Text Size A A A

Sun Pharma In The News

Tell a Friend Print Home » Media » Sun Pharma In The News

Sun hands over trial report or anti-infertility drug to govt


THE govemment will examine SunPharma'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 against such use globally, letrozole is approved and widelyused to cure infertility in womenin India and not breast cancer as there are new drugs to treat it. "Sun Pharma's Letrox is the only brand (using letro'zole) 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," drug controller general of In'dia (DCGI)Dr Surinder Singh said.
In addition to the PMS, government will examine Sun pharma's clinical trial reports of the medicine in India and also the published global clinical reports of the drug. PMS refers to the reports of a drug or device which have al'ready been launched in the market to confirm or deny the safety of a drug.
The decision was taken by a Drug Technical Advisory Board (DTAB) headed by Lakhbir Dhaliwal, head ob'stetrics & gynaecology PGI Chandigarh which met last Saturday. If the technical committee finds higher risk in the use of the drug as an infertility medi'cine, 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 is likely to take a fi'nal call on the usage of the drug as an infertility drug in its next meeting scheduled for the first week of Febru'ary, Mr Singh added.
When contacted, the Sun Pharma spokesman said; "We have conduced 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 an industry expert said.
Letrozole is the original drug developed by Swiss company Novartis AG, which it sells under the brand name Femara to treat breast cancer in post-menopausal women. Dr C M 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 AG) and Canadian health regulator have issues warnings against the use of this drug to treat infertility because of ad verse 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?" He said, globally, there are little or no clinical reports for the use of the drug to treat infertility.
DTAB, the apex body on technical matters concerning the pharma industry, is examining whether a set of drugs banned in some parts of the world should be allowed to be used in the country. The DCGI will take appropriate action based on the recommendation of the DTAB. Other drugs under the scanner include phenylpropanolamine or PPA (found in cough and cold remedies like Vicks Action-500, Solvin, Wincold), gastrointestinal tegaserod (marketed as Ibsinorm, Tegod, Tegibs), anti-bacterial gatifloxadn (Gaity) and painkiller nimesulide (Nice and Nimulid).