ACRP to open new chapter in India

Fresh graduates in medicine, life sciences and pharmacy can now have a US affiliated post-graduate route to help in the development of future blockbuster drugs. The Association of Clinical Research Professionals (ACRP), the apex body in the US that monitors and sets up guidelines for clinical research, is all set to come to India.

The ACRP would bring in courses that would prepare Indian men and women to sharpen skills required at various steps of conducting clinical research and trials in India. The first institute has been set up in Pune, and will have a batch of 50 students starting this year.

According to international norms, every potential new medicine has to undergo rigorous trials on animals and humans before it is even considered for marketing. Human trials, which are conducted over many years and many countries, require specialised training for people conducting the trials.

This specialised training is in most cases taken care of by the sponsor company, the one that is trying to bring the new drug out. People working on these projects are generally graduates in life sciences or pharmacy.

According to the industry data, at least 35,000 clinical research professionals are required by a rapidly growing clinical research and trials industry in India. Currently, there is no certified training institute in India that offers such courses.

'We expect to open at least 25 to 30 institutes in India in the coming years, and are the only affiliates of ACRP in India,' said Dr Praful Naik, head of research, Bilcare, which is investing in setting up the ACRP affiliated institutes in India.

However, the institute's qualification would be equivalent to a post-graduate diploma and not a full-fledged degree, he said.

The Bilcare Academy would have fees of three lakh for the one-year course that would have hands on training, apart from theoretical classes for students, said Santosh Hegde of Bilcare.

According to Bilcare, all students clearing the course would have ACRP accreditation enabling them to participate in clinical trials and research anywhere in the world.

The company is spending about ₹20 to 30 crore in setting up the institute which would provide placement services to students, said Dr Naik. The company's main business interest is in speciality pharma packaging and research, and it targets ₹100 crore by 2010 from the revenues.

Email author: suprotip.ghosh@hindustantimes.com