Date:21/12/2004 URL: http://www.thehindubusinessline.com/2004/12/21/stories/2004122103120400.htm

Back Separate norms likely for drug trials on children, elderly, pregnant women

Nithya Subramanian

New Delhi , Dec. 20

WITH a large number of clinical trials poised to move to India, the Health Ministry is planning to come up with separate protocols and norms for testing of new drugs on specialised population groups such as geriatrics, paediatrics and pregnant or nursing women.

These are likely to be part of the Amendments to Schedule Y of the Drugs and Cosmetics Rules, 1945. Previously, the rules merely stated that for drugs having potential use in children, permission for clinical trials in the paediatric age group is normally given after Phase III trials (that is conducted on a large number of patient volunteers). "However, if the drug is of value primarily in a disease of children, early trials in paediatric age group may be allowed," it said.

The new rules propose that the timing of paediatric studies in the new drug development programme would depend on the medicinal product, the type of disease, safety considerations, and the efficacy and safety of available treatments. "When clinical development is to include studies in children, it is usually appropriate to begin with the older children extending the trial to younger children and then infants," it said.

It further said that 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 evidence of potential benefit.

The revised norms will also make it possible for geriatric patients to be included in Phase III clinical trials and in Phase II as well in meaningful numbers if the disease intended to be treated is a disease of aging. Also, this would be allowed when the new drug is likely to alter the geriatric patient's response with regard to safety and efficacy compared with that of the non-geriatric patient.

Pregnant or nursing women can be included in clinical trials only when the drugs are intended for use by them. Also as a precaution, the rules clearly state that for new drugs to be used during pregnancy follow up data on the pregnancy, foetus and child would have to be submitted.

Added to this, the latest amendments will place more responsibility on the Ethics committee that will oversee the trials.

"The ethics committee should exercise particular care to protect the rights, safety and well being of all vulnerable subjects participating in the studies," it said.