Aiming to assist the pharma companies to comply the Good Laboratory Practices (GLP) which becomes mandatory on November 1, 2010, the Department of Pharmaceutical (DoP) is formulating a Rs 275-crore cluster scheme 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. The project is at the conceptual stage only.

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.

Sources said that the project is at the conceptual stage and it may take some more time before it takes a final shape. The project has been submitted to the finance section of the chemicals ministry for its approval and once it receives the finance section's green signal, it will go to the union finance ministry for its final nod. Officials said that though the department has initially proposed the scheme for Rs 275 crore, the department may consider to increase the amount once the scheme becomes a success in the country.

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.