The Union Health Ministry has banned the manufacture, sale and distribution of 328 fixed-dose combinations (FDCs) of drugs with immediate effect and restricted another six, stated several media reports.
Among the banned drugs are that are widely popular include painkiller Saridon, skin cream Panderm, combination diabetes drug Gluconorm PG and antibiotic Lupidiclox. The Health Ministry has been trying to ban them for the past two years to get these ‘irrational’ and ‘unsafe’ drugs banned.
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Last December, the SC had asked for the matter to examined by the Drugs Technical Advisory Board (DTAB). The DTAP report had said there was no therapeutic justification for ingredients in 328 of the FDCs and recommended banning them. It also suggested restricted manufacture and sale subject to certain conditions of six FDCs. On 15 drugs, the SC had ruled that government couldn’t use the DTAB report to prohibit them, but it could still look into the safety of those 15 drugs with a fresh investigation.
The All India Drug Action Network, a civil society group which one of the petitioners welcomed the decision saying: “ “The banned FDCs account for about Rs 2,500 crore and represent only the tip of the iceberg. In our estimate, the market for unsafe, problematic FDCs in India is at least one-fourth of the total pharma market which is valued at Rs 1.3 trillion,” it said in a statement.
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