India to implement E-Governance for Clinical Trials

The health ministry of India  is planning to introduce e-governance for clinical trials in four years. The move will enable drug companies that

want to carry out clinical trials in India to register online from any part of the world. Once the required approval for conducting trials is obtained, the companies can also submit research data online to the country’s drug regulator Drug Controller General of India (DCGI), seeking marketing approval for their drug.

To maintain confidentiality, once the data is fed into the Software the software will split the information into components and no one individual would have an access to the complete information provided by a company.

“Confidentiality of the data submitted by companies would be taken care of,” the official added. The software will automatically send relevant data to various departments for clearances.

The drug regulator would deliver online approvals to companies after validating all the information submitted by companies. According to the official, it would take about four years to put the system in place and e-governance is expected to be implemented in the country by 2013.

The government also intends to make use of IT to discourage volunteers to enroll into more than one clinical trial resulting in adverse drug reactions. The government is using a finger printing software available through which clinical trial centres can be interlinked.

The drug regulator has also asked companies to install the software so that they can enroll first time volunteers and avoid drug reactions during trials.

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