Govt notifies new clinical trial rules

Aiming to boost indigenous drug discovery, the central government has come out with a new set of clinical trial rules that set fixed time frame for the drug regulator to approve or reject a clinical trial proposal.

The applications for clinical trials of new indigenous drug candidates are to be disposed of within 30 days.

In the absence of a communication from the Drugs Controller General of India, the applications for such trials will be deemed to have been approved, according to the new rules, notified by the Union Health Ministry last week.

For drugs developed outside India, disposal of clinical trial applications by way of approval or rejection or seeking further information has to be done within a period of 90 days.

The previous clinical trial rules did not have any time limit for the DCGI to act on the applications leading to long-wait for companies that submit applications to the regulator.

Rules for local clinical trials have been relaxed too. As per the new rules, the requirement may be waived if the new medicine is approved and marketed in a country, already approved by the regulator.

A local clinical trial may also be waived if the application is for import of a new drug for which the DCGI had already granted permission to conduct a global clinical trial which is ongoing in India and in the meantime the new drug has been approved for marketing in a country specified by the DCGI.

The final rules were notified after almost a year of consultation within the government as well as discussions with the stakeholders after the draft rules were published in February 2018.

In case of injury to people participating in the trial, medical management is to be provided as long as required as per the opinion of the investigator or till such time, it is established that the injury is not related to the clinical trial, whichever is earlier.

Set formulae to determine the quantum of compensation presently followed under administrative orders has been incorporated as a Schedule to the rules. The compensation in cases of death and permanent disability will be decided by the DCGI.