The Hindu Business Line : Off-label use of drugs

ASPIRIN, originally a pain and fever medicine, is also given to patients with heart problems, since it is found to have blood-thinning properties. Pfizer's famed impotence drug Viagra or sildenafil citrate was originally developed for chest pain. And anti-cancer drug Letrozole is also used by doctors to treat infertility.

Examples are aplenty regarding the "off-label" use of medicines — where drugs are prescribed by doctors for illnesses beyond the application indicated on the label of the medicine.

So does the "silent label" (as doctors call off-label use) benefit the patient — ``since doctors prescribe what is best suited to treat an illness.'' Or does it expose the patient to the risk of being used for research or experimental purposes?

In December last year, manufacturers of anti-cancer drug Letrozole (Dabur and Sun Pharma ) had come in for the stick from the Union Health Ministry, following reports of the drug being used to treat infertility.

Subsequently, a lot of brainstorming has taken place and the Indian Medical Association (IMA) has recently given guidelines to the apex Ministry to facilitate legalising off-label use of drugs.

"Doctors prescribe a medicine for an application not indicated on the label, only when convinced of its additional benefits. When science starts reporting off-label benefits, doctors base their decision on unbiased published data and evidence. Barring doctors from off-label use will prevent a patient from getting the best treatment for his illness," argues Dr Sanjiv Malik, Secretary General, IMA.

Pharma companies are not inclined to re-apply to the Government for the new indication, as the regulatory clearance procedure is ``lengthy, cumbersome and expensive,'' he points out. IMA says that off-label use of medicines is seen in countries such as the US, the UK, Europe, Australia and Canada.

Doctors point out: ``Hundreds of drugs in India are being used off-label.'' The Government needs to amend the Drugs and Cosmetics Act to legalise it. Further, they point out: ``Off-label usage is frequently adopted in children and old people, since children and the elderly are often excluded from drug trials because of concern about liability, medical problems, and vulnerability to adverse effects. As a result, the majority of prescription drugs carry no specific directives for either group.''

Fifteen years ago in the US, health insurance companies refused to pay for medicines used in applications not indicated on the label. The US authorities ruled favouring off-label use and defined it, points out Dr Malik.

Similarly, once off-label use of a drug becomes apparent — doctors, drug manufacturers and the regulatory authority in India (the Drug Controller General of India - DCGI) should look to label the additional usage at the earliest instance, points out IMA.

But, healthcare workers feel that off-label use could result in the ``abuse of drugs.'' ``It should not be left entirely to the discretion of doctors. Off-label use should be cleared by the DCGI, otherwise pharma companies could test drugs on patients, as a prelude to doing proper clinical trials for drugs,'' they caution.

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