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Health Ministry recommends post-trial access of NCE to trial participants

Shardul Nautiyal, Mumbai
Wednesday, May 13, 2015, 08:00 Hrs  [IST]

In order to permit expanded access to an investigational drug for treatment of a patient, the Union health ministry has recommended that in case a New Chemical Entity (NCE) is found to be beneficial in clinical trial, the trial participants should have post-trial access to such NCE.

It was recommended by the Ministry that post trial access of the investigational products may be provided to the subject found beneficial during the course of the trial on the basis of recommendations of the investigator and ethics committee. This is  especially in the cases where no alternative therapy is available to the patient.

However, such post-trial access of the investigational product should be permitted after obtaining the consent of the patient, however, there would not be any liability of the sponsor in use of the drug. The sponsor shall arrange to provide the drug in such cases free of cost as the drug might not have been permitted to be marketed. The recommendation further states that Drugs and Cosmetics Rules, 1945 may therefore be amended appropriately.

In a recent meeting of the apex committee on technical matters of the health ministry, the Drug Technical Advisory Board (DTAB) members were informed that US FDA has a programme for expanded access to investigational drugs for treatment use. US FDA may permit expanded access to an investigational drug for treatment of individual patient if the physician/investigator certify that the risk to the patient from the investigational drug is not greater than the probable risk from the disease or condition. The US FDA will then determine the potential benefits vis-a-vis the potential risk of the treatment use with the drug considering the recommendations of both the investigator and the Ethics Committee.


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