The Indian Medical Association has sought legislative changes for doctors in India to be able to lawfully prescribe drugs for treatments other than those for which the drugs were initially approved, a demand some doctors have called “irresponsible” and “dangerous.”
In a policy statement submitted to the health ministry the association said doctors in India should be allowed to prescribe drugs for unapproved indications when there is scientific evidence and medical opinion to justify such “off-label” treatment.
“Doctors should have the right to provide patients the benefits associated with off-label use of drugs as long as unflinching medical literature has given them confidence for such therapy,” said Dr Sanjiv Malik, secretary general of the association. “Doctors write off-label prescriptions in the best interest of patients, but they have a responsibility to interpret information received from any source before making clinical decisions,” the association said.
Indian law does not currently allow drugs to be prescribed for indications for which they have not been approved. Amendments to the Indian Medical Council Act two years ago made off-label prescribing illegal. The association has said that off-label prescribing is widespread in many countries, including the United States. “Disallowing off-label use could result in patients being denied the best therapy,” said Dr Malik.
The controversy over off-label use of drugs grew after a drug company was accused last year of promoting an anticancer drug, letrozole, for the treatment of infertility in women (BMJ 2003;327:768).
The association’s demand has provoked strong reactions from the medical community. “If individual doctors or medical associations take on the role of drug regulators, we’ll have therapeutic chaos,” said Dr Ranjit Roy Chowdhury, president of the Delhi Medical Council.
Some doctors have also cautioned that India lacks appropriate checks to ensure that off-label prescribing is done ethically.
“It is dangerous to suggest that doctors should be free to decide about off-label use based on their experience and knowledge,” said Dr Sanjay Nagral, chairman of the Forum for Medical Ethics in Bombay. “Drug companies are a major source of information for practising doctors. Unfortunately, there is no culture here of seeking objective medical information,” Dr Nagral said.
Drug industry analysts also say that off-label use of drugs as practised in the United States cannot be transplanted to India. “This is an irresponsible suggestion,” said Dr Chandra Gulhati, editor of the Monthly Index of Medical Specialities India. “Doctors here cannot have this freedom, given the low level of patient awareness and the influence of drug companies on prescription practices.”
Dr Gulhati said approved drugs should be considered for unapproved indications only in highly controlled environments such as hospitals in situations where the potential benefits of the drug clearly outweigh its risks and with the approval of ethics committees and patients’ consent.