Indian drug majors Sun Pharmaceuticals and Dabur India Ltd have both admitted to the DCGI that they have been unknowingly promoting anti-cancer drug, letrozole, in the treatment of female infertility. The two companies have written to DCGI that they have stopped promoting the product for unlicensed use and assured not to repeat such practices again.
Highly placed Central Drug Standard Control Administration (CDSCO) sources informed that the department has decided not to take any punitive actions against the companies in the wake of the confession and the assurance.
The companies have informed the DCGI that there are published reports, which suggested the use of the drug for infertility. They had been promoting the product based on such information. However, the companies have realized their mistakes have decided to not to promote the drug for infertility, it is learnt.
Sun Pharma was promoting Letroz, as an infertility drug in the country. Letroz is marketed through Inca Specialties, a division of the company. The company is also having the same drug marketed under a different brand name "Letoval", by Spectra, yet another division of Sun.
Dabur also had two brands of letrozole. Trozet used to be promoted for cancer treatment and Foliripe for infertility. However, its not clear whether the companies have announced any decision to withdraw these brands from the market as the brand name can still tempt the doctors to prescribe the medicines for fertility treatment. For example, the brand name Foliripe is suggestive of ripening of ovarian follicles and has nothing to suggest its anti-cancer properties.
It should be noted that the drug regulatory authority has no control over the "off label" use of the drug by the doctors.
The companies' reply came after the DCGI sought explanation from Mumbai-based Sun Pharmaceuticals on the matter. Pharmabiz had reported that all companies that are into the manufacture of letrozole in India were attempting to market their product for the unlicensed purpose. However, Sun Pharma and Dabur were the only ones having separate brands.
DCGI has approved the drug for the treatment of breast cancer only. Worldwide, letrozole is not used for any disorder except breast cancer.