To prevent spread of unsafe antibiotics or its irrational combinations, the country’s drug regulatory watchdog is considering a proposal to be the approval authority, rather than delegating it to state offices, News18 has learnt.
All applications for approval of antibiotics are likely to fall under the category of ‘new drugs’ which are approved centrally by the Central Drugs Standard Control Organisation (CDSCO) and not states.
The move is aimed at preventing antimicrobial resistance (AMR) triggered by overuse and misuse of antibiotics. The regulator has been banning several fixed dose combinations of drugs or cocktail medicines which have proven to be irrational and harmful. Majority of these drugs are being approved by state regulators.
The problem of Antimicrobial Resistance (AMR) has been highlighted as a global health priority in multiple high-level forums ranging from the UNGA, G7 to G20.
In a recent meeting of the country’s apex panel of experts — Drug Technical Advisory Board (DTAB) – experts were apprised that the AMR has been recognised as a serious and growing threat to public health, globally.
The experts considered the proposal to include all antibiotics in the definition of ‘new drug’ in New Drugs and Clinical Trial Rules, 2019.
“DTAB deliberated on the matter. Antimicrobial resistance can be caused due to misuse of antibiotic, antiviral, antifungal, etc. and accordingly recommended that the matter may be deliberated in the Drugs Consultative Committee (DCC) initially.”
While DTAB advises the central and state governments on technical matters, DCC advises DTAB on matters related to Drugs and Cosmetics Act ensuring the uniformity in implementation of laws. The panel consists of central and state government representatives.
In another move to prevent AMR, DTAB, in the same meeting, has cleared the proposal to introduce ‘blue strip or box’ for providing AMR warning on the label of the antimicrobial products to keep special focus on antimicrobials.
News18 had on September 18 first reported the government’s plan to insert new rules under Drugs and Cosmetics Act and Rules, to manufacture ‘blue colour strips for antimicrobials’.
Now, DTAB has deliberated the matter and agreed “to suitably amend the labeling requirements under Drugs Rules, 1945 for addressing the issue of AMR”.
Further, the panel of experts also recommended taking necessary steps for awareness of the public as many people are still unaware about the threat of AMR.
AMR occurs when bacteria and other pathogens develop resistance to antibiotics or other drugs, making medicines ineffective when people become ill and need them the most.
The move holds importance as new data shows that in 2019, bacterial antimicrobial resistance was responsible for 3-10.4 lakh deaths in India, according to the new Global Research on Antimicrobial Resistance (GRAM) Project, findings of which were published in The Lancet.
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