Innovation in pharma packaging

Pranay Kumar, Chief Environment Officer, Vasudha Ecofriends Projects gives valuable insights on the trends which will determine growth in pharma packaging in times to come

Pharma packaging is evolving with the rise in demand of innovative designs, security features and track and trade features. At the same time, raw materials, primary, secondary and tertiary packaging is self transforming to reduce cost, unburden the logistic chain and increase visibility.

Sustainable (biodegradable/ bioplastic) plastics are slowly working on the minds of pharma and packaging companies. The consumers’ reduced time availability and simultaneous rising awareness of pros and cons of drugs in educated urban areas needs different packaging raw material to printing to tracking.

Small towns and villages still rely on local pharmacists, which mandates strong security features and pictorial depiction.

Last but not the least, the government regulating the pharma sector, which also calls for reducing the prices and waste, is set to transform the sector like never before.

Here we delve in-depth on smart packaging evolution and innovation.

Concerns in pharma packaging

In recent years, certain factors have encouraged the pharma industry to transfer the landscape of its packaging.

First and foremost, concerns in the Indian market is counterfeiting and safety of products. Many generic drugs sold in large volumes require much less resources than patented products , thus making these drugs target for easy copying including the packaging.

Higher level of awareness and regulatory compliance have resulted in precise, compact product information. This field is evolving as further explained.

Top trends in packaging

1. Smart packaging
2. Environmentally and financially sustainable packaging
3. Digital marketing
4. Holistic packaging
5. Communication through colours

Patient compliance for drugs is a very critical but evolving domain in India. As our healthcare system (right now almost non-existent) evolves in India, targeted patient data and its usage would transform itself towards customisation.

Safety and exposure to hazardous product regulations have led to huge volume rejections for Indian drug companies. India is a major exporter in regions like Africa, Russia, West Asia. These rejections led to a tumultuous phase in the industry. Now, Indian drug companies have pulled all stops in engraining and embedding; literally hidden and visible
information.

Waste reduction and cost optimisation are leading to sustainable packaging design, alternatives like biodegradable plastic packaging compatible with tertiary, secondary and primary packaging.

United Nations agencies also intend to reduce waste exported in form of packaging. There are many remote places and countries without proper waste strategy, where United Nations does not wish to aggravate the rising waste situation.

Anti-counterfeit methods

Safety and security solutions can be categorised into three basic types:

1. On-package solutions
2. Serialisation (or track and trace)
3. Direct product testing

The most prevalent technology implemented and recommended is on-package solutions and direct product testing is the least used anti-counterfeiting method

On-package solutions can be divided into two types:

1. Overt features, which are expected to assist the users to confirm genuineness of a pack and are significantly visible, complex and expensive to reproduce, thus creating a significant barrier to counterfeiting and
2. Covert features, which  aid the brand owner to recognise a counterfeited product while remaining invisible to the customers and counterfeiters.

Barcodes

Barcode is a more used overt technology. Barcodes play a key role in enabling retailers, manufacturers, transport providers and hospitals to automatically identify and track products as they move through the supply chain. The advantages of the technology are:

• A product can be identified uniquely across the globe using laser or camera-based systems
• Barcodes are generally in B&W and can be scanned electronically
• They are used to encode information such as product or serial numbers and batch numbers.

The disadvantages are as follows:

It is ‘read-only’ and not secure and little data is stored

Chances are that it might be replicated from an original one 2D colour barcode technology which aims at increasing data density and robust data transmission is better method than simple barcode [black and white lines of various thickness] technology.

Colour barcodes are also an alternative. They

– Increase the data embedding capacity than normal 2D barcodes
– Provide high level security and data confidentiality

Here two points of informations are merged. One is the data source and the other image source or colour source, both are overlapped to create a complex 2D barcode.

