The R&D plan, focused on diseases affecting poor nations, is expected to be ready by 2008 and may benefit Indian drug firms and contract research organisations in a big way.
The model, being discussed by the Inter-Governmental Working Group (IGWG) of the WHO, focuses on identifying potential drugs for diseases like malaria, TB and dengue and developing them with the assistance of public-funded research organisations.
The clinical trials will be carried out by collaborating with contract research organisations and manufacturing through partnerships with the drug firms that are interested in products that have a market value between $100 million and $500 million. Institutions like Indian Council of Medical Research (ICMR) will be the key link in such projects.
According to WHO sources, Indian firms stand to benefit tremendously due to their manufacturing strengths, emerging clinical trial expertise and the presence of a huge population for almost all diseases that are predominant in developing countries.
"Global drug discovery firms aiming at blockbuster drugs normally ignore medicines that have a market potential of less than $500 million. Even mid-sized global firms are not interested in drugs that contribute less than $100 million. Indian firms, which have successfully been tapping low-value, high-volume drug opportunities, will find this an excellent business option," said a health ministry official.
There are at least 25 Indian pharmaceutical firms and an equal number of contract research organisations that will benefit, officials say. Lupin, for instance, might be the first choice for any research collaborator when it comes to TB drugs, they added.
According to officials, the model is already working through the Drugs for Neglected Diseases Initiative (DnDi), an NGO floated by global research organisations, including ICMR. The Medicines for Malaria Venture's (MMV's) tie-up with Ranbaxy to develop a malaria drug is another initiative in this regard. Though the MMV stopped sponsoring the research mid-way, Ranbaxy is going ahead with its research with central government funding.
On the other hand, major funding agencies like Bill & Melinda Gates Foundation, Clinton Foundation and health NGOs like Medicines Sans Frontiers (MSF) are keen to support such collaborative research. Bill Gates Foundation had last year announced grants worth $68.2 million to help accelerate research on neglected tropical diseases.
The IGWG, whose vice-chairperson is India's health secretary, is in the process of exploring various models that could help achieve faster and cheaper drug development for diseases.
The inter-ministerial consultative group on public health, innovation and intellectual property of the central government is to meet next month to finalise its recommendations to the IGWG.
