Govt outlines action plan for Schedule H & H1 drugs

The plan is also meant to ensure prescription sale of antibiotics

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Govt India
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Last Updated on November 28, 2023 by The Health Master

Taking strong view of the fact that antimicrobial resistance (AMR) is increasingly becoming a serious threat to public health, the Union health ministry has outlined an action plan towards strong implementation of the provisions of the Drugs And Cosmetics (D&C) Rules, 1945 to ensure that no drugs including antibiotics in Schedule H and H1 category are sold at retail pharmacies without prescription of a registered medical practitioner (RMP).

Concerns have been raised regarding the sale of prescription drugs at retail pharmacies across the country without prescription of RMP. Besides this, in recent decades, widespread and rampant use of antibiotics, especially in low and middle income countries have led to the phenomenon of AMR.

The action plan envisages strengthening and enforcing regulations to minimise the substandard, spurious, falsely labelled and falsified antimicrobials, strengthen legislation to regulate prescription and dispensing of antimicrobials and identify additional regulatory interventions or support needed to effectively implement Schedule H1 and X restrictions.


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The plan is also meant to ensure prescription sale of antibiotics and their use under supervision; regulate bulk selling, importation and labelling for specific use.

Union health ministry in consultation with various stakeholders had developed and released National Action Plan on AMR (NAP-AMR) earlier which talks about interventions planned which consider harmonized approach across various sectors to address use of and resistance to antimicrobial agents in human health.

Modern medicine is incomplete without antibiotics which are being used across the globe in the treatment of deep-rooted infections, complex surgeries and even common ailments.

“New drugs take time for development, testing and approval before they are available to patients and bacteria keep on evolving. If we do not instil behaviour change, we will continue to stimulate bacteria to develop resistance against the new antibiotics of the future,” according to an industry expert.


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