Usha Sharma -Mumbai
As per Minister of Health and Family Welfare Dr Harsh Vardhan’s recommendations, Central Drugs Standard Control Organization (CDSCO) has proposed to create an information technology (IT)-enabled system for conducting clinical trials in India. The endeavour is to enable complete transparency and accountability in the functioning of CDSCO. The CDSCO has issued a notice to all stakeholders on creating an IT enabled system for online submission of various information on clinical trials yesterday (July 28) and has invited suggestions/comments within three weeks time to the office of Drugs Controller General (India) (DCG(I)).
This was one of the recommendations of the expert committee chaired by Prof Ranjit Roy Chaudhary which suggested the use of IT during all stages of clinical trials to ensure transparency and faster dissemination of information among stakeholders, including the general public.
It has accordingly been decided that the latest technology and modern tools need to be adopted by CDSCO to discharge duties including grant of approvals/ licences, enforcement etc.
Dr GN Singh, DCGI said, “As per direction from the new Government, we are working to bring complete transparency in the clinical trial system. It will provide complete information to laypeople related to the progress of clinical trials across India and also plug the current gaps which exists in the clinical trial approval system.”
According to sources within the CDSCO office, complete IT implementation will cost around Rs 150 crores. It is amenable to consider tailor-made solutions for clinical trial activities. It has planned to invest in a phase-wise manner, with the first phase requiring an investment of around Rs 50 lakhs.
In the first phase, CDSCO proposes to create an IT-enabled system for online submission of various information on clinical trials to streamline the process of approval, maintaining a comprehensive database and monitoring of clinical trials for ensuring the protection of the rights, safety and well being of trial subjects and authenticity of the data generated.
The notice requires that all information related to sponsor/CROs, investigators ethics committees (ECs) and patients should be captured through online means in an organised manner. On the proposed IT-enabled system, a sponsor /applicant needs to submit the information related to clinical trial to DCG (I), which will have full title of the trial, sponsor’s protocol code number, name or abbreviated title of the trial. The notice also has three annexures which detail the information required to be uploaded by the various stakeholders.
Seeking the cooperation of the CRO industry, DCG (I) has requested CROs to share feedback/ comments so that they can simultaneously brief the National Informatics Centre (NIC) on industry requirements. “I am sure we will be able to speed up the clinical trial approval process by approximately 60 per cent and all issues related to delay in approval process will get resolved efficiently,” adds Singh. He indicated that he hoped this could be accomplished within the next six months.