DGFT’s track and trace initiative has spurred solution providers to come up with innovative labelling options to cope with regulatory requirements By Usha Sharma
It is now more than five years after the Directorate General of Foreign Trade’s (DGFT) January 2011 announcement that all drugs and pharmaceutical products exported from India would need to incorporate track and trace systems. The roll out of the initial two phases, at the tertiary and secondary packaging levels did have its glitches but most companies are more or less in line with the mandate.
However, manufacturers realised that 2D barcoding in the third phase, at the primary packaging line, presents a different level of challenge. The primary packaging line consists of containers like bottles, vials, ampoules and blisters, which are in direct contact with the drug, unlike the boxes and cartons at the previous two levels. The information to be printed on the labels on individual products, be they bottles, vials, ampoules, or blister strips, has to be readable but expiry dates, batch numbers, unique serial numbers, etc could lose their readability on certain products like medicine strips, vials, single therapy kits etc.
As Siddhant Bhambhani, Product Management, ACG Inspection Systems explains, each primary packaging product type (bottles, vials, ampoules, blisters) presents unique labelling challenges. “The first product type, bottles are the easiest as “thermal transfer printers can be installed on the labelling lines for printing, and coordinated with labellers for product rejection. The challenge is to aggregate them with secondary serial numbers, as the 2D code is present on the circumference of the bottle. Advanced camera systems are already available in the market to pick the 2D code by scanning the bottle 360 degrees,” he says.
The second product type, vial/ ampoule, are challenging due to their small size and the high speed of the packaging lines. He suggests that laser engraving is the only way to print 2D bar code on vials/ampoules or their labels. “This is difficult but possible. However, the need for serialising vials/ ampoules is limited as these products are packed into cartons, which are the saleable unit.”
Blisters, says Bhambhani, are the most challenging of the lot as till date there is no proven method to serialise blisters on live production lines. “In general, printing of text/ logo on blisters is done on the lidding foil with the use of UV flexo printers. The challenge in printing 2D code on blisters is the knurling effect of the foil. Knurling of the foil on blaster machines is unavoidable, and this would distort the quality of the print. This would lead to high rejection percentage. The other solution is packing blisters in mono cartons and then printing 2D bar codes on it.”
Converting challenges into opportunities
As the saying goes, necessity is the mother of invention. Bhambhani points out that when the government started with the track and trace initiative, they were not ready to print on the products at such fast printing speeds. But in response to the new regulatory requirement, industry leaders put in more efforts into creating the technology to meet client requirements.
Innovation in labels for instance could address many regulatory needs. As Karan Kapur, Director, JK Labels explains, “Labels can fulfil all needs of regulations, innovations, high speed application, security, differentiation of product in a very economical way unlike (other) primary packaging components.”
In a highly regulated sector like pharma, every component needs to meet standards and not every company can achieve the high benchmarks required by this sector. Thus though the size of the pharma labelling market has consistently grown at a healthy15-20 per cent per annum, according to Kapur, there are not more than 10 label printers in India who follow all regulations of pharma companies. This for instance requires GMP compliance, adherance to SOPs, installing plant and machinery to meet the standards of the pharma industry, including the latest inspection machines to check for text variation in labels. “It is extremely difficult for any label printing company to get audited by a large pharma company without having the right QA/QC systems since they are very particular which they should be,” says Kapur. Thus regulatory pressures have ensured that only the very quality conscious solution providers choose to serve the pharma sector.
Up the learning curve
Kairus S Dadachanji, Managing Director, SCHOTT KAISHA, agrees that implementing 2D bar coding on primary packaging lines is a difficult task, indicating that implementing primary barcoding in India is still at an early stage, where certain authentication features need to be added. He also opined that this may be also due to cost concerns and confusion over GS1 standards.
He also quotes data from PharmaSecure, a company offering solutions to protect medicines against counterfeits, which states that difficulties arise while achieving 100 per cent reading rates of codes on primary packaging using standard process.
On a more positive note, Samit Yadav, Vice President – Operations and Technology, PharmaSecure, puts these challenges as down to the initial phases of a learning curve. “Introduction of any new feature on product packaging initially has a learning curve. As the experience of brand owners and manufacturers grows in this field, implementation efficiency increases. Currently, there may be some challenges in direct printing related to the packaging line speeds, the compatibility of inks with substrates or the physical dimension of the primary packaging. Given the current scale and technological advances, there is enough opportunity for the industry to provide viable solutions,” explains Yadav.
The importance of labelling in the pharma sector cannot be overemphasised. Labels are the sometimes the only link between a manufacturer and the external world (the retailer/stockist and the consumer), providing vital information of the product, like expiry dates, batch numbers/ lot numbers, unique serial numbers etc. Besides, it also provides information to patients about the product and acts like a bridge between the manufacturers and consumers.
The nature of the product creates the challenge. As Kapur explains, “Vials and ampoules require labels that meet their low mandrel performance i.e. performance of a label around a small diameter. Hence, they require less GSM paper which cause less edge lifts and more commonly now PP/PE labelling. Also, since they are bottled at very high speed, a film-based substrate is always suitable which does not tear. Regarding 2D barcoding on ampoule labels, the trend is yet to catch on and very few companies have currently adopted this.”
The trend in the country, according to Yadav, is that bottles and vials of medicines have labels affixed and the technology can be extended to affix pre-printed (advanced) labels. “The existing labels will need minor artwork changes to create space for the 2D data matrix. This involves no changes in the existing processes at the packaging lines. Label converters will have to invest in printing variable 2D barcodes. This is a fairly a well known technology and is governed by a mature set of standards.”
