Budget dispute over India's CDAI

24 December 2007

The cost of establishing the Central Drug Authority of India has been called into question as it has been reported that the federal government has not provided for a grant to help with setting up costs. Instead, the new agency will rely on a new fee for Good Manufacturing Practice certification inspections, increases in the registration fees for imported medicines, new drugs, manufacturing and clinical trials, the India-based on-line business magazine Pharmabiz.com stated.

Both the Finance Ministry and the Planning Commission have ruled out central funding for the CDAI. The estimated 73.0 million rupees ($1.9 million) first year costs, forecast to rise to 236.7 million rupees in year 10, is therefore expected to be shouldered by drug manufacturers. Pharmabiz warns that sudden major fee rises are possible if the new regulator experiences an income shortfall or overspends.

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