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Barriers To Commercialization Of Novel
Medical Technologies In India
A survey of medical device professionals in India reveals the
key barriers to increasing access to appropriate medical technologies in the
country.
The Indian medical device market is valued at about $3
billion, growing 15% per year. It is a relatively small market to serve a
population of over 1.3 billion people, reflecting the extremely low utilization
of medical technology in the Indian healthcare system. Further, the medical
device market in India is dominated by imports, which account for approximately
75% of the devices sold in the country and are priced out of the reach of most
patients. This presents an opportunity to medical device innovators who are
looking to address the disease burden in India by increasing access to
appropriate medical technologies.
The top-three barriers cited were a lack of sufficient
early-stage financing, inadequate regulations around manufacture and sale of
medical devices, and the lack of intellectual property (IP) protection for new
technologies. For instance, as the figure below shows, over 90% of survey
respondents consider the lack of funding to be a critical barrier to
commercialization.
Approval of the Medical Devices Regulation Bill, already
drafted and presented to the Parliament first in 2006 and then again in 2012,
will be an important first step in streamlining all laws concerning medical
devices in India.
Second, adequate IP enforcement, especially in the fragmented
segments of the medical technology ecosystem such as prototyping shops and
distributors, would protect and encourage innovation in the Indian market.
Third, medical technology should be introduced to medical
students as part of their coursework at the undergraduate level (MBBS or
similar) so that the future doctors are aware of the range of therapies that
benefit their patients and are open to adopting new technologies as part of
their practice of medicine.
Fourth, engineering students should be exposed to medical
technology in order to create a pool of skilled engineers who can develop new
medical devices appropriate for the Indian setting.
Different stakeholders of the Indian medical technology
industry, such as startup companies, investors, entrepreneurs, multinational
companies, management schools, medical and engineering colleges and government
organizations, should embrace opportunities to engage with each other and build
a collaborative network to help develop and commercialize new medical
technologies.
The Indian growth story, which is slated to add 500 million
people into the middle class by 2025, up from 50 million today, presents
enormous opportunities for healthcare innovation, and the medical technology
industry must seize them.
(Ref:
http://lifesciences.ieee.org/publications/newsletter/
january-2013/258-barriers-to-commercialization-ofnovel-medical-technologies-in-india)
Panel Recommends Bringing Of CDSCO Under
Dept Of Pharma
PARLIAMENTARY panel attached to the Ministry of Chemicals and
Fertilizers has asked the Ministry to take up urgently the matter of bringing
the CDSCO under the administrative purview of the Department of Pharmaceuticals
(DoP) for better check on quality of drugs.
The DoP itself had taken up the matter with the Cabinet
secretariat and the Prime minister’s Office, clearly stating that the CDSCO may
be brought under the DoP.
Pushing the matter to the PMO, Lok Sabha member Dr. Sujan
Chakraborty had also written to the Prime Minister some time back with the same
demand. He pointed out that the very creation of the DoP was to bring all
important functions under the single Department to facilitate growth of Pharma
industry. If the CDSCO was not brought under DoP, the very purpose of the DoP
would remain unfulfilled, he said.
The DoP, in its submission to the PMO, also claimed that as
the issues relating to pricing, availability and quality of medicines are
closely interlinked, CDSCO should be a part of the DoP so that it may be able to
play its role more effectively to achieve its main objective to ensure
availability of life saving drugs at, reasonable prices as envisaged in the drug
policy.
“Quality is an essential parameter while considering the
pricing and availability of medicines. In the absence of jurisdiction over the
issue of quality of medicines, the DoP finds itself handicapped to do full
justice to the role assigned to it. It is, therefore, extremely important to
bring the quality control set up under the DoP”, the department conveyed to the
PMO.
(Ref: Page No. 1, Chronicle Pharmabiz, Feb. 14, 2013)
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