The noose is all set to tighten against organizations which conduct clinical trials for pharmaceutical companies.
The Drug Controller General of India (DCGI) is all set to make it mandatory for all clinical research organizations (CROs) in India to register with it so that their activities can be closely monitored and their scientific credentials checked. The draft rules were published on January 19. A copy of the rules is available with the TOI.
What is interesting is the requirement for CROs to maintain all records for a period of five years after the final results are submitted, so that these can be scrutinized any time. New rules say, "All records such as protocols, approvals from the Central Drugs Standard Control Organization and ethics committee, audit certificates, completed and final reports, shall be maintained. All documentation and communication are to be dated and preserved safely for five years after completion of the study or submission of the data to CDSCO."
