India Pursues Paperless Clinical Trial Approval Process

The Central Drugs Standard Control Organization (CDSCO) of India announced plans to put their approval process for clinical trials exclusively online. This decision is in response to the Union Health minister Harsh Vardhan’s request that the CDSCO be more transparent about its process and function. This new system is still in the planning stages, and many concerns must be addressed before the plan is implemented. 

The Clinical Trials Registry-India (CTRI) has been online since 2007, encouraging clinical trials to register before the first participant is enrolled. According to the CTRI website, eleven of India’s biomedical journals require that those studies considered for publication must be previously registered.

The new proposed system, outlined by the CDSCO in their stakeholder briefing, would be much more comprehensive than the existing CTRI. This system would include expanded information sections and would require drug developers to add and update information for every step of the approval process. For instance, the system could track the ethics committee of a study and the frequency of their meetings. The CDSCO hopes that this new process will make the clinical trial approval process more streamlined and transparent.

This proposal comes on the heels of the newest regulations and guidelines to govern patient safety in clinical trials released in January of this year. Some drug-developers think these guidelines are overly strict and worry that the inevitable slow-down and resulting cost would lead many to consider holding trials in other countries. A paperless online approval process could work to alleviate some of these concerns.

However, some are concerned about the security of the system which requires the input of many more trial participants’ personal details. Shoibal Mukherjee, former VP of American-headquartered Quintiles told the Economic Times, “I see a major concern regarding patient confidentiality. The security level of this database has not been specified, and it’s unclear how the regulator will keep patient identifiers secure.”

The CDSCO is working to address these concerns, and an official at the drug-regulator’s office describes the initiative as a “work in progress”