Vitafoods India 2024 concludes successfully, 7200 attendees at the three-dayevent
SUPPLYCHAIN
India’s logistics: Welcoming the era of productivity
1994MARCH 2024,` 40
Thankyou,Express Pharma for the opportunityto share our experience on this wonderful platform of PPL2024.It is always a great feeling to be associated with you
Thanks to the entire Express Pharma Team for making the PPL Conclave a strong knowledge sharing platform. Happyto contribute and learn from all participants. Special thanks to myeminent co-panellists !
It's reallyan honour and privilege to be part of an esteemed panel discussion and share the dias with industryexperts at the PPLConclave 2024.Thanks Team Express Pharma,all panel members and moderator
Great event.Wonderful theme.Manyuseful insights.Thanks Express Pharma for organising such a wonderful event and providing us the opportunityto hear from eminent speakers of the pharma packaging fraternity
Biocon Biologics
I would like to acknowledge the dedication of the Express Pharma team.This has resulted in the evolution of events like PPLyear after year.I stronglybelieve that their receptive attitude towards feedbackhas been a significant reason for notable improvements.I express mysincere appreciation for another fantastic event! I want to commend their hard workand dedication that trulyshone through,and myteam had a great time.Thankyou for making it so engaging and enjoyable.
I want to give a huge applause for the entire team of Express Pharma for organising and making the event a great success. The event hosted a wide range of subject experts presentations, panel discussions and latest trend discussions. It was a great platform to interact with industryexperts,solution providers and fellowpackaging experts.
Mysincere thanks to all myfellowpanelists
Looking forward to see and meet you all in future events
I would like to express myheartfelt gratitude for giving me the opportunityto present at PPLConclave 2024 .It was trulyan honour and a privilege to share myinsights and expertise with a diverse audience of industryprofessionals,partners,and participants. I would also like to extend mygratitude to the entire Express Pharma team for their hard workand dedication in making the PPLCo nclave 2024 a resounding success.The seamless execution and attention to detail were evident in everyaspect of the event,and I commend you all for your commitment to excellence.Thankyou once again and looking forward to future collaborations and the opportunityto contribute to the success of future events.
Ashland’s klucel™ xtend hydroxypropylcellulose (HPC) can match the release profile of hypromellose controlled release formulations at half the polymer concentration. This step change matrix former gives you the opportunity to develop smaller tablets and lower operating cost.
For more information or sample request, please contact our solver rakesh.narne@ashland.com
Chairman of the Board
ViveckGoenka
Sr.Vice President-BPD
Neil Viegas
Vice President-BPD
Harit Mohanty
Editor Viveka
Editorial Team
Lakshmipriya
Art
Senior
Senior
Marketing
Rajesh
Ashish
Debnarayan
Production
The February 16 announcement of Novartis' strategic review of its India subsidiary, including an assessment of the shareholding of Novartis AG in Novartis India, is the latest sign of MNC pharma's recalibration of strategic plans for one of the largest pharma markets.
Novartis India currently employs nearly 8100 people and is wholly separate from Novartis Healthcare, which includes the Novartis Corporate Center in Hyderabad, the commercial arm of Novartis in India, and R&D teams, which currently conduct clinical trials at more than 300 trial sites in the country. As per the release, the strategic review will not impact Novartis Healthcare.
Novartis is following in the footsteps of peers like AstraZeneca, which announced last November that it is looking to sell off its manufacturing facility and go the contract manufacturing route.
Over the last few years, we have seen more MNC pharma go the licensing route and more recently, sell off brands to their contract manufacturers. For instance, in November 2021, Encube Ethicals, which was Sanofi's contract manufacturer for Soframycin Skin Cream for more than 20 years, acquired some of these brands — Soframycin and other legacy associated brands Sofradex, Sofracort, Soframycin-Tulle for India and Sri Lanka markets. Similarly, J B Pharma recently bought Novartis' ophthalmology brands. Glenmark Pharma, Dr Reddy's Laboratories, Cipla and Torrent Pharma also have similar manufacturing and marketing deals with MNC pharma for key brands.
These moves seem designed to reduce MNC pharma's exposure to manufacturing, especially of older branded generic molecules where the margins are thinning by the day. As of now, MNC pharma is not pulling the plug on their R&D centres, which serve as the backend to global clinical trial sites. In fact, BMS has just announced a $100 million investment in Hyderabad for a new facility which will expand the company's global drug development, IT and digital capabilities.
As India transitions to become the drug development BPO of the world, adding a digital edge to global drug development programmes, it's a win-win for both sides. MNC pharma can sharpen focus on next-generation cures and higher margin therapeutic areas like oncology, while contract manufacturers like Encube Ethicals get to buy legacy brands and transition from B2B to
As India transitions to become the drug development BPO of the world,MNC pharma sharpens focus on nextgeneration cures and higher margin therapeutic areas
B2C players.
