CHENNAI: The Union health ministry has revoked the ban imposed on the sale and manufacture of the controversial drug letrozole for infertility treatment. The drug, which was commonly used for breast cancer treatment in post-menopausal women across the world, was approved for use in India in 2007 based on the drug regulator’s approval and clinical trials conducted by an Indian company, Sun Pharmaceutical Industries. Prior to this, Clomiphene citrate was the only option Indians had since 1962.
However, there were also allegations that the approval norms were violated during the launch of letrozole. There were controversies and a notice issued by the original manufacturer of the compound, Novartis (a Switzerland-based healthcare firm), was ignored. Novartis warned that using it in pre-menopausal women could lead to health risks.
Within a year after the drug hit the stores in the first week of April, reports surfaced that it was misused by Indian doctors for inducing ovulation (stimulating the ovary to produce oocyte).
In 2008, when CPM leader Brinda Karat raised a query in the Parliament on safety aspects of the drug, the health ministry replied that regulators had waived safety studies and rules were relaxed to approve this drug (trials had 55 women, instead of 100).
According to international journals, some of the possible side-effects associated with this drug include bone and foetal malformation, oestrogen deprivation and ovarian atrophy. However, the drug continued to be in use for the next three years under various brand names such as letroval and letroz. In 2011, the centre issued a government order restricting the use of this drug for infertility therapy.
The local manufacturer had proposed to rescind the order the same year and formed an expert committee with scientists from Indian Council for Medical Research (ICMR) to look into this.
The council, in an earlier study, had opposed the use of this drug for infertility therapy. However, in 2016, ICMR had recommended its usage through another study.
Speaking to Express, Dr RK Sharma, director of reproductive biology, maternal and child health, ICMR, said that their final report was based on systematic review and meta-analysis including studies across the country and data on trials provided by international agencies.
Following a favourable report from ICMR, the Drug Technical Advisory Board (DTAB) in its 75th meet on January 3 gave its nod for revoking the ban. Based on this, the drug was back in the stores after nearly five years.
But the medical fraternity stands divided over the reintroduction of letrozole. “Doctors started prescribing it even when phase II of the trial was going on abroad. The side-effects forced many doctors including me to avoid letrozole,” Dr Jayam Kannan, Managing Director, Tamil Nadu Federation of Obstetricians and Gynaecologists, said. She added that with the final (double-blind crossover) phase of the trials completed in 2012, corrections were made to ensure minimum side-effects.
On the other hand, senior gynaecologists said that it was better to avoid taking risks when safer options were available.