But globally, there have been some labelling innovations. As Dadachanji divulges, advanced labeling becomes an alternate solution for 2D barcoding and countries like the US, France, and Australia are already using these alternatives. These allow better identity (of the product and organisation), while meeting all regulatory requirements.
Advanced labelling has still to catch on in India as it is at a relatively nascent stage. However, will adopting such methodologies ensure authenticity and maintain brand identity in the market? According to Bhambhani of ACG Inspection Systems, “As of now, most of the alternative solutions that are currently available, require a decent amount of space. For example, RFIDs. If we go in for the smaller size RFIDs, they become extremely costly and are not feasible for use. The only way currently to incorporate a 2D barcode at the current lines speeds is to engrave the barcodes onto the glass using lasers. CIJ printers can also be used, however, the quality of the print and the speed at which it functions does not meet the requirements of majority of the ampoule vial lines in India.”
Challenges of implementing 2D bar coding on primary packaging lines
Primary packaging refers to containers which are in direct contact with the drug, and can be be classified in to the following product types – bottles, vials, ampoules, blisters. Each product type presents unique challenges.
Bottles – These are the easiest amongst the primary types listed. Thermal transfer printers can be installed on the labelling lines for printing, and coordinated with labellers for product rejection. The challenge is to aggregate them with secondary serial numbers, as the 2D code is present on the circumference of the bottle. Advanced camera systems are already available in the market to pick the 2D code by scanning the bottle 360 degrees.
Vials, ampoules – The challenge vial/ ampoule lines provide is their small size and high speed of the packaging lines. Laser engraving is the only way to print 2D bar code on the vials/ ampoules or their labels. This is difficult but possible. However, the need for serialising vials/ ampoules is limited as these products are packed into cartons, which are the saleable unit.
Blisters – This is the most challenging of the lot. Till date there is no proven method to serialise blisters on live production lines. In general, printing of text/ logo on blisters is done on the lidding foil with the use of UV flexo printers. The challenge in printing 2D code on blisters is the knurling effect of the foil. Knurling is unavoidable for the foil on blister machines, and this would distort the quality of the print. This would lead to high rejection percentage. The other solution to this issue is packing blisters in mono cartons and then printing 2D bar codes on it.
Source: Siddhant Bhambhani, Product Management, ACG Inspection Systems
Though there were considerable delays in implementing the various phases of the track and trace initiative, none in the industry today dispute the benefits of the system. Dadachanji avers that incorporating 2D barcodes on labelling will ensure efficiency of products and maintain the brand identity in the market. Enabling track and trace mechanisms at the primary, secondary and tertiary levels of packaging for all export products will also safeguard from drug counterfeiters as the alpha numeric digit encoded in 2D barcode on label will ensure the identity of the manufacturers.
Yadav agrees, saying, “2D data matrix coupled with track and trace technology are a worldwide accepted approach to identify leakage in supply chains. The 2D data matrix can be used by various stakeholders in the supply chain to track product movements. Ultimately, the end consumer can verify the product too. It can solve problems such as divergence, product recalls and help identify points of leakage. The 2D data matrix empowers consumers and stakeholders to be sure of the product origin.”
The 2D code can also empower patients to check if their medicines are authentic. As Bhambhani points out, “One of the key benefits of serialisation is brand protection with tools like end-user authentication. The 2D code on the label could be verified for authenticity by patients through mobile/ equivalent technology. This would be a great driver for individual manufacturers to enhance their brand identity in the market.”
All these measures will help companies to secure their products from any kind of counterfeit/ fake menace. Kapur expresses, “Labels can fulfil all your needs for regulation, innovation, high speed application, security, differentiation of product in a very economical way unlike primary packaging components. For regulations, labels can have low migration adhesives, inks etc. On the security front, labels can have many features like security inks: thermochronic and optically variable inks, several different security face materials like void and UDV, taggants, holograms, artwork related security etc. In case of differentiation labels, foiling, screen printing, attractive inks and RM, laminations, metallic inks etc, can be utilised.”
Yadav mentioned, “Labels manufactured in India are supplied both to the domestic as well as the international markets, which are well versed with GMP. Label suppliers are supported by material suppliers who invest in research to ensure that fresh stocks, adhesives and liner materials are used in compliance with pharma industry norms and requirements.”
What next?
What could be the next move which will help pharma companies as well label manufacturing companies go to the next level?
Yadav suggested, “The labelling industry is constantly evolving to cater to the needs of the pharma industry. PharmaSecure in partnership with leading holography providers in India are supplying holographic scratch off labels. These labels combine the best of physical security of the hologram and the digital security offered by our class leading psID(R) products. PharmaSecure has provided over two billion unique codes to the industry and these were either printed directly or applied via labels to the product packages.”
Kapur of JK Labels too is upbeat. As he explains, innovation in pharma labelling could be driven by regulation, security, application, face material or for decorative purposes. For examples, if you have an Minimum Order Quantity (MOQ) you can choose your own face material, gumming GSM and release liner. Secondly, labels with luminescence ink could be used to detect labels on high speed lines. Low migration ink and papers, labelling moist bottles, conformable labels for substrates like blood bags and freeze proof raw materials are other innovative pharma labelling techniques and solutions that could soon make their way to the market.
Summing up, Dadachanji predicts, “The future of innovative pharma labelling is bright and offers integrity for conceptualisation and may become a benchmark for quality attributes.”
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