Antimicrobial resistance (AMR) presents a significant public health challenge to governments worldwide, including India. The rise of multidrug-resistant (MDR) pathogens globally has rendered many existing antibiotics ineffective, necessitating the development and introduction of new treatment options.

Regulatory approvals for some new antibiotics may be filed before the Indian National Drug Regulatory Authority (NDRA), including for plazomicin, cefiderocol and combination drugs such as cefepime / zidebactam, cefepime / enmetazobactam, meropenem / vaborbactam, and imipenem / cilastatin / relebactam. These drugs, primarily injectable treatments, are intended for serious infections caused by multidrug-resistant bacterial pathogens.

However, the introduction of these drugs in India presents several challenges. Introduction of new antibiotics requires enhanced microbiology laboratory capacity in health facilities, trained human resources in antimicrobial stewardship, robust supply chains for timely and affordable access to new antibiotics and effective regulation of the private sector to prevent irrational use to optimise clinical outcomes as well as preserve the effectiveness of antibiotics.

Given these multifaceted concerns, there is an urgent need for a national policy framework — under the National Programme on AMR Containment, the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) — to ensure both access to these new antibiotics and regulation of their use in the public health system and private health sector.

This framework is essential to prevent the emergence of resistance due to irrational use, while also ensuring that patients with life-threatening infections have timely access to the treatments they need. 

Regulatory, supply framework for new antibiotics  

India and many other low- and middle-income countries currently lack a dedicated regulatory, supply and access framework for the introduction of new antibiotics, particularly those with demonstrated efficacy against severe bacterial infections. Such a framework is essential for making life-saving drugs available to patients, while safeguarding against irrational use and overuse.

A valuable precedent can be found in India’s regulatory and supply framework for drug-resistant tuberculosis (DR-TB). When new TB drugs bedaquiline and delamanid were first registered by the US Food and Drug Administration in 2012 and the European Medicines Agency in 2014, India faced one of the highest burdens of DR-TB and many patients with extensively drug-resistant TB were dying after failing the then-available regimens.

At the time, the CDSCO and the Revised National Tuberculosis Control Program (RNTCP) allowed approval of the new TB drugs, with the condition that they could only be supplied to the programme. These new TB antibiotics were available through RNTCP only under a conditional access programme and later rolled out more widely as part of all-oral DR-TB regimens, in line with evolving WHO guidelines.  

RNTCP manages forecasting and pooled procurement through tendering at the national level for bedaquiline and delamanid, along with other DR-TB drugs. Private healthcare providers can enrol as DR-TB centres in the Programmatic Management of Drug-Resistant Tuberculosis to access these drugs for their DR-TB patients, based on drug susceptibility testing and report treatment outcomes to the RNTCP. This approach is aimed at ensuring the appropriate use of the new TB drugs minimising the risk of resistance, and providing them free of cost to DR-TB patients across the country.  

Similarly, a regulatory and supply framework modelled on this approach could be adapted to introduce new antibiotics targeting acute, life-threatening infections caused by MDR pathogens. 

The partnership between the NDRA and the TB programme in managing new TB drugs offers valuable insights for introducing new antibiotics to treat multidrug-resistant (MDR) infections. Acute infections caused by MDR pathogens, where reliable microbiological diagnosis is available, often demand immediate access to new antibiotics.

The TB programme’s experience offers a useful model for introducing new antibiotics, but adjustments will be necessary to address the unique challenges associated with treating MDR infections in critically ill patients.

Any future regulatory framework for introducing new antibiotics must closely align with the National Programme on AMR Containment, integrating a pooled procurement and supply chain system. Such a system would accommodate the urgency of treating severe infections while ensuring proper oversight to prevent irrational use.  

Closing the access gap

The recently adopted UN political declaration AMR emphasised that more people die from the lack of access to effective antibiotics than from AMR itself, yet the magnitude of the access gap remains largely unknown with limited monitoring capacities.

Furthermore, the declaration put forward the necessity for nations to coordinate efforts and take actionable steps, including by leveraging existing financial mechanisms to support global and regional access initiatives, such as SECURE — the Antibiotic Facility.

The Indian government’s commitment as part of the political declaration to ensure timely and equitable access to affordable medical tools, including antimicrobials and diagnostic tests, must translate into concrete action, balancing stewardship efforts with ensuring that patients receive the necessary treatments as part of its national strategy. 

As India confronts the growing threat of drug-resistant infections, it is essential for the National Programme on AMR Containment, ICMR and CDSCO to prioritise regulations that not only mitigate the risk of irrational use of new antibiotics but also ensure timely access to life-saving treatments.

By adapting the lessons learnt from the TB programme to managing MDR infections, India can strike a delicate balance between expanding access to new antibiotics and ensuring their responsible use. This approach will ultimately protect both patients and public health, safeguarding the long-term effectiveness of these essential drugs.

Source: downtoearth