The Department of Pharmaceutical (DoP)'s Rs. 275-crore cluster scheme for providing assistance to the pharma companies to comply with the Good Laboratory Practices (GLP) has been finalised and it will soon be sent to the planning commission for its green signal. However, the scheme will not be a reality before next year, as it may take some months for getting the final nod from the planning commission and the union finance ministry, sources said.
Senior officials in the DoP said that the department has almost finalised the scheme and it is giving final touches to the scheme after detailed discussions held between the senior officials in the ministry. After the discussions, the scheme has been internally approved and the department will make the necessary changes as per the discussions. It will soon send the same to the planning commission for its sanction, officials said and added that the scheme will be finally launched somewhere next year only. However, the GLP becomes mandatory in the country on November 1, 2010.
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 to 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.