The Department of Pharmaceuticals (DoP) has initiated efforts to set up a Good Laboratory Practices (GLP) Compliant large animal facility for clinical trials in the country in public private partnership mode. This is in line with its promise of building up adequate infrastructure for the pharmaceutical industry to flourish.
As part of its capacity building exercise, the DoP has called for expression of interest from public-funded institutes, public sector units and private organizations with experience in drugs and pharmaceutical sector to set up the facility in one of the major pharma hub. The facility, in compliance with the latest GLP norms, is estimated to come up with an investment support will be of Rs. 5 crore, according to a DoP notification.
Evan though the pharma industry needs large animal trials for testing new drugs, the country at present has a very few number of large animal facilities. The industry, which is involved in New Chemical Entity (NCE) research, are currently going abroad to carry out their studies which cause delay and loss of foreign exchange to the country.
Setting up of the facility will help the country to save foreign exchange and further, being a favourite outsourcing destination for global multi national companies, India can also earn foreign exchange through conducting large animal trials, expects the government. “Carrying out of the regulatory research for the large animals in India will decrease the drug discovery cycle time which is an intangible benefit. By carrying out these tests in India the brand image of the Indian Pharma industries or CROs will increase and thereby the profit will also increase”, explains the DoP letter.
The Department will release the fund in two phases of Rs. 2.5 crore each. Initially, 50 per cent of the money 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.
As a partner, the DoP has not proposed return from the laboratory in the form of revenue, except putting forward conditions for conducting training of analysts and testing of samples from government organizations and public sector undertakings on concessional rate, details the DoP.
The facility will also be the first GLP compliant large animal house for the government. Even though primate animal experimentation is carried out by few organizations like Central Drug Research Laboratory (CDRL), Lucknow, National Institute of Immunology (NII), Indian Institute of Science (IISc) and recently by National Brain Research Centre (NBRC) and National Institute for Research Reproductive Health (NIRRH), with the stringent CPCSEA Act, there are no GLP compliant large animal facilities under the government sector.
The department as part of its Indian Pharma Vision 2020 has earlier declared capacity building projects including setting up two world class animal houses, three pre-clinical drug discovery centres and three world class drug testing and analytical laboratories in the country, in a set timeline. The DoP, earlier in December 2009, has initiated efforts to set up the drug testing laboratories, one for chemical testing and two separate facilities for biological drugs testing.
As part of its capacity building exercise, the DoP has called for expression of interest from public-funded institutes, public sector units and private organizations with experience in drugs and pharmaceutical sector to set up the facility in one of the major pharma hub. The facility, in compliance with the latest GLP norms, is estimated to come up with an investment support will be of Rs. 5 crore, according to a DoP notification.
Evan though the pharma industry needs large animal trials for testing new drugs, the country at present has a very few number of large animal facilities. The industry, which is involved in New Chemical Entity (NCE) research, are currently going abroad to carry out their studies which cause delay and loss of foreign exchange to the country.
Setting up of the facility will help the country to save foreign exchange and further, being a favourite outsourcing destination for global multi national companies, India can also earn foreign exchange through conducting large animal trials, expects the government. “Carrying out of the regulatory research for the large animals in India will decrease the drug discovery cycle time which is an intangible benefit. By carrying out these tests in India the brand image of the Indian Pharma industries or CROs will increase and thereby the profit will also increase”, explains the DoP letter.
The Department will release the fund in two phases of Rs. 2.5 crore each. Initially, 50 per cent of the money 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.
As a partner, the DoP has not proposed return from the laboratory in the form of revenue, except putting forward conditions for conducting training of analysts and testing of samples from government organizations and public sector undertakings on concessional rate, details the DoP.
The facility will also be the first GLP compliant large animal house for the government. Even though primate animal experimentation is carried out by few organizations like Central Drug Research Laboratory (CDRL), Lucknow, National Institute of Immunology (NII), Indian Institute of Science (IISc) and recently by National Brain Research Centre (NBRC) and National Institute for Research Reproductive Health (NIRRH), with the stringent CPCSEA Act, there are no GLP compliant large animal facilities under the government sector.
The department as part of its Indian Pharma Vision 2020 has earlier declared capacity building projects including setting up two world class animal houses, three pre-clinical drug discovery centres and three world class drug testing and analytical laboratories in the country, in a set timeline. The DoP, earlier in December 2009, has initiated efforts to set up the drug testing laboratories, one for chemical testing and two separate facilities for biological drugs testing.
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