Thursday, May 12, 2011

A change in inclusion/exclusion criteria will require approval from DCGI

Is it necessary to obtain DCGI/EC approval for clinical trial of nutraceutical and register the trial in CTRI? Is it essential to carry out toxicity studies? Binu Kuruvilla DCGI approval is not required unless the indication claim is as per definition of a new drug as per Drugs & Cosmetics Rules.  

The definition of drug is as follows: All medicines for internal or external use of human beings and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings.

In addition, you should consider new drug definition as per Rule 122E.

A drug is considered a new drug if
1) it is a new chemical, biological or recombinant bio-technological or such devices or delivery systems
2) a drug already approved for certain claims is now being considered for modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration
3) fixed dose combination of two or more approved drugs, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of individual drugs already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration EC approval is essential. Registration of clinical trial in CTRI is voluntary. The requirement of toxicity depends on the available human safety data of nutraceutical and duration of the treatment with the nutraceutical in the clinical trial.  

What is the current situation of investigator initiated trials in India - applicable regulations, investigators keenness, funds?