The Hindu Business Line : Biocon arm Clinigene opens clinical trial centre

BIOCON India's clinical research subsidiary, Clinigene International, has opened a human pharmacology unit (HPU) that will conduct phase 1 clinical trials and related studies for pharma R&D companies.

Five domestic and six international pharma majors have enlisted Clinigene, set up three years ago, to conduct clinical research for their pipeline drugs, Dr Arvind Atignal, COO of Clinigene, said.

The 26-bed, 3,000 sq.ft HPU set up with a total investment of Rs 6 crore is located at the superspecialty Sagar Apollo Hospital. The unit will conduct trials in compliance with global ethical and regulatory standards and will focus on bio-availability and bio-equivalence studies of drugs on healthy human volunteers, Dr Arvind said. The BA/BE study unit is located at Biocon.

About Biocon's ambitious project to develop and produce human insulin, he said the clinical results were expected by end-March. The company would then apply to the regulator for clearance for its commercial production.

According to the Biocon CMD, Ms Kiran Mazumdar-Shaw, clinical trials, a vital link in the drug discovery path, can provide an estimated $70 million business opportunity for Indian clinical research organisations and India is being singled out because of its cost benefit, diverse volunteer populations and vast medical pool.

The India advantage lies in the faster enrolment of patients - where the Western players have failed - and will cut the time required to complete clinical trials, she said.