Baxter India Private Ltd's (BIPL) newly set up Rs 35 crore continuous ambulatory peritoneal dialysis (CAPD) fluid system manufacturing plant at Manesar, near Delhi, was inspected by the Union ministry of health last week. The plant is undergoing trial runs since March this year. The company is expecting issuance of manufacturing licence by the ministry of health (MOH) soon.

The company, a subsidiary of Baxter International Inc, US, is a leading supplier of CAPD therapy in the country. In 1956, Baxter designed and manufactured the first commercially available, completely disposable dialyzer and the first complete hardware system for hemodialysis. It was in 1979 that Baxter released the first complete continuous ambulatory peritoneal dialysis system.

BIPL was expecting to start production sometime in April 2002. "The plant is awaiting MOH licence," BIPL MD Sanjiv Verma told Pharmabiz.com from New Delhi.

According to information, the start-up of the facility suffered a setback during the Indo-Pak border tension when Baxter had to pull out its international resources at the site in response to travel advisories issued by various foreign governments.

"The international team has returned in recent times and the MOH inspection of the plant was carried out last week. We are awaiting feedback from the MOH team," Roy Chaudhury of BPIL said from New Delhi.

As part of validation protocols for different systems, processes and equipment, as well as for training of BIPL's personnel, the company has carried out some trial runs. The output from the trial runs is destroyed under strict supervision as it is not saleable product.

"We can issue production from this plant for use by patients only after we secure appropriate manufacturing licence as per law of the land," he added.

In CAPD, dialysis, or removal of waste products from blood, carries on all the time. Unlike haemodialysis, the patient can move around as normal and carry out daily activities. The dialysis takes place in the peritoneum, or the natural lining of the abdomen.

In order to perform CAPD, patients have to undergo a small operation to insert a catheter (a slender tube for passing or removing fluids) into the abdomen. Dialysis fluid enters the peritoneal cavity, extra fluid and waste travels across the peritoneal membrane into the dialysis fluid, and after a few hours, the dialysis fluid is drained.