The Union Health Ministry may allow phase I clinical trials for the drugs discovered abroad soon, it is learnt. Currently, phase I trials cannot be initiated in India for new drug substances discovered in other countries unless phase I data from other countries is made available to Indian authorities. The DCGI, however, gives approval to phase I trials for drugs developed in India.

The Drug Technical Advisory Board (DTAB), which met recently in Delhi, has recommended to the Health Ministry to give approval to the phase I trials in the country for the drugs discovered in other countries. The recommendations of DTAB consisting of senior Health Ministry officials, including DCGI are generally accepted by the Ministry.

According to experts in the clinical research area, DTAB might have been impressed by the huge improvements in the technical and other aspects of the clinical research industry in the country. The industry has come a long way since its inception some years ago and now it has all the attributes of the international standards, whether it is the quality of skilled and technical staff, equipments, lab, environment, ICUs, etc. Easy availability of volunteers at cheaper prices is also contributing to the growth of the clinical research in the country.

The DTAB is convinced with the progress the contract research organisations have made during the last couple years. The decision will have major impact on the contract research organisations in the country as the phase I trial has a huge business potential, the expert who does not want to be quoted said.

So far, Indian government has not been giving approval to the phase I clinical trials for the drugs for which pre-clinical trials were conducted abroad on the ground that phase I trials involved huge risk. It is in the phase I trials that the discovered medicine is exposed to the human body after the successful trials on animals. The risk is much more as the drug is experimented on the healthy human being. For these reasons, the clinical trial institutions for the phase I trials should be equipped with all kinds of emergency services and highly qualified staff.

As India refused to give permission, the drug companies world over have been moving towards other cheap markets like China.