The Department of Pharmaceuticals (DoP) will prepare a detailed project report to help the pharma units, especially the small scale sector, to adopt WHO-GMP norms with financial assistance from the Government, and submit it to the Planning Commission.


As per the initial estimates, the Department would need Rs.1200 crore as subsidy to help out the pharma units as most of them still not GMP-compliant. Out of the 10,000 plus SME pharma units in the country, only about 800 are certified by the CDCSCO for WHO-GMP production, prompting the DoP to look out for more assistance from the Planning Commission.


According to the plans by the DoP, the number of GMP-certified units should be increased to minimum 2000 by 2012 and the subsidy, hence, should be given to at least 1000 units. The DoP would look again into whether to improve the current Credit Linked Capital Subsidy Scheme (CLCSS) or to rework again on the Pharmaceutical Technology Upgradation Fund Scheme (PTUF) while preparing the fresh DPR to be submitted to the Planning Panel, sources said.


One suggestion is to press upon the MSME to expand the list of equipments and expenditure approved in the CLCSS scheme for SSI pharma. And the admissible capital subsidy under the scheme also should be increased from the current Rs.25 lakhs to minimum Rs.1 crore. Also the banks should be requested to provide the soft loan interest rates for this upgradation.


Another option is to go back to the PTUFS which was mooted for the 11th Plan and resubmit it to the Planning Commission and the Department of Expenditure through the Expenditure Finance Committee for assistance under the 12th Plan. The DoP would work out the detailed project based on these options, sources said.


DoP had already written to the DCGI to formally prepare the list of machinery and equipments required for WHO-GMP manufacturing standards and send to the Department. The DoP would then send it to all industry associations for feedback and this would also be part of the DPR to be prepared, sources added.