Utter confusion prevails among the pharmacists and the state drug regulators about the applicability of the recent notification issued by the union health ministry suspending manufacture, sale and distribution of controversial drug, letrozole, for induction of ovulation in anovulatory infertility, with immediate effect.

Though it was clearly mentioned in the notification that “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 (“induction of ovulation in anovulatory infertility”) in public interest,” there is still confusion among the pharmacists and the state regulators whether the ministry has suspended the drug as a whole or only its indication for infertility.

Sources said that a large number of pharmacists across the country have already removed the drug letrozole from their shelves after the notification.

The confusion was further compounded when the state drug controllers in some states issued directives to the pharmacists stating that the manufacture, sale and distribution of the drug letrozole is suspended.

Meanwhile, experts said that the drug letrozole has not been banned, but its indication for infertility has been suspended by the Drugs Technical Advisory Board (DTAB) of the health ministry on October 10. “There is no question of suspending the drug as the question before the DTAB was to examine whether the drug is safe for the indication of infertility or not,” experts said and added that the drug can be sold in the country for the indication of breast cancer in postmenopausal women.

Letrozole, a research molecule of Novartis, is approved for use in cases of breast cancer in postmenopausal women all over the world.

But the drug courted controversies when the Drug Controller General of India (DCGI) Dr Surinder Singh gave the marketing nod to the Mumbai-based pharma company Sun Pharmaceuticals for the indication of infertility.

The DCGI's approval of the drug for infertility triggered a debate in the country as there were reports that its use in women of child bearing age is strictly prohibited elsewhere in the world due to severe side effects such as estrogen deprivation, ovarian atrophy, uterine atrophy, increased incidence of foetal malformations, foetal resorption and foetal death.