Hyderabad capital of Andhra Pradesh is set to house Asia's first catheter manufacturing facility, which will not only bring down the cost of catheter based disposables but could also become an outsourcing hub for multinational companies.
Relisys Medical Devices Limited, a seven-year old company, Tuesday announced that the facility would be ready by December. Trial production is slated to begin by January next year.
The Rs.80 million facility, coming up at Manglapalli village in neighbouring Ranga Reddy district, will have the capacity to produce half a million catheter-based products annually.
To be developed as per US Food and Drug Administration (FDA) norms, it will produce 150,000 to 200,000 diagnostic catheters and 60,000 to 70,000 interventional catheters, used to pass stents to cardiac arteries.
N. Krishna Reddy, cardiologist and chairperson of Relisys, told reporters that Andhra Bank had come forward to extend a term loan of Rs.45 million for the facility.
He later told IANS that the facility would be a big boost to development of medical devices in a country, which presently produces only IV sets. "From the lowest level we are jumping to the sixth level," he said.
Krishna Reddy hoped the facility would cut the prices of catheters by 50 to 70 percent. India imports catheters at prices ranging from Rs.400 to Rs.3,000.
"This facility can not only cater to the region but also become an outsourcing hub for MNCs," he said.
The company also announced the launching of international multi-centre clinical trials of the new version of drug eluting cobalt-chromium stent coated with porous carbon-carbon nano-matrix.
Clinical trials would be conducted at nine centres in India as well as in Brazil, South Korea, Italy and Japan. The company has entered into a worldwide licensing agreement with Blue Membranes GmbH, Germany, for carbon-based drug delivery platform.
The use of porous carbon-carbon nano particle coating will eliminate the use of polymer based platform, thus completely reducing tissue inflammation and reaction (in cardiac arteries).
"Blue-Membranes will enforce the collaboration with Relisys that enables us to exploit our drug-delivery technology. We also aim to integrate manufacturing capabilities of Relisys to provide high quality manufacturing services for integrated solutions," said Soheil Asgari, CEO of Blue-Membranes.
Animal trials of this version of advanced drug eluting stent were recently completed at the Cardiovascular Research Institute, Washington.
The company had earlier completed clinical trials for its first generation drug eluting stent at All India Institute of Medical Sciences, New Delhi, Military Hospital, Pune, and Care Hospital, Hyderabad. More than 500 stents have been used since evaluation was completed six months ago.