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Health Ministry Revives Steps To Table
Pending Bill On Medical Devices In Monsoon Session
The Health Ministry has initiated steps to push the long
pending bill on medical devices with the consent of the States and hopes to
table it in the Parliament during the monsoon session.
The Ministry held a meeting recently with stakeholder
associations like FICCI and the Association of Indian Manufacturers of Medical
Devices, apart from the senior officials from the Central Drugs Standard Control
Organisation (CDSCO) to discuss the issue. In the face of continuing opposition
from some States, the meeting decided to follow up the activities to secure the
assent of all the States, sources said.
Besides, the Ministry is also reportedly under pressure from
Prime Minister’s Office to table the bill in the Parliament at the earliest so
that the growing medical devices sector would get a much needed impetus in the
form of regulatory mechanism.
“The proposed amendment to the Drugs and Cosmetics Act (D&C
Act) will lay down separate provisions for Medical Devices. The salient features
of the bill would be to provide a separate definition of Medical Devices, their
risk based classification for regulatory control, Clinical Trials on Medical
Devices, Conformity Assessment Procedures, Penal provisions, etc.,” sources
said.
Currently, medical devices are treated as drugs. With only 14
notified devices regulated under the D&C Acts, thousands others remain
unregulated in the country. The industry, which opposed the moves to increase
the number of devices under regulation, wanted separate guidelines and
definition for medical devices.
Meanwhile, many States are still opposed to the bill but
assent of all the States are required as health is under the concurrent list.
The Ministry had circulated the draft among the States, after revising it on the
basis of the recommendations by the Parliamentary Standing Committee attached to
the Health Ministry. The bill has been pending now for over four years.
Hoping that the bill will go to the Parliament during the
monsoon session, the ministry had already sought Rs.205 crore from the Planning
Commission to set up regulatory mechanism for the sector during the next Five
Year Plan period.
( Ref :
http://pharmabiz.com/ArticleDetails.aspx?aid=69765&sid=1 )
India-Canada To Foster Joint R&D Projects
In Biotech, Health Research, Medical Devices
Under the Canada-India agreement for scientific and
technological cooperation, India and Canada will soon foster joint research and
development (R&D) projects in areas of biotechnology, health research,
pharmaceuticals, medical devices and nanotechnology as it applies to these
sectors.
The key objectives of this joint programme are to encourage
domestic competitiveness through the transfer of technology and knowledge
resulting from international S&T partnerships; to foster international S&T
partnerships and collaborative research with an emphasis on industrial outcomes;
to accelerate the commercialization of R&D that would benefit Canada and the
partner country, through international partnerships, with a focus on small and
medium-sized enterprises; to access international technologies for
Canadian enterprises; to promote Canadian R&D capacity and Canada as a
destination for foreign technology-based investments; to encourage the mobility
of researchers and to promote Canada as a career destination for foreign
researchers and highly qualified personnel; and to strengthen overall bilateral
S&T relations.
The Department of Biotechnology (DBT) will be the
implementing organization on the Indian side, while the International Science
and Technology Partnerships Canada (ISTPCanada), a non-governmental organization
will be implementing the project on the Canadian side.
This Canada-India programme aims to foster and support the
development of collaborative R&D projects that bring together companies,
research organizations, academics and other collaborators from both countries
for the joint development of innovative products or processes. It aims to
stimulate innovative R&D projects (engaging small-to-medium-sized companies
and/or larger, well established firms) that address a specific market need or
challenge; demonstrate high industrial relevance and commercial potential; and
aim to deliver benefit to all participants, and more broadly, to both nations.
These projects help participants to become more competitive by developing global
research-based alliances with the potential to foster increased or expanded
international R&D collaboration.
Eligible Indian applicants for this programme include
researchers and managers of Indian companies, academic institutions, research
hospitals or other R&D institutions (including not-for-profit research
institutes recognized by DBT) that are headquartered and operate in India.
Eligible Canadian applicants must be researchers or managers
of for-profit companies that operate and are headquartered in Canada. Canadian
subsidiaries of companies headquartered outside of Canada are typically not
eligible for support. However, as ‘benefit to Canada’ is a key objective and
among the most important selection criteria, ISTPCanada may grant an exception
to such subsidiaries if they have R&D facilities in Canada and can demonstrate
that Canada will accrue clear economic benefit from the bilateral R&D project.
Academic institutions, research hospitals, other institutes or research
associations are strongly encouraged to participate in the projects as
co-investigators.
Each proposal must include an eligible lead from Canada and
India. Although it is not mandatory, projects that engage a technology developer
and a technology end-user/first customer are strongly encouraged.
( Ref :
http://pharmabiz.com/NewsDetails.aspx?aid=69943&sid=1 )
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