Clinical research has grown exponentially over the past decade in India because of cost advantage, treatment natïve patient, qualified doctors conversant in English etc. India was the second most preferred country to conduct clinical trials outside the US in 2009. However, recent years have witnessed a decline in number of trials in India (529 in 2010; 253 in 2012). The number of drugs entering the Indian markets had been gradually reducing even before the current slump in clinical research activity (270 in 2008;140 in 2011; 44 in 2012 and 25 in 2013). This necessitates a relook on the strategy so as to optimise clinical research in Indian context. The problems and possibilities around the clinical research arena can be broadly grouped as capacity building issues and ethico – regulatory ones.
In India, Drug Controller General (India) (DCGI) is the competent authority for approving clinical trials as well as manufacturing and marketing drugs. DCGI grants approval after appropriate clinical trials are conducted in India with adequate number of trial subjects. To begin with, there are scant training resources to train adequate number of researchers so as to carry out research activities as per the international standards. There is a need to build dynamic training modules and platforms which confirm to international regulations and best practices while addressing peculiar national needs. The training infrastructure needs to be flexible enough to accommodate ever changing regulatory landscape. We have a thriving knowledge base of traditional medicine systems which cater to a large segment of the population are regulated by a separate Department of AYUSH. There is a requirement of involving AYUSH practitioners in collaborative research and reorient the research regulations so as to effectively monitor research in AYUSH. Recent draft notification regarding regulations for ‘Phytopharmaceuticals’ is a step in this direction.
Though India has a robust regulatory apparatus, it is perceived that Indian patients being poor and less informed are vulnerable. While isolated instances of unethical clinical trials cannot be ignored, a more informed debate and perception management is the need of the hour. The confidence building amongst all stake holders has now assumed paramount importance. Read More
