Friday, June 30, 2017

MNC Cos, hosps earn hefty profits on med devices

Jun 30 2017 : The Times of India (Chennai)
Cos, hosps earn hefty profits on med devices
New Delhi:

Maha, Odisha Regulators Want Centre To Act
Even though the government has capped prices of cardiac stents, this has failed to bring much relief to patients.Companies, distributors and hospitals continue to earn hefty profits ranging from 40600% on other medical devices such as catheters, orthopaedic implants and surgical equipments, data submitted by regulatory authorities from Maharashtra and Odisha shows.Raising concerns about the hefty profit margins on such products, the Food and Drug Administration (FDA) authorities of the two states have asked the Centre to take immediate action and bring all types of catheters and other such critical medical devices under the purview of price control.
Recent reports submitted by the state authorities to the central drug pricing authority ­ National Pharmaceutical Pricing Authority (NPPA)­highlights that profit margins earned by hospitals on balloon catheters ranges between 25%472%, whereas that on guided catheter ranges from 50-529%. Similarly, distributors in the supply chain earn a profit margin ranging from 20%-211% on balloon catheters and 64-119% on guiding catheters. Manufacturers also earn a substantial margin on such products ­ ranging between 17-120% on balloons and 3-154% on guiding catheters.
“There is an urgent need to bring statutory provisions so that there will be fixed profit margin in the supply chain of balloon catheters and guiding catheters based on its import manufacturing cost to the company ,“ the Maharashtra FDA wrote in its report to NPPA earlier this month. Both Maharashtra and Odisha FDAs have been writing to the Centre highlighting such anomalies in pricing of medical devices since past few years.
It is imperative to note that the government has already started the process for bringing more medical devices under price control. While the health ministry has set up a committee to evaluate data to be able to include such critical devices under the National List of Essential Medicines, the National Pharmaceutical Pricing Authority (NPPA) has initiated stakeholder consultation for fixing up prices.
The latest reports by state regulators were released on Thursday on the website of the All India Drug Action Network. The reports also show that MRP of urine bags is 500% higher than the cost as supplied to hospital, and similarly cost of oxygen bags is approximately 300% higher than MRP . As per the report, 18 surgical equipment or medical devices are priced high including intraocular lenses ­ where margins are as high as 200-300%.
The government has started deliberations to bring around four critical devices--apart from cardiac stents, which are already under price control--under the NLEM. Once under NLEM, such devices will automatically fall under the purview of price control and companies will have to sell them at an MRP fixed by the regulator.
Initially, the regulator had shortlisted 19 such commonly used medical devices, including catheters, heart valves, orthopaedic implants and intraocular lenses, and asked companies to submit price and production data related to them.
Jun 30 2017 : The Times of India (Chennai)
MRP of stents, valves must be declared
New Delhi:

Medical devices which are declared as `drugs' such as stents, valves, orthopaedic implants, syringes and tools for operations will now have to declare their maximum retail price (MRP) and other details including that of manufacturer and importer. These also need to mention the consumer helpline number of lodging any complaint.The new rules, which come to effect from January 1 also makes it mandatory for e-commerce firms to mention MRP of products, which is aimed at ending any ambiguity whether the online firms are actually giving huge discounts that they claim in their advertisements.
“Even after capping of prices of medical devices many companies were not displaying (the rates). The new rules will be of great help to consumers at large and particularly the poor.The companies have to follow these norms under the legal Metrology Rules,“ consumer affairs minister Ram Vilas Paswan told TOI.
Earlier, all medical devices were covered under the Legal Metrology (Packaged) Commodities Rules. But in 1995, some of them were declared as drugs and so they stopped mentioning MRP . A sub-committee set up to propose changes in the Rules had recommended bringing them back under MRP regime. A consumer affairs ministry official said that the application of Legal Metrology Rules will provide another layer to protect consumers' rights. Nonapplication of MRP led to a crisis where consumers were charged arbitrarily by hospitals for medical devices and the health ministry had to cap the prices of stents.

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