After its failure in this direction last year, the Department of Pharmaceuticals (DoP) has once again started the process of engaging a consultant to facilitate establishing afresh or upgrading the existing Good Laboratory Practices (GLP) compliant chemical testing laboratories, GLP compliant biological testing laboratories and GLP compliant large animal houses in public private partnership (PPP) mode in different locations of the country.
The main responsibility of the consultant would be to carry out assessment of above mentioned kinds of existing facilities in the country vis-à-vis requirements of pharma industry, gaps if any, and indicate the manner in which this gap could be filled in. It also has to clearly state if the gap should be filled in by establishing new GLP compliant facilities or upgrading the existing facilities so as to make them GLP compliant or a combination of both.
Moreover, the consultant has to draw up detailed schemes based on the result of assessment, in PPP mode. The extent of investment required in establishing new facilities and/or upgrading the existing facilities should be indicated. The funding pattern i.e. the share to be borne by the private entity and the government of India should be indicated. The manner in which the facilities would be operationalised and managed should be stated indicating clearly whether these would be financially viable and prove helpful in promoting the development of pharmaceuticals industry in the country.
The proposed laboratories, to be established or upgraded under the scheme, have to comply with international (OECD) GLP norms as well as guidelines laid down by the National GLP Authority of India. Through this initiative, the DoP expects facilitation by way of inspiring innovation and catalyze and compliment the R&D efforts of the Indian pharma industry.
The DoP had planned the scheme to help the companies to comply with the Good Laboratory Practices that has been made mandatory in the country from November 1, 2010. The laboratories were planned to be created in the clusters in different parts of the country. For this purpose, the DoP had floated an expression of interest for appointing a consultant early last year itself. But, due to some reasons known to the DoP authorities only, it could not finalise the consultant.