Archive for November 2009

“Single-window” and e-governance

“Single-window” and e-governance

The most recent initiative announced by the CDSCO is possibly one of the most exciting. The Ministry of Health and Family Welfare has agreed to invest close to INR250 Crore (around $50 million) in an e-governance initiative for the CDSCO to operate efficiently and transparently. Some of the e-governance initiatives contemplated include online submission of all forms, a digitalized interactive portal, digitalization of records and online approvals with digital sign. Currently, six Indian government departments have some role in approving certain aspects of drug regulations, a situation that leads to delays and a waste of resources. US-based technology solutions provider MGRM is developing a system to track and manage the complete drug regulation process. By 2013 companies are expected to be able to file and track applications online and access information concerning licensing, regulation, monitoring and even inspection audits13. Initiatives such as the central registry of volunteer fingerprints and another recently launched initiative of releasing on a daily basis, correspondence concerning drug and device companies would be accessible via the system. Internal to the CDSCO, the technology is expected smooth the interface between relevant government departments.

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What are PROTOCOL DEVIATIONS, EXCEPTIONS AND VIOLATIONS?

Protocol when goes haywire its what????

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