New Delhi, Sept 17, 2018 : The Supreme Court on Monday lifted ban on sale of painkiller Saridon and two other drugs.
The top court ruling comes after the September 13 order by the Ministry of Health that banned the manufacture for sale or distribution of 328 fixed-dose combination (FDC) drugs. The banned medicines included brands like Piramal Healthcare’s Saridon, Alkem Laboratories’ Taxim AZ and Macleods Pharma’s Panderm Plus cream.
A bench of Justices R F Nariman and Indu Malhotra issued notice to the Centre and sought its reply on the plea filed by some drug makers and pharma associations.
The medicines whose sale was allowed were Saridon, GlaxoSmithKline’s Piriton, Juggat Pharma’s Dart and another drug, the details of which could not be immediately known.
FDCs are two or more drugs combined in a fixed ratio into a single dosage form. The domestic pharmaceutical market size is pegged at around Rs 1.18-1.2 lakh crore, reports Business Today, and FDCs reportedly make up nearly 50% of the sales.
Public health experts and doctors in India and abroad have warned against the increasing use of antibiotic combinations as it may be contributing to antibiotic resistance.
India poses a particular concern as the market share of combination drugs versus single drugs is bigger than anywhere in the world.
An expert panel formed by the Drugs Technical Advisory Board (DTAB), in its report to the Centre, stated that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings.
DTAB said these combinations may lead to overuse. According to the technical body, there is no need to expose the patients to that many ingredients when one will do the work. The notification stated, “Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC…any kind of regulation or restriction to allow for any use in patients is not justifiable.”
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