Cancer drug letrozole is at the centre of a controversy over its being promoted as a fertility enhancer. The Union government has issued notices in this regard to Mumbai-based Sun Pharmaceuticals and Uttar Pradesh-based Dabur India Limited. While the latter has removed Foliripe -- the brand name under which it sells letrozole -- from the market, fresh evidence has reportedly surfaced that the former was encouraging the clinical trials of the medicine for this purpose
cancer drug letrozole is at the centre of a controversy over its being promoted as a fertility enhancer. The Union government has issued notices in this regard to Mumbai-based Sun Pharmaceuticals and Uttar Pradesh-based Dabur India Limited. While the latter has removed Foliripe -- the brand name under which it sells letrozole -- from the market, fresh evidence has reportedly surfaced that the former was encouraging the clinical trials of the medicine for this purpose.
In September, the Monthly Index of Medical Specialities (mims), a drug industry journal, had accused Sun Pharma of recommending letrozole for infertility treatment. mims' version has been borne out by a national daily, which recently reported that Sun was getting doctors to carry out clinical trials of the drug on the sly. More than 400 women were allegedly given the drug at private clinics not recognised as research institutions.
According to mims' publisher Chandra Gulhati, the entire exercise is meant to push the sales of the drug. While the demand for its anti-cancer form is to the tune of Rs 50 lakh, the infertility market is worth around Rs 6 crore, he reveals.
Experts agree a licence should have been obtained before marketing the drug. They, however, feel that in limiting the use of the medicine to oncology, the authorities have needlessly done away with a "wonder pill" for conception. It is noteworthy that the curbs have been imposed on purely ethical grounds, and there is no scientific evidence to suggest that the drug has side-effects when consumed for this purpose.
"It is better than the standard drug, clomiphene citrate, which is prescribed for fertility problems," asserts Aniruddha Malpani of Malpani Infertility Clinic, Mumbai. "Data needs to be collected on its harmful as well as beneficial effects so that the correct decision can be taken," points out M Kochar of Sir Ganga Ram Hospital, New Delhi. "The companies should try to get the drug registered expeditiously for this use," suggests Anoop Gupta of the Delhi ivf & Fertility Research Centre.
The Drug Controller General of India, Ashwini Kumar, reveals that some applications have already been filed for registering the drug as a fertility enhancer. But not only is the process cumbersome, it would also be an additional expenditure for the companies. Dabur has decided to market the drug as Trozet and sell it only to oncologists, says company spokesperson Sharad Goel. Down To Earth's repeated attempts to elicit a response from Sun Pharma went in vain.
Letrozole is recommended for treating breast cancer in women whose hormonal system has been disturbed due to menopause. The chemical reduces the amount of oestrogen in the body. This curbs the growth of the tumour. Significantly, a high amount of oestrogen also inhibits conception. Hence doctors have been giving this drug to women wanting to conceive. One of the known side-effects of the drug is that it can damage the foetus.
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