Mah FDA Order
May Hit Domestic Stent Makers
government's directive making it mandatory for manufacturers of drug
eluting stents (DES) to produce USFDA and CE certification to market
their products in the state will hit Indian manufacturers badly,
according to the Bangalore-based medical devices manufacturer Vascular
Maharashtra is the
biggest user of DES in the country and the state government decision
could result in a dip in sales of stents. A Shrinkage in the market
which is growing at around 25% annually will be quite bad for the
domestic manufacturers, according to Swaminath Jayaram, managing
director, Vascular Concepts. The current DES market in terms of units
is estimated at 50,000 a year. Vascular Concepts and Shahjahan Medical
Technologies of Surat are the only two DES manufacturers in the
Jayaram said the
instruction from Maharashtra FDA is a big blow to manufacturers and
cardiologists since it will lead to delay in approvals, shortage and
increase in price of DES.
The only positive
impact of the notice is that it provides a level-playing field for the
30 global players in the country, he said. Since stents are used as an
interventional product in human body, it is advised to have a
regulatory fram work. Hence manufacturers were anxious to know why the
central government had not bought in a regulation on the sale of such
medical devices. However, he said the Maharashtra government's notice
was a hasty step and it was not clear on what basis it was issued.
Under the circumstances, the government must have a dedicated Act to
manufacture and market medical devices, including DES.
(Ref : Chronicle
Pharmabiz dated June 30, 2005)
In Rs 86-cr JV For Stem Cell Bank
South Korean life
sciences major Histostem is planning a joint venture with the
Maharashtra government to set up a Rs 86-crore cord blood and stem
cell bank and process centre near Mumbai.
Histostem is a
biotechnology company engaged in developing human cell based therapy.
It is currently involved in cell therapy research, public cord blood
bank for transplantation, family cord blood bank and human leukocyte
antigen (HLA) assays. The company has developed the technology of
mixing cord blood for transplantation to adult patients. It is among
the biggest cord blood banks with over 45,000 cord blood units.
Maharashtra had also
signed an MoU for a joint venture with Maharashtra Industrial
Development Corporation (MIDC). "Today's agreement is one more step in
making the MoU a reality," a government official said. Earlier the
company had signed an MoU with the government of India to utilise
umbilical blood to farm stem cells that are found in the umbilical
cords of new borns.
Stem cells are
increasingly used for treating diseases like osteoporosis, diabetes,
benign tumours, hepatic and renal failures as well as treatment of
congenital disorders like autism.
(Ref : Economic
Times dated July 9, 2005)