The move would 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).

“We are planning to bring in e-governance for clinical trials in the country. India would be the first country to implement such a concept. It will be done through a software. We believe information technology is our strength and why not make use of it,” the DCGI Dr Surinder Singh said.

With e-governance in place, 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, Dr Singh said.

Confidentiality of the data submitted by companies would be taken care of, Dr Singh assured. “Once the data is fed into the system, the information would be broken into components and no one individual would have an access to the complete information provided by any company,” he said.

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 enrol into more than one clinical trial resulting in adverse drug reactions. “There is a finger printing software available through which clinical trial centres can be interlinked. We have asked companies to install the software so that they can enrol first time volunteers and avoid drug reactions during trials,” said Dr Singh.