Lotus Labs, a subsidiary of Iceland based Actavis, has commenced a large dermatology clinical end point trial in 35 sites involving 1,100 patients. Regulatory permissions have been received for this trial and the sites selection process has been completed. This trial is conducted for US submission and is undertaken on behalf of a US-based multinational company.

The key purpose of the trial is to evaluate clinical effectiveness of treatment for acne. The trial will last for about nine months.

The company has conducted several phase-I to phase-III clinical trials in the areas of neurology, cardiology, vaccines, dermatology, tropical diseases, anti-infectives to name a few for submissions in India and abroad.

"Many large trials are coming our way and these are expected to take off in the next few months. We will be undertaking trials in the areas of neurology, and dermatology involving multiple centres and large number of patients," stated Sudhir Pai, commercial director, Lotus Labs.

The company is growing at the rate of 50 per cent this year and has completed more than 1500 studies till date. So far we have gone through 36 regulatory audits successfully. In 2008 alone, we had six regulatory audits including two from US FDA Both the audits were completed without a single regulatory observation or non compliance, he added.

Lotus has facilities in four locations which cover three units in Bangalore and one at Chennai. The total bed capacity is 350 and the facility is equipped with 12 LCMS MS machines. The Scientific Data Management System used for reporting is CFR Part 11 compliant.

In mid 2007, Lotus Labs received approvals during two audits conducted by the regulatory authorities of Austria and Brazil. In 2006-07, the company went through five audits of which three were US FDA. In addition, there were also regular client audits taking place at its premises.

The company had allocated last year Rs 20 crore for facility expansion. Around Rs 6 crore was set aside for a new facility at Basawevaranagar in north Bangalore spanning around 6,500 sq ft Another Rs 4 crore was spent for the installation of LCMS.

Further, the company also went in for a new clinical unit spread over an area of 30,000 sq ft facility on the Hebbal Road in Bangalore at an investment of Rs 3 crore. This 100-bed facility has taken the total bed strength of Lotus to 350.