The Union health ministry's long awaited proposal to accord permission to drug companies to conduct phase-I clinical trials in the country for which molecules were developed outside India is stuck between the technical experts and the political powers. While the technical experts in the ministry are in favour of according immediate permission to conduct phase-I clinical trials, the political powers led by the minister are showing reluctance fearing public outcry against the move.

Sources said that the technical experts in the ministry, including Drug Controller General of India (DCGI) Dr Surinder Singh are in favour of immediately allowing the drug companies to conduct phase-I clinical trials in India, which has been a long standing demand of the big pharma companies, especially the big multinational companies who will be the major beneficiaries of the government decision.

But, the political powers led by union health minister Dr Anbumani Ramadoss are not in favour of according permission to conduct phase-I clinical trials immediately, which the successive central governments have been withholding on the plea that the decision will make Indian subjects guinea pigs as it is in the phase-1 trials a new drug is introduced to the humans for the first time.

The political powers fear that in the wake of the unfortunate incidents involving the AIIMS and Wyeth which brought into focus the entire gamut of safety of clinical trials especially the phase-1 trials, any move to introduce phase-I trials will only create public outcry. With the general elections just round the corner, the political leaders do not want to drag the government into another controversy, especially an issue involving the public health.

In fact, the ministry had prepared a draft proposal in this regard providing guidelines while conducting phase-I trials in India. 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. Health experts and NGOs are opposing the draft proposal on the plea that 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.

The pressure from the big companies is understandable as phase I trial is a huge business of multi billion dollars. 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, a large part 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, cheaper manpower and an English speaking people. So far, phase-I trials are approved by the government for such drugs which are discovered in India only.