Challenges of 2D barcodes

1. Barcode symbols require dark colors for bars like black, blue, dark brown, dark green, and light colors for background
2. These dark and light combination is more preferable so that barcode symbols can be recognised by a scanner
3. There must be a adequate contrast between the dark bars and light background
4. Opposite combinations can create problem at the time of scanning because of poor contrast ratio and unreadable barcodes
5. Hence, Color Barcodes have not yet been popular because of high expense and poor combination of colors to create a color barcode

Watermarking

These are classified again into

Overt technology: Clearly visible and do not require detection. Include holograms, inks that change color with view angle, metachromic inks that change color based on the light source, and thermochromic inks that change color based on temperature
Covert technology: Include fluorescent inks, which are invisible in daylight but exhibit distinct fluorescent shades on exposure to UV light. Contain some form of taggant that is only visible or detectible through more sophisticated hand-held readers such as laser pens. Covert solutions offer increased security as compared to overt solutions.

The properties of watermarking are as follows:

Capacity: The number of bits that can be embedded in the host image
Perceptual Transparency: It should be invisible to human eyes without affecting the quality of the original image
Robustness: The watermarked data should not be removed or eliminated by unauthorized distributers, thus it should be robust to resist common signal processing manipulations such as filtering, compression etc
Security and Safety: The watermark should be detected by authorized person

Here we describe two types of watermarks Colour watermarks and Digital watermarks.

Color Watermark is a kind of information security and data protection technology. It is typically used to identify ownership of copyright media

Digital image watermarking: Information is embedded in cover image to prove ownership, Information must remain detectable even if image is manipulated
Applications of digital image watermarking: Copyright protection, health care, fingerprinting, ID card security, authentication and integrity verification

Two types of digital watermarking techniques are as follows:

Spatial domain: In this technique the watermark can be inserted directly by manipulating the pixel intensity values of the original image
Transform or frequency domain: In this technique digital image is transformed into frequency domain such that transform coefficients can be modified to hide the watermark and the reverse transformation is applied to get the watermarked images

Recently Digimarc, an Indo French collaboration, is developing an innovative method of water marking. Recently, new schemes have been proposed which are based on a quantization process. The purpose of a color quantization process is to represent an image by a limited number of colors with a minimal visual distortion.

In this process  two watermarks have embed in the same host image where the first one is embedded in the chromatic plane and second one embedded in the lightness component.

Another method  quantization index modulation (QIM) quantizes the color of each pixel in the host image by one of the numbers of the colour quantizers.

But the quantization and processing steps are not optimal because they do not take into account the HVS sensitivity.

To give imperceptibility in a watermark the color difference between a pixel and its watermark counterpart should be uniform over the whole image.

To do the same is a uniform quantization is applied in a uniform color space with the quantizer step size tuned to provide imperceptible colour differences between neighbour pixels.

The deliverables of Digimarc where product it self becomes the barcode (invisible) are

• New Color BarCode solution,
• A new Digital Watermark solution
• A new anti-counterfeit packaging solution for medicinal packaging.

The interesting features of Digimarc are

• Watermark printed packaging not directly from the spatial domain but indirectly from the chrominance domain
• Develop a generic solution to increase the package surface coverage by a watermark whatever the area (white background, color patterns, spot colors, color gradient, text,
• Innovating on increasing the package surface coverage
• The Digital Barcode is designed to be readable using red LED illumination or white light strobe illumination. In this project, the effects of the spectral distribution of the light source on the watermarking process implemented

Thus as we can see above pharma packaging is far ahead of other industries in working on very secure operational and futuristic methods to keep ahead of times and deliver cost effective and robust solutions.

Besides above methods pharma industry is also working on reducing, recycling its waste including biodegradable plastics. In 2015 a lab report and a complaint by an NGO led to banning of PET bottles for liquid pharma packaging. This decision was based on a flawed report by the said lab, which was proven by Dr Habbu of Reliance Industries. The author had also written in Express Pharma quoting USFDA, USEPA and an Elsevier paper that PET for pharma packaging is least h armful. (refer to the article).

Biodegrading plastics is one the method of reducing pharma packaging waste. Its sustainable as it leads to biodegrading the waste, which cannot be economically collected and/ or recycled. UNDP is working with certain pharma firms to make their plastic packaging biodegradable.