There are many reasons for MNC pharma's strategic pullback from the India market. The cutthroat competition in India's pharma market has seen MNC pharma's market share eroding over time, with many Indian subsidiaries contributing minuscule revenue to the global turnover. It is obvious that MNC pharma will invest in markets with more promise.
India is also continuing to take a tough stand on intellectual property rights. For instance, the Indian Commerce Ministry recently confirmed its rejection of Switzerland’s demand for data exclusivity for medicines in the India-EFTA trade deal and also emphasised the importance of protecting the country’s generic drug production and supply.
It's also true that a crackdown on manufacturing quality, which is now being addressed, made Indian pharma players refocus on the domestic market. Duplication of distribution networks and sales teams would be counterproductive and for now, it is serving both sides to play to their strengths.
But MNC pharma's re-set mode has triggers beyond the India market. Most MNC pharma firms are set to lose more patents on key brands in the coming decade, opening these brands to price erosions. Governments are also cracking down on pricing, adding more medicines to the national list of essential medicines.
Takeda's manufacturing collaboration with Biological E for its dengue vaccine QDENGA is an example of how such deals make business sense as well as serve public health interests. As per the release, the manufacturing collaboration is for multi-dose vials which are the preferred packaging for national immunisation programmes as they offer economic and logistical advantages by minimising packaging and storage expenses, while also reducing medical and environmental waste.
Indian pharma will have to re-set its goalposts in response to such transitions. While it shelves its Discover in India dream, for the time being, Develop in India seems a good way to remain in the game.
VIVEKA ROYCHOWDHURY, Editor viveka.r@expressindia.com viveka.roy3@gmail.comOptimizeyourcoatingprocesswiththeTPRCoaterbyRomacoTecpharm. Withperforatedpantechnology,itexpertlycoatstabletsandpellets, managingbatchesfrom 25%to100% inonesingledrum!
In-Walldesignconcept
Fullyautomaticparametersetting
IntuitiveHMIwithManualand Automaticmodes
BuiltinAISI316L,withsurfacesin contactwiththeproductmirror polishedwithroughnessRa<0.5. Readytomakeachange?
Detachabledeflectors
Rotatingarm
Perforatedpan
Schlick®spraynozzles
The event featured more than 12 educational sessions by 40+ expert speakers from the nutraceutical sector
Informa Markets successfully concluded the 2nd edition of Vitafoods India at the Jio World Convention Center, Mumbai recently. The threeday event was held from February 1315, 2024, designed to showcase the fast-transforming Indian nutraceutical market.
The event was graced by dignitaries, including Chief Guest Aatram Dharamraobaba Bhagwantrao, Minister of Food and Drugs Administration, Government of Maharashtra; Sanjaya Mariwala, President, Association of Herbal and Nutraceutical Manufacturers of India (AHNMI);
Dr Nilesh Amritkar, President, Association of Food Scientists & Technologists (AFSTI); Dr Vaibhav Kulkarni, Hon. Secretary, Health Foods and Dietary Supplements Association (HADSA); Umesh Kamble, Secretary General, Chamber for Advancement of Small Medium Businesses (CASMB); Yogesh Mudras, MD, Informa Markets in India; Julien Bonvallet, Group Brand Director, Informa Markets and Rahul Deshpande, Sr Group Director, Informa Markets in India.
Recognising the sector’s importance, Minister of Food and Drug,
STATEMENT ABOUT OWNERSHIP AND OTHER PARTICULARS OF EXPRESS PHARMA, MUMBAI, AS REQUIRED UNDER RULE 8OF THE REGISTRATION OF NEWSPAPERS (CENTRAL) RULES, 1956
FORM IV (SEE RULE 8)
1.Place of Publication:Mafatlal Centre, 7th floor, Ramnath Goenka Marg, Nariman Point, Mumbai 400021
2.Periodicity of its publication:Monthly
3.Printer’s Name:Ms.Vaidehi Thakar
Whether citizen of India:Yes
Address:Mafatlal Centre, 7th floor, Ramnath Goenka Marg, Nariman Point, Mumbai 400021
4.Publisher’s Name:Ms.Vaidehi Thakar
Whether citizen of India:Yes
Address:Mafatlal Centre, 7th floor, Ramnath Goenka Marg, Nariman Point, Mumbai 400021
5.Editor’s Name:Ms.Viveka Roychowdhury
Whether citizen of India:Yes
Address:Mafatlal Centre, 7th floor, Ramnath Goenka Marg, Nariman Point, Mumbai 400021
6.Name and address of individuals:The Indian Express (P) Ltd who own the newspaperMafatlal Centre, 7th floor, Ramnath Goenka Marg, Nariman Point, Mumbai 400021 AND Shareholders holding more than:Indian Express Holdings & Entp One per cent of the total capitalPrivate Limited Mafatlal Centre, 7th floor, Ramnath Goenka Marg, Nariman Point, Mumbai 400021
:Mr.Viveck Goenka & Mr.Anant Goenka Mafatlal Centre, 7th floor, Ramnath Goenka Marg, Nariman Point, Mumbai 400021
:Mr.Shekhar Gupta & Mrs.Neelam Jolly C-6/53, Safdarjung Development Area, New Delhi 110 016
I, Vaidehi Thakar, hereby declare that the particulars given above are true and to the best of my knowledge and belief.
sd/Vaidehi Thakar PublisherDate :1/3/2024
Government of Maharashtra, said, “Vitafoods India 2024 is a significant event for the growing nutraceutical industry in India. This three-day extravaganza, hosted in Mumbai, reflects our government's commitment to fostering a business-friendly environment, evident in our dedication to ease of doing business. The internationality of Vitafoods India, connecting professionals from over 40 countries, underscores the global appeal of this industry.
