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The government of India has an ambitious plan to
increase competitiveness of the Indian Medical Device industry globally by
helping it to bring down the manufacturing cost significantly. As per Mr Ananth
Kumar, Minister for Chemicals & Fertilizers and Parliamentary Affairs, “Setting
up of Medical Device parks can bring down the manufacturing cost by another 30
per cent and make Indian medical technology sector globally competitive, due to
pooling of common facilities,”
With the initiative from the Hon. Chief Minister of
Andhra Pradesh Mr N. Chandrababu Naidu, Andhra Pradesh us emerging as
manufacturing hub for medical devices with establishment of country’s first
Medical Technology Manufacturing Zone, Andhra MedTech Zone ( AMTZ ) in
Vishakhapatnam. As per Dr Jitender Sharma, CEO, AMTZ, the brain behind the
project, one among many opportunities is to, “Get to the small and medium
enterprises, build and support them so that they become exporters, essentially
meaning strengthening of the micro , small & medium enterprise (MSME) sector”. |
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Mr Ananth Kumar has also put forward a proposal that
the Central government will soon establish three mega industry parks in Gujarat
which will include Medical Devices, Pharmaceutical Formulations and Bulk Drugs
Parks. The Gujarat Chief Minister Mr Vijaybhai Rupani has already accepted the
centre’s proposal and would like to see that these parks come up at the
earliest.
As we all agree, the medical device manufacturer is
responsible for the safey and effectiveness of the final device. The device, its
components and raw materials that come into contact with human tissue must all
be evaluated for biocompatibility. Through a very well researched article, Dr
Vinny Sastri, President, Winovia LLC, U.S.A., has given very detailed
understanding of “ How To Meet Biocompatibility Needs Of Polymeric Medical
Components”. Dr Sastr, apart from his long and rich experience in the Quality
Management Systems (QMS), is also the author of the book,” Plastics In Medical
Devices : Properties, Requirements and Applications”.
One more important aspect covered in this issue is
about QMS and the changing scenario & challenges in Medical Device Regulations
through an article by Mr Sanjay Shah. This issue also highlights the global
regulatory science priorities for assuring safety, effectiveness and quality of
medical devices.
It also includes our regular columns highlighting
Global Trends, Industry News , Technology as well as important events for the
benefit of our readers.
D.L. Pandya
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