A staggering 39 million people worldwide could succumb to antibiotic-resistant infections over the next 25 years, according to a landmark study published in The Lancet.

A staggering 39 million people worldwide could succumb to antibiotic-resistant infections over the next 25 years, according to a landmark study published in The Lancet. This chilling projection underscores the urgent need to combat antimicrobial resistance (AMR) as a critical global health crisis. Conducted by the Global Research on Antimicrobial Resistance (GRAM) Project, the study is the first comprehensive analysis of AMR trends, outlining its alarming future impact.

Key Findings: AMR-Related Deaths on the Rise

The GRAM study reveals that over one million people died annually from AMR between 1990 and 2021. Even more concerning is the forecast for 2050, where nearly 2 million people are projected to die directly due to AMR each year—an increase of nearly 70% compared to 2022. Furthermore, AMR is expected to contribute to 8.22 million deaths annually by 2050, representing a 75% surge from the 4.71 million deaths recorded in 2022.

Age-Related Trends in AMR Mortality

• Children under five years old: Deaths declined by 50% between 1990 and 2021, yet AMR still poses a threat.
• Adults aged 70 and older: AMR-related deaths rose by over 80%, with this demographic expected to bear the brunt of the mortality burden by 2050.

While AMR deaths among young children are expected to halve by 2050, fatalities in older populations will more than double, highlighting the aging population’s vulnerability.

Global Health Implications of AMR

Antimicrobial resistance occurs when bacteria evolve and no longer respond to medications, rendering treatments ineffective. The consequences of unchecked AMR are far-reaching and devastating. AMR already claims more lives than HIV/AIDS and malaria combined, with 1.2 million direct AMR-related deaths in 2019 alone. By 2050, this figure will balloon to a total of 39 million deaths across all ages.

Geographic Disparities

AMR-related deaths will disproportionately affect regions such as:

• South Asia: Expected to account for 11.8 million deaths directly due to AMR between 2025 and 2050.
• Sub-Saharan Africa and Southern/Eastern Asia: These regions will also see significant rises in fatalities, driven by limited healthcare access and ineffective infection control measures.

Historical Data and Projections

The GRAM study analyzed 520 million records from hospital data, deathc ertificates, and antibiotic use across 204 countries and territories. Based on historical trends, AMR-related deaths have steadily increased since 1990, with 1.14 million deaths directly attributed to AMR in 2021.

AMR’s Most Common Culprits:

• Methicillin-resistant Staphylococcus aureus (MRSA): Deaths increased from 57,200 in 1990 to 130,000 in 2021.
• Carbapenem-resistant Gram-negative bacteria: Resistance to these antibiotics grew from 127,000 deaths in 1990 to 216,000 in 2021.

Without significant intervention, these pathogens and others will continue to fuel rising mortality rates.

The Urgent Need for Global Action

To mitigate the escalating AMR crisis, the study calls for a comprehensive global strategy focused on:

• Infection prevention and vaccination programs
• Minimizing inappropriate antibiotic use
• Research and development of new antibiotics targeting resistant bacteria
• Access to quality healthcare and antibiotic treatments

The Future of AMR: What Lies Ahead?

Based on current trends, AMR is expected to directly cause 1.91 million deaths annually by 2050, a stark 67.5% increase from 2021. In total, more than 39 million deaths will result directly from AMR between 2025 and 2050. However, with improved healthcare infrastructure and targeted development of antibiotics, an estimated 92 million deaths could be averted.

Key Solutions to Avert Catastrophe:

• Improved infection care: Particularly in regions like South Asia, sub-Saharan Africa, and Southeast Asia, better access to antibiotics could prevent millions of deaths.
• Innovation in drug development: The creation of new antibiotics targeting Gram-negative bacteria could save over 11 million lives globally by 2050.

Conclusion: A Call to Action

The findings from this study highlight the growing and evolving threat of antimicrobial resistance. Without prompt and coordinated efforts to prevent, manage, and treat infections caused by resistant bacteria, millions of lives will be at risk. Now is the time for governments, healthcare organizations, and researchers to intensify efforts to avert a global health catastrophe. 