Strict compliance is vital, with the government implementing strong monitoring frameworks for nutraceutical integrity.”
Vitafoods India 2024 garnered significant support from the essential nutraceutical associations, SHEFEXIL, AHNMI, HADSA,WIN and PBFIA
Emphasising on the growth of nutraceutical Industry, Mariwala said, "In our pursuit of sustained growth, the government's initial actions are pivotal. However, it's evident that our journey toward establishing a formidable presence in the global nutraceutical arena requires concerted efforts and continuous initiatives. Through incentivising manufacturing modernisation, prioritising accurate clinical trials, launching nationwide awareness campaigns, resolving regulatory conflicts, unifying industry alliances, and fostering collaborative endeavors, we pave the way for industry advancement. Vitafoods India heralds the anticipation of further discussions and collaborations, fortifying our collective efforts to propel the
nutraceutical sector towards success."
At the heart of Vitafoods India 2024 were two dynamic
zones - The Global Trends
Zone and The I nnovation Zone. The Global Trends Zone served as a hub for cut-
ting-edge nutraceutical products from global brands, spotlighting themes such as gut health, positive ageing,
women’s health, and innovative formats. The Innovation Zone provided a platform to witness 10 breakthrough March 2024
innovations in the nutraceutical world.
Over 12 educational sessions, featuring 40+ expert speakers, provided invaluable insights into the rapidly evolving nutraceutical landscape.
Sessions on gut health and women’s nutrition garnered a lot of attention, reflecting a growing interest in these crucial health topics.
A session was dedicated to discuss and explore the latest innovations and trends in sports nutrition, emphasising new formulations and personalised supplements' impact on performance.
Additionally, there was a Power Breakfast organised in collaboration with Women in Nutraceuticals (WIN), focusing on empowering women leadership in the nutraceutical sector. Also, a panel discussion by the Plant-Based Foods In-
dustry Association (PBFIA) explored the rising popularity of plant-based nutrition.
The event featured an array of domestic and international participants, including KSM-66 Ashwagandha, Biogen Extracts, Brenntag, Omniactive Health Technologies, Roquette India, Sami Sabinsa Group, Krishna Enzytech/Collagen Lifesciences, and more.
Furthermore, Vitafoods India 2024 garnered significant support from the essential nutraceutical associations, including Shellac and Forest Products Export Promotion Council (SHEFEXIL), Association of Herbal and Nutraceutical Manufacturers of India (AHNMI), Health Foods and Dietary Supplements Association (HADSA), Women in Nutraceuticals (WIN), and Plant Based Foods Industry
Leaders,experts and innovators came together to unravel the latest advancements and trends shaping the landscape of pharma packaging and labelling
Express Pharma recently organised the sixth edition of the Pharma Packaging and Labelling (PPL) Conclave, presented by West Pharma and powered by Cilicant. This premier event brought together industry leaders and experts to explore the latest advancements and trends shaping the landscape of pharma packaging and labelling.
The event also received support from Gold Partners – Optel Group, Korber Pharma, Romaco India; and Silver Partners – Bharat Rubber Works, Bossar Packaging, Yash Packaging, Nichrome India, Gerresheimer, Universal Medicap, ACE Technologies & Packaging Systems, Indmark Group, Terrasoul Polymers, Automed Systems, Indmark Paperform, and Moldtek Packaging.
PPL Conclave 2024 featured distinguished speakers offering insights into regulatory updates, cutting-edge technologies, innovative packaging solutions, and sustainable practices. The event addressed topics crucial for the advancement of pharma packaging. Delegates engaged in lively discussions, fostering an environment of collaboration and knowledge exchange. The distinguished lineup of speakers provided valuable perspectives on the challenges and opportunities in the everevolving pharma packaging industry.
It commenced with a Welcome Address by Viveka Roychowdhury, Editor, Express Pharma and Express Healthcare who welcomed the delegates and explained the vision of PPL Conclave. A lamp lighting ceremony followed the Welcome Address and provided an auspicious start to the event.
L-R: Viveka Roychowdhury,Editor,Express Pharma; Chakravarthi AVPS,Global Ambassador,WPO; SM Mudda,MD,Misom Labs; AjayBapat,Pharma Consultant; Manish Jain,MD,Cilicant; and VinayakJoshi,Sr.National Sales Manager,West Pharmaceutical Services
Chakravarthi AVPS, Global Ambassador, World Packaging Organisation gave the Keynote Address at PPL Conclave 2024. He shared valuable insights as a packaging evangelist and expert. He acknowledged and commended the packaging fraternity on their progress and urged packaging professionals to continue innovating and evolving.
