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Medical Device Sector Delinked From
Pharma
The government has accepted the long-standing demand of the
medical devices sector to delink it from the pharmaceutical sector. The health
ministry has agreed to delink schedule M III of the Drug Rules, which deals with
medical devices, from schedule M, which deals with drugs and pharmaceuticals.The
revised schedule is being put up on the website of the Central Drugs Standards
Control Organization (CDSCO) inviting comments from the public after which a
notification will be issued through the law ministry for changing the Drug
Rules.
Schedule M III provides requirements of factory premises for
manufacture of medical devices under the Drugs and Cosmetics Rules (DCR), 1945.
However, it relates only to three medical devices, namely sterile perfusion and
blood collection sets and syringes and needles. A large number of notified
devices are currently being regulated under the provision of DCR, 1945.
The Drugs Technical Advisory Board (DTAB) in its August 2015
meeting recommended that Schedule M III be incorporated under DCR 1945 and the
rules amended so that it was exclusively for medical devices, while schedule M
was applicable only to drugs. “Nowhere in the world are pharmaceutical and
medical device sector governed by the same set of legislations as has been
historically happening in India,” said a statement of the Association of Indian
Medical Device Industry (AIMED). This has had a detrimental impact on the
medical devices sector, it added.
The Drugs Technical Advisory Board (DTAB) in its August 2015
meeting recommended that Schedule M III be incorporated under DCR 1945 and the
rules amended so that it was exclusively for medical devices, while schedule M
was applicable only to drugs. “Nowhere in the world are pharmaceutical and
medical device sector governed by the same set of legislations as has been
historically happening in India,” said a statement of the Association of Indian
Medical Device Industry (AIMED). This has had a detrimental impact on the
medical devices sector, it added.
But there needs to be a separate law book, separate rule book
and separate regulatory authority.
(Ref:
http://timesofindia.indiatimes.com/india/Medical-devicesector-delinked-from-pharma/articleshow/50130958.cms)
AIMED Launches UdaiMed, India’s First
Industry - Academia Collaboration For Medical Devices R&D
The Association of Indian Medical Device Industry (AIMED) has
launched ‘UdaiMed’, a new sunrise forum for collaborative interface between
user, developer, academia, industry and medical device development in India.
The objective of this momentous milestone collaboration for
academic-industry in India is to make on-campus research more aligned to medical
device industry’s needs and catalyze ‘Makein- India’ programme.
To take forward this objective, AIMED & UdaiMed also signed
its first MoU with TiMed (Technology Business Incubator), a not-forprofit
registered society promoted by Sree Chitra Tirunal Institute for Medical
Sciences and Technology (SCTIMST), Thiruvananthapuram, for encouraging
innovation and entrepreneurship in medical technologies through technology
business incubation support to innovators, start-ups and industry.
TiMed will offer office and laboratory space with several
common facilities like internet access, library, canteen, video-conferencing
facilities for taking forward this collaboration.
“I am absolutely positive that the new collaboration will
construct a better synergy between industry needs and academic research while
taking care of fund shortages for research,” added Nath.
Explaining the need for such an initiative, Nath pointed
towards the ground realities of campus R&D in India stating that, “R&D
institutions and engineering colleges do product development in isolation while
industry has little or no idea of work being done there, and often such
researches have no relevance for industry. Collaboration between institutions
and industry is completely absent even as most development is for peer academia
acclaim rather than meeting industry’s needs or contributing to country’s
competitive prowess.”
As a next step, Dr Jitender Sharma, head of Healthcare
Technology Division of NHSRC, MOH&FW (also party to this initiative) said
“AIMED/UdaiMed could request the government to auction all patents which are not
yet commercialised so that these can be put to use by Indian manufacturers for
the benefit of Indian consumers and medical fraternity.”
(Ref :
http://pharmabiz.com/ArticleDetails.aspx?aid=91645&sid=1)
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