A Bangalore-based company specialising in clinical trials is taking advantage of the recent change in intellectual property laws.
As part of a World Trade Organization agreement signed in 1995, India has committed itself to honouring product patents from 2005. This change in intellectual property law is expected to boost growth in the clinical trials market. Previously, India's patent laws only recognised processes, with no specific requirement for clinical trials. As a result, most of the 20,000 or so pharmaceutical companies in India today make generics.
But as foreign companies expand into India, expertise, and business, will continue to grow. Take Lotus Labs Ltd, a private limited company based in Bangalore. This subsidiary of Actavis, a $600m company headquartered in Iceland, was founded in February 2001, and specialises in bioequivalence studies and clinical trials. In the last four years, it has completed more than 500 bio studies and several Phase III trials.
Lotus has three clinical facilities, including a state-of-the-art 12-bed unit for Phase I trials located on the 25000ft2 campus of St John's National Academy of Health Sciences in Bangalore, a 1200-bed hospital covering everything from paediatrics to cardiology to oncology to obstetrics. Lotus's two other facilities offer 7000ft2 and 52 beds of capacity and 12000ft2 and 78 beds of capacity, respectively.
Lotus uses state-of-the-art equipment such as LCMSMS and HPLC. It has six LC-MSMSs, four HPLCs, and more than 120 fully developed and validated methods.
Lotus's clinical laboratory focuses on haematology, biochemistry, serology, urine analysis, and ECG screening and analysis of healthy volunteers and patients. The company is currently conducting several global multicentre trials. It has access to leading medical institutions, highly qualified investigators and well-trained monitors for the conduct of GCP-compliant trials. The main areas of focus include cardiovascular medicine, oncology, dermatology and neurology.
Lotus has about 250 skilled and fully trained personnel for conducting clinical studies (bioequivalence and Phase III), bioanalytical, pharmacokinetics, statistical analysis and reporting.