18 October 2011
By , Kounteya Sinha
New Delhi , India
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.
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 and distribution of Letrozole for induction of ovulation in an ovulatory infertility with immediate effect. The Centre 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.”
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 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 the drug has a Rs–37 crore market in India, which is growing at 35% annually.