Regulating off-label drug use in India: The arena for concern.

Abstract

Off-label use of drugs is relatively common in medical practice, even if it's often not supported by strong scientific evidence. Off-label use of medicine not only involves physicians and pharmaceutical companies, but regulatory agencies and patients as well. Therapeutic options might get restricted without off-label prescribing in some patient population. Off-label uses can be useful to patients with an orphan disease where sometimes it can be the only available treatment. Permitting the promotion of drugs for off-label uses may be appropriate in instances in which a drug can improve the quality (e.g., same or better outcomes at lower cost). Although many controversies exist, experts generally agree that further efforts are needed to increase access to suitable off-label drugs for patients with rare and other diseases. However, they also concur that potential inappropriate promotion, as well as possibly dangerous prescribing practices for these drugs, should be prevented. Proponents argue that the key benefit of allowing manufacturers to distribute off-label information is that it allows more data to be readily available to physicians, enabling them to make better treatment decisions.