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Ban on Letrozole:

New Delhi :

The infertility drug Letrozole, suspected of causing genetic abnormalities in children conceived by its use, has been banned by the Health Ministry with effect from 17 October 2011, on the ground that it “ … is likely to involve risk to humans and safer alternatives are available”. Earlier, the Indian Council of Medical Research (ICMR) had been directed by the Drug Controller General of India to assess the safety factor through a two-year clinical testing programme, and the ban came even before the testing began, according to a member of the Expert Panel constituted to look into Letrozole’s side effects.

Indian medical practitioners interviewed were divided. The ban paves the way for the monopoly of the only other competitor-drug available in the market, namely, Clomiphine Citrate, which carries a higher risk of genetic abnormalities, according to a Senior IVF practitioner at the All India Institute of Medical Sciences. Another medical practitioner – the head of the IVF department of Sir Ganga Ram Hospital, felt the ban was justified. The drug was banned in developing countries, and she did not prescribe it, she said. In the west, US, Europe, and Canada do not allow Letrozole to be used as an IVF drug.

 

Source: India Express