Of the several interesting debates and discussions at PPL Conclave 2020, one of them was on ‘Labelling trends for the next decade.’ Moderated by Gautama Buddha, Pharma Consultant, the panellists for this session were Dr M Khalid Ahmed Khan, Assistant Drugs Controller, Drugs Control Department, Karnataka, Prabir Das, Head of Packaging Service, OSD India, Mylan Laboratories, Rajshri Pardeshi, Manager-Packaging Development & Labelling, Glenmark and Dr Reema R, Safety Labelling Manager, Novartis.
The moderator started off by explaining the need for this discussion and accentuating the importance of labelling. He outlined how labels on any pharma product play critical roles in terms of communication, compliance and in building confidence in patients. The panellists chipped in with their insights and spoke on the current trends in labelling and threw light on various uses of labels in pharma packaging. They unanimously agreed that labelling is a multi-purpose function and apart from offering crucial information it provides tamper-evidence, prevents counterfeiting, enhances traceability, enables easy recalls and engages very effectively with the consumers. Thus it’s role expands to encompass regulatory compliance, supply chain safety and security, product information, and authentication.
The panellists also highlighted how in times of stringent regulatory scrutiny, labelling can assist in product traceability and recalls, if required. They also stressed on the need to educate retailers and wholesalers of the labelling requirements that a product should satisfy. For instance, Khan informed that the Karnataka State Drug Control Department conducts workshops for the chemists at every block level and interacts with them to teach them about compliance.
Experts were also of the opinion that intelligent packaging and labelling solutions can play key roles in ensuring that systems and machines are interconnected and talk to each other for better outcomes. They also pointed out how incomplete and insufficient information on labelling leads to miscommunication and confusion but through digitalisation and automation, it is possible to give out a lot of pertinent information to the stakeholders, even within small spaces. A lot of time, cost and manpower can be optimised with technological advancements.
Thus, the potential of artificial intelligence, machine learning, blockchain, cloud solutions to help the labelling sector provide a lot of value to the stakeholders in the life sciences sector was clearly established during the discussion. The discussion ended with the panellists agreeing on the need for more understanding and effective implementation of good labelling practices in the pharma sector.
AccelTRA to accelerate generic drug launches
After the content-rich and meaningful industry insight panel discussion on labelling trends for the next decade, Shraddha Sharma, Marketing Manager, West Pharmaceuticals Packaging India was a speaker at PPL Conclave 2020. Sharma made a presentation on AccelTRA to accelerate generic drug launches and highlighted key facts about the healthcare industry.
In her presentation, she mentioned that top 50 injectable biologic companies are relying on West and Daikyo and nearly 41 billion components are manufactured annually. While providing an industry insight of the pharma sector, she mentioned that from 2016 to 2018 there has been a 20 per cent increase in ANDAs approved by the FDA. According to her, injectable ANDA approvals increased by 67 per cent. Whereas the total injectable ANDA observed a decline of 16 per cent from 2017-18. However, 47 per cent of approved injectable ANDAs consisted of eight companies. Overall, ANDA approvals for the US market continued to increase in 2018 while injectables declined.
Her presentation also touched upon the growing generic markets and its rising filling packaging requirements. Understanding the intensified requirements of pharma companies, she explained the filling timeline, marketing decisions which need to be taken by a pharma company before the product launch and the crucial factor of understating the packaging requirements.
After putting the perspective of the global generic drugs market, Sharma highlighted on their AccelTRA components which are designed to deliver quality, speed and simplicity to meet the unique needs of the generics biopharma market. She also spoke on AccelTRA- RTS/RTU which is specially designed for new launch companies targeting the EU and Row markets. While giving insight about this, she also spoke about AccelTRA Select which is targeted for the US market.
She also informed about that pillars of the AccelTRA Elastomer Components programme is to deliver quality, speed, and simplicity to its generics customers. At the end of her presentation, she also mentioned the West Knowledge Centre and topics which will be covered in the centre.
Barcode quality for global compliance
Shivashankar Nagarajan Director, Sandilyam Automation Systems started by with giving a brief introduction about his company. He mentioned that the company has a large client base from multiple user segments, of which pharma is of special importance. Then, he gave a detailed presentation on barcode quality for global
compliance. Stressing on global barcode standards compliance and verification he also touched upon the importance of verification, analysis and compliance reporting and GS1 importance to the pharma supply chain.
He also informed that all 2D matrix codes are verified in a similar way, with a common approach outlined in the standard ISO/IEC 15415. Each matrix code will also have a reference decode algorithm defined in the respective symbol specification, as well as a definition of the fixed pattern damage. Nagarajan continued explaining the reference decode which is a basic, repeatable method for attempting to decode the code and it will also define the grid where module centres will be measured. Moving on, he also gave a brief introduction on reflectance measurements which will be made at grid crossing points in order to grade the parameters: modulation, reflectance margin, symbol contrast and fixed pattern damage.
Nagarajan elaborated on the barcode quality which is critical for identification and traceability. He informed that barcode quality on all prescription and many over the counter (OTC) drugs’ primary product ‘labels’ (which also includes the folding cartons they may be packaged in and unit-dose packaging, including cups, blisters, etc., where offered) has been covered by FDA regulations.
With a minimum bar code quality grade of ‘C’ required by both HIBCC and GS1 (and incorporated by reference in the FDA ‘bar code rule’), pharma manufacturers have to take barcode quality seriously. In principle, a drug package with less than a ‘C’ grade barcode can be declared ‘mislabelled’ and be subject to recall. For this reason, pharma packagers pay pretty strict attention to barcode quality. He further informed that for European Union, medical products – quality, safety and innovation regulations on BARCODE marking and quality compliance and Russian regulations are now recommending mandatory barcoding including compliance to ISO 15415. While summing up his session, he highlighted the key benefits of implementing ISO/GS1 verification and its long-term benefits.
