Delay in dedicated animal testing lab holds up pre-clinical drug trials

Delay in dedicated animal testing labholdsuppre-clinicaldrugtrials

Y.V. Phani Raj
Updated23 May 2007

Delays in finalizing funding for a dedicated animal drugs testing facility in Hyderabad, the first of its kind in India, is costing domestic pharmaceutical companies dear, forcing them to spend twice the money and time on pre-clinical trials at animal labs overseas.

Very few Indian drug companies—with the exception of majors such as Ranbaxy Laboratories Ltd and Dr Reddy’s Laboratories Ltd—have captive small-sized animal facilities for conducting pre-clinical trials. Smaller companies are having to wait for as long as six months to avail of testing slots at US-based facilities.

Despite about 100 acres of land having been allotted to the proposed National Animal Resource Facility (Narf) last year, funding for the Rs300-crore project, being set up by the Indian Council for Medical Research (ICMR), together with the National Institute of Nutrition, is awaiting clearance from the Union ministry of health and family welfare.

The ministry is considering roping in a private partner to set up Narf, a government official said. “It is not a question of delay. The health ministry is examining its feasibility and if it could be taken on through the public-private partnership route,” said Vasantha Muthuswamy, senior deputy director general at ICMR, which comes under the health ministry. The proposal to set up Narf was first made in 2004.

Animal studies mark the beginning of testing of drugs in living organisms and are critical to check if they can be tested on humans.

Typically, of 1,000 molecules screened by a drug company, just about 50 reach pre-clinical animal testing stage, and only one or two candidates go into human trials. Pre-clinical animal studies are carried out for about six to eight months and constitute about a fifth of the drug development cost.

The project director of Narf, P. Suresh, said the facility would have international accreditation for conducting pre-clinical trials for new drugs, vaccines, recombinants and herbal products.

Apart from accommodating animal houses and testing labs, the facility will also train personnel qualified to carry out animal trials.

Advinus Therapeutics is the only Indian company to have such an accreditation in India currently. Narf will also seek approvals from the US Food and Drug Administration, Suresh said.

Once the Union government approvals are given, Narf can be set up in three years, Suresh confirmed. “The Hyderabad facility will make the country self sufficient in the availability of specific breeds of animals, both small and large, for research.

The new facility will also strive towards collaborating with global pharmaceutical and research organizations, especially those in the US, Japan and Europe that are looking at cost effective facilities in India,” the Narf project director said.

Suresh expects animal testing in India to cost a third of what it costs in the West. For instance, an experiment involving 24 dogs would cost about Rs6 crore in the US, while in India it would cost only Rs2 crore, he said.

Bhuma Shrivastava contributed to this story.

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