Lotus Labs, a leading player in clinical research and a subsidiary of Iceland-based Actavis Group intends to step up its activities in India by focusing on clinical data management (CDM) and pharmacovigilance.

The company is in the process of devising a business plan to tap potential opportunities in this area. For the last nine years, Lotus Labs has proved its capability in bioavailability, bioequivalence and various pharmacokinetic studies and clinical development including data management,, biometrics and clinical trial lab services. “Now, we are in the process of assessing capabilities to increase presence in CDM,” Dr Yati Chugh, managing director, Lotus Labs Ltd, told Pharmabiz

“While we will continue to strengthen out capabilities and offering in the space of Bio equivalence, clinical trials, Pharmacokinetics and statistical services, we intend to look at Data Management services in a big way. Although Bio-analytical services provides a major component of the revenues, our expertise in medical writing, generation of accurate, and consistent trial data in compliance with regulatory guidelines can help us to increase focus on CDM. Going by the available scientific acumen and low cost of skills, this segment is the future for India’s clinical research space,” said Dr Chugh.

Presently, CDM majors in the country include Quintiles, Parexel and Clinsys. As an India-based CRO, the company intends to strengthen its position in CDM. Another focus would be Pharmacovigilance, added Dr Chugh who joined Lotus Labs early this year.

In terms of infrastructure, Lotus Labs currently has a total bed strength of around 360 beds spread across its three facilities in Bangalore at its corporate headquarters in Vasanth Nagar, St John’s Medical College Hospital, Jakkur and at Chennai. “We will roll out expansions depending on the third party business orders. Within another three months, we will be able to share the growth initiatives,” said Dr Chugh.

In terms of personnel strength, Lotus Labs has around 420 people and is looking at hiring in the areas of clinical research, business development and quality assurance.

Commenting on the clinical research in India, he said that the sector registers considerable growth because of better competitive costs which makes it much-sought after by multinational companies to off load trials to India. However, a serious issue to be handled is the misconception among the non-governmental organizations which are opposing to human studies.

The government of India will need to speed up its permissions for conduct of clinical trials. There is need to permit phase-I studies for new chemical entities from developed by global companies. While US FDA consents Indian companies for phase-I, the irony is that international CROs are not allowed to conduct the same here. If Indian regulatory authorities permit this, then the CRO industry is set to experience significant growth, pointed out Dr Chugh.