Indian regulatory authorities should allow to conduct phase 1 study for compounds developed abroad if India's expertise and skill to invent new drugs is to be recognized internationally according to Dr Ramanand Nadig, president and deputy dean of the Mumbai-based Clinical Research Education and Management Academy (CREMA).

He said that so far regulatory authorities have given 38 approvals for phase 1 studies in the country for products developed in India. But what will trigger international interest is when the country accords permission for new drugs developed outside. He added that while the west has accepted Indian Clinical Research data from phase II trials conducted in accordance with ICH GCP norms, they are keenly awaiting India's policy decision on phase I studies.

Dr Nadig, who has involved in many phase 1 trials for global pharma and is one of the pioneers in stem cell research, was speaking on 'Challenges in Phase 1 Trials', in a seminar organized by Drug Information Association, Tamil Nadu chapter.

"India should no longer wait for most initial phase 1 drug development work to happen outside, in various countries. If we need better drugs we should share the pains and gains with others, and should become part of phase 1 studies as well. Our foray into initial phase 1 trial will help us for innovative drug development in the future", Dr Nadig said.

To avoid the anxiety of conducting a first in man initial phase 1 study, he said, a phase O study with micro doses can be carried out. Since, India is a signatory of the IPR (Intellectual Property Right), it cannot not expect the benefit of newer novel drugs as generics any longer.

Dr Nadig asked why India cannot consider a parallel phase I permission when the country has already given approval for phase II as parallel permissions. He admitted that the country's experience with phase II was well accepted and certain CROs had specialized in offering those services to foreign sponsors.

On the commercial side, he said "early to market is the buzz word in clinical research and the speed with which we can recruit and complete a trial is India's greatest contribution. A novel anti-cancer drug or a new Flu vaccine can get into the market early because of our contribution in drug development. The after effects can closely be monitored as we gain experience with this sort of research", he said.

Further he said the country's regulatory body should consider thinking of a closer supervision and monitoring of phase I trial and gain benefit out of it for the future.