In a bid to safeguard citizens from the bad effects of fixed-dose combination (FDC) drugs, the Union Health Ministry on Wednesday prohibited the manufacture, marketing and sale of 328 FDC drugs. The banned items include several commonly used cough syrups, painkillers, and cold and flu drugs such as Saridon, the skin cream Panderm, diabetes drug Gluconorm PG, antibiotic Lupidiclox and antibacterial Taxim AZ.
According to the Drug Technical Advisory Board or DTAB, the ingredients, used in these medicines do not have therapeutic justification and should be banned in public interest. Combination drugs are basically the combinations of two or more active drugs in a single dosage form.
A battle was started back in 2016 between the health ministry and manufacturers after the government in March 2016 banned 344 FDCs and further added five more to the list. Though the pharma firms of above-mentioned products moved to various high courts and the Supreme Court to challenge the ban, the apex court on December 15, 2017, directed the Drugs Technical Advisory Board to examine whether the products should be banned from the market.
The DTAB, which recently submitted its report to the Centre said there was no therapeutic justification for the ingredients in 328 FDCs and that these could be a risk to people. The board recommended banning them.
The drug advisory body, however, has recommended restricted manufacture of six FDCs based on their therapeutic justification. The popular medicine brands, which were granted exemption from a complete ban are some popular cough syrups, painkillers and cold medication, which have been manufactured since before 1988.
However, the court told the ministry to look into the safety of these drugs by initiating a fresh investigation if it wanted to impose a complete ban on them.
Earlier, the health ministry constituted the Kokate Committee, which recommended a review of all FDCs in the market in the interest of patients’ safety.