Although the union ministry of health has indicated that the off-label use of drugs might be permitted in case of doctors, DCGI office is all set to have a strict monitoring on pharmaceutical companies indulging in promoting such use of drugs with a commercial intent.

According to Ashwinikumar, Drug Controller General of India (in-charge), promotion of a drug product by pharma companies for a different indication that is not permitted while approval of the drug is totally illegal. Though the arguments for off-label use of drug by the experienced doctors may be justified in emergency situations, the industry can never use this provision for promoting the products among the doctors, he said.

"Hence, whether the doctors are permitted or not for the use of drugs for off-label indication, the department has already informed to all its zonal offices and also the state drug controllers to keep a strict vigil on the companies against such practices and also to initiate instant penal action against the companies," Ashwinikumar told Pharmabiz.

He added that this move was on after the controversy of an illegal promotion of breast cancer drug, letrozole, for treating female infertility by certain companies in India came to notice of the department. "We had then directed the companies to desist from such practices as these promotions by the companies are clear violation of the section 122-E (b) of the Drugs and Cosmetics Rules," the DCGI said.

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.