Health Policy

India: Online process for clinical trials by 2013

In order to improve the process of clinical trail approvals, the Government of India is planning to introduce e-Governance project for clinical trails by 2013. this movement will enable companies from any part of the world to file online applications to seek approval for clinical trials from the drug controller general of India (DCGI).

With the help of e-Governance project, companies would be able to send online all required information for filing for clinical trial approval. The DCGI office would then examine the data provided online and generate queries. After validating the information given by companies, approvals for these trials would be delivered online. The software would split the information and send relevant data to various departments for clearances. According to the drug quality regulator, it would take about four years to put the system in place and e-governance is expected to be in implemented in the country by 2013.

The government also intends to make use of information technology 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 companies have asked companies to install the software so that they can enroll first time volunteers and avoid drug reactions during trials. The government also intends to make use of information technology to discourage volunteers to enroll into more than one clinical trial resulting in adverse drug reactions.

 

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