After its failure in this direction during the last two years, the Department of Pharmaceuticals (DoP) has once again started the process of engaging a consultant to facilitate establishing afresh or upgrading the existing GLP compliant chemical testing laboratories, GLP compliant biological testing labs and GLP compliant large animal houses in public private partnership (PPP) mode in different locations of the country.

Through this initiative, the Department expects facilitation by way of inspiring innovation and catalyze and compliment the R&D efforts of the Indian pharma industry. 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.

The main responsibility of the consultant would be to carry out assessment of existing GLP compliant testing facilities vis-à-vis requirement of pharma industry, gap analysis and recommend 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 DoP had planned the scheme to help the companies to comply with the Good Laboratory Practices (GLP) 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 expression of interest several times during the last two years for appointing a consultant.  But, due to the reasons known to the DoP authorities only, it could not finalise the consultant so far. Now, the DoP has rescinded all its earlier proposals in this connection.