India has announced it won’t be adding Merck’s COVID-19 pill to its national treatment protocol due to concerns about its safety.
It can cause fetal defects and cell changes, according to the country’s medical research council.
On Wednesday, the state-run Indian Council of Medical Research (ICMR) said it had become aware of “major safety concerns.”
“It can cause teratogenicity and mutagenicity, and it also can cause cartilage damage and be damaging to muscles,” ICMR Director-General Balram Bhargava stated.
“More importantly, contraception will have to be used for three months if this drug is given, because the child born could be problematic, with teratogenic influences.”
A teratogen is an agent than can harm the development of a fetus, while mutagenic drugs change the genetic makeup of the subject.
Merck claims a study of its drug proves it does not lead to birth defects or cancer, and that study had actually used even higher doses and longer periods of administration than those normally used in humans.
“The WHO has not included it, the UK has not included it as of now. As of now, the current recommendation stands that it is not part of the national taskforce treatment,” Bhargava said.
The drug was approved by the Indian regulator in December and had been due to go on sale on the private market next week.
Neither Merck nor Dr. Reddy’s Laboratories, an Indian drugmaker that had planned to launch a generic version of the pill, has so far responded to media requests for comment.
The drug has been approved for use elsewhere in the world, including in the UK, Japan, and Denmark.
Nonetheless, the trial data was disappointing, with many countries opting to use Pfizer’s more effective COVID-19 pill instead.