India plans large animals facility involving dogs and monkeys for drug testing

India is planning to set up a large animal experimentation facility involving dogs and monkeys to facilitate the booming clinical research market in the country.

The proposed facility for testing drugs on large animals such as dogs and monkeys before studying them on humans will be set up in public-private partnership model.

The large animal facility will be a Good Laboratory Practices (GLP) compliant laboratory with a motive to provide adequate infrastructure for the pharmaceutical industry.

The exact location of the facility is still not clear. However, the government is planning to build the facility in one of the major pharma hubs in the country.

The Department of Pharmaceuticals (DoP) has invited expression of interest from public-funded institutes, public sector units and private organisations with experience in drugs and pharmaceutical sector to set up the facility.

The large animal facility is estimated to cost Rs 10 crore in which the government support will be of Rs 5 crore, according to a DoP notification.

DoP is planning a two-phases of Rs 2.5 crore each of the proposed Rs 5 crore fund. 50 per cent of the fund will be provided on production of installation report and remaining 50 per cent on production of GLP certification or accreditation by the competent authority.

The Scheme is proposed to continue initially for three year (remaining period of 11th Five Year Plan) with total requirement of Rs 15 crore and after the period, assessment would be made for the outcome for further development of the project.

“It is a partially funded project and Government of India as the partner has not proposed return in the form of revenue. However, the training of analysts and testing of samples from Government organizations/PSUs etc. would be undertaken on concessional rate as decided at the time of agreement/award of work,” the notification said.

The goal of this initiative is build up national facilities which can meet national as well as international regulatory requirements to test the quality and safety of the pharmaceutical.

The drug discovery process involves target identification and target validation and the lead identification, lead validation and proof of concept in vitro and in vivo pre-clinical tests followed by clinical trials.

In the pre-clinical data and its safety, toxicological and the pharmaco-kinetic data need to be obtained for small animals (rodents) and the large animals include non-primates like dogs and and primates monkeys primates.

These large animals (dogs) testing is possible only with some of the multinational companies under private sector.

With the recent activism and the new CPCSEA Act, there are no GLP Complaint, large animal facilities under the Government sector.

The primate animal experimentation is carried out by few organizations like CDRL, Lucknow, NII (CSIR) and Indian Institute of Science and recently by National Brain Research Centre (Manesar) and National Institute for Research Reproductive Health (Mumbai).

As a resultant of it,those Indian companies which are involved in New Chemical Entities (NCEs) Research are sending their molecules abroad and a large foreign exchange is being spent for this purpose.

Further, a large number of manpower can be trained, the DoP notification said.

The large animal facility can also be used to carry out the regulatory toxicological testing for the NCEs developed by Multinational Companies/ Companies from abroad.