50 research projects delayed

Over 50 drug research projects that involve animal experimentation are feared to have come to a standstill in the country due to delay in clearances of research proposals by the competent authority "" the Committee for the Purpose of Supervision and Control of Experiments on Animals (CPCSEA).

The research-oriented drug industry complains that the last meeting of CPCSEA, held in March, has not cleared any major research proposals. The applications are pending since November 2007, they allege.

Countering the industry claim, government sources said the CPCSEA has indeed cleared all research proposals that were complete at the March meeting. "All proposals that could pass expert scrutiny got cleared," they added.

Industry feels the March meeting had a lot of pending proposals as CPCSEA, contrary to its normal practice of holding meetings every alternate month, chose to have only one meeting after November. "There was a delay of almost four months which resulted in the piling up of over 50 research proposals before CPCSEA. The last month's meeting, however, considered only one proposal, that too related to a government dairy development institution while all drug research applications were not touched," they allege.

The government sources said the CPCSEA had, in November, formed several sub-committees to study the merits of the research proposals. "The sub-committees needed some time to make their observations which led to the delay," they point out.

Meanwhile, industry officials say that pending approvals are not only affecting in-house R&D programmes of companies, but also troubling contract researchers with specific timelines for each research project.

According to the senior scientists attached to the R&D centre of a Mumbai-based drug firm, research projects get stuck even if one approval gets delayed. "Only after we get the CPCSEA approval can we apply for import licence. It takes another three to four months before we can get the import done. We are facing problems from both sides.

The company managements will not listen. Most often CPCSEA delays approvals with unnecessary queries. If the proposal is being held over for some clarifications, we will have to wait till the next meeting. CPCSEA should remember that each query puts us under tremendous pressure."

Officials sources said that CPCSEA, which had cleared the entire backlog in November, is planning to clear all valid applications in its forthcoming meeting planned early next month.