The long-pending proposal of the Department of Pharmaceuticals (DoP) to set up Good Laboratory Practices (GLP) compliant labs in different clusters of the country to help manufacturers especially the small and medium scale units seems to be heading nowhere with the Department is yet to appoint the consultant.
Yet another time, the DoP has extended the last date for submission of applications for selecting a consultant. From the earlier announced date of May 31, the government now pushed it till June 30. After inviting expression of interests (EoI) to appoint the consultant with April 25 as the deadline for tenders, the date first was extended to May 31.
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.
Sources in the Department said the deadline was being extended as there were not enough responses from the industry, though official notification did not specify any reasons for extending the date. The note, however, said “the entities having submitted their proposals till May 31, 2011 need not apply afresh.”
When contacted by Pharmabiz, the officials also refused to disclose the number of entries it got during the last three months. The sources also made it clear that the Department wanted to go ahead with the proposal at the earliest.
According to the original EoI, 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.
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.