Centre makes U-turn, lifts cancer drug ban

Almost four years after the parliamentary standing committee hauled up the government for approving an anti-cancer drug — “letrozole” — for improving female fertility in violation of laws, the drug is back, with the government revoking the suspension on sale and distribution of the controversial drug.

Making a “U-turn” after it had suspended its sale on the grounds that it was likely to involve “risk” to human beings, the government on Monday revoked suspension of the drug following the advice of government’s largest technical body on drugs — the Drugs Technical Advisory Board (DTAB) — and Indian Council of Medical Research (ICMR) that recommended that the drug be allowed for induction of ovulation in

The sale of the drug had been suspended on the grounds that it was likely to involve ‘risk’ to human beings

anovulatory infertility.

“The ICMR conducted a systematic review and meta analysis, including studies in India, in respect to 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,” said the notification.

Though globally the drug is used for treatment of breast cancer, in India it was being administered to young infertile women to help them conceive. The issue was taken up by the parliamentary standing committee which in their report of 2013 blamed the government for “gross violation” of the laws of the land (for approving the drug without any studies), and had lambasted the government officials for having colluded with private interests in getting the drug approved in violation of laws.

The government’s move to revoke the ban has therefore come as a shocker to many. C.M. Ghulati, editor of medical journal Monthly Index of Medical Specialities, said, “The drug is not used anywhere in the world for the treatment of fertility. It is shocking that in India we have found its new use. What evidence do we have to revoke the suspension of the drug. Even the parliamentary standing committee had pulled up the government earlier for this.”

However, for IVF experts, the drug is a boon.