Many frontline US pharmaceutical companies are seriously looking at low cost countries, particularly India, to entrust soon about 30 per cent of their Clinical Pharmacology bio-analytical requirements, clinical trials and support services every year. But, the US companies have to be satisfied with the infrastructure, standards and capabilities of the Indian firms, a high level source close to the US companies told Pharmabiz. However, he added, relaxing of India’s regulations pertaining to first in man studies of molecules developed outside India will also be a critical factor in this decision. The source, now in India and in the process of identifying potential Indian CROs and studying the existing regulatory mechanisms, said on condition of anonymity, at least one US company might soon initiate on-site assessment and discussions with the Indian companies based on the initial feedback, once zeroed on select few companies. At present, a typical large multinational pharma company may conduct 30 per cent of the bio-analytical studies and phase I clinical trials within US, 30 per cent in Europe, 10 per cent in Japan and the rest 30 per cent conducted mainly at lower cost centres such as Poland, Russia, Singapore and Hungary. Most of the US pharma majors have their own phase I trial centres in Europe, US and other major centres, and about half of their work is outsourced to other companies. Global pharma companies may conduct 2,000 to 5,000 Clinical Pharmacology studies each in a year, and if even 10 per cent of all such studies are relocated to India, this number will be ‘significant,’ according to the source. The US companies reckon India to be a major market in future considering key factors like advantages in language and communication capabilities, availability of trained manpower, data transfer facilities, and above all, feel India could be cheaper to about 50 per cent in comparison to the expenses in developed countries.
