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Clinical trial registry run by ghost staff, registers over 1,000 clinical trials.

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TNN    12 August 2022

Beyond June 30, 2022, the Clinical Trial Registry of India (CTRI) does not exist anymore since there has been no official order extending its existence. Also, no further extension has been given to the existing staff of CTRI, but the supposedly non-existent ghost staff has registered over 1,060 clinical trials. CTRI has continued to receive hundreds of applications for clinical trials, even after the government has been taking measures to regularise the staff who have been running CTRI for the last 16 years. 

The CTRI is a completely paperless online repository of data of more than 45,000 registered clinical trials. The registry, which was started as a three-year pilot project in 2007, has been running in project mode with regular extensions, instead of being given permanent status. Despite, the Drug Controller General of India mandating the registration of all clinical trials from September 15, 2009, and a 2013 amendment in the Drugs and Cosmetics Rules 1945 which mandated that clinical trials be registered with CTRI before enrolling the first participant for any study. 

In a case, filed by CTRI employees in the Delhi high court, the employees have requested that the registry be made a permanent feature of the National Institute of Medical Statistics (NIMS) and that their services be regularised. The government, on the other hand, stated that the CTRI was not a permanent feature of NIMS, which is under ICMR. The government also added that the project was "extended from time to time". An affidavit issued by the NIMS stated that making a project permanent or not is an executive function and therefore a policy decision. Official correspondence attached to the petition showed that ICMR had committed to ensuring the continuity of the project after the pilot years.

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