Jatin Takkar: Why packaging inks are the new frontier in pharma safety

For decades, the pharmaceutical industry has relied on packaging to be the final, infallible guardian of its products. Yet, recent regulatory shifts and high-profile contamination events have exposed a critical truth: the protector can become a source of profound risk. For the pharma industry, achieving true compliance means moving beyond simply ticking regulatory boxes to embracing a proactive “Safe by Design” philosophy.

Why packaging safety is non-negotiable for pharma

Packaging safety is mandatory and rests on three core pillars: regulatory compliance, consumer safety, and perceived safety. For the pharma industry, failure in any one of these areas carries catastrophic consequences.

The ultimate failure is the patient-level impact. The industry has seen tragedies like the Thalidomide scandal (where testing failed to identify harm to unborn life) and the Sartan contamination (where N- nitrosamine carcinogens were found in Valsartan tablets). Such events obliterate consumer trust and permanently scar brands.Beyond domestic risk, a contamination issue can severely restrict international market access. When a product is recalled globally — as happened with the 2022 Diethylene Glycol (DEG) contamination in Indian-made cough syrups, which tragically resulted in the deaths of 66 children in The Gambia — it not only threatens consumer safety but also damages the image of India as a reliable exporting nation.

The protector as a source of chemical contaminant

The packaging material, particularly the printing ink on the exterior, can introduce contaminants that migrate into the drug product. Chemical migration is the process by which chemical components in the ink and packaging structure transfer to the drug product, bypassing the intended packaging barrier.

The three primary modes of migration are.

Set-Off: This occurs when the printed side (outside) of a flexible packaging material, such as an aluminum lidding reel, is rolled up against the unprinted side (inside) during storage. Ink components transfer to the inner surface, which then directly contacts the pill or tablet.

Diffusion/Permeation: This is the transfer of chemical contaminants directly through the packaging substrate itself, such as a thin plastic film or paperboard.

Gas-Phase Transfer: Volatile ink compounds evaporate into the headspace between the packaging material and the product. These compounds can then condense onto the product’s surface or be absorbed into the pill or tablet.

Defining a safe ink for pharma

What constitutes a safe ink for pharmaceutical use? It must be a migration-optimised ink. True migration optimisation requires the rigorous selection of all raw materials — binders, solvents, additives, and pigments — to minimise the transfer of contaminants, going far beyond excluding a single chemical. A migration-optimised ink should go one step further and be formulated to minimise the transfer of non- intentionally added substances (NIAS) and other harmful components.

Common contaminants used by the Indian printing ink industry

This solvent is an aromatic hydrocarbon classified as a CMR Category 2 substance (suspected of damaging the unborn child). Toluene was banned for use in food packaging inks by the Bureau of Indian Standards through IS 15495, mandated by FSSAI.

Untreated or mildly treated mineral oils are classified as Group 1 (established) human carcinogens by the IARC. These pose occupational health risks, including various cancers for workers in the printing industry, and contradict the food safety principles FSSAI laid out.

Many synthetic dyes composed of aromatic amines linked to carcinogenicity and mutagenicity continue to be deployed in the ink industry.

Stringent global regulations such as the Swiss Ordinance and the German Ink Ordinance set the gold standard by employing positive lists of approved substances and defining strict migration limits for packaging inks. For the pharma industry, partnering with suppliers who embed this level of proactive safety and transparency is no longer optional—it is fundamental to managing risk, safeguarding consumers, and securing the integrity of the supply chain.

Jatin Takkar is the head of product safety and regulatory, Siegwerk India