Even as the Union health ministry is seriously considering to allow permission to conduct phase I clinical trials for molecules developed outside India, medical experts and NGOs are bracing up themselves to oppose the move on the ground that the government move will make Indian subjects guinea pigs for the benefit of multinational companies.

Voicing concern over the development, well known health expert Dr CM Gulhati, who is also the Editor of the medical journal MIMS, said that the government move will put many poor and illiterate patients in India in grave risk. The draft is so loosely worded that it can be interpreted the way it suits drug companies and other vested interests both at home and abroad.

As per the draft proposal, new drug substances can be tried on human subjects in India if there is agreement between the foreign innovator and an Indian firm to jointly develop the substance. Dr Gulhati said that since the nature of agreement is not specified in the draft, a foreign drug company can sign an agreement with an Indian company by paying an annual fee to become a partner in drug development. Since there are a large number of pharma companies in India, such a thing is not difficult. Another major issue is that the draft did not define who is an Indian company, Dr Gulhati said.

Apart from the medical experts, NGOs working in the health sector such as Lawyers Collective and Medicines Sans Frontiers are also opposing the government move. "We are studying the draft proposal and will oppose it as it will make the Indian subjects as guinea pigs just for the benefit of some of the big foreign companies", spokespersons of these NGOs said. However, they refused to further divulge their plans.

Around 2000 new molecules are at different stages of development in different parts of the world and are almost ready for the phase I trials. Once the government gives its green signal, many of them are expected to reach in India for trials as the country is becoming a clinical research hub due to several favourable conditions like availability of skilled manpower, varied ethnic groups and cheaper manpower. So far, phase I trials are approved by the government for such drugs which are discovered in India only.