Centre’s Disagreement on Unapproved Antibiotic – Asks States to Monitor

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The central government has raised questions about the selling of unapproved antibiotics. It is found by researchers that banned drugs are sold in the market without any license. Following so, the centre has asked drug controllers of all UTs and States to share the list of antibiotic combinations they have licensed. Furthermore, it has advised them to monitor the presence of any unapproved antibiotics in the market.

26 combinations of antibiotics were prohibited by the Central Drugs Standard Control Organization (CDSCO) in 2018. Nevertheless, a reexamination that was published in the Journal of Pharmaceutical Policy and Practice in 2022 revealed that a sizable quantity of these antibiotics were still on the market. Additionally, the study discovered that following the ban, sales of antibiotic combinations containing chemical components from the same pharmacological classes as the prohibited pharmaceuticals rose. Similar non-banned formulations saw an increase in sales as well.

It has further raised the concern that FDCs that are marketed in India, were not approved by CDSCO. These were approved by state-level regulators who are not enough equipped with such technical expertise.