Lotus Labs, the contract research major had a team of inspectors from l'Agence Française de Sécurité Sanitaire des Produits de Santé (Afssaps), a French Health Products Safety Agency for an inspection of the premises in Koramangala in Bangalore on July 7 and 8, 2003. This is for the first time in the country that a team of inspectors from France visited India for an audit of a contract research organisation (CRO). Lotus Labs was seeking marketing rights in Europe for its services and Afssaps intimated them that they were keen to come in for an assessment of the company.

The two-day audit was stringent and tough. The French team closely inspected the facility and analysed every single document of the standard operating procedures. The report of the inspection would be sent from France, V V Raghavan, managing director, Lotus Labs told Pharmabiz.com.

Usually the assignments for European companies do not require an inspection of premises, however, the visit by the French audit team is important for Lotus Labs to bag future assignments from Europe, said Raghavan.

"Once this approval is sought we are confident of several enquires and many of them would be converted to concrete business propositions in clinical trails," he informed.

The company had participated in a Clinical Trials Research seminar-cum- exhibition in Hungary early last month and received a lot of enquires from US and Europe for bio equivalence studies apart from enquires in Phase I.

According to Raghavan, to convert a bio equivalence enquiry into a final contract it takes a minimum four weeks on the other hand if it is a Phase I or Phase III trails, the minimum time required for finalisation was between three to six months.

Between February 2001 and June 2003, Lotus Labs conducted 230 bio equivalence studies.

Currently, Lotus Labs is conducting studies on a cardiology drug that is being tested on 600 patients at three hospitals - St. Johns Medical College Hospital, Wockhardt Hospital and Heart Institute and Manipal Heart Foundation. For the Phase III trails there are around 3- 4 projects under negotiation. Among the ongoing Phase III assignments are for a gastroenterology drug, a study on hypertension drug for the University of Canada and a trails on lifestyle disorders (hypertension and diabetes) for a multinational company where the study is spread over 12 centres.

The main strengths of the company is its technical pool, infrastructure including the installation of software which eases the generation of trails reports like for instance- Winlonlin which is pharmacokinetic software, SAS 8.0 version for statistics and a Clinical Trial Data Management Report System (CTDMRS) used for or biometric identification. It was developed in-house in association with Bigtec, a bioinformatics company.

As part of its expansion plans the company appointed a Chief Scientific Officer, Dr Gopal Muralidharan who has over 20 years of experience in Phase I Clinical Trials to head the Phase I project at Lotus Labs which will now be conducting a study in the next six months for Wyeth Ayerst, a research-based, global pharmaceutical company. It will be shortly opening a corporate office which is close to its present centre in Koramangala, and in the next few months the construction of its facility at St. Johns Medical College Hospital is scheduled to take off on the 20,000 sq. ft area where 56-bed facility is expected to come up for conducting Phase I trials and a few bio equivalent studies. In addition, the company is also working for a US multinational company for interpreting assignments where Lotus Labs is assigned to interpret and collate clinical trails submit the data report.

The company's manpower strength increased from 33 in 2002 to 67 in June 2003 and will be 75 in August 2003. Several technical people are hired in the core clinical research areas. It also plans to start another centre in North Bangalore which is a 25-30 bed facility for conducting trails on patient population where six to seven studies are expected to be conducted. The company registered a turnover of Rs. 6.85 crore ending March 2003 and between April-June 2003, its earning amounted to Rs. 2.5 crore. We hope to close the financial year ending March 2004 with revenues generated to the tune o Rs. 13 crore, said Raghavan.

According to Raghavan, the main issue to be handled in the area of clinical trails in India is the need for an awareness campaign which highlights the importance and indispensability of drug trials on humans. He lauded the simplified import procedures for clinical supplies, which is now a boon for CROs to get foreign companies conduct trials through simple and fast approvals in India.