2025-09-11

A few decades ago, pharmaceutical packaging’s goal was straightforward and quite operational: protect the product, pass the stability test, and meet regulatory guidelines. But today, the packaging conversation is expanding to traceability, sustainability, patient-centric design, and even digital access. Every packaging component, or material choices made by a brand, now also speaks for the brand, their values, and the kind of future we’re building together.   

As a supplier to pharma manufacturers, I see this shift playing out firsthand. And it’s no longer just the packaging heads asking questions. Now, it’s the plant directors, procurement teams, and even the commercial heads who want to know: Are we future-ready?

Let’s start with what’s changing

The biggest wave right now is in serialisation and traceability. What was earlier restricted to exports has now expanded to the Indian domestic market, especially for prescription drugs. QR codes are now mandatory on all packaging levels, and the data must sync with the government’s portal in real time.  

This means new infrastructure on the packaging floor: high-speed cameras, vision systems, data management tools, and trained QA teams to verify that serialisation is error-free. For large companies, these are feasible upgrades. But for many mid-sized manufacturers, this is a significant investment both financially and operationally.

Labelling norms are also evolving. Font sizes, colour codes, pictograms for storage instructions, even Braille for chronic and life-saving medicines — all of these are being reviewed by CDSCO. In some cases, digital leaflets (via QR code) are being trialled for institutional sales and hospital-use drugs.

At a manufacturing level, these sound like small changes. But anyone who has run a packaging line knows that adjusting artwork, revalidating printed materials, and updating SOPs takes time, coordination and many re-approvals. Even embossing Braille on cartons means buying new tooling, recalibrating sensors, training line staff and changing the documentation.

For manufacturers, this is not just a compliance update but a major investment in complying with the evolving regulations while becoming patient-centric.

Then we have a bigger challenge - sustainability

EPR regulations under the Plastic Waste Management Rules have tightened. These days, pharma companies are being asked to clearly document their sustainability goals and phase out traditional packaging materials like PVC. There’s a lot of development happening towards more sustainable packaging like mono-materials, recyclable laminates, and eco-friendly labels and cartons.

Here, too, the transition is not simple. Packaging lines are built around certain substrates. Switching to recyclable films might require equipment modifications or longer sealing times. This would impact cycle time, throughput, and sometimes even pack dimensions, which then impacts transport and shelf-space planning.

The other reality is cost. Many of the newer materials are still more expensive than legacy options. So, companies are caught balancing regulatory compliance, environmental responsibility, and cost efficiency, all at once.

From a vendor’s perspective, all of this changes the expectations placed on us

Pharma companies today expect their packaging suppliers to be partner who understands the regulations, anticipate the risks, and provide ready solutions that save time.

We are increasingly being asked to support with documentation — from regular technical data sheets and COAs to documents supporting their queries about carbon footprint, labour ethics, recyclability of even the smallest of packaging components. And the timelines are shorter. Regulatory updates are happening every quarter. So, flexibility and responsiveness are pretty much expected at speed.

For us, it means investing in internal knowledge, updating processes, and being much more involved in our customers’ development cycle. We’ve had to train our teams not just in packaging specs but in CDSCO notifications, EU sustainability goals, and US FDA compliance updates.

The bigger picture here is that India is aligning itself with global expectations

With the EU aiming for 100 percent recyclable packaging by 2030, and the US strengthening digital track-and-trace norms, Indian manufacturers can no longer maintain separate standards for domestic and export markets. That creates duplication and inefficiency.

For vendors like us, that also means designing materials and solutions that are acceptable everywhere. And more importantly, helping our customers make that shift gradually, without overwhelming their systems. The best packaging changes are those that integrate seamlessly without disturbing existing validations, line speeds, or QA checks. That’s the approach we’ve taken, and it’s what our customers increasingly value.

So, what does the road ahead look like?

I believe we’re going to see greater collaboration between pharma companies and their packaging partners as digitisation, traceability, and sustainability take the front seat. The industry is moving from transactional buying to strategic co-development, and this is a very positive shift because working together will bring in quicker solutions for better compliance.

For pharma manufacturers, my advice is this: treat packaging as a capability and a differentiator, rather than just a functional cost. Proactive problem-solving will benefit the business in the long run, rather than just reacting to the regulatory changes.

And for vendors like us, the message is clear: we have to show up not just with products, but with answers.