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.

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 country.

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)

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.

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)