Lotus Labs has just received an approval from Drug Controller General of India (DCGI) to carry out the bio-equivalence studies according to the guidelines laid down by the international council of organisations.

V.V Raghavan, managing director, Lotus Labs told Pharmabiz.com that the DCGI consent was an achievement and a significant effort for the company's pursuit as a clinical research organisation. "We have just fulfilled a mandatory requirement and our next action plan is to apply for UK MCA and US-FDA approval. We will now project ourselves in the European countries for conducting Phase I and Phase III trails apart from aggressively marketing ourselves in the US, " he added.

The company has moved into its new facility in Koramangala, Bangalore where in an area of 9,500 sq. ft., it has invested around Rs. 1 crore to under take bio-equivalence studies and clinical trails. Incidentally, it has retained its earlier outfit located in north Bangalore for clinical purposes. By end of September 2002, Lotus Labs will install its second LCMSMS to speed up the studies. It has so far completed 100 bio-equivalence studies and plans to move on to conduct phase III trails for companies abroad before November 2002.

We have been conducting several bio-equivalence studies for US-based companies and now we are receiving enquiries from Israel and Germany for conducting bio-availability studies.

Lotus Labs will also be participating in CPhI, Paris commencing from October 1-3, 2002 where it will put up a bigger stall to market its capabilities to a larger audience.

With over 1,500 volunteers available in its data bank, the company has made volunteer recruitment a full time affair, informed Raghavan.

The negotiations for conduct of clinical trials- phase I and Phase III with Bangalore's leading missionary hospital and medical education centre- St. Johns Medical College and Hospital is expected to be through by next week.

In association with a leading Bioinformatics major, in Bangalore, Bigtec, the company has been engaged in the development of a biometric identification software known as Clinical Trial Data Management Report System (CTDMRS) which is scheduled to be operational next week, informed Raghavan.

The unique software CTDMRS can create an impression of the thumb, which helps, to prevent duplication of volunteers. The extra security features of the software are an advantage as clients abroad will be convinced of the studies.

The company plans to enter into drug discovery going in a few years and is in a dialogue with premier research institutions abroad after it has been recognised for its entire gamut of clinical trial phases. "Our main revenue earner is clinical trails programme phases," informed Raghavan.

Lotus Labs is making a concerted effort to establish its credibility in its studies and trials. "In the next five years, we hope to be the foremost clinical research organisation in India and a top ranking CRO in Asia.

The company has registered a four times growth rate since its inception in December 2000 where its current turnover is pegged at Rs. 2.6 crore and is confident of Rs. 8 crore financials by the end of March 2003.