The Department of Pharmaceuticals (DoP) will send a Rs.
275 crore proposal for constructing GLP compliant Labs in clusters at
different parts of the country to the planning commission soon as it has
almost finalised the draft.
The DoP's project, under which the
department will provide grant to a group of companies for constructing
GLP compliant Labs with common facilities in different parts of the
country, aims to assist the pharma companies to comply the Good
Laboratory Practices (GLP) which has become mandatory in the country
from November 1, this year.
According to sources, the DoP is
giving final touches to the draft proposal as per the recommendations of
the internal finance section of the union chemicals ministry. Once
these minor changes are effected, the DoP will send the proposal to the
planning commission, and the DoP is hopeful that the department will be
able to launch the project by early next year, sources said.
Under
the scheme, the DoP will provide 70 per cent grant to the clusters in
the general areas in the country, while the department will provide as
much as 90 per cent grant to the north eastern states like Sikkim and
Nagaland, and hilly areas of the country like Himachal Pradesh and
Uttarakhand. The total cost of one project should not exceed Rs.
15 crore and there should be at least 10-15 companies to float a
special purpose vehicle in a particular cluster to execute the project.
The
scheme will be a boon to the small and medium pharma companies as
constructing or modifying the existing labs to comply with the GLP norms
will be difficult for them as it involves a huge financial burden. As
per the scheme, the GLP compliant lab should have all the parameters as
per the GLP guidelines. It should have all the common facilities to
cater to the needs of the pharma companies to comply the GLP.
The
DoP's initiative in this regard is significant as union ministry of
health had recently notified the Schedule L-I of Rules 74, 78 and 150 E
under Drugs and Cosmetics Third Amendment Rules 2008 giving the
pharmaceutical industry time till November 1, 2010 for compliance of
Good Laboratory Practices.