Bangalore, April 16, 2007: “India has all the competitive advantages for conducting clinical trials. As the country is increasingly becoming a favored destination for clinical trials, a gap analysis needs to be done to scale up all resources for clinical trials. This scale up is essential for India to cope with the large global clinical trial projects,” said Dr Narges Mahaluxmivala, President, Clinical Development Services, Quintiles, at the recently concluded ‘Conference on Clinical Research and Development in India’. The Institute of Clinical Research India (ICRI) in association with the Department of Science and Technology of India hosted the event for the first time in Bangalore, India. The conference was preceded by a two-day training workshop on Pharmacovigilance organized by ICRI and World Health Organization (WHO).

 

At the two-day conference, held between April 14 and 15, 2007, national and international delegates put forth a gap analysis in clinical trials in India. It is a well-known fact that the world is looking at India as a clinical trial destination of choice. However, is India capable of handling large, complex clinical trials? Twenty-five speakers at the conference highlighted important issues that India must pay immediate attention to handle large clinical trial projects effectively and to sustain a steady growth in the clinical trials market.

 

“It is pertinent for Indian companies and research institutes to meet the large demands put on them in clinical trials in an effective way. India has a great potential for serving the world and this is the right time for it to gear up and strengthen its regulatory requirements and manpower,” said Dr Sten Olsson, Chief WHO Program Officer and Head of External Affairs at the conference.

 

The conference largely focused on overcoming the existing barriers in conducting clinical trials in India. Dr Anoop Agarwal, Principal ICRI, Mumbai, said, “The objective of organizing a workshop is to train clinical trial investigators and professionals in India on pharmacovigilance and adverse reaction monitoring. The conference aimed at overcoming technical, regulatory and political barriers in clinical trials.”

 

There is a large influx of clinical trials from across the globe heading towards India. Major pharmaceutical companies and global Contract Research Organizations (CROs) are expanding staff and business activity in India. In this situation, it is mandatory for India to tackle issues to sustain in the industry keep other competing countries at edge.

 

Infrastructure: Creating large-scale exclusive clinical trial facilities in India are a must. There is a need for hospitals to create special beds for clinical trials. Research institutions and pharmaceutical companies should establish clinical trial centers that do not overlap with the existing R&D facilities.

 

Manpower: There is an acute manpower attrition in India. Qualified and experienced clinical trial investigators are the need of the hour. Experienced investigators who can take decisions in adverse situations have to be strengthened.

According to Dr Vijai Kumar, President Excel Life Sciences Inc., USA, India presently requires about 4,000 experienced Principals Investigators for major trials.

There is a requirement for experienced nurses, biostatisticians, researchers and coordinators in every clinical trial, and India must train the manpower available in these areas to suit clinical trial evaluation. India has a crunch in auditors, who can audit the effectiveness of a clinical trial.

 

Data Management: Effective data collection, storage and maintenance need to be strategically adapted in India. Electronic data storage and analysis need could help streamline some cumbersome process and would also save significant time.

 

Regulatory Compliance and Ethical Issues: “India needs to implement a robust GCP-compliant ethical framework and environment,” said Dr Nermeen Varawalla, Vice President Corporate Development of PRA International. Although, the Indian Government has revised the ethical guidelines for clinical trials in 2007, CROs must practice and follow the guidelines diligently.

 

A number of such issues are bogging down on clinical trials industry in India. It is essential for the government to work in coordination with CROs, regulatory bodies and patients to help India gain the earmark as the best destination for clinical trials. The conference did set a platform to create the necessary awareness among the CROs who participated in the workshop and conference.