The Department of Pharmaceuticals (DoP)'s renewed attempts to find a consultant to facilitate setting up of GLP compliant chemical/biological testing labs and GLP compliant large animal houses, to help the companies to comply with the Good Laboratory Practices (GLP), came a cropper so far as the department is learnt to have received poor response for its advertisement for the same.
As the department did not get the desired response, it has now extended the last date of submission of applications to August 31, 2012. The DoP had issued advertisements in prominent national newspapers in early June this year inviting consultants to facilitate setting up of GLP compliant chemical/biological testing laboratories and GLP compliant large animal houses in the clusters in different parts of the country. The last date for submitting the application was July 16, 2012. Now it has been extended.
This is not the first time the DoP is found fumbling on this front. The DoP had floated an expression of interest for appointing a consultant early last year itself. But, it could not finalise the consultant last year, due to poor response. The DoP had planned the scheme to help the companies to comply with the GLP that has been made mandatory in the country from November 1, 2010 itself. The laboratories were planned to be created in the clusters in different parts of the country.
After its failure in this direction last year, the DoP has once again started the process of engaging a consultant in this regard in June this year.
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.