Wednesday, December 29 2004 20:22 Hrs (IST) - World Time -

Bhubaneswar: The Indian Medical Association (IMA) today (Dec 29, 2004) sought to put to rest the debate over 'off-label' usage of drugs saying it was legal and absolutely necessary but cautioned medical practitioners to exercise utmost care while prescribing them.

IMA's outgoing national president P V George told reporters at the 69th annual conference of the association in Bhubaneswar that off-label use, meaning use of drugs for indications, doses or routes of administration not included in the labelling approved by the Drug Controller of India, should be left on the physician's professional judgement.

'A registered medical practitioner may lawfully use an approved drug for an unlabelled indication based upon scientific evidence and medical opinion. Doctors write off-label prescriptions only when it is in the best interest of the patient and amply justified', George said.

Pointing out that therapeutic advances were often achieved at a rapid rate while progress through licensing authorities was slow, he said labelled indications might not reflect current knowledge or well proven uses of drugs making them over-restrictive.

'Unless there is compelling reason to amend the label, most manufacturers are content to let doctors deviate from the package instructions and prescribe drugs for other purposes. Off label use of drugs is absolutely legal,' he said.

IMA Honorary Secretary General Sanjiv Malik said off-label use neither amounted to research nor experimentation, as had been observed in certain quarters, and according to medical ethics, there was a distinction between 'Practice of medicine' and 'research'.