The Union Health Ministry will soon take a final decision on the controversial drug letrozole, which is being re-examined by a sub-committee of the Drug Technical Advisory Board (DTAB) of the ministry on whether the drug should be allowed to be marketed for sub-fertility in young menstruating women in the country. The drug is being marketed by Sun Pharmaceuticals in the country as a remedy for sub-fertility in young menstruating women.

The DTAB sub-committee on letrozole, constituted by the health ministry on November 9 last year to re-examine the drug in the wake of public outcry against the drug, will hold its crucial meeting in the first week of February to take a final call on the drug, which was a research molecule of Novartis and is indicated for use in cases of breast cancer in postmenopausal women all over the world.

The sub-committee, headed by Dr Lakhbir Dhaliwal, head obstetrics & gynaecology, PGI Chandigarh, has already held two-three meetings and a final decision on whether the drug should be allowed to be marketed for sub-fertility in young menstruating women in the country will be taken on the next meeting. “Another meeting will be held in the beginning of February and a clear picture on letrozole issue will be available only after this meeting. Apart from senior health ministry officials, company representatives will also be present in the meeting to present their views,” Dr Dhaliwal said.

Ever since the Mumbai-based pharma company Sun Pharmaceuticals was given the marketing nod for letrozole by the Drug Controller General of India (DCGI) a couple of years ago, there was an outcry from the medical fraternity in the country against the drug 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.

When criticism against the drug reached its crescendo, the DCGI decided to leave the matter to the consideration of the DTAB, the highest body under the union health ministry on technical matters concerning the pharma industry in the country. The DTAB in its meeting on November 9 decided to constitute a sub-committee under Dr Dhaliwal to re-examine the controversial drug.