India’s clinical acumen and quality of healthcare infrastructure designated to conduct human studies are two key parameters which have impressed US FDA officials. The country is an important destination for clinical trials not just for a patient pool but the expertise which it has armed with in terms of personnel and hospital sites, said Dr Steve Wilson, director of Division Biometrics III, Centre for Drug Evaluation and Research, US FDA.
Going by the importance of the India as a hub for pharma research and manufacture, US FDA which set up an office here is now assessing India’s strengths. “We are here to learn and make available answers to the government of India’s Ministry of Health and Family Welfare, Drugs Control General of India office on the areas that need to be attended to strengthen the sector,” Dr Wilson told Pharmabiz.
US FDA has gathered India’s efforts in research for drugs in tropical diseases and reverse engineering capability with molecules and orphan drug studies. There is a huge pool of potential pool of life sciences entrepreneurs who have been successful. From a perspective of a developing world, India has made a mark in clinical research, added Dr Wilson. “However there are global trial issues associated with ethics.
We are confident that Indian regulator will iron out these challenges, because we understand the complications and complexities in the conduct of clinical research. We are looking at India’s capability in terms of physicians and site management and intensifying efforts to encourage adoption of highest standards of science and ethics,” said Dr Wilson.When asked about the opportunities for India with the recently announced US Healthcare Bill, Dr Wilson said personalized medicine and bio-similars/biogenerics have the huge challenge of proving ‘comparative’ efficacy. The need for data submission at every stage can help such companies engaged in bio-similars and generic formulations to make a mark in US.
