Online clinical trial applications could be mandatory by October end

CDSCO aims to attract global clinical trial in India

Central Drugs Standard Control Organisation (CDSCO) plans to go fully online for submission of applications for clinical trial registration in one month’s time.

The trial run of an IT enabled system for online submission of clinical trial applications started in early September for the purpose of feedback/suggestions only, with physical submission of applications continuing as usual. Before making it mandatory, CDSCO has asked stakeholders to share their feedback and suggestions within a month’s time.

Dr GN Singh, Drugs Controller General of (India) said, “Before going fully online, we have introduced the first phase of an IT enabled system for online submission of clinical trial applications as a trial run. And asked the industry to raise technical difficulties so that we can rectify issues before going fully online.”

In order to improve transparency, accountability and efficiency in processing of clinical trial applications and monitoring, CDSCO with the approval of Ministry of Health and Family Welfare, Government of India has taken the initiative to create an IT enabled system for online submission and processing of applications as well as monitoring of clinical trials in the country. The objective of the software is to simplify the application process and also to be user friendly.

Reactions to the newly launched initiative have already started coming in. For example Singh reveals, “We recently received a query from the US that they are finding it difficult to open the page for online submission of clinical trial applications. To resolve this issue, we have instructed the NIC team to fix the issue as early as possible.”

In March 2015, the CDSCO issued an office memorandum for nomination of representatives for e-governance and digitalisation of services at the CDSCO. It has initiated a comprehensive e-governance programme for filling online applications, processing of application, issuance of licenses/permissions/approvals/NOC’s and tracking of the status of applications for various purposes. Centre for Development of Advanced Computing (CDAC) was entrusted the job to develop the required software.

While summing up, Singh says, “Behind all these initiatives, our aim is to offer advanced user friendly technology for the global user and attract global clinical trials to India.”