He also lauded PPL Conclave as a unique platform that strives to encourage and promote excellence in the pharma packaging and labelling segment through engaging and insightful discussions and networking activities.
He also expressed his views on the key drivers of growth in packaging, emphasising that communication and patient convenience are critical factors for the future.
Chakravarthi AVPS,Global Ambassador,World Packaging Organisation
He expressed that pharma packaging will have to evolve continuously to keep pace with progress in pharma R&D.
AVPS also said that technology advancements are ushering great shifts in pharma and healthcare. India is poised to grow phenomenally with its expertise in IT and pharma, now it is upto all stakeholders to build and sustain better synergies to optimise growth potential. Speaking of pharma exports, he said that several countries look at India for affordable, good quality medicines.
He concluded the session by urging the industry to stay updated about latest technology, trends and regulations, strive for highest levels of quality, look for strategies that will optimise growth and put in their best efforts to build and sustain India Pharma Inc's growth story.
Prabhaharan Sankaran, Sr Technical Account Specialist, West Pharmaceutical Services gave a very insightful presentation on ‘Evolving regulations in packaging of injectables’. He pointed out that regulatory requirements for pharma products are rapidly changing to enhance patient safety and market compliance.
Giving an overview on various regulations, he gave examples of recent and upcoming developments such as the revised USP <660> chapter, effective from October 1, 2023, which allows all Type I glass passing the test to be used for applicable drugs. Another example was an upcoming new standard, USP <382>, addressing elastomeric components. It will be enforced on December 1, 2025. He also informed that in the EU, Notified Body opinions are now critical for Marketing Authorization Application submissions as per EU MDR. Additionally, the updated EU GMP Annex 1, effective since August 25, 2023, mandates a more rigorous contamination control strategy, recommending the use of RABS and isolators.
Moving on, he shared how packaging
performance expectations have increased over time and West is equipped
with the scientific knowledge, quality, and services needed to meet these
Komal Bhavsar, AGM-Business Development, CILICANT, took the stage at PPl Conclave 2024 to give a presentation on the theme of "Inn ovation in active packaging." In her presentation, Bhavsar explored the recent advancements in active packaging and their role in ensuring product stability, extending shelf life, and improving patient safety.
The session highlighted the importance of intelligent active packaging solutions, and shed light on CILICANT's contributions to maintain the quality and integrity of primary packaging. It also spotlighted a standout product - FREXIL dust-proof canisters. Bhavsar informed that these canisters were developed to address the issue of dusting commonly associ-
Komal Bhavsar,AGM-Business Development,CILICANT
Packaging performance expectations have increased over time and West is equipped with the scientific knowledge,quality, and services needed to meet these growing demands
growing demands. Sharing information about West’s growing portfolio of products for the pharma industry and their advantages, he assured that his organisation is equipped to ensure that drug products reach market on schedule.
ated with activated carbon-based canisters. She explained how they safeguards products from potential contaminants and eliminates dusting concerns. They also feature a spillproof design, enhancing their practicality for users.
Bhavsar explained that FREXIL, formulated with Cilicant's patented technology, prioritises customer acceptance and ease of use, recognising canisters as a widely preferred desiccant format.
The session offered valuable insights about moisture control and odour mitigation. It also elucidated how the adoption of smart active packaging solutions from CILICANT can aid packaging strategies, optimise product quality and enhance customer satisfaction.
As the focus on healthcare increases and the demand for advanced therapies grows, close attention to packaging innovation becomes imperative to guarantee the safety, efficacy, and integrity of biopharma products and vaccines.
Therefore, the first panel discussion at PPL Conclave 2024 was on an interesting and pertinent topic, "Packaging for high-value biopharmaceuticals and vaccines."
The esteemed panel of experts for this session were Ajay Bapat, Pharma Consultant and the Moderator of this discussion; Vinayak Joshi, Sr National Sales Manager, West Pharmaceutical Services; Avinash Ballal, Head of Packaging Development, Serum Institute of India; Saravanan TJ, Associate Director - Packaging Development, Biocon Biologics; Kumar Suman, AGM and Head of Injectable Packaging Development, Macleods Pharmaceuticals; and Tridip Majumdar, Head of Packaging Development-Sterile at Dr Reddy's Laboratories
The experts on the panel deliberated on how innovations in packaging design, material and technologies are continuously evolving to meet the stringent requirements of the biopharma industry, focusing on maintaining the highest standards of safety, efficacy, and regulatory compliance.
The discussion examined the critical role of Quality by Design in developing and adopting packaging solutions for high-value biopharma products. The panellists also highlighted the growing trend of prefilled syringes (PFS) and examined the challenges linked such as viscosity and dosing accuracy.
