New Delhi: The Central government has ordered an immediate ban on 16 Fixed Dose Combination (FDC) drugs for human use, stating that use is ‘likely to pose a risk to human health.’
Issuing a gazette notification, the Union Health Ministry prohibited the manufacture, sale and distribution of 16 FDCs, citing a “lack of scientific evidence to support their rationality” and the absence of any therapeutic justification for combining these ingredients in fixed doses.
The list includes penicillin-class antibiotics such as Amoxicillin + Serratiopeptidase, and Amoxicillin + Serratiopeptidase + Lactobacillus sporogenes, used for the treatment of bacterial common infections.
Additionally, the list includes 10 combinations containing Aloe Vera as one of the ingredients, which are dispensed over the counter without prescription.
The combinations, termed “irrational”, were examined by an expert committee in 2021 and subsequently by the Drug Technical Advisory Board (DTAB), which also recommended a complete ban on the flagged formulations.
The ministry said a sub-committee of the DTAB had also provided an opportunity to the stakeholders of the concerned fixed-dose combinations to present relevant data.
Following a review of the submissions, the sub-committee, in its report, endorsed the proposal to ban the select formulations for human use in the larger public interest.
The latest move comes in a series of crackdowns over the past 12 months, during which the ministry has imposed a complete ban on more than 50 irrational combinations. Most recently, 29 vitamin-mineral supplements were banned in February this year.
Source : Economictimes
