Information supporting the use of the drug in children, pregnant women, nursing women, elderly patients, patients with renal or other organ systems failure, and those on specific concomitant medication is required to be submitted if relevant to the clinical profile of the drug and its anticipated usage pattern.

 

(1) Geriatrics.-

 

Geriatric patients should be included in Phase III clinical trials (and in Phase II trials, at the Sponsor's option) in meaningful numbers, if-

 

(a)  The disease intended to be treated is characteristically a disease of aging; or

 

(b)  The population to be treated is known to include substantial numbers of geriatric patients; or

 

(c) When there is specific reason to expect that conditions common in the elderly are likely to be encountered; or

 

(d) When the new drug is likely to alter the geriatric patient's response (with regard to safety or efficacy) compared with that of the non-geriatric patient.

 

(2) Paediatrics.-

 

(i) The timing of paediatric studies in the new drug development program will depend on the medicinal product, the type of disease being treated, safety considerations, and the efficacy and safety of available treatments.  For a drug expected to be used in children, evaluations should be made in the appropriate age group.

 

(ii) If the new drug is for diseases predominantly or exclusively affecting paediatric patients, clinical trial data should be generated in the paediatric population except for initial safety and tolerability data.

 

(iii) If the new drug is intended to treat serious or 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.

 

(iv) If the new drug has a potential for use in paediatric patients – paediatric studies should be conducted.  These studies may be initiated at various phases of clinical development or after post marketing survelliance in adults if a safety concern exists.

 

(v) The paediatric studies should include -

 

(a)   Clinical Trials,

 

(b)   Relative Bioequivalence comparisons of the paediatric formulation with the adult formulation performed in adults, and

 

(c)   Definitive pharmacokinetic studies for dose selection across the age ranges of paediatric patients in whom the drug is likely to be used.  These studies should be conducted in the paediatric patient population with the disease under study.

 

(vi) If the new drug is a major therapeutic advance for the paediatric population – the studies should begin early in the drug development , and this data should be submitted with the new drug application. 

 

(vii) Paediatric Subjects are legally unable to provide written informed consent, and  are dependent on their parent(s)/ legal guardian to assume responsibility for their participation in clinical studies. Written informed consent should be obtained from the parent/ legal guardian.

 

(viii) For clinical trials conducted in the paediatric population, the reviewing ethics committee should include members who are knowledgeable about pediatric, ethical, clinical and psychosocial issues.

 

(3) Pregnant or Nursing Women.- 

 

(i) Pregnant or nursing women should be included in clinical trials only when the drug is intended for use by pregnant/nursing women or foetuses/nursing infants and where the data generated from women who are not pregnant or nursing, is not suitable.

 

(ii) For new drugs intended for use during pregnancy, follow-up data (pertaining to a period appropriate for that drug) on the pregnancy, fetus and child will be required.  Where applicable, excretion of the drug or its metabolites into human milk should be examined and the infant should be monitored for predicted pharmacological effects of the drug.

 

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