000 to Rs 75,000. Here the distributors are force to pay Rs 25,000 to Rs 35,000 to doctors and they pay Rs 2,000 to Rs 3000 to Cath Lab Technician for selling each drug eluting stent. There is no doctor in any private hospital or government hospital or army hospital or railway hospital who uses drug eluting stent without taking bribe. Doctors are the chronic terminal cancers of health care system of India.
Government knows everything but do not do anything. How long we can tolerate this. If government do not take steps public should do something.
In western countries doctor’s practising licence is cancelled.
Manufacturing cost for each drug eluting stent is less than Rs 2000 but patient pays more than Rs 100,000 for each stent used.
Patient and patients party are helpless murgas or bukras.
Any doctor who is doing angioplasty or cath lab technician you know is highly corrupt person. They are richest people of the society with lot of black money. Huge black money can be recovered if government investigate pan card of these doctors.
Do you think MCI & Health Minister do-not know what is going on?