Wednesday , September 29 2021

Govt bans 328 fixed dose combination drugs with immediate effect

The Health Ministry has banned manufacture, sale and distribution of  328 Fixed Dose Combination drugs with immediate effect. Six other  drugs have been allowed restricted manufacture. The health ministry has exercised powers under section 26A of the Drugs and Cosmetics Act, 1940 in invoking the ban. The 328 FDCs have been banned through gazette notifications dated September 7, 2018. 

FDCs are two or more drugs combined in a fixed ratio into a single dosage form.

Many of the banned drugs are combinations of basic flu drug paracetamol with other unneccesary chemicals. Among them being the combination of propyphenazone, paracetamol and caffeine, which is the combination of pain reliever tablet Saridon.  

Several other banned drugs are combinations of the antibiotic amoxycillin with other unessential chemicals.

Another major set of banned FDCs are combinations of diabetic drug Metformin with other redundant chemicals.

Combinations of antihistamine Cetirizine with other needless  chemicals forms another major chunck of banned FDCs.

The ban has not come without efforts on the part of government and the ministry. 

On March 10, 2016, the health ministry had banned 344 FDCs under the section 26 A of the Drugs and Cosmetics Act, 1940, and five more subsequently. Some Pharmaceutical companies then moved high courts as well as the Supreme Court against the ban. In December 2017 the Supreme Court ordered the matter to be referred to the Drugs Technical Advisory Board, which has since recommended, among other things, that 328 FDCs have no therapeutic justification for their ingredients and may be a risk to humans. 

Fifteen FDCs of the 344 prohibited in March, 2016, are not part of the notification because they claim to have been manufactured prior to September 21, 1988. 

The Health Ministry also relied on the advice of an Expert Committee that it had appointed to examine these FDCs.. That committee too made similar recommendations. 

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