Addressing the industry's strides towards digitalisation and automation, the panel underscored their potential in enhancing capabilities and efficiencies in packaging biopharma products and vaccines. However, they also acknowledged the importance of overcoming challenges such as scale, training, and navigating evolving regulations to fully leverage these advancements.
With a focus on fortifying biopharma and vaccine supply chains through technology, the discussion highlighted the integration of real-time data loggers and Vaccine Vial Monitors (VVM). These in-
L-R: AjayBapat,Consultant,Packaging Concepts (Moderator),VinayakJoshi,Sr.National Sales Manager,West Pharmaceutical Services, Avinash Ballal,Head - Packaging Development,Serum Institute of India,Saravanan TJ,Associate Director - Packaging Development,Biocon Biologics,Tridip Majumdar,Head-Packaging Development-Sterile,Dr Reddy's Laboratories,and Kumar Suman,AGM,Head-Injectable Packaging Development,Macleods Pharmaceuticals
● QualitybyDesign is a keyaspect for creating and adopting packaging for high value biopharma products
● Prefilled syringes (PFS) are a growing trend,but are facing challenges in terms of viscosity,dosing accuracy.Big challenge for PFS is product nature itself
● Digitalisation and automation add to capabilities and efficiencies of packaging biopharma products and vaccines.But,scale, training,evolving regulations,etc are keyto leverage potential
● Biopharma and vaccine supplychains are getting fortified through technology.Real time data loggers and VVM protect efficacyand qualityof high value biopharma products and vaccines
novations were emphasised as crucial elements in protecting the efficacy and quality of high-value biopharma prod-
ucts and vaccines. The panel collectively agreed on the necessity of staying vigilant on these fronts to ensure the con-
tinued success of the industry in delivering safe and potent healthcare solutions.
Ashley Reynolds, Sales Director, Körber Pharma Packaging AG, shed light on the advantages of an eco-design approach in pharma packaging with a compelling case study. Reynolds illustrated how a strategic shift towards sustainable practices yields numerous benefits such as reduced environmental impact, material optimisation, and substantial cost savings.
The focal point of the case study was Körber's Dividella NeoTOP Solution. It informed how this solution helps gain significant advantages including a reduction in the number of pallets required for packaging materials, which in turn, results in substantial savings in sea freight costs ($2.6 million savings per year) and air freight costs ($11.05 million savings per year)
AshleyReynolds,Sales Director,Körber Pharma Packaging AG
Reynolds also explained how this solution from Korber streamlines the manufacturing process steps, leading to efficiencies in board sizes, weights, and volume. This, in turn, translated into cost savings across material, logistics, and manufacturing processes. Körber's eco-design approach resulted in a remarkable 28 per cent reduction in the carbon footprint associated with the packaging.
Reynolds also highlighted the tangible positive outcomes stemming from adoption of eco-design principles, and emphasised Körber's dedication to greener practices in pharma packaging.
In summary, Reynolds' presentation at the PPL Conclave 2024 illuminated Körber's success story in adopting an eco-design approach, showcasing real-world benefits.
Srinivas Naidu, Sr GM - Packaging Development at Sun Pharmaceutical Industries gave a very interesting presentation that unraveled the exciting realm of AI's potential applications in packaging and medical devices.
He highlighted that while AI is not yet considered a low-hanging fruit in the packaging domain, in the next two years, there may be significant strides in commercial applications, particularly in vision systems and artwork (A/W) management.
Pointing put that often there is overuse of the term "AI", he emphasised that careful consideration and realistic expectations are crucial for the successful integration of AI technologies.
His presentation explored several applications, showcasing the potential impact of AI in the industry. For instance, in packaging, AI-enabled cameras are able
Srinivas Naidu,Sr GM - Packaging Development at Sun Pharmaceutical Industries
to detect defects in products such as capsules, tablets, and blister packs very easily. The presentation also looked at the integration of AI-enabled OCR systems to achieve high accuracy in batch over-coding, variable print, and machine-readable data. Likewise, AI's capability to streamline artwork processes was also presented. Common corrections and modifications could be performed in a single iteration, significantly reducing overall artwork making time.
Thus, the session painted a compelling picture of AI's potential in revolutionising the packaging industry. It drew attention to the imminent commercial application and their transformative impact on the industry. Naidu concluded the presentation by emphasising that it is imperative to approach AI integration with a balanced perspective, acknowledging both its promises and limitations.
Karthik Deepak Pollamalla, GM Sales - South India, Optel Group gave a presentation on track and trace solutions for the pharma industry. He began with an insightful overview of Optel, emphasising its role in providing track and trace solutions. He also highlighted the crucial importance of traceability in the pharma industry, touching upon aspects such as product integrity, authenticity, safety, regulatory compliance, sustainability, and brand reputation.
A significant portion of the presentation focused on Optchain, an intelligent supply chain solution suite designed to drive outcomes. The Optchain platform was described as a supply chain control tower, offering enhanced visibility and transparency by capturing and connecting granular data throughout the supply chain. The traceability capabilities of Optchain were underscored, emphasising its role in optimising supply chain performance and sustainability while adhering to local regulations and international standards.
