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MTaI Puts Forward Key Recommendations To
Govt For More Enabling Environment For Medical Devices Industry In India
The Medical Technology Association of India (MtaI), an
association of research-based medical technology companies, has put forward some
key recommendations for the consideration of the policy makers that would pave
the way for a more enabling environment for the medical devices industry in the
country.
At a MedTech Summit held in New Delhi recently, the industry
leaders stressed that in view of recent policy changes in the medical technology
space, there is a need for the sub-sectoring and sub-categorization of medical
devices on the basis of the engineering complexity, for policy and decision
clarity.
Import substitution as a focus of policies needs to be
replaced with greater efforts directed towards ensuring global competitiveness
through export promotion and meeting global quality standards. The recently
presented NITI Aayog action agenda recognizes the significance of global
companies’ presence for the domestic industry to compete with and grow.
Make in India, a noble initiative, should however be
implemented in a phased manner. It must focus on the devices that have the
potential to be made locally in the short run, instead of the advanced
technologies that require a more enhanced ecosystem and know-how that may take
years to develop in the country.
This means that policies must factor in the existing gaps in
the domestic manufacturing industry, and promote ease of doing business by way
of reduced inter-organizational delays, enhanced startup industrial finance,
simplified regulations such as single-window clearance, and greater investment
in infrastructure. Sanjay Bhutani, director, MTaI asserted, “the industry
continues to be largely under- understood and under prioritized.”
Another key recommendation put forth at the Summit was to
expand the bed capacity in the country. This is particularly crucial given the
rising burden of diseases in the country today and the lack of access to quality
healthcare. Many pockets of the country remain underserved, and are calling out
for real-time scaling up of solutions to address this demand. The expansion of
the healthcare delivery system will automatically provide an impetus for the
medical devices market to grow.
Further, for long term advantage, infrastructural development
and fiscal incentives are needed to keep the wheels of innovation and R&D
rolling. This will simultaneously help achieve the twin objectives of greater
patient access as well as the availability of latest and high-quality
technology.
MTaI endorses the Trade Margin Rationalization Report of the
Department of Pharmaceuticals, provided unique and deserving sub-sectoral
nuances are given due consideration.
Any access enhancing (price control) mechanisms must be
preceded by a careful impact analysis on creation of geographical access
barriers, on quality of outcomes, reverse medical tourism, and decreased
incentive to innovate.
The MedTech Summit today brought together the much needed
interface of policy makers, industry, doctors with the patients. Key departments
and ministries such as the ministry of commerce and industry, department of
health and family welfare, and the NITI Aayog were represented at the Summit.
The medical technology industry was represented by top MedTech companies
including inter alia Abbott Vascular, Alcon, Bard, Bausch & Lomb, Boston
Scientific, Johnson & Johnson, KARL STORZ, Medtronic, Olympus, Terumo, and Vygon
India.
(Ref :
http://pharmabiz.com/NewsDetails.aspx?aid=104403&sid=1 (September 22, 2017).
Gujarat FDCA Writes To Health Ministry
To Accelerate Process of Setting Up Much Awaited Medical Device Testing Lab At
Vadodara
The Gujarat Food and Drug Control Administration (FDCA) has
written to the union health ministry to accelerate the process of setting up the
much awaited medical device testing lab at Vadodara in Gujarat, MoU for which
has recently been signed between the Government of India and Gujarat Government.
The drug testing lab project, which was originally
recommended by the Union commerce ministry, will be developed with technical
support from Healthcare Technology Division of National Health Systems Resource
Centre (NHSRC) of the union health ministry.
“Ministry of Commerce has also sanctioned an amount of Rs.15
crore for the flagship project for which the site at drug testing lab at
Vadodara has already been approved based on a recently concluded audit. The
Union health ministry has also appointed HLL, a central government agency for
procurement of equipment through a global tendering process,” according to an
official associated with the development.
Gujarat FDCA in the past had also sent a proposal to HLL for
urgent procurement of testing equipment towards setting up the testing lab.
Setting up of a dedicated medical device testing lab in the
country would be a boon for the Indian manufacturers to help adhere to
compliance towards patient safety as the country today lacks in registering and
thereby reporting adverse events due to faulty medical devices at the point of
care.
Proposal for setting up a testing lab is the culmination of
an Engineering Export Promotion Council (EEPC) Meet at Ahmedabad one and a half
years ago which realised the need for setting up a dedicated medical device
testing lab to ensure quality assurance of medical devices manufactured in the
country.
Till date, products are usually sent to foreign countries for
testing due to lack of a reliable and advanced medical device testing facility
in the country. Though the government plans to set up two medical device testing
labs in the country at Vadodara in Gujarat and another at Noida subject to
getting approvals, medical device testing lab in Gujarat would be the first and
the only dedicated biomaterials and implants testing lab in the country. The lab
at Noida will be set up primarily to test electrical and electronic medical
devices in the country.
(Ref :
http://pharmabiz.com/NewsDetails.aspx?aid=104462&sid=1 (September 26, 2017)
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