With the permissions for phase I clinical trials are getting increasingly difficult and delayed in India, the domestic companies are now looking towards foreign countries especially China and Canada for carrying out the trials, claim the industry players. But Drug Controller General of India (DCGI) has denied any stalemate in giving approvals.
Following a series of controversies about trails in recent past, the Central Drugs Standard Control Organisation (CDSCO) was extra-cautious in granting license for phase I studies, virtually forcing the Indian companies to shop overseas for trial subjects, they claimed.
“The authorities seem to be in the mood not to take any risk, because of lots of controversies happened in the recent past. Only very few permissions were given in the last one year for phase I trials. This is spoiling not only the clinical trial business, but also discouraging the research and development efforts of Indian companies,” said the managing director of a Gujarat-based pharmaceutical firm, without wanting to be named.
DCGI Dr G N Singh, however, denied the allegations of deadlock in granting approvals. “Our priority is the safety of the people. We clear all applications for clinical trials that are found in order. Of course, if application is found to be lacking on any aspect, it gets pending. There are no cases of deliberately denying permissions,” he told Pharmabiz.
“We have been clearing the pending applications for clinical trials on a priority basis and there is nearly no backlog now. We will achieve break even soon in this regard,” he added.
“Compared to India, it is easier to get permission in countries like Canada and China. Even European countries grant approvals easily. Besides, many of the companies also do not want to take chances and land in controversies in India,” claimed another industry leader.
The Association of Clinical Research Organizations (ACRO) had also some time back pointed out a slump in the trials, especially in phase I cases, in India due to regulatory concerns and uncertainty. The market has been growing very rapidly, but slowed down due to these factors, the ACRO noted, while urging the DCGI to work on making the regulatory system more conducive for the trials.