The Central government is exploring the pros and cons of legalizing "off label" use of medicines in India. The official move in this regard has come after the recurring reports of use of drugs for unapproved indications in recent months. The pharmaceutical industry and the Indian Medical Association have been lobbying hard for such a change.

The recently held Drugs Technical Advisory Board (DTAB) meeting of the Central Drugs Standard Control Organisation (CDSCO) is known to have discussed the possibilities of allowing a registered medical practitioner to prescribe any drug that has been approved for sale in the country. The DTAB had observed that the practice of restricting the use of certain drugs to certain specialists is not a common practice among drug regulatory authorities. The discussions were based on a representation made by IMA with regard to the off label use of drugs. The IMA is of the opinion that once DCGI releases a particular drug for use, the medical profession should be given the privilege to use it. "A particular drug may be used by a doctor for different diseases. Moreover, the practice of medicine is regulated by Medical Council of India. It would not be correct to classify drugs to be used by a particular specialist only", they had noted. These restrictions were imposed to avoid possible indiscriminate use / prescription of these drugs except by medical specialists who possess adequate qualification and experience in respect of use of such drugs.

As a fall out of the discussions, IMA was asked to submit a detailed report on the various aspects relating to off label use of drugs. It is known that IMA had recommended for a change in the drug laws, which can lawfully allow a registered medical practitioner to use an approved drug for an unlabelled indication when such use is based upon sound scientific evidence and sound medical opinion.

Accepting the committee's recommendation, CDSCO has decided to put forth its suggestions in the forthcoming Drugs Consultative Committee meeting. The authorities have observed that off label use of drugs by medical practitioners may be out of scope of direct intervention by drug authorities in the context of available provisions under Drugs and Cosmetics Act. It has decided to examine the issue in the forthcoming DCC meeting.