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Provisions Of DPCO, 2013 Applicable
To Notified Medical Devices: NPPA
The National Pharmaceutical Pricing Authority (NPPA) has
clarified that orthopaedic implants along with other medical devices will be
treated as drugs, hence provisions of DPCO, 2013 are applicable to notified
medical devices.
Refuting the contention of the medical devices manufacturers,
especially the manufacturers of orthopaedic implants, that the provisions of
DPCO 2013 are not applicable to medical devices, the NPPA said, “Para 20 of DPCO,
2013 provides for monitoring of non-scheduled formulations. Orthopaedic implants
along with other medical devices are notified as ‘drug’ under Drugs & Cosmetics
Act & Rules thereunder. Therefore your contention that the provisions of DPCO,
2013 are not applicable to medical devices is totally incorrect.”
It may also be noted that Para 25 of DPCO, 2013 requires
every manufacturer/importer to issue a price list in Form V. Further Para 29
empowers the government to call for any record and to inspect such report at the
premise of the manufacturers relating to sales of the formulations, which
include 14 notified medical devices. Accordingly, it has been decided to seek
the following information/documents in order to examine price violation, if any,
in respect of notified medical device, manufactured /
imported / marketed by the company, the NPPA further mentioned in its
clarification.
Earlier in May this year, the NPPA had sought detailed
information about the prices of notified orthopaedic implants from the
manufacturers to initiate stringent action if they are found to be charging
exorbitant prices from the consumers in violation of Drugs & Cosmetics Act. The
NPPA’s action was in the wake of reports in the media that the prices of
orthopaedic implants regulated as ‘drugs’ under Drugs & Cosmetics Act & Rules
thereunder, are sold at exorbitant price with high profit/trade margin.
The NPPA had then asked the manufacturers of notified
orthopaedic implants to provide details like product specification with brief
description/literature for different types of notified medical devices
manufactured/imported by the company and other details like ex-factory price/
landed cost (including applicable duties); distributor cost; maximum retail
price (MRP); and percentage of increase in MRP (year to year) in the last three
years.
The NPPA said that Para 20 of the DPCO, 2013 provides for
monitoring the prices of non-scheduled formulations and to ensure that no
manufacturer/importer/distributor is allowed to increase the MRP of a
nonscheduled drug more than ten per cent of MRP during preceding twelve months
and where the increase is beyond ten per cent, it shall reduce the same to the
level of ten percent of maximum retail price for next twelve months. The
manufacturers/ importer / distributor shall be liable to deposit the overcharged
amount along with interest thereon, from the date of increase in price in
addition to the penalty.
(Ref:
http://www.pharmabiz.com/NewsDetails.aspx?aid=89286&sid=1)
Gujarat FDCA To Meet Commerce Ministry
To Seek Release Of Funds For Biocompatibility & Medical Device Testing Lab
Gujarat Food & Drugs Control Administration (FDCA) is
expected to meet commerce ministry to speed up the release of funds for setting
up of the country’s first biocompatibility and medical device testing lab. The
state drug regulator had earlier this year drafted a proposal to the Centre to
sanction a budgetary allocation of Rs.15 crore for the same.
The Engineering Export Promotion Council (EEPC) under the
commerce ministry constituted to support the growth of engineering sector
including medical devices has given positive response towards setting up of this
lab. It is understood that the status of this ambitious proposal is in the final
stages of approval.
Dr. H G Koshia, commissioner of Gujarat FDCA informed that
once the funds are released, the work on the project will be immediately
commenced within the food and drug testing facility in Baroda. He said that
getting funds from the Centre is the tough task as once that is cleared, they
will be able to make progress quickly especially since they have already
identified a suitable location within the building, which is located in the
middle of the thriving industrial belt.
“The funds that we have sought is for infrastructural
development, acquiring high tech equipments for testing and getting trained
manpower. It is an ambitious project and will certainly help to support the
industry in the long run, especially since, in spite of it being one of the
growing sector, India does not have a biocompatibility and medical device
testing lab in the country. If things go as planned, we hope to operationalise
this lab as early as end of this year.”
It is understood that medical device manufacturers who wish
to do business today are forced to pay huge price for their products to be
tested by international testing agencies. At present, domestic manufacturers are
forced to send their devices to other countries like Singapore to get their
products tested before marketing it. International testing agencies do the
biocompatibility study for them, generating the data and filing the reports for
the manufacturers, a process which is not only time consuming but also very
costly for domestic manufacturers.
Expressing strong support to this move, experts pointed out
that this will not only offer an affordable option for the manufactures but will
also instill confidence among the stakeholders.
(Ref:
http://pharmabiz.com/ArticleDetails.aspx?aid=89485&sid=1)
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