Lotus Labs, St. John's Medical College to jointly set up drugs trial centre
The Bangalore-based Lotus Labs will shortly tie-up with St. John's Medical College to set up a drug trails facility. The company is receiving a venture funding to the tune of Rs. 5 crore which will help to plan its future expansion plans, V.V Raghavan, managing director, Lotus Labs informed.
The tie-up calls for setting up a facility in the premises of St. John's Medical College campus. The facility will have a drug trails centre to conduct bio equivalent and bio- availability studies for major pharma companies in the country and abroad. Lotus Labs has been conducting clinical trails. So far it has been engaged in 23 projects. Lotus Labs is the first clinical research organisation in the country engaged in phase 3 and phase 4tails and the fourth in the world engaged in such trails.
The bioinformatics division of the company will develop clinical trails data management software to be used for clinical and analytical labs. The technology edge, which sets Lotus Lab apart for major pharmaceutical companies to assign clinical trail assignments, is that all guidelines under ICH and US-FDA are strictly adhered to.
The sources informed that all the protocols meet international requirements and the clinical studies carried out can be used by pharma companies for submission to regulatory authorities in several developed and developing countries. "We cater to all clientele in India and abroad in carrying out clinical studies strictly in accordance with ICH guidelines and GCP norms, " said Raghavan.
Currently, the infrastructure at Lotus Labs includes a clinical area with volunteers, qualified physician as a clinical investigator, computerized volunteer data bank, emergency handling equipment, association with leading hospital for handling emergencies, etc. The Bio-analytical lab is equipped with LCMSMS, HPLC's with Auto sampler, Auto Injector, Solid Phase Extraction Unit, GC, Refrigerated Centrifuge, Deep freezers etc and is manned by trained Bio-analytical chemists.