DCGI revises its 50 bed hospital, 3 clinical trials per investigator rule

The Drug Controller General of India has finally decided to revise the earlier move that made maximum 3 trials per investigator and minimum 50 bedded hospital mandatory for clinical research companies

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New Delhi: The Drug Controller General of India (DCGI)’s office on the afternoon of August 02, 2016, issued two fresh notifications regarding the conduct of clinical trials in India. Dr G N Singh, DCGI finally decided to revise the earlier order that had made the maximum 3 trials per investigator and minimum 50 bedded hospital mandatory for clinical research companies.

As per the revised rules, the cap on the number of trials an investigator can undertake at any point in time has been removed and the Ethics Committees have been empowered to decide on how many trials an investigator can undertake after examining the risk and complexity involved in the trials being conducted. The detailed circular can be assessed here.

In another circular (details), the DCGI also softened its earlier rule to have minimum 50 bedded hospital for any clinical trial. The cap on a minimum number of 50 beds for a clinical trial site has also been revised with the Ethics Committees now being vested with the responsibility of examining and deciding whether a clinical trial site is suitable for a trial or not, irrespective of the number of beds.

The move has been widely appreciated by the industry and the prominent companies who feel that it will help in removing the unnecessary hurdles to conduct trials in India.