[1] Since 2009 the Central Drugs Standard Control Organisation has mandated that anyone conducting clinical trials in India must preregister before enrolling any research participants.

[4] The Central Drugs Standard Control Organisation made trial registration mandatory on 15 June 2009.

[7] The CTRI requests all the information which the World Health Organization recommends for clinical trial registries.

[8] Additionally, the CTRI collects information specific to the circumstances of India, including the address of the principal investigator, the name of the ethics committee overseeing the trial and confirmation of their government registration; proof of permission from the Drugs Controller General of India, the expected end date of the trial; all study sites; and the method of randomising participants and the allocation concealment.

[11] Another factor is that the registration form itself lacks the precision which researchers would typically want, and for example, the "type of study" field is recording unclear responses.