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Planning Commission Calls For Amendment
To D&C Act To Monitor Medical Devices Sector Setter
The Planning Commission has suggested the amendment of the
Drugs and Cosmetics (D&C) Act to include medical devices incorporating
provisions for their risk based classification, clinical trials, conformity
assessments and penalties.
The recommendation has been included in the draft plan
document for the current 12th Five Year Plan, which will be approved shortly.
“As recommended by the Mashelkar Committee, a Central Drug Authority needs to be
set up. This authority would review the issuance of licences for manufacture and
sale of drugs. Once this Authority is in place, suitable strengthening of its
infrastructure and laboratories would be done. The Government would mandate that
labels on drugs and food fully disclose all its ingredients,” the document said.
The Plan panel also recommended strengthening of existing,
and creation of new drug testing laboratories to ensure the quality of drugs
being produced in India, whether they are used for domestic distribution or for
export to other countries.
“Institutional frameworks for regulation of clinical research
and trials to ensure safety of research subjects will be a priority. In
addition, efficient assessment and approval of new technologies, drugs and
devices would also be done. The process of approval and introduction of new
medical technologies, and devices, would be notified. India still has to
safeguard itself from TRIPS plus provisions which will evergreen patents for
more than 20 years. Safeguards like compulsory licensing, parallel imports, and
so on, need to be adopted to protect national’s public health,” the panel said.
(Ref.:
http://pharmabiz.com/NewsDetails.aspx?aid=72881&sid=1 )
Plastindia To Strengthen Ties With
Pharma Sector To Enhance Plastics' Use
PLASTINDIA Foundation, an apex body of major associations
connected with plastics including government organisations, expressed interest
in exploring better business opportunities with the pharma industry for the use
of plastics in the packaging of pharma products.
The size of the plastic industry today is about Rs. l,25,000 crore, of which the share of pharma industry is hardly seven percent, which is
very minuscule representation considering the huge size of the industry and the
potential it holds. Especially since plastics differ from metallic materials in
many ways, with their durability and re-usability that can be used to
manufacture containers not only for solid dosages but also for blood and
injections as well as for liquids that are to be administered parenterally.
Plastindia Foundation further stressed that they are looking
forward for greater opportunities that will help in developing a symbiotic
relation between both the sectors. And stated that the industry is open to
provide extensive range of custom made services to support the use of plastics,
within the pharma and medical device industries.
Just recently, to create a pool of skilled technicians and
engineers who can think globally and implement expertise on the work floor that
would be beneficial to the industry and economy at large, the foundation had
initiated a major project to set up an internationally recognised university in
Gujarat in collaboration with the University of Massachusetts Lowell (UMASS).
The plastindia International University (PIU) will be the first institution in
India that will impart information on polymer
technology from concept to commercialisation.
(Ref : The CHRONICLE PHARMABIZ December 13, 2012 P.g. No.
02)
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