Mah FDA Order May Hit Domestic Stent
The Maharashtra 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 Concepts.
Firm 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
Nirma Close To Sealing Core Deal
Seven months after it announced its intent
to acquire ailing Ahmedabad based Core Healthcare's intravenous fluids
and medical devices business, FMCG major Nirma is learnt to be close
to be wrapping up the deal for a little upwards of Rs 300 crore.
Maharashtra FDA Wrong In Insisting On US FDA Nod For Using DES :
The decision of the Maharashtra FDA to
insist on US FDA approval for manufacture of drug eluting stents (DES)
and on trade licences from the state drug control department to market
them is illogical. This will only create shortage of stents, push up
prices and create a monopolistic situation in the market, according to
leading cardiologists in Bangalore.
Systems For Medical Devices With BIS Fixing Approval Standards
The Central Government is likely to come
out with a European Union model regulatory system for medical devices
that are manufactured or marketed in the country. The highlight of the
proposed system is that it will entrust Bureau of Indian Standards (BIS)
to fix the quality standards for the medical devices. The Central
drugs regulatory authority will, however, continue as the inspection
and licensing agency but the approvals will not be under them.