NGO Launches Nationwide Campaign Against Unapproved Medical Devices

Public Response Against Helplessness and Action for Redressal (PRAHAR), a Delhi based non-governmental organisation, has launched a multi-city campaign 'Making Cardiac Care Fair' against implant of 'life threatening illegal medical devices' on unsuspecting patients.

The campaign will focus on bringing experts together to discuss the issue, disseminating factual information through a Helpline, which will register queries and complaints from patients. Further, it is conducting a poster campaign and setting up information help desks in associated hospitals, conducting knowledge workshop to attract media response etc. Following the recent reports on unapproved Drug Eluting Stent (DES) being used in unsuspecting patients, PRAHAR has launched a 'Patient Helpline Number' where victims can register their complaints and seek assistance. Patients could also get first hand factual information on matters related to cardiac care, said the organizers while launching the campaign at Chennai, recently.

The organizers said that though the issue in limelight was of DES, the campaign of PRAHAR was against the entire practice of implanting unapproved medical devices in patients. Proper assistance for cardiac patients is assured in the Helpline number 011-30884200.

According to the statistics from industry sources, 50 per cent of angioplasties in India involves illegal cardiac stents, which means, everyday almost 85 patients are subjected to become victims carrying unapproved pieces of metals in their body, said Abhay Raj, Executive Committee Member, PRAHAR. He said that out of 60,000 patients put through angioplasty in India annually, 30,000 receive unapproved cardiac stents, as per the statistics.

Dr S. Mullassary Ajit, Senior Consultant Cardiologist, Institute of Cardio-Vascular Disease, pointed out the need of regulatory measures for medical devices and Christopher M. Solan, Former Director, US FDA, Cardiovascular, explained the regulatory steps taken by the Eurpean and US authorities on such devices. The campaign was launched in Delhi on 27th July and would be launched in various parts of the country within a short period, said PRAHAR sources.

(Ref : Chronicle Pharmabiz dated 4 August 2005)

Relisys To Commission New Catheter Facility By Early 2005

Relisys Medical Devices will soon commission its catheter manufacturing facility at Ibrahimpatnam near Hyderabad.

The facility is expected to go on stream by December 2005 and the trial runs are likely to start from January 2006. The facility is to cost Rs 6 crore and the company has tied up with Andhra Bank for a term loan of over Rs 4 crore.

The catheter manufacturing units is part of the second phase of the Rs 11 crore expansion project envisaged by the company, comprising three phases. The first phase of the project involved prototype and technology development and Rs 3 crore has been invested in this direction, NG Badari Narayan, managing director of Relisys, told Pharmabiz.

The integrated facility will manufacture catheters that can be used in neurology segments. Narayan said the catheter facility would be able to produce catheters in cardiology segment upto 1.5 lakh to 2 lakh units per annum, catheters in nephrology segment upto 50,000 to 60,000 units per annum, and about 5 lakh to 10 lakh units per annum.

He said the company would go for US FDA approval for catheters and critical care products. It plans to obtain FDA approval for catheter facility by April 2006. The company also plans to seek WHO GMP Certification for its Drug Eluting Stents.

It may be noted that Relisys had formed a consortium with two companies, Hingarh Pharma (Vijaywada) and Dynamic Medical (Hyderabad). Relisys is assisting the companies in manufacturing low end products by offering know - how, targeted particularly to the US markets.

(Ref : Chronicle Pharmabiz dated August 11, 2005)