The presentation went beyond mere traceability, delving into how Optchain contributes to sustainability
efforts. By monitoring and providing visibility into the environmental and social impact of the supply chain, the
Santosh Singh, GM-Sales & Marketing, shared insights into innovative packaging solutions at PPL Conclave 2024. He highlighted the evolving landscape of pharma packaging and gave an overview of his company's solutions for this segment.
His session highlighted Romaco's technical expertise and cutting-edge approaches to serve the industry.
His presentation showcased a blister packaging machine from Romaco Noack, called Unity 600. Going into details of the producs, he informed that it is super fast and eco-friendly, using less energy and reducing carbon emissions. He also informed that it can trace each blister pack from start to finish, ensuring quality. The Unity 600 is flexible and can handle different types of packaging, like paper blisters.
He concluded his presentation with an emphasis that Romaco Noack's Unity 600 blister packaging line stands out for its innovation in sustain-
Santosh Singh,GM- Sales & Marketing,Romaco India
Optchain optimises supply chain performance and sustainability while adhering to local regulations and international standards
solution aims to empower users to make informed decisions that align with sustainability goals. Real-time production and supply chain efficiency were highlighted as additional benefits derived from Optchain, facilitated by improved operational intelligence.
Romaco Noack's Unity 600 blister packaging line supports in sustainability, traceability,and energy efficiency, making it a versatile and ecofriendly solution
ability, traceability, and energy efficiency, making it a versatile and ecofriendly solution for the pharma packaging industry.
Engaging discussions that highlighted cutting-edge technologies and breakthroughs in pharma packaging and labeling were part of the thought-p rovoking sessions and knowledge exchange during PPL Conclave 2024.A riveting panel discussion on 'AI and Automation: Revolutionizing Pharma Packaging and Labelling' was one of them.
A panel of experts came together at PPL Conclave 2024 to explore and unravel the potential of artificial intelligence and automation in reshaping the future of pharma packaging and labelling. The session was moderated by Avinash Kumar Talwar, VP - MRO & Pkg. Material Sourcing (Strategic & Plant), Global Supply Chain Management, Dr Reddy's Laboratories. The panelists were Chandi Prasad Ravipati, Head-Packaging Development, Aurobindo Pharma; Santanu Chowdhury, Sr GM - Packaging Development, Sun Pharmaceutical Industries; Prabir Das, Pharma Expert and Dr Sajeev Chandran, VPPharma R&D, Lupin.
The discussion underscored the shift in pharma packaging industry with the growing integration of AI and automation. It examined how advancements in technology are revolutionising packaging processes by enhancing efficiency, accuracy, and overall productivity. Experts also discussed how AI and automation helps to streamline quality control, optimise time as well as reduce human errors, resulting in increased speed and cost-effectiveness.
The discussion accentuated AI’s role in improving operational efficiency and reducing downtime in the industry. It also explored critical drivers of pharma automation, emphasising the need for efficacy, compliance, growing demands, and affordability as primary motivators for embracing advanced technologies. The panel emphasised that AI possesses the capability to provide sequential, optimal, and fragile sequencing, enhancing precision and reliability of pharma packaging processes. However, the speed versus compliance is a central challenge; a
L-R:Mr Avinash Kumar Talwar,VP- MRO & Pkg.Material Sourcing (Strategic & Plant),Global SupplyChain Management,Dr Reddy's Laboratories (Moderator),Chandi Prasad Ravipati,Head-Packaging Development,Aurobindo Pharma,Santanu Chowdhury,Sr GMPackaging Development,Sun Pharmaceutical Industries,Prabir Das,Pharma Expert,Dr SajeevChandran,VP- Pharma R&D,Lupin
● Al is a valuable strategyto eliminate downtime and improve operational efficiency
● Need of efficacy,compliance,demands and affordabilityare keydrivers of pharma automation
● Al has power of providing sequential,optimal and fragile sequencing
● Speed vs compliance is the challenge while using Al and automation
delicate balance is required when leveraging AI and automation to ensure both efficiency and adherence to
regulatory standards. Overall, the discussion established that AI is a powerful tool in pharma packaging,
with potential to address industry challenges and drive optimal and compliant operations.
In the ever-evolving pharma packaging regulations landscape, staying abreast of compliance requirements is paramount. This dynamic environment demands constant adaptation from industry players to ensure the safety, efficacy, and global adherence of pharmaceutical packaging standards.
So, the first panel discussion on Day 2 of PPL Conclave 2024 was on ‘Pharma Packaging Regulations: Navigating Compliance in a Global Landscape.’
A stellar panel shared their views and insights on this pivotal topic. Moderated by Tripti Nakhare,Associate VP-RA&PDD, FDC, this discussion had several important takeaways for the audience. The other panelists for this discussion were SM Mudda,MD, Misom Labs; Sekhar Babu Puli,Head-Packaging Development, MSN Labs; Pradeep Dhargalkar,Former Head of Packaging Development, Unichem Laboratories and Prafull Deshpande,Head - Packaging Development, Lupin.
