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Centre’s lens on unapproved antibiotic combos, asks states to monitor availability

May 21,2024

New Delhi: Centre has asked drug controllers of all states and UTs to share a list of antibiotic combinations licensed by them for manufacturing and marketing in their respective jurisdictions. It has also asked states/UTs to monitor the availability of unapproved antibiotic combinations, if any, present in markets under their jurisdiction and take action, reported.

In 2018, Central Drugs Standard Control Organisation (CDSCO) had banned 26 antibiotic combinations. However, a follow-up study published in the Journal of Pharmaceutical Policy and Practice in 2022 showed that a significant number of such antibiotics remained available in the market. Also, the study found, sales of antibiotic combinations containing chemical compounds belonging to the same drug classes as the banned drugs increased after the ban. Sales of similar non-banned formulations also went up.

Some pharma companies promoted products containing new non-antimicrobial components to the banned combination to dodge the govt order, therefore nullifying any attempts to reduce antibiotic resistance caused by the consumption of such drugs. An antibiotic combination refers to fixed dose combination medicine comprising two or more antibiotics in a fixed ratio of doses and available in a single dosage form.

“Although antimicrobial FDCs (fixed-dose combinations) have been critical in improving clinical outcomes among patients with certain infections such as tuberculosis and HIV, use of such FDCs for routine bacterial infections is inappropriate as it drives AMR (antimicrobial resistance) by selecting co-resistant microorganisms. Thus, their indiscriminate use is widely discouraged, including in World Health Organisation’s AWaRe framework of antimicrobial prescribing,” the study said.

It added that many FDCs marketed in India were never approved by CDSCO, their approval comes from state-level regulatory bodies that, at times, lacked sufficient technical expertise to make such decisions.

Source: Healthworld

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