DRUGS BAN - POLITY
News: Govt. bans 14 combination drugs after panel flags risks, questions
efficacy
What is in the news?
● Recently,
Fourteen Fixed Dose Combination (FDC)
medicines found to lack therapeutic relevance have been banned by the Union Government.
Key takeaways from the news:
● The
ban, which comes into effect immediately, follows recommendations of an expert committee formed to examine the
efficacy of these drug combinations.
○ The
expert Committee said that there is no
therapeutic justification for these FDCs and the FDCs may involve risk to human
beings”.
● Government
banned the drugs under section 26A of the Drugs
and Cosmetics Act, 1940.
● The
list includes medicines used for cough, fever and infections;
● An
expert committee says there is no therapeutic justification for these
combinations and they may involve risk to human beings.
● The
Central Government is satisfied that it
is necessary and expedient in the public interest to regulate by way of
prohibition the manufacture for sale, and distribution for human use of the
said drug in the country,” the notification said.
● The
banned FDCs are part of 344 fixed-dose combinations prohibited for sale by the
Union Health Ministry in 2016 but the makers of 15 such drugs challenged the
decision in Delhi High Court.
What is fixed dose combinations:
● According
to the Central Drugs Standard Control
Organisation (CDSCO), FDCs refer to products
containing one or more active ingredients used for particular indication(s).
Drugs banned by the government:
● Nimesulide
& Paracetamol dispersible tablets
● Amoxicillin
Bromhexine
● Pholcodine
Promethazine
● Chlorpheniramine
+ Codeine Phosphate + Menthol Syrup.