The invisible threat: Why packaging inks are the next major recall risk for pharma

Jatin Takkar, Head - Product Safety & Regulatory, Siegwerk India writes that packaging is emerging as a potential source of contamination due to unsafe ink chemistries. With global standards evolving, the industry must shift from reactive compliance to a proactive 'Safe by Design' approach that ensures packaging inks are as safe as the medicines they guard

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For decades, the food and pharma industries have relied on packaging to be the final, infallible guardian of its products. Yet, high-profile contamination events and evolving global standards have exposed a critical truth: the protector, if not meticulously controlled, can become the source of profound risk. Achieving true compliance and securing consumer safety demands that the industry moves beyond simply ticking regulatory boxes to embrace a proactive, "Safe by Design" philosophy that starts with the chemistry of packaging inks.

The fundamental expectation of pharma packaging, be it a blister foil, a folding carton, or a label, is to protect the Active Pharmaceutical Ingredient (API) from external factors like moisture, light, and microbial ingress. Packaging is basically the barrier against the outside world.

However, the raw materials used in packaging materials, particularly printing inks, represent a significant, often unmonitored contamination pathway. The chemicals from the inks, applied to the outer layer, can migrate into the drug itself, compromising patient safety.

The Indian ink industry, especially in the absence of explicit, mandatory pharma-specific guidelines for packaging inks, has historically deployed several controversial chemicals.

Toluene: A common solvent, Toluene is classified as a Carcinogenic, Mutagenic, or Reprotoxic (CMR) Category 2 substance. While the Food Safety and Standards Authority of India (FSSAI) and the Bureau of Indian Standards (BIS) have banned its use in food packaging inks, its prevalence elsewhere poses a critical cross-contamination risk that contradicts fundamental food and drug safety principles.