The discussion centered on the criticality of a robust packaging strategy to ensure compliance with regulations and control cross-contamination in the pharma industry. The participants also highlighted the need for harmonising pharmacopoeias and regulations to enhance compliance and maintain highquality standards.
A vital point raised was the pivotal role of packaging in product traceability, be it for anti-counterfeiting measures, regulatory compliance, or efficient handling of product recalls. The discussion underscored the need for a sound packaging approach to support these traceability requirements.
Addressing a specific concern, it was noted that certain packaging materials containing nitrocellulose (NC) could lead to nitrosamine impurities. The panel’s recommendation was to opt for NC-free materials and inks to mitigate this issue.
Moreover, the discussion spotlighted the evolving trend of pharmacogenomics and thereby the growing need for personalised packaging.
L-R: Tripti Nakhare,Associate VP-RA&PDD,FDC (Moderator),SM Mudda,MD,Misom Labs,Sekhar Babu Puli,Head-Packaging Development, MSN Labs,Pradeep Dhargalkar,Former Head of Packaging Development,Unichem Laboratories,and Prafull Deshpande,Head - Packaging Development,Lupin
● Asound packaging strategyto control cross contamination is keyto complywith regulations
● Harmonising of pharmacopoeias and regulations will bring better compliance and qualityacross pharma products and processes
● Packaging is pivotal in product traceability.Traceabilityis keyfor anti-counterfeiting,regulatorycompliance or product recalls
● Certain packaging materials which contain nitrocellulose (NC) can lead to nitrosamine impurities.Using NC-free materials/inks can help deal with this problem
● Pharmacogenomics is a growing trend,so packaging also needs to be personalised.Technology-enabled packaging is the future.
Embracing the circular economy in pharma packaging and labelling represents a dual commitment – a moral responsibility towards sustainability and a strategic imperative for resilient business practices, aligning ethics with efficiency.
So, the final panel discussion at PPL Conclave 2024 - Circular economy in pharma packaging and labelling: A moral and business imperative focused on this very important issue and its impact. Our experts explored the intersection of morality and business in the pharma packaging landscape in this discussion, ably steered by the moderator, Gagan Deep, Former Head Packaging Development, Himalaya Wellness Company.
The other panelists were Anindya Munshi, VP and Head-Packaging, Dr Reddy's Laboratories; Soumyanath Mishra, Associate VP & Head-Packaging Development, Mankind Research Centre; Anahita Karande, Head - Packaging Development & Procurement, Alembic Pharmaceuticals; Sivaji Chakraborty, Head – Packaging Development, Fresenius Kabi and Bhupesh Mittal, Global Packaging & Design Manager, Bayer.
The participants acknowledged the increasing prominence of sustainability in this sector, and highlighted the need for a comprehensive approach to integrate eco-friendly practices into packaging and labelling processes.
The discussion addressed environmental concerns and looked at approaches to promote the reuse of materials within the pharma supply chain. In the course of the discussion, the feasibility of incorporating recycled materials into primary pharma packaging was also discussed and deliberated upon. It was suggested that, subject to stringent stress tests and regulatory approvals, the middle or last layers of primary packaging could be made from recycled materials.
Experts also drew attention to the economic benefits of optimising packaging designs to not only reduce costs but
L-R: Gagan Deep,Former Head Packaging Development,Himalaya Wellness Company(Moderator),Anindya Munshi,VPand HeadPackaging,Dr Reddy's Laboratories,Soumyanath Mishra,Associate VP& Head-Packaging Development,Mankind Research Centre, Anahita Karande,Head - Packaging Development & Procurement,Alembic Pharmaceuticals,Sivaji Chakraborty,Head – Packaging Development,Fresenius Kabi,Bhupesh Mittal,Global Packaging & Design Manager,Bayer
● Sustainabilityin pharma packaging is an important aspect and continue to gain prominence in the coming years
● Use of recycled material for primarypackaging is also possible.The middle layer or last layer of primarypackaging can be made of recycled material after it passes stringent stress tests,subject to regulatoryapprovals
● Optimising packaging can help reduce costs as well as promote sustainability
● Product environment footprint (PEF) and organisation environment footprint (OEF) should also be considerations while selecting suppliers of packaging
also contribute to sustainability, thereby trying to establish a harmonious balance between financial considerations and environmental responsibility.
Panelists stressed the importance of considering the product environment footprint (PEF) and organisation environment footprint (OEF) when select-
ing suppliers for packaging materials. This could ensure that sustainability practices are associated with the entire product life cycle and organisational operations.
The discussion concluded that embracing a circular economy in pharma packaging and labelling is not
only a moral obligation to mitigate environmental impact but also a strategic business move. Measures such as the integration of recycled materials, optimisation of packaging, and the careful selection of suppliers contribute to a holistic and sustainable approach within the pharma industry.
