After more than five years since it was banned in the country for risk to human beings and safer alternatives were available in the market, the Union health ministry has now revoked the suspension on manufacture, sale and distribution of the controversial drug, letrozole, for induction of ovulation in anovulatory infertility.

“Now, therefore, the Central Government in exercise of the powers conferred by section 26A of the said Act, hereby rescinds the notification of the Government of India in the Ministry of Health and Family Welfare, Department of Health and Family Welfare, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide G.S.R. 752(E), dated the 12th October, 2011 with immediate effect, except as respect to things done or omitted to be done before such rescission”, the ministry said in its gazette notification.

The ministry’s decision to cancel the suspension on letrozole comes following a favourable research result by the Indian Council for Medical Research (ICMR). The ICMR had conducted a systematic review and meta analysis including studies in India in respect of the drug letrozole for induction of ovulation in anovulatory infertility and the expert committee of the ICMR recommended that suspension of manufacture and sale of the said drug may be revoked. Besides, the issue was also examined by the Drugs Technical Advisory Board (DTAB)of the ministry in its 75th meeting held on January 3, 2017 and recommended that the suspension of manufacture, sale and distribution of the said drug may be revoked and the drug be allowed for induction of ovulation in anovulatory infertility.

Earlier, on October 12, 2011, the Union health ministry, on the recommendation of DTAB, had banned the manufacture for sale, sale and distribution of letrozole, after taking note of the fact that the use of the drug letrozole for induction of ovulation in anovulatory infertility was likely to involve risk to human beings and safer alternatives are available. The DTAB is reported to have expressed the view then that it was necessary and expedient to regulate by way of suspension of the drug for the indication of induction of ovulation in anovulatory infertility in public interest.

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

Ever since the Mumbai-based pharma company Sun Pharmaceuticals was given the marketing nod for letrozole by the Drug Controller General of India (DCGI) in 2009, there was an outcry from the medical fraternity in the country against the use of the drug. 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 the drug was launched in the country, there were allegations that the approval was granted in flagrant violation of Indian safety laws.