Why critical-care injectables are among the hardest medicines to produce

When hospitals in the United States began delaying elective procedures in 2024 over a shortage of intravenous saline solutions, it exposed a structural vulnerability that rarely makes headlines. A Baxter International’s manufacturing plant in North Carolina, damaged by Hurricane Helene, disrupted supply of critical injectables — the fluids consumed daily in emergency rooms, intensive care units, and operating theatres.

What started as a regional industrial crisis quickly became a national healthcare emergency.

The reason the disruption spread so fast, and so far, is worth understanding. Critical-care injectables are not interchangeable with tablets or capsules. They are made in highly specialised sterile facilities, governed by some of the strictest global compliance frameworks in any manufacturing sector. Supply chains for these medicines are not redundant by design; rather, they are lean, concentrated, and deeply sensitive to any single point of failure. When one facility goes offline, there is rarely alternative capacity standing by.

A comparable fragility is now visible in India. The ongoing geopolitical tensions are affecting the availability of crucial solvents and intermediates required to manufacture injectables. Unlike many other dosage forms, sterile products depend on very specific, validated inputs that cannot simply be substituted mid-process. When raw material availability is disrupted, it does not merely slow production; rather, it can shut down entire lines.

An industrial shortage of LPG, widely used in ampoule sealing, illustrates this precisely. Several drugmakers in Gujarat have recently reported halted filling and finishing operations, with some reporting only a few days of operational stock remaining. Industry bodies including the Indian Chamber of Commerce have called for state intervention, to restore consistent LPG availability, noting that prolonged shortages could interrupt production of essential injectable medicines used to treat conditions such as malaria, metabolic acidosis, and chemotherapy-induced nausea where delays have direct clinical consequences.

The engineering challenge most people don’t see

Part of what makes sterile injectable manufacturing so difficult to scale or replicate quickly is the depth of infrastructure it requires. We are not just talking about clean rooms. A functioning sterile facility depends on continuous and validated purified water systems, uninterrupted power supply, clean steam generation, industrial gas infrastructure, environmental monitoring, and highly specialised aseptic filling equipment – all operating in concert, under regulatory oversight, simultaneously. A disruption to any one of these systems can compromise an entire batch.

The production process itself demands aseptic filling environments, validated sterilisation cycles, and rigorous environmental monitoring. Even minor contamination events can lead to batch rejection, not because the quality systems are overly cautious, but because injectable medicines enter the bloodstream directly. There is no margin for error. This is what makes these products genuinely hard to manufacture, and why a relatively small number of global facilities are qualified to produce them.

The economics of sterile injectable manufacturing further concentrate risk. High capital requirements, lengthy regulatory approval timelines, and the need for deeply specialised technical expertise limit the number of facilities capable of producing these medicines. As a result, supply chains depend on a relatively small pool of manufacturers. When one facility goes offline, alternative capacity is rarely available immediately.

The US IV fluid shortage demonstrated how reliance on a single high-volume site can disrupt healthcare delivery nationwide. When that pool shrinks even slightly whether from a natural disaster, a compliance failure, or a raw material shortage, the entire system feels it.

Why India’s stakes are different

For India, the stakes are even higher. According to The Lancet Infectious Diseases, an estimated 1.07 million people in India were infected with deadly, drug-resistant bacteria in a single year, yet, fewer than 8% received appropriate treatment. The study found that 7.8% of infections were treated correctly, leaving close to a million patients without the life-saving injectables they needed. As antimicrobial resistance intensifies and healthcare systems become more dependent on last-line therapies, the ability to ensure consistent access to sterile injectables is not a supply chain concern. It is a public health crisis waiting to deepen.

India is also not just a consumer of these medicines, but a global supplier too. Any sustained disruption to Indian sterile injectable manufacturing has downstream implications for healthcare systems across Africa, Southeast Asia, and beyond. The domestic fragility, in other words, carries an international consequence.

What resilience actually requires

Solving this is not a matter of building more factories. It requires a systems-level rethink of how these supply chains are designed, incentivised, and protected.

Diversification of raw material sources is a starting point. However, it is insufficient on its own if manufacturers remain dependent on narrow, unvalidated supplier networks. Domestic production of critical intermediates needs active investment, not just policy intent. For sterile injectables specifically, utility infrastructure such as power, industrial gases, and purified water must be treated as strategically essential, not as a procurement function sitting quietly in the background.

Strategic stockpiling of essential raw materials and creating genuine redundancy in sterile manufacturing capacity would materially reduce exposure to single-point failures. These are not new ideas, but they have consistently lost out to cost optimisation in peacetime. The recurring disruptions of recent years make the case for treating resilience as a form of capital investment, rather than overhead.

Policy alignment will also be decisive. Incentivising investment in new sterile injectable facilities, enabling faster regulatory pathways for capacity expansion, and supporting supply chain localisation are necessary steps. So is structured public-private collaboration to identify which critical-care medicines carry the highest systemic risk and to secure their production chains accordingly. This kind of mapping exercise, understanding which products have the fewest manufacturers, the most concentrated raw material sources, and the least substitute options, remains foundational work that remains largely undone.

A public health imperative

Critical-care injectables sit at the intersection of pharmaceutical science, infrastructure reliability, and public health preparedness. Their production is inherently complex, and their supply chains are uniquely sensitive to disruption. The events of the past two years from North Carolina to Gujarat are not isolated incidents. They are signals from a system under strain.

As antimicrobial resistance rises and healthcare delivery leans more heavily on advanced injectable therapies, the resilience of this manufacturing ecosystem can no longer be treated as a background industrial concern. It is, in the most direct sense, a matter of whether the medicines reach the patient when they are needed. That makes it not just an industrial objective, but a public health imperative.

About the author

In his role as executive director at Venus Remedies, Akshansh Chaudhary is at the helm of formulating and implementing business strategies and taking logistical decisions that enable the company to achieve its organisational objectives. As the company’s chief technology officer, Chaudhary is responsible for propelling Venus Remedies through the adoption of cutting-edge technologies across all its operations. Having completed his Master’s in Design and Technology from Parsons School of Design, New York, and an engineering degree from BITS Pilani, Dubai, Chaudhary follows a systems-driven and process-oriented approach to solve pressing business problems. Heading plant operations, he oversees a wide range of functions, including quality assurance (QA) and quality control (QC) operations, inventory control and engineering. Chaudhary also leads the company’s CSR initiatives, including the adoption and revamp of regional schools. His CSR efforts reflect his commitment to creating a positive impact on the community, fostering educational opportunities and supporting local development.