Finally, India bans ‘fertility’ drug Letrozole-ToI-18.10.11

The Breast Cancer Drug Was Being Administered To Infertile Women To Help Them Conceive

Kounteya Sinha TNN 

New Delhi: India has banned manufacture, sale and distribution of controversial drug Letrozole. 
    Though globally the drug is used for treatment of breast cancer, in India it was being administered to young infertile women to help them conceive. 
    A 16-member committee, under special director general of health services Dr D C Jain, decided to ban the drug. 
    The Union health ministry’s notification on Monday said, “In exercise of the powers conferred by Section 26A of the Drugs and Cosmetic Act, 1940, the Central government has suspended the manufacture for sale, sale and distribution of Letrozole for induction of ovulation in anovulatory infertility with immediate effect. The Central government is satisfied that it is necessary and expedient to regulate by way of suspension of manufacture, sale and distribution of the drug for the said indication in the public interest.” 
    It added, “The Central government is satisfied that the use of the drug for induction of ovulation in an ovulatory infertility is likely to involve risk to human beings and safer alternatives to the said drugs are available.” 
    Over the years, there has been a growing suspicion that the drug’s side-effects have led to severe genetic abnormalities among babies born to infertile women. 
    Dr Chandra M Gulhati, editor of Monthly Index of Medical Specialties, India, a journal on drugs, said, “Letrozole sold under various brand names in India such as Letroz and Letoval is internationally approved for treatment of breast cancer in post-menopausal women. Both, the Canadian drug regulator and the innovator company Novartis have warned gynecologists not to misuse it for female infertility. Research on 150 pregnancies has shown that babies born to mothers who had consumed Letrozole to increase fertility have suffered from bone malformations, cardiac stenosis and cancers.”
    Dr Gulhati added that Letrozole has Rs-37 crore market in India, which is growing at 35% annually. Brands like Letroz and Letoval, made by Sun Pharma, are in great demand. While, minor players are Oreta (Dr Reddys), Letz (Chemech) and Shantroz (Shantha Biotech). 
    Ministry sources said the committee that took the decision included gynecologists, reproductive biologists, pharmacologists and research experts. 
    Dr Gulhati said “It is no more the first drug of choice for breast cancer as several new ones are now available. But, it still has a big market. This clearly shows how Letrozole’s use for inducing ovulation is still rampant in India.”