Centre's notification bans use of medicine for infertility treatment

Confusion has been reigning in the pharmaceutical sector ever since reports about the Centre banning the manufacture, sale, and distribution of drug letrozole have been out, with most pharmacists taking this important breast-cancer drug off the shelves without much ado.

Breast-cancer patients, who are currently on letrozole, are the ones who have found themselves at the receiving end as the drug seems to have disappeared from most pharmaceutical outlets all of a sudden.

Letrozole is an essential drug which is prescribed globally for post-menopausal women undergoing treatment for breast cancer. In India, for a long time, more than oncologists, the drug was being prescribed by infertility specialists for inducing ovulation in young women as part of infertility treatment.

The Centre's notification banning the manufacture, sale, and distribution of letrozole was issued on October 12. Even though the notification clearly stated that the drug was being banned for use in infertility treatment, pharmacists chose to remove the drug from their retail counters as a ‘safety' precaution and in the absence of clear guidelines from the Drugs Control Department. Inquiries with several prominent medical shops in the city revealed that letrozole was no longer being stocked or sold by many. Only some shops around the Medical College Hospital area were stocking the drug now, a pharmacist at Statue Junction said.

“I stopped selling it as soon as I read about the ban in the newspaper. The prescriptions were mostly from gynaecologists. I am now told that letrozole can be sold to cancer patients but as long as I do not get a clear directive from authorities, I am not courting trouble,” the owner of a pharmacy at Sasthamangalam said.

The drug, primarily sold under the brand names Letroz and Letoval here, was being studied by the Drugs Technical Advisory Board (DTAB) following concerns that babies born to mothers who used letrozole were at risk of genetic malformations and cancer. It was based on the report of the DTAB that the Centre banned the drug for ovulation induction.

“I have had at least six of my patients calling me in an agitated state that they had difficulty buying letrozole. This is a drug which we prescribe long term — for as long as five years — and pharmacists might be fearful of giving out repeat doses of the same prescriptions if there are no clear directives to them,” Krishnan Nair, prominent oncologist and founder-director of the Regional Cancer Centre, said.

He pointed out that even though there were other alternatives to letrozole, this was the cheapest drug and there were several recent studies which had reported it to be the most effective drug than other molecules.

The Drugs Controller (in charge), Sathish Kumar, pointed out that there should be no room for confusion as the Centre's notification clearly said the indication for which letrozole was banned.

“We had sent out a statement that pharmacists can accept letrozole prescriptions which are given by oncologists alone and that the drug may be stocked as its use for cancer treatment has not been banned. We will ensure that clear guidelines are issued,” he added.