|
States And Central Health Agencies For
Indian Products While Procuring Medical Devices
The Union Health Ministry has asked the states and central
health agencies to open their doors for Indian products while procuring medical
devices like coronary stents.
Last month, the ministry had sent an advisory to all the
agencies asking them to change their tender conditions so that Indian medical
device manufacturers too can take part in the bids, sources told DH.
If the states relent and modify the procurement documents,
then it may lower the cost of several medical procedures, including coronary
angioplasty, as Indian devices are available at a fraction of the cost of the
imported instruments.
The July 18 advisory directs the health agencies to consider
the Central Drug Standards Control Organisation (CDSCO) permitted medical
devices rather than insisting on the US Food and Drug Administration (USFDA)
approval.
A large number of tenders by the central and the state health
agencies insisted on USFDA certifications to qualify for the same, which is a
disadvantage for the domestic sector. The tenders often do not even consider
alternative options such as ISO 13485 certification. “This results in denial of
a fair chance to the domestic manufacturers to compete in such procurements,
which not only impedes competition but also affects the Make in India effort,”
says the advisory.
Besides the coronary stents, other common devices procured in
bulk are chemistry analysers, opthalmological equipment and lenses; several
types of evacuation tubes and in-vitro diagnostic equipment and reagents.
“The insistence of USFDA certification by central and state
government health institutions had seriously undermined the credibility of our
own regulators. No other country in the world insists on only one certification
source and that too USFDA exclusively. All major countries have their own
domestic or alternate international certification,” said Rajiv Nath, forum
coordinator in the Association of Indian Medical Device Industry.
(Ref:
http://www.deccanherald.com/content/563184/buy-indian-medicaldevices-states.html).
New Niper Campus In Gandhinager ( Gujarat )
To Emerge As A Vibrant R & D Centre Dedicated To Medical Device Industry
In a strategic development, the National Institute of
Pharmaceutical Education and Research (NIPER), Gandhi Nagar in Gujarat, has
recently started the operations of its independent campus at Palej village. This
comes as a much needed reprieve for the pharma and medical device sector, as
this campus has the capacity to support the ongoing research and development
requirements to meet the growing demands in the sector for innovation and
skilled manpower.
Interestingly, NIPER campus, which is still under
construction, is also the country’s first national Centre of Excellence (CoE)
for medical devices. Apart from imparting studies and conducting research and
development in the field of pharmaceutical, this institute will also work on
developing new medical devices for the pharmaceutical industry.
Till recently, NIPER Ahemdabad, which had commenced its
operations from the academic year 2007-08 in Gujarat, was housed in the reputed
institute B V Patel Pharmaceutical Education and Research Development (PERD)
Centre. It is important to note that NIPER till now had only one fully
functional campus, at Mohali in Punjab. The Gandhi Nagar campus in Gujarat being
the second one to have an independent campus.
Dr. H G Koshia, commissioner of Gujarat FDCA, informed that
it has already started post graduate and PhD courses on various subjects
relating to pharma technology, quality assessment, etc.
He added, “The new campus is far more spacious and built
keeping in mind the current R&D and educational demands of the country. Most
importantly, NIPER Gandhi Nagar will be able to take in more students and engage
them in a healthy environment that will encourage them to play an important role
in contributing towards achieving research activities that are internationally
recognised to cater to the needs of the industry and the academia world-wide.”
Built in 60 acres of land provided by the State government
with an estimated investment of over Rs. 500 crore, the new campus has the
potential to emerge as a vibrant research and development centre dedicated in
the field of medical devices. NIPER Gandhi Nagar is expected to further
pro-actively encourage students to take up research activities so that they can
establish themselves as innovators. It is understood that the students will go
through the specialised courses designed to achieve the goals which is required
in the pharmaceutical sciences and management.
(Ref:
http://www.pharmabiz.com/ArticleDetails.aspx?aid=96941&sid=1)
|
