Health

India says safety concerns restricting use of Merck COVID pill

“We
have to remember that this drug has major safety concerns,” Balram
Bhargava, head of the state-run Indian Council of Medical Research, said.

“It can
cause teratogenicity, mutagenicity and it also can cause cartilage damage and
be damaging to muscles. 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.”

Teratogenic
drugs can harm the development of a foetus while mutagenic ones can permanently
change the genetic material of a person.

Merck and
Indian drugmaker Dr Reddy’s Laboratories Ltd , which plans to launch a generic
version of the pill early next week, did not immediately respond to requests
for comment.

Drugs in the
same class as Merck’s pill, called molnupiravir, have been linked to birth
defects in animal studies. Merck has said similar studies of its drug – for
longer and at higher doses than used in humans – show that it does not cause
birth defects or cancer.

Bhargava
said Indian health experts had twice deliberated on the Merck drug – which the
country’s regulators approved late last month and goes on sale on the private
market from next week.

“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,” he said.

The comments
could hurt private sales of the drug when it hits the market as most doctors
tend to follow recommendations from federal health officials.

See also  Philippines to acquire missile system from India for $375m

The US FDA’s
Antimicrobial Drugs Advisory Committee voted 13-10 in November to recommend the
drug after discussing concerns it could cause the virus to mutate as well as
the potential birth defect worries. Both FDA scientists and Merck have
suggested the drug should not be recommended during pregnancy.

The UK in
November was the first country to approve the pill, but further trials are
underway.

Related Articles

Back to top button