The union ministry of health is learnt to have proposed a fresh amendment to the Drugs and Cosmetics Rules to incorporate relevant provisions for allowing off-label use of drugs by medical practioners under certain conditions. The new proposal follows the recommendation of recently set up expert group, which studied the matter concerning use of drugs by doctors for an indication not mentioned in the approved label.

According to sources in the Central Drug Control Organisation (CDSCO), since off-label use of drugs by the medical practitioners does not come under the ambit of drugs regulatory framework currently, there have been issues concerning such uses left unresolved in many instances. Therefore, the health ministry had set up an expert group comprising doctors and pharmacologists under the chairmanship of Dr R Sambashivarao, additional director general, DGHS, to study the matter and recommend appropriate changes in the regulatory framework to deal with such cases.

"There were even controversies in connection with promotion of drugs for non-approved indications by pharmaceutical companies," said the sources. However, the expert group, after identifying the fact of off-label use of drugs by individual doctors based on their experiences in emergency cases, has suggested that it is essential to amend certain provisions of Drugs & Cosmetics Rules to incorporate relevant sections for allowing the same under certain conditions, the sources added.

It may be recalled that the Central ministry, following recurring reports of use of drugs for unapproved indications in recent months, was exploring the pros and cons of legalizing "off label" use of medicines in the country. In addition, the pharmaceutical industry and the Indian Medical Association also 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 for different indications based on his experience. The DTAB had observed that 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 permits a particular drug for use, the medical profession should be given the privilege to use it.