Explanation:

• The new rules will apply to clinical trial, bio-availability or bio-equivalence study, new drugs and regulation of ethics committee relating to clinical trial and biomedical health research.
• These rules provide for the disposal of clinical trial applications by way of approval or rejection or seeking further information within 30 days for drugs manufactured in India and 90 days for drugs developed outside India.
• In case of no communication from DCGI, the application will be deemed to have been approved.
• The requirement of a local clinical trial may be waived for approval of a new drug if it is approved and marketed in any of the countries to be specified by the Drugs Controller General with the approval of the government.
• The 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 and certain other conditions.
• In case of injury to a clinical trial subject, medical management will 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.
• Also, the compensation in cases of death and permanent disability or other injury to a trial subject will be decided by the Drug Controller General.