The Supreme Court on Monday allowed the sale of Saridon, exempting the painkiller from last week’s government order banning manufacture and distribution of 328 fixed-dose combination drugs for human use.
FDCs are two or more drugs combined in a fixed ratio into a single dosage form.
Doctors and public health experts in India and abroad have warned that increasing use of antibiotic combinations in India may be contributing to antibiotic resistance.
India is a particular concern as the market share of combination drugs versus single drugs is bigger than anywhere in the world.
The Centre's decision came on a recommendation of a panel of experts that favoured a ban on drugs that are “irrational”, cited safety issues and lack of therapeutic justification.