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Mah FDA Order May Hit Domestic Stent Makers

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.

Korean 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 Mumbai.

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 : Bangalore Cardiologists

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.

EU Model 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.