DoP to go ahead with proposal to set up GLP labs, issues tender to finalise consultant
April 06, 2011, 0800 IST – Source : Pharmabiz News
Amid reports that the Department of Pharmaceuticals (DoP) has shelved the proposed scheme of setting up GLP compliant labs in different parts of the country, the DoP has now invited expression of interests to appoint a consultant and thus making it clear that the proposal is still on.
The call for EoI was made to advise the government on setting up GLP compliant chemical testing laboratories, GLP compliant biological testing laboratories, and GLP compliant large animal house in public private partnership mode.
The consultant would assess the 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. Based on such assessment, the agency will draw up schemes for establishing labs or upgrading the existing facilities so as to make them GLP compliant laboratories or Large Animal Houses. “A combination of both of the above options may also be considered. The schemes have to be drawn in PPP mode,” according to the tender which has put the last date of application as April 25.
The DoP had planned the scheme to help the companies to comply with the good laboratory practices that has been made mandatory from November 1, 2010. The laboratories were planned to be created in the clusters in different parts of the country. Some earlier reports said the DoP had shelved the plan.
“We are going ahead with the proposal and the first step is the appointment of the consultant to prepare the detailed project report and for that we have now issued the tenders,” said a senior official from the Department.
“Through the 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 tender said.
The agency will also suggest the exact number of different types of GLP labs needed to be upgraded or established. It will also recommend geographic distribution of each type of such laboratories keeping in view the likely demand in different locations in the country as may be projected by the Industry and assessment of the consultant.