Off-label Medicine Use in India: Need for linking Research with Policy and Practice

Abstract

Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Some key concerns regarding off-label use of medicines include scientific evidence to support its use, benefit-harm ratio and coverage by health insurance. In India, off label use of drug is very common. Review of studies in India show off-label prescription in the areas of neonatal care, pediatric age group, peri-operative indications and cancer.

Offf label prescription laws in India should focus not only on the health care provider but also the manufacturers promoting off label use without scientific evidence. In individual clinical practice, physicians can use the deprescribing process and algorithm used to address polypharmacy to identify inappropriate or unnecessary medications and discontinue them. Off label use of medicine is an issue which invites research and intervention at both the micro and macro levels of the health system. To ensure healthy outcomes, the decision on off-label use of medicine requires a fine interplay between clinical autonomy, ethics and evidence based treatment guidelines and policies.