New Delhi, Sept. 23: A leading Indian pharmaceutical company is marketing an anti-cancer drug to boost fertility in women without securing mandatory government approvals.
Although the drug, Letrozole, is approved in India and elsewhere in the world to treat breast cancer, it is not certified to treat infertility. But Sun Pharmaceuticals has been marketing Letrozole for “improving fertility” in women.
“The drug is not approved for any other use anywhere in the world,” said the editorial in the current issue of the Monthly Index of Medical Specialities, a top pharmaceutical products journal.
Responding to a charge in the editorial that it is “illegally promoting” Letrozole for fertility, Sun Pharmaceuticals admitted that Letrozole has not yet been approved by the drugs controller of India.
“It is possible that some marketing people may have gone overboard with information from published medical papers and from interactions with infertility experts,” Sun said in a statement. “We are investigating this.”
Pharmaceutical firms need mandatory approval from the drugs controller of India, permission from hospital ethics committees, and have to conduct trials in India with informed consent if the drug is to be prescribed to Indian patients for uses other than breast cancer, the journal said.
It added that animal studies show Letrozole is toxic to embryos and can cause foetal abnormalities, such as incomplete formation of the skull and bones of the feet. The editorial further claimed that other side effects include ovarian tumours, liver cancer and atrophy of the reproductive tract.
Clomiphene is the standard drug used for increasing ovulation in women. The journal said Sun has made “misleading and contradictory” claims in a leaflet distributed to doctors in an attempt to downgrade the use of Clomiphene.
Under Indian laws, if a drug approved for a specific use is to be used for another disorder, it has to be considered a “new drug” and needs fresh government approval after undergoing a series of tests and trials involving both animals and humans. No such trials have been undertaken on Letrozole as a fertility agent, the medical products periodical said.
“But our experience suggests that the drug has worked on Indian women,” a Sun spokesperson said. “We are now in the process of applying to the drugs controller to allow us to do a formal study based on international experiences and publications.”
The US Food and Drug Administration approved Letrozole for cancer therapy in January 2001.
Some researchers have tested its effect on ovulation, in the hope that it might help treat infertility. But lead researcher Robert Casper cautioned that no controlled trials, acceptable to regulatory agencies, have been conducted so far.
Dr Shyam Aggarwal, an oncologist in the Ganga Ram hospital of Delhi, said Letrozole is used to change the hormone balance in females. Its primary function is to reduce the production of Estrogen in females.