As India emerges to become a key destination for conducting clinical trials that are vital for marketing drugs and diagnostic devices, numerous Contract Research Organizations (CROs) are setting up base in the country. A recent entrant is Manipal AcuNova, a collaborative venture between Manipal Education and Medical Group (MEMG) International India and AcuNova Life Sciences Pvt Ltd gearing up to grab a significant share of the global and local business. The company finds itself in an advantageous position with the advanced hospital infrastructure and clinician support that is expected to give it the much-needed edge in the market.

D A Prasanna, Vice Chairman & Managing Director, Manipal AcuNova, states in an interview with Nandita Vijay of Pharmabiz that intellectual acumen, reliability and cost-effectiveness would be the biggest strengths of the sector and his company would be in a position to deliver customer expectations. Prasanna, an alumnus of IIM Ahmedabad & GE Global Business Leadership Program at Crotonville, was the founder member of the Wipro team that initiated the company's entry into IT, served as the CEO of GE Medical in India, after which he became Executive Chairman, Manipal Group. In addition, he serves on the board of various pharma companies and research institutes. Excerpts:

How would you describe the present scene of clinical research in the country?

It is a three-year-old industry in India with a global approach, which is a good sign that CROs here are just not serving companies in the country but are looking at international horizons. The advantage of intellectual acumen, reliability and cost-effectiveness will be biggest drivers of this industry. CRO is an emerging industry gearing up for a global presence.

What makes Manipal AcuNova an ideal setting for clinical trials?

Each of the centres at Bangalore's Manipal Hospital and at Kasturba Medical College (KMC) Manipal is located in unique environments having the support of the super specialty hospitals with a 'patient-physician' availability. The Bangalore facility has access to the stem cell research and genetic centre and will serve as a contract research organization (CRO). The one at Manipal has the bio-analytical and bio-equivalence centres. In addition, the University of MAHE provide all the resources including the animal house and Pharmacogenomics core facility situated at the KMC Life Science set-up under the research and development scheme from the Department of Science and Technology (DST) and Technology Information Forecasting and Assessment Council (TIFAC), Government of India, which will also add value to its existing technological and clinical expertise to provide special insights into drug efficacy. KMC Manipal AcuNova and Manipal AcuNova at Mangalore, will serve as clinical reference labs. What is interesting is that, even if Manipal AcuNova does not own all these, we can have access to the centres. This makes us operate in an ideal intellectual environment and creates a big difference when we take up a broader range of research issues.

What are the kind of services offered by Manipal AcuNova?

Primarily KMC will focus on bioavailability and bio-equivalence (BA/BE) studies, phase I to III trials performed for generic drugs, new drug delivery systems and new chemical entities. We can do special studies like research into the drug performance with reference to the genetic background of patients to assess efficacy parameters. There is a need for such a kind of services because India is becoming a major player in the generics market. Many countries want detailed and authentic information of their products to enter the regulatory markets. There is an increasing requirement of this service.

To handle such critical areas of research calls for ample professionals who are qualified, intuitive and trained. Does the country at the moment support such talent?

This is a knowledge intensive industry looking out for quality of manpower so we employ PhDs, postgraduates and medical doctors in the field. We have strength of 75 people at the moment, out of which 25 are in Manipal. We need not have lot of supportive staff because it will be provided by the MAHE. We have employed another 20 in Mangalore and 30 in Bangalore.

What will be the future investments at these centres?

Investments will depend on the response from the clients. It is vital to be perceived as a reliable and prompt research institute to bag the research sponsorships. In fact the criteria which sponsors adopt for selecting CRO is the speed to complete an assignment, access to right regulatory clearances and being cost competitive.

In that context, for regulatory approvals, there is a need to progress from Indian regulatory certifications to US and Europe and in the meanwhile, also seek approvals from Brazil and Australia authorities. A timetable needs to be developed to ensure that each step is cleared. At times, clearances are sought when we get clients from those countries. For instance, if we get a US client, before he comes and audits, we make sure to conduct a pre-audit by a certified foreign expert who could pinpoint the lacunae which could be rectified. So when the client comes for audit we give him full disclosure. So even though we don't have a US FDA certification, the fact that we have gone through a methodology for compliance gives the client the added confidence on our service. If the regulatory authority accepts his drug file, it automatically means that we are capable of delivering a US FDA compliant service.

Could you throw more light on the joint venture of Manipal and AcuNova?

AcuNova Life Sciences is basically a terminology given to its employees who have also contributed their share of money that represents a sign of intellectual hospice. Our total funds mobilization was Rs 50 crore. The three centres came up at an investment of Rs 15 crore each and we will continue to invest. With a US subsidiary, we are trying to create a global delivery model on-site. We are open to creating those on-site facilities for large clients requirements and are in talks with customers to offer a seamless delivery solution in clinical research.

In the wake of stiff competition, how does Manipal AcuNova stand apart?

Broadly CROs are classified into three categories: Large companies having a global presence and serving as sponsors for phase III trials for a three-year phase, national presence and the university born CROs which operates. There are lots of them operating at the University of Pittsburg, Harvard. We are positioning ourselves like that. This is a base emerging out of intellectual India.