Study on kids must for drug approval

Jayashree Padmini - New Delhi

THE Centre, in an effort to enhance the scope of clinical development criteria to match with international practices, is making detailed studies on paediatric population mandatory at an early stage for new drugs relevant to children in life threatening disease conditions.

The Schedule Y amended draft which is likely to be notified shortly states that, ‘‘If the new drug is intended to treat serious life-threatening diseases, occurring in both adults and paediatric patients, for which there are currently no or limited therapeutic options, paediatric population should be included in the clinical trials early, following assessment of initial safety data and reasonable evidence of potential benefit’’. It further states that in such circumstance where this is not possible, lack of data should be justified in detail.

DCGI could insist on paediatric studies when a new drug application has potential use in children. These studies could be initiated at various phases of clinical development or after post marketing surveillance in adults if safety concern exists. In cases where there is only limited paediatric data at the time of submission of application, innovator companies need to generate more data in paediatric patients after marketing authorisation for use in children is granted.

According to the draft Schedule Y, paediatric studies should include clinical trials, relative bioequivalence comparisons of the paediatric formulation with the adult formulation performed in adults, and definitive pharmacokinetic studies for dose selection across the age ranges of paediatric patients in whom the drug is likely to be used.

These studies need to be conducted in paediatric patient population with the disease under study, insists the draft. The amendment for the first time makes it mandatory to start studies as early as possible in the drug development cycle, in case any new drug has major therapeutic advance for paediatric population. This data generated should be submitted along with the new drug application.

Informed consent is must for paediatric studies as well but from the parent/legal guardian rather than the subject. Further, for clinical trials conducted in the paediatric population, the reviewing ethics committee should include members who are knowledgeable about paediatric, ethical, clinical and psychosocial issues.

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