Addressing pharma coding essentials with end-to-end solutions
Bharat Jadhav, Product Sales Trainer, Markem Imaje gave an overview of the company’s presence and significantly mentioned about the company’s diversified business presence. He informed that the company has been operating in India for the last four decades with a manufacturing unit in Delhi. It is a global manufacturer of industrial products focussing on innovative equipment and components, speciality systems and support services in four key areas: engineered system, fluids, refrigeration and food equipment.
Elaborating on the company’s offering to the pharma industry, he stressed on the importance of pharma coding and evolving regulatory requirements from regulated and non-regulated markets and solutions offered by his company to the pharma industry.
He also gave a brief update on primary and secondary digital coding technologies and solutions offered by his company. While giving a technical insight on current technology adoption by pharma companies in primary and secondary coding he also touched upon coding technology for mono cartons.
Jadhav rationalised the investment in adopting Markem Imaje’s products. He stated that it optimises the cost based on volumes by picking the right tech. His presentation also touched upon the Industry 4.0 and how the pharma industry is moving aggressively in adopting industry 4.0. Jadhav pointed out that out of 100 per cent only 10 per cent cost of printing code is visible and the remaining per cent costs are hidden which are designated in different categories like unplanned downtime, risk management and safety, warranty costs, customer perception, replacement cost, training and education etc.
At the end of his presentation, he highlighted the organisation’s key performance indicator (KPIs) and its unique solution platform – CoLOS. It is an intelligent data management system tailored for all industries and an integrated solution enabling a company to manage the entire production line with maximum efficiency and accuracy. It is a networked software solution connecting centralised product data, line control systems and operations personnel. Jadhav mentioned that the company believes that it is an information management system which is the heart of packaging intelligence.
Patient-centric packaging: Case studies
Rajesh Mishra, Head, Packaging Development, Abbott Healthcare gave an overview of Abbott Healthcare. He presented case studies on patient-centric packaging and elaborated on product development challenges and how pharma companies are still struggling with conventional issues like opening the packaging, and induction sealing.
Highlighting the need for underrating patient’s requirement and accordingly designing the products, Mishra pointed out that for different disease conditions there are different packaging requirements. For example, elderly, disabled, paediatric, different age group, language, gender and their affordability, access to medication. Emphasising that Abbot Healthcare understands all of these points and products and services are designed by R&D as per the intended patient’s needs.
During the presentation, he mentioned that traditionally, pharmaceutical packaging has been more product-centric, but in today’s context packaging is not only ‘Product Centric’ but also ‘Consumer Centric.’ He also mentioned about the innovation introduced by Abbott Healthcare smart dosing concept for Creon SD and its benefits among pancreatic exocrine insufficiency (PEI) patients. During the presentation, he also talked about LiDoCon – a metered liquid dosing device which is free from spillage, contamination, cleaning while maintaining dosing accuracy introduced by Abbott Healthcare. Moving to the third case study, which was on anal fissure, he explained the current process of dispensing and application of medicaments from tubes which is unpredictable, unsafe, unhygienic and often difficult, however, the company has introduced AcuReApt which is a secondary packaging which provides excellent consumer experience with its reusable multi-compartment zipper pouch and communication through Abbott Smartpack digital link. He also shared that for most of these innovations the company has received awards and recognition.
PANEL DISCUSSION: Rethinking packaging for oral dosage forms
The last panel discussion at PPL Conclave addressed a crucial topic, ‘Rethinking packaging for oral dosage forms.’ As one of the most preferred routes to administer medications, it has become imperative for re-examine the current products in oral dosage forms and evolve to meet changing consumer demands.
As a result, packaging too will have to continuously evolve and transform to keep pace with the advancements in this segment and meet the requirements of the present and the future. And, this is exactly what the last discussion at PPL Conclave 2020 focussed on. A distinguished panel consisting of Rahul Bhargava, Pharma Consultant (Moderator); Barun Kumar Dey, Director – Packaging Development, Dr Reddy’s Laboratories; R Chandi Prasad, General Manager-Packaging Development, Aurobindo Pharma; Pradeep Dhargalkar, Pharma Consultant; and Ajay Bapat, Pharma Consultant updated the audience about the evolving trends, and advancements in this arena and discoursed on newer approaches needed for packaging of these medications.
Moderated by Bhargava, the discussion highlighted the role of packaging in enabling dose efficacy, high stability, cost efficiency and patient compliance. The panellists also analysed the impact of automation and digitalisation on the packaging of oral dosage forms. For instance, the experts informed that 43 per cent of patients are known to not complete their dosage and more than half of the medicines end up in the dustbin. But, clever packaging can assist the patient and the manufacturer with patient compliance. Similarly, active and intelligent packaging solutions can ensure proper oxygen and moisture protection while maximising the package’s barrier properties and communicating effectively with the patient. The panellists also stressed how crucial is the role of packaging in educating the patient about the product’s composition.
The discussion also addressed the need for customisation in pharma packaging and pointed out that factors like geography, socio-economic status and language can play a significant role in packaging design. So, what may work in Europe may not work for a patient in remote India. Therefore, the experts recommended the packaging fraternity to prepare themselves for small batches and customise their solutions for different types of consumers. The panellists also suggested that pharma companies need to set up a separate cell for customer feedback to help manage customer expectations. Thus, the discussion was a very interesting one with several takeaways for the