The ministry of health has banned the manufacture, sale and distribution of 328 fixed-dose combinations (FDC) of drugs and restricted another six. The ban, which comes into effect immediately, comes after a lengthy legal battle between the drug manufacturers and the government after the latter banned these drugs in 2016, saying they were irrational and unsafe.
Around 6,000 brands will be affected by the ban and these include popular drugs like painkiller Saridon, antibiotic Lupidiclox, skin cream Panderm, diabetes drug Gluconorm PG and antibacterial AZ.
On March 10, 2016, the government banned 344 FDCs and later added five more drugs to the list but manufactures of the drugs appealed in high courts and the Supreme Court against the ban. The Supreme Court in December 2017 asked the Drugs Technical Advisory Board (DTAB) to examine drug manufacturers’ complaint.
In its report, the DTAB stated that the ingredients used in the 328 FDCs could pose serious health risks to the people taking these medicines and recommended banning them.
The board also recommended restricted manufacture and sale of six other FDCs. The Supreme Court said the DTAB report can’t be used to ban 15 of the 344 drugs in the original list as these have been manufactured locally since before 1988. These included popular painkillers, cold medications and cough syrups with combined annual sales of over Rs 740 crore.
However, the apex court gave the government permission to initiate safety checks into these 15 drugs and ban them if they were unsafe.
All India Drug Action Network (AIDAN), a civil society group, which keeps a watch on safety and access to medicines, lauded the ban and requested the government to act swiftly on the 15 excluded FDCs.
“The banned FDCs account for only Rs 2,500 crore of the overall sales of medicines which is minute, while the overall market share of unsafe FDCs is one-fourth of the total pharma market, which is valued at Rs 1.3 trillion,” AIDAN said in a statement.
Many large pharma companies claimed that since 2016, they have phased out such drugs or changed the combination and the FDCs in question are less than 2 percent.
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