After certain recent controversies, the Government of India had constituted a Committee under the Chairmanship of Dr R Samba Shiva Rao, Additional Director General, Health Services, to look into the aspect of Off-Label usage of drugs. The Committee, after extensive deliberations had authorised the IMA Headquarters to draft a Policy Statement on Off-Label Usage of Drugs.

The National President, Dr P V George had constituted a Committee in IMA to do the needful. The Committee under the Chairmanship of Dr P V George, National President, had submitted a detailed report to the Government in the form of a Policy Statement of IMA on this subject. The IMA’s Policy Statement is mentioned below:

IMA’s Policy Statement on Off-Label Usage of Drugs and the Status Analysis

(1) Off-label uses are defined as the use of a drug for indications or doses or routes of administration that are not included in the labelling approved by the Drug Controller. The prevalence and clinical importance of prescribing drugs for unlabelled uses are substantial.

This is often necessary for optimal patient care. It is imperative that registered medical practitioners have access to accurate and unbiased information about off-label uses of prescription drugs. IMA strongly supports the addition to approved labelling those uses of drugs for which safety and efficacy have been demonstrated.

(2) IMA believes that a Registered Medical Practitioner may lawfully use an approved drug for an unlabelled indication when such use is based upon sound scientific evidence and sound medical opinion. But they also have the responsibility to interpret the information received from any source before making clinical decisions.

Competent doctors write off-label prescriptions only when they are in the best interest of the patient and their use is amply justified. Doctors draw on a variety of sources to make the decision: Personal clinical experience, the collective experience of colleagues, and studies reported in scientific journals and at professional meetings. These sources are frequently used in paediatrics and geriatrics, since children and the elderly are often excluded from drug trials because of concern about liability, confounding medical problems, and increased vulnerability to adverse effects.

As a result, the majority of prescription drugs carry no specific directives for either group.

(3) Therapeutic advances are often achieved at a rapid rate while progress through licensing authorities is slow. The labelled indications may not reflect the current knowledge and may not include well-proven uses of a drug and may be over restrictive.

Off-label use of drugs is often the leading edge in patient care and research. In most instances they may be the treatment of last resort. Because off-label prescriptions are legal, pharmaceutical companies have little incentive to obtain new indications for their approved drugs.

To do so, they must show evidence from clinical trials that the drug works for the new purposes- a process that takes time and money. So, unless there is a compelling reason to amend the label, manufacturers are content to let doctors deviate from the package instructions and prescribe drugs for other purposes.

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