Right for Everyone?
India does have some gaps in its drug discovery and development offering. The perception is that medicinal chemistry is well established, while preclinical research is still being developed, and Phase I studies are beginning to be set up. Relatively straightforward repeat organic synthesis works well, but we have not tried larger-scale medicinal chemistry projects, Dr. Rees commented, Also, we have found with organic synthesis, the timelines are sometimes longer than in-house, mainly because deliveries from chemical suppliers are sometimes slower in India and can hinder the progress of work.
According to Dr. Furr, areas, such as drug safety, are also limited, as there are not enough facilities offering primate studies and DMPK analysis. However, with a large preclinical testing center at Hyderabad planned, this could all change. Additionally, Phase I studies are currently only allowed for drugs of Indian origin.
At the ERBI meeting many speakers agreed that for those companies looking for opportunities to outsource chemistry, produce drugs for diseases of developing countries, or set up later-stage clinical trials, India offers much more than just cost savings.
Large companies never have an even workflow, so it is essential to outsource some peaks of activity, while still maintaining the knowledge base in your company to resource for the troughs, Dr. Furr explained. In this respect, India offers great value as it has well-trained and committed researchers.
Some Western companies have regarded India as a no-go area because of problems with protecting their intellectual property, Jeanette Walker concluded. But with the signing of the World Trade Organization Trade-Related Aspects of Intellectual Property Rights agreement, India is really committed to removing that last stumbling block.
This will, I believe, encourage European companies to consider dealing with Indian biotechs on a much deeper level. Because of the skills of its scientists coupled with a strong desire to develop its own pharma industry, India is becoming more than just a place to offshore your chemistry. As Dr. Shaunaks collaboration with Shantha shows, it can offer an excellent opportunity to out-license technology, and I would encourage European companies to consider this avenue more actively.