The country’s drug regulatory watchdog is thinking about taking on the responsibility of approving antibiotics and their combinations in order to prevent unsafe usage, rather than giving this task to state offices. Approval for antibiotics will most likely be categorized as ‘new drugs’ and approved centrally by the CDSCO, not by individual states.
The aim of the action is to stop antimicrobial resistance (AMR) caused by excessive and incorrect use of antibiotics. The authority has prohibited numerous fixed dose combinations of drugs or cocktail medicines that have been shown to be illogical and dangerous. Most of these medications are being endorsed by state authorities.
The issue of Antimicrobial Resistance (AMR) has been acknowledged as a top global health priority in various high-level discussions such as the UNGA, G7, and G20. During a recent DTAB meeting, experts were informed that antimicrobial resistance (AMR) is increasingly seen as a major threat to public health worldwide.
The proposal to classify all antibiotics as ‘new drugs’ in the New Drugs and Clinical Trial Rules, 2019 was evaluated by the specialists. “DTAB discussed the issue.” Misuse of antibiotics, antivirals, and antifungals can lead to antimicrobial resistance. Therefore, it is suggested that the issue be discussed first in the Drugs Consultative Committee (DCC).
Although DTAB provides technical advice to central and state governments, DCC provides advice to DTAB on issues concerning the Drugs and Cosmetics Act to maintain consistency in law enforcement. The panel is made up of representatives from both the central and state governments. In an additional step to combat AMR, DTAB approved the proposal to include a ‘blue strip or box’ on antimicrobial product labels during the same meeting to emphasize the alert on antimicrobials.
Government intends to introduce new regulations within the Drugs and Cosmetics Act and Rules for the production of ‘blue color strips for antimicrobials’. Currently, DTAB has discussed the issue and decided to make necessary changes to the labeling requirements in the Drugs Rules, 1945 to tackle the problem of AMR.
Additionally, the panel of specialists also suggested implementing measures to educate the public as a large number of individuals are still uninformed about the dangers of AMR. AMR happens when bacteria and other pathogens become resistant to antibiotics or drugs, causing medications to be ineffective when people get sick and require them. New data from the Global Research on Antimicrobial Resistance (GRAM) Project, published in The Lancet, reveals that in 2019, bacterial antimicrobial resistance caused 3-10.4 lakh deaths in India, making the recent action significant.