Law on biomedical research soon
The draft ethical guidelines on biomedical research on human participants chalked out by Indian Council for Medical Research (ICMR) may soon become a law. The move comes at a time when India is increasingly being eyed by global pharmaceutical companies for clinical studies.
The draft proposes to prevent the pharmaceutical companies from conducting clinical trials without prior approval from the accredited Ethical Committee. The panel of experts during the seminar on meeting challenges and actualising the potential in clinical trials held on the third day of Bangalore India Bio on Friday, pointed that Asia would become the second largest pharmaceutical market in a decade, with India and China playing a crucial role.
Dr Ferzaan Engineer, CEO, Quintiles Research India, felt that while China was way ahead of India in Research and Development (R&D), India was strong in clinical drug development and IT. "Hence, both India and China compliment each other and need to work together,” he said.
He said when India started conducting clinical trials, it was mostly outsourced work. However, now a full cycle of research was being done in Asia. Innovation possibility, development of drugs and finding market in Asia itself are being thought of now, he said.
Managing Director and Founder of Ecron Acunova, D A Prasanna cited size of population, knowledge of English, disease burden, naive patient advantage and western medical education as the advantages that India had over other countries in attracting pharma companies for clinical trials. However, he noted that India does not have a significant share in the biopharma market.
For instance, Poland which is much smaller than India registered 2,328 clinical trials till December 2009, as compared to India's 1,256 trials. This was 50 percent more than what was being conducted in India, said Prasanna. Compliance to EU and US laws, building therapy area competence to certain depth, need to graduate to phase 3 trials and increasing the area of expertise were some of the ways forward, he said.
Prasanna revealed that while there was no apex body to accredit investigators of clinical trials, FDA recognition to doctors acting as investigators was available. Seventy per cent of FDA accredited investigators are in South India out of which 30 per cent are in Karnataka. He added that Karnataka, Tamil Nadu, parts of Andhra Pradesh and Maharashtra were doing most number of clinical researches at present.
DH News Service
