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Medical Devices To Come Under Price
Control
The National Pharmaceutical Pricing Authority (NPPA) is
looking at the ways to keep a tab on the prices of medical devices already
included in the category of drugs, after its study found that the prices of
these products varied wildly in the domestic market.
The agency is looking at the different options including
monitoring the prices that go beyond the stipulated 10% annual increase for the
medical devices as many of them have already been included in the list of drugs,
sources said. The NPPA is already taking actions against pharma companies if the
prices of non-scheduled formulations go beyond the stipulated 10% increase in an
year. However, since the move is still on to bring in new regulations for the
devices sector and possibility of including all devices under a new Schedule,
the agency is still in discussion with the other agencies concerned, it is
learnt.
The government had asked the NPPA to collect data on prices,
supply and availability of medical devices in the country. It was also asked to
study the pricing patterns existing in other countries especially those with the
same kind purchasing power.
As per the data collected by the agency, it was found that
prices of devices like stents, catheters, orthopaedic implants and heart valves
varied widely. Lowest price of catheters available in the market is Rs. 11,000
where as the high-end models are as costly as Rs.78,000 making a huge
difference, sources said citing a case.
Likewise, prices of some other devices of the same category
varied from Rs.3,800 to 8,000. The pattern was noticed almost across the board,
sources added.
The huge margins, annual rise in the prices, unethical
practices in the sector, apart from the variation in prices have come to the
notice of the NPPA, promoting it to look at the options to bring some control.
(Ref: The Chronicle Pharmabiz dated December 16, 2010)
Biomedical Research Bill may Soon go
to Health Ministry for final nod
After remaining dormant for over six years, the modified
‘Biomedical Research Human Subjects Promotion and Regulation Bill’ aimed at
protecting the safety and rights of humans used in scientific research may soon
go to the Union health ministry for final approval and submission before the
Union cabinet.
The review committee set up by the Department of Health
Research has given the final touches after consulting the stakeholders and the
draft is ready for sending to the Health Ministry, sources indicated. The
Department hopes that it will get the nod of the Cabinet soon so that it can be
introduced in Parliament next year itself.
The committee has met recently and fine-tuned the bill as
many of the features had become irrelevant since it was pending for many years
which saw remarkable changes in the industry in general and the research in
particular. The new draft has addressed all concerns of the stakeholders and the
department has tried to make it comprehensive in line with the latest
developments in the research like stem cells which were included in the
prohibited category when the bill was first drafted, sources said.
The Bill seeks to protect the human subjects used in any form
of scientific research – behavioural or intrusive—done by an academic
institution or pharmaceutical company. At present, the research on human
participants have been guided by the draft guidelines announced by the ICMR long
back and the approvals given by the DCGI. The Bill is going to put these
guidelines as statutes, so that it can be enforced sternly. Though the companies
were asked to follow the guidelines, there are no provisions to take action
against the errant researchers now.
The bill provides for setting up a Biomedical Research
Authority to monitor research on humans. One of the key highlights of the bill
is the provision for increasing the penalty for violation of ethical guidelines.
The revised Bill increases the maximum penalty from Rs.1 lakh fine and six
months imprisonment to Rs.10 lakh fine and an imprisonment between five and 10
years. Penalty would be graded as per the nature of violations like not taking
consent of participants, misinformation to the ethics committee, serious
injuries etc. The punishments also include debarring from research and
forfeiting of registration, apart from imprisonment.
The Bill prepared by the Indian Council of Medical Research (ICMR)
was in fact pending since 2004 after the first draft was made and later it was
vetted by the law ministry in January, 2006. However, still it could not be
cleared due to many reasons and the present ICMR director general Dr V M Katoch
took initiative to put it back on the track on the priority basis.
http://www.pharmabiz.com/article/detnews.asp?articleid=59055§ionid=
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