The government will examine Sun Pharma’s post marketing surveillance studies (PMS) and clinical trials report of breast cancer medicine Letrox (chemical name letrozole) to decide whether the drug should be banned from being marketed, as an anti-infertility drug among young women.
Despite warnings, letrozole is approved and widely used to cure infertility in women in India and not breast cancer, as there are new drugs to treat it. “Sun Pharma’s Letrox is the only brand (using letrozole) in the market for over two years, which is used to treat infertility. We will ask for the PMS and examine whether the drug should be allowed for treating infertility,” said drug controller general of India (DCGI) Surinder Singh. In addition to the PMS, the government will examine Sun Pharma’s clinical trial reports of the medicine in India and also the published global clinical reports of the drug. The PMS refers to the reports of a drug or device, which have already been launched in the market to confirm or deny the safety of a drug.
The decision was taken by Drug Technical Advisory Board (DTAB) headed Lakhbir Dhaliwal, head obstetrics & gynaecology, PGI Chandigarh, which met last Saturday. If the technical committee finds higher risk in the use of the drug as an infertility medicine, the DCGI may ban the drug from being marketed as an infertility drug. But companies may continue to sell their brands as a breast cancer drug. An official communication to this effect would be sent to Sun Pharma shortly.
The DTAB may take a final call on the usage of the drug, as an infertility drug in its next meeting scheduled for the first week of February, Mr Singh added.
When contacted, the Sun Pharma spokesperson said: “We have conducted a trial as required, subsequent to which we have received marketing approval. We will also comply with additional requirements, if any.”
Besides Sun Pharma, few other companies such as Dabur Pharma (now Fresenius Kabi) and Dr Reddy’s sell letrozole under different brands in the domestic retail market and are promoted as an infertility drug, said an industry expert. Letrozole is the original drug developed by Swiss company Novartis, which it sells under the brand name Femara to treat breast cancer in post-menopausal women.
Dr CM Gulati, a medical expert, said, India is the only country where letrozole is marketed to treat sub-fertility in young menstruating women to treat infertility. “The innovator company (Novartis) and Canadian health regulator have issues warnings against the use of this drug to treat infertility because of adverse side effects. If it was indeed useful, why would Novartis not take advantage of it in countries like the US and make billions of dollars?”