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Speedier regulatory approval needed for antibiotics: Report

antibiotics pills

HQ Team

September 30, 2022: A report on the current status of antimicrobial research in Brazil, India, and South Africa says that less strict regulatory barriers against the development and approval of new antibiotics will be beneficial against antimicrobial resistance (AMR).

Rampant usage of antibiotics in developing countries has led to Antimicrobial resistance (AMR), a growing healthcare challenge in these countries. The development of new antibiotics targeting drug-resistant infections can slow the spread of AMR.

Any innovations in antibiotics are very slow or almost non-existent due to the high cost of development and production. The low prices and easy availability of the present combinations of antibiotics further harm the economics of R&D. In the last 60 years, there has been negligible investment in any new research in this field.

According to the report, published by One Health Trust in collaboration with AMR Industry Alliance, financial incentives and market reforms are essential to boost antibiotics research. What would further aid the progress in their R&D is addressing regulatory hurdles that will hasten approval of new antibiotics.

Director of One Health Trust, Dr Ramanan Laxminarayan, said: “Antibiotics are different from other drugs in many respects, including the need for the periodic introduction of new drugs to replace ones to which resistance has developed and the complexity of trials to identify drugs that are effective against drug-resistant pathogens.”

The report highlights the importance of recognizing new antimicrobials targeting severe or life-threatening infections as a critical need.

The report recommends:

  • Creating a specific category for antimicrobials that target serious and life-threatening infections within the regulatory framework provided for accelerated approval pathways.
  • Leveraging existing programs for expedited approval for drugs targeting TB, HIV, and COVID-19 to accelerate the approval of antimicrobials targeting serious and life-threatening infections, such as multidrug-resistant infections.
  • Increasing regulatory authorities’ capacities to deal with the complexity of AMR and novel clinical trials.
  • Promoting regulatory harmonization to facilitate the adoption of reliance pathways for accelerated approval of antimicrobials.

Dr Laxminarayan also noted: “Much has been written about the growing morbidity and mortality caused by antibiotic resistance, especially in low- and middle-income countries. The problem is frequently blamed on the overuse of antibiotics and appropriately so, but insufficient attention has been given to the underlying problem of lack of access to antibiotics. Appropriately, this report identifies the acknowledgement of AMR in regulatory frameworks for drug approvals as an opportunity to improve the wider availability of new antibiotics.”

The COVID pandemic has added to the urgency in combating the increasing threat of drug-resistant strains of bacteria. More than 1.3 million people worldwide are dying each year from antibiotic-resistant infections, and it is estimated this number will grow to 10 million per year by 2050, according to The Lancet and WHO. 

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