With significant medical infrastructure in its major cities, large pool of trained clinical investigators and ample patient population, India has, of late, made its presence felt in the global clinical research (CR) market. To secure a further distinguished place on the global CR market map, the regulators are moving heaven and earth to expand the clinical research opportunities and strengthen India's position as a centre for clinical research. In our quest to know more about Indian capabilities in clinical research, its regulatory scenario and other aspects, Nandita Vijay interviewed Dr Ferzaan Engineer, chief executive officer, Quintiles India. He provided an overview of the Indian clinical research sector and Quintiles India's operations. Excerpts:


What are India's capabilities in clinical research and the key advantages it enjoys over other developing countries?
In addition to its large patient population across all major therapeutic areas, India has significant medical infrastructure in its major cities and a large pool of well trained clinical investigators. English is the language of medical education and care, making it easier for Western companies to conduct research in India. Also, India has a strong technology infrastructure that can be leveraged to improve the capture, processing and analysis of clinical trial data. India's first class technological capabilities have also played a role in the quick adaption of electronic data capture in clinical research.

As the leading CRO in India, how do you view the current regulatory scenario?
Quintiles welcomes regulations that strengthen standards to protect patients. Since Quintiles opened its first office in India in 1997, we have followed the strictest ethical codes and have been successfully audited by the Food and Drug Administration (FDA). Our standard operating procedures (SOPs) are applied uniformly across the globe. Indian regulators have made significant progress in recent years in terms of clarifying applicable rules, streamlining permissions that are required and publishing guidelines pertaining to patient safety, including requirements from ethics committees.

How would the recent Schedule Y 1 impact the industry?
To the best of my knowledge this is not yet published. Generally, we welcome a contemporary and robust regulatory infrastructure that is efficient, transparent and has the requisite standards for patient safety and data integrity.

Has the current economic slowdown affected the clinical research sector?
Quintiles can only speak for itself. Our business continues strong, particularly in India, where we are experiencing excellent double-digit growth.

How do you see the delay in allowing foreign players to conduct phase 0 (micro dosing) and phase I studies in India?
The regulatory authorities are taking a stepwise approach to expanding the opportunities for clinical research in India. Any new opportunities should be accompanied by strong standards to protect patients.

If foreign players are allowed to conduct phase 0 and I studies in India, what all opportunities would it bring along with it?
We believe additional opportunities in phase I will emerge in the future. However, we can't give a guess as to when. We are planning to open a phase I facility in Hyderabad, where we will do studies that are permissible under current regulations, such as studies of new formulations of approved drugs and food-drug interactions. If and when regulations allow first-in-human studies, we will have the requisite experience, systems and infrastructure in place. The expansion of clinical research opportunities should strengthen India as a centre for clinical research.

Quintiles has been in India for around a decade. What are the latest developments in terms of expansion in infrastructure, projects and manpower?
Quintiles' move into India in 1997 has been very well rewarded. As I mentioned, we are planning to open a phase I facility in Hyderabad early next year. Hyderabad will be our fifth location in India. With phase I, Quintiles India will offer the same services that the company offers around the world. Quintiles has established an ECG lab that operates 24/7 to analyze digital ECGs from investigator sites around the world and about 80 per cent of our clinical trials in India use EDC rather than paper.

We are a centre of excellence for data management with our largest data management centre located in Bangalore and for cardiac safety with our ECG labs located in Mumbai and Bangalore. In 2007, we opened a central laboratory in Mumbai to support our growing clinical research business in India. We now have more than 1,250 employees in India, and we are currently conducting more than 140 clinical trials.

Finally, customers are comfortable working with Quintiles in India. All of the top 20 global pharmaceutical companies do business with Quintiles in India. Established in 1997, Quintiles India pioneered the CRO industry and has four offices in the country (Bangalore, Mumbai, Delhi and Ahmedabad).

The company expanded its Singapore operations in 2008 to meet business demand in the Asia-Pacific region. But, how do you see India as a location for Quintiles' future growth efforts?
India remains a key contributor to Quintiles' sustained global growth. In addition, pharmaceutical companies are outsourcing more of their drug development activities, including data management to India. The strong technology infrastructure in India will be able to accommodate the increase in outsourcing and the growing use of electronic data capture (EDC) and other technologies in clinical research. The pharmaceutical industry needs to transform itself, particularly to improve efficiency in drug development, and the work we are doing in India will make the drug development process better and faster.

Could you give us an overview of the Quintiles' success in India and its strength?
Quintiles has been at the forefront of the growth of clinical research industry in India. Since coming to India in 1997, Quintiles has expanded rapidly. We started doing conventional phase II-III clinical studies, and have added our data management centre, cardiac safety lab, central lab and now we are adding a phase I facility. We have more than 1,250 employees in India. We also have helped develop the drug development infrastructure within India, training investigators in good clinical practice (GCP) guidelines.

What are the company's key strengths in bagging the trials?
Customers appreciate the value they receive from Quintiles. We follow global standard operating procedures that improve efficiency, while maintaining the highest quality standards. Besides, our global knowledge and expertise help to identify issues before they become problems. We have been leaders in the adaptation of new technologies such as EDC to clinical research, and in the creation of global standards to optimise the capture and processing of data. We have been pioneers in India and throughout Asia, so our understanding of the market is quite deep.

What are the likely future efforts emerging from the India operations?
We will continue to strengthen our traditional services, which are growing rapidly. We will continue to leverage technology to transform the clinical development business to help our customers develop safer, more effective medicines faster. Also, we will continue to look at new technologies that may be useful in improving the drug development process.