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

For decades, the food & pharmaceutical 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 pharmaceutical 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. These include: 

• Toluene: A common solvent, Toluene is classified as a CMR (Carcinogenic, Mutagenic, or Reprotoxic) 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.
• Mineral oils (MOAH/ MOSH): Components of mineral oils, specifically the Aromatic Hydrocarbons (MOAH), are considered potential genotoxic carcinogens that have been widely documented to migrate from packaging (especially recycled board) into products. The use of mineral oil-based inks undermines the principle of providing a safe packaging material.
• Benzophenone and photoinitiators: These compounds are essential for UV-curing inks, but their unreacted residues are highly prone to migration. Benzophenone, in particular, has repeatedly haunted the pharma industry, resulting in issues due to its discovery in packaging component where it can permeate the material and contaminate the product itself. 

These are only the most recognised threats. The future of packaging safety is already under threat from numerous other chemicals, including:

• Per- and Polyfluoroalkyl Substances (PFAS): Often used for grease resistance, these “forever chemicals” are facing global bans due to extreme persistence and health concerns.
• Synthetic dyes: Many synthetic dyes contain aromatic amines, which are linked to carcinogenicity and mutagenicity, posing a quiet but severe risk when used in primary or secondary packaging.

The cost of non-compliance

Packaging safety is no longer just a technical issue; it is a business imperative that impacts:

• Consumer safety and trust: The ultimate failure is the patient/customer-level impact. High-profile incidents, such as the Sartan contamination (where N-nitrosamine carcinogens were found in certain blood pressure tablets, leading to massive global recalls) and the tragic Diethylene Glycol (DEG) contamination in Indian-made cough syrups, obliterate consumer trust and permanently scar brands and nations.
• Perceived safety: Even the fear of contamination can destroy consumer confidence overnight, especially when international scrutiny is involved.
• Indian exports and global Image: When a product is recalled globally, it severely restricts international market access, damaging India’s image as a reliable global pharmacy and threatening its export economy.

Pharma industry needs to understand what is safe packaging inks

Given the absence of a specific mandate, the pharma Industry must proactively define its requirements for packaging safety. True safety begins with understanding the core concept of migration-optimised inks.

A migration-optimised ink is far more than just “Toluene-free ink”. It is a solution “Safe by Design,” meaning every single component, from solvents, binders and pigments to photoinitiators and additives, has been carefully selected and assessed to minimise the risk of chemical transfer into the drug.

Key considerations for the pharma industry must include: 

1. Strict raw material selection: The supplier must adhere to a positive list approach, where only substances explicitly evaluated for their migration limits are used, following the highest global standards.
2. Mitigation of non-intentionally added substances (NIAS): NIAS are chemical compounds that have not been intentionally added to the packaging component but may be present as impurities, reaction by-products, or degradation products. A truly safe ink supplier must have stringent quality control and supply chain transparency to identify and mitigate NIAS formation.
3. Debunking marketing gimmicks: The industry should not be misled by simple marketing claims like “Toluene-free inks” or “Mineral Oil-free inks.” The replacement of just one hazardous chemical with an unverified or less-controlled alternative often results in “regrettable substitution,” where the replacement chemical poses a new, equally dangerous, or even unknown risk. Safety is about the careful selection of all raw materials, not the mere replacement of one.

Addressing the regulatory gaps

The pharma sector, unlike the food industry, lacks specific, dedicated guidelines for printing inks used on its packaging. This regulatory absence creates a dangerous scenario: Pharma companies, whose core expertise lies in drug formulation and manufacturing, are inadvertently placed in the role of packaging and ink safety experts – a field where they inherently lack deep knowledge.

The closest concept often adopted by the pharma industry as a best practice is the Food Grade Ink concept, which in the Indian context, translates to the BIS Standard – IS 15495. While adopting IS 15495 is a crucial first step for domestic compliance, it is fundamentally insufficient for global export markets.

For companies dealing with exports, particularly in highly regulated markets like the EU and the US, a much higher degree of sensitivity and care is required. These global markets demand adherence to global standards that rigorously consider the chemical migration aspects. Therefore, companies must adopt globally benchmarked standards.

Securing the future of pharma

The path to safeguarding the pharma supply chain runs directly through the chemistry of its packaging. The days of treating packaging as a commodity are over. Pharma companies must recognise the inherent risks associated with printing inks and elevate their standards to global best practices immediately. This vigilance requires strong, knowledgeable partners who not only possess the correct know-how and expertise in migration concepts but also deeply understand the complex, fragmented regulatory landscape and, critically, operate with complete transparency.