PPLLeadership Awards and PPLInnovation Awards,held in conjunction with the Pharma Packaging and Labelling (PPL) Conclave 2024,celebrate individuals and teams promoting and contributing towards excellence in pharma packaging
Express Pharma recently concluded the the Pharma Packaging and Labelling (PPL) Awards at Le Meridien, Hyderabad. The event, held in conjunction with the Pharma Packaging and Labelling Conclave 2024, aimed to recognise and honour the contribution of individuals and teams in the pharma packaging industry who have significantly contributed to innovation and excellence. It had two segments - PPL leadership Awards and PPL Innovation Awards.
The evening commenced with a warm Welcome Address by Viveka Roychowdhury, Editor, Express Pharma, who provided insights into the vision behind PPL Leadership Awards and PPL Innovation Awards.
She said that the PPL Leadership Awards remain an endeavour to recognise and reward immensely talented pharma packaging professionals each year, who have created and are creating an impact by their dedication, innovation and creativity. Over the past five editions, more than 80 pharma packaging professionals have been awarded in four categories: Stalwarts, Leaders, Achievers and Rising Stars, based on their levels of seniority. She also explained that Pharma Packaging Innovation Awards seeks to expand the Awards from the individual level to the corporate level. Roychowdhury underscored that the PPL Awards serve as a celebration of individuals and teams who are playing a pivotal role in advancing the pharma industry through innovation and excellence.
Next, Chakravarthi AVPS, Global Ambassador, World Packaging Organisation, and Jury member of PPL Awards 2024 took the stage to elucidate the methodology employed in selecting the deserving winners. He urged the industry to be proactive and send in their nominations so that outstanding professionals and teams in pharma packaging get the recognition due to them and endeavours like PPL Awards succeed in its vision.
Subsequently, the awards were presented by Roychowdhury along with Vinayak Joshi, Sr National Sales Manager, West Pharmaceutical Services; and Manish Jain, Founder and MD, Cilicant. Jury members – Chakravarthi AVPS, Global Ambassador, World Packaging Organisation; S M Mudda, MD, Misom Labs; Ajay Bapat, Consultant, Packaging Concepts; and Prabir Das, Pharma Expert also joined in honouring the deserving winners.
The PPLLeadership Awards 2024 acknowledged the noteworthycontributions of seven pharma packaging professionals in two categories –Achievers and Rising Stars.
Winner Category
DipakPawar Achievers
Harshad Tambe Achievers
Ramesh Sajja Achievers
Srinivas Sukasi Achievers
Harish M Rising Stars
Lovaraju R Rising Stars
Sandeep Kumar Rising Stars
This year,PPLInnovation Awards were also initiated with an aim to recognise brilliance and excellence of pharma packaging and labelling teams,and their contributions to redefine the packaging landscape,push boundaries and bring in cutting-edge advancements.
These awards were given across four categories this year: Sustainable Packaging,Patient-centric Packaging,Intelligent Packaging and Disruptive Packaging Innovation.The winners are as follows:
Category Winnner Initiative
Sustainable Packaging Aurobindo Pharma Eliminating pallets and container stuffing
Intelligent Packaging Mankind Pharma Tablets in a wallet pack
Patient-centric Packaging MSN Laboratories Vial Safe Guard
Disruptive Innovation Sun Pharmaceutical Industries
13 layer active oxygen barrier LVPbag for Paxitazinfusmart®
L-R: Members of PPLLeadershipCouncil 2024-25 - SM Mudda,Anindya Munshi,Srinivas Naidu,Tripti Nakhre, Avinash Kumar Talwar,Chandi Prasad R,Soumyanath Mishra,Prabir Das,AjayBapat and ChakravarthiAVPS
The awards evening also witnessed the announcement of the PPLLeadershipCouncil 202425.This is a forum of packaging leaders working within the industrywho will help Express Pharma on emerging trends and technologies,regulations,opportunities and challenges etc,share insights with the industrythrough articles,interviews,quotes on Express Pharma and help tracknewtalent within the industry.
Roychowdhurytookthe opportunityto felicitate the jurymembers as well after the presentation of the awards.
The event concluded on a high note with a networking gala dinner,fostering interactions among industrypeers.PPLLeadership Awards 2024 and Pharma Packaging Innovation Awards 2024 are continuing efforts byExpress Pharma to recognise and spur further innovation in the field of pharma packaging and labelling.
Sanjay Vyas,Executive VPand MD,Parexel examines the challenges associated with rare diseases in India,and emphasises on the need for innovative technologies such as precision medicine,CRISPR,and AI to improve diagnosis and treatment to address the complexities of rare diseases and ensure timely and effective care
Orphan diseases, also known as rare diseases, are a variety of conditions that affect a small percentage of the population. By definition, rare diseases are those diseases with a prevalence rate of one case in a population of 10,000 people. Rare diseases are of two types: primary and secondary. Primary rare diseases are caused due to genetic or congenital defects. On