A circular issued on ‘good manufacturing practices’ in August describes the recall procedure as well as the law in this respect, but it is doubtful whether these provisions are implemented.

A circular issued on ‘good manufacturing practices’ in August describes the recall procedure as well as the law in this respect, but it is doubtful whether these provisions are implemented. The CDSCO list (and that of States) should provide details on sample size as well as the time and place of collection. Collecting samples from distributors’, chain suppliers, as today most of the drugs r purchased from such chains for additional discounts and schemes supplied to distributors and retailers from outside States, such unethical practices must be monitored 

Finally, medicines are life and death matter. The industry needs the right dose of regulation and freedom

it is high time that both industry and government come together to deal with this menace

https://chat.whatsapp.com/Iili8jkCHeYJYi3x89OPuF

POV Admin Pharma Forum : Kamlesh Doshi

Spurious or NSQ: How India’s drug industry is evading regulatory action?

Spurious or NSQ: How India’s drug industry is evading regulatory action?

While spurious drugs and not-of-standard quality are distinct by definition, medical experts agree that both zero-ingredient and substandard medicines are equally harmful in terms of treatment. 

In a damage control effort following the latest product inspection report by India’s drug regulator, the pharmaceutical industry has issued statements that further confuse patients.

While individual drug manufacturers whose brands appeared in the August drug alert attribute the situation to the presence of spurious drugs in the market, an industry lobby contends that the real issue is the misrepresentation of the term "not-of-standard quality (NSQ)" as synonymous with "spurious" drugs. They assert that no spurious products should be linked to the industry and that the concerns over NSQ are being exaggerated.

While spurious drugs and NSQs are distinct by definition, medical experts agree that both zero-ingredient and substandard medicines are equally harmful in terms of treatment.

The Central Drugs Standard Control Organisation (CDSCO) published its August inspection report last week, naming several commonly used drug brands found to be of either NSQ or spurious quality. The alert identified leading brands such as Clavam 625 (antibiotic), Pan-D (antacid), Pulmosil Injection (hypertension), Pantocid (antacid), Telma H (blood pressure), Deflazacort (muscular dystrophy), and Paracetamol IP (anti-pyretic) among others.

The Indian Pharmaceutical Alliance (IPA) expressed deep concern over what it described as a gross misrepresentation and distortion of facts by certain media outlets regarding the CDSCO's drug alert. The IPA stated that misleading coverage irresponsibly conflates “not of standard quality” with “spurious,” unfairly implicating legitimate manufacturers in the production of counterfeit drugs.

One of the companies named in the CDSCO alert, Alkem Laboratories, denied the claims regarding its brands' quality. Alkem stated that the samples listed in the CDSCO report are spurious and not manufactured by them. The company emphasized the existence of counterfeit drugs as a significant concern, yet it appears the IPA's primary focus is not on the potential health risks posed by NSQ medicines.

The IPA highlighted that manufacturing spurious drugs is a serious criminal offense that endangers public health. The association pointed out that linking legitimate manufacturers with spurious products can severely damage reputations and have financial repercussions, ultimately tarnishing India’s standing as a reliable supplier of medicines globally. “It is critical that a clear distinction between NSQ and spurious drugs is made,” the IPA stated.

The IPA will continue to collaborate with the government to strengthen systems and implement stringent measures against spurious drugs. This issue is vital for both India’s global reputation and public health protection.

Alkem Laboratories also refuted the CDSCO claims regarding its products Pan-D (sales of Rs 2,803 million in the first half of 2024) and Clavam 625 (sales of Rs 2,657 million in the first half of 2024), stating that the batches in question are not-of-standard quality. The company emphasised its commitment to quality and patient safety, asserting that all its products adhere to current good manufacturing practices (cGMP).

"In its investigation, Alkem compared the CDSCO’s samples with its actual product batches and found significant differences in physical appearance, color, and labeling. The company has submitted a response to the CDSCO, including an assessment report confirming that the samples collected are indeed spurious and not manufactured by Alkem," the company claimed.

CDSCO inspectors regularly collect samples from medicines sold in the domestic market, issuing alerts on its website after testing them in competent laboratories. While the regulator’s findings are factual, it is crucial for both the industry and the regulator to address these issues effectively to protect public health.