But the implementation of the rules of Plastic Waste Management 2016 of Ministry of environment, Forests and Climate Change, Government of India  (MoEFCC) is archaic and without any hierarch.  Though MoEFCC is the final authority, each state and even municipality is creating its own rules without a shred of scientific approach. Certain District magistrates/ Commissioners are have stated ( unfortunately)  “ if the product burns without leaving any residue , we will know that its plastic and disallow it and if leaves a residue , we will allow that product.” With 9 mandated methods for testing biodegradability prescribed in PWM 2016 by MoEFCC , this is the hilarious yet ineffective and unproductive diktats.

MoEFCC, GoI needs to assert its authority , if it really cares about waste management. Even Central Pollution Control Board (CPCB) is not agreeing to ministry of environment’s rules.

CPCB is creating its own oblique rules creating loss of emolument, chaos in pharaoh, plastics and packaging industries. Though it has started with plastic bags, the confusion in sub-rules of CPCB might encroach on other types of plastic packaging including pharma  plastic packaging.

Each company involved and effected is also creating further confusion by not working on fundamental rules and International laws (ISO)  but just trying to prove its knowledge or relying on heresay.

To give the example of the chaos and confusion created by CPCB’s rules, the author will explain what happened to the plastic bag segment of plastic and packaging industries.

Rules of plastic waste management 2016 and confusion and conflict in its implementation

According to Ministry of Environment (MoEFCC), Government of India 2016 notification there are nine methods to test biodegradability only one method ( IS 17088) has been allowed

Despite the fact that most plastics land up in landfills, which are Anaerobic (withoutOxygen)in nature,why only IS 17088, an expensive and time consuming (approximately 9-10months) was chosen is beyond the author’s comprehension. A 45 day test period the same test method (IS 17088) exists but it was overlooked or missed. Same thing is being mooted in draft BIS method for Agricultural mulch film, which will spell disaster for the fields and farmers as those tested under IS 17088 will biodegrade above the soil thus contaminating it.

The most spectacular point overlooked by the ministry or the industry is that 50 microns bags are being allowed along with biodegradable bags (of less than 50 micron thickness as per IS17088), which will increase the plastic waste by a humongous 250 per cent!

More unfortunate reason given for increased thickness is that it would be collected by the rag pickers ! Majority of the rag pickers are children below the age of 17-18 , is our government relying on an exploitative system to manage its waste ? In short term the plastic bag industry may benefit from increased volume sales but as the plastic waste increases , the agencies will finally ban the plastic bag altogether sounding the death nail of the industry. This has already happened in states like Karnataka and Punjab.

Sustainability lies not only in reducing the waste but also to save the lakhs of jobs.

Secondly, only one lab namely CIPET was mandated and allowed by CPCB to test thus creating a business monopoly for CIPET.  Further to extend and complicate the situation an endorsement by CPCB was put in place.  Is it that CPCB does not trust NABL,a government body for certification and verification of labs? If this is the case, why has CPCB not come out with a rule that it will inspect ALL labs across the country testing pollution parameters?

Does CPCB trust its  own recommended lab? Does CPCB has time to endorse thousands of bags manufacturers across the country?

April 2018 brings a ban on multilayered , which cannot be recycled. Pharma industry will be one of the many effected industries. Keeping in mind the above difficulties faced by plastic bags manufacturers, pharma industry should not wait for  the time “when they came for me, none was left to save me” situation. It should be proactive on solid waste (read plastic waste ) and clarify itself on rules to follow.

I have suggested a three point solution to Ministry of Environment, Government of India response to which is still awaited. It follows

1. Allowing all nine test methods for biodegradability for all types of polymers and applications and allowing thickness less than 30 microns in most carry bags.
2. Allowing  all NABL approved labs to test the biodegradibility of plastics.  CIPET, Chennai can test a maximum of only five samples as admitted by it in an RTI query. This will enable any company to test the plastic packaging within the time period allowed by MoEFCC by  April 2018.
3. Withdrawing endorsement by CPCB as it creates a trust deficit between the NABL  accredited labs and CPCB. The step will also result in an impossible task for CPCB with thousands lining up for endorsement.

The intention of MoEFCC is very noble and laudable but simplifying the process , giving options to the industries and asserting its authority will create an alignment and would result in implementation of the intention of reducing the plastic waste ! The industry needs to be proactive and not stall the waste management efforts of the governments through courts. Ultimately to be a good corporate citizen we need to make our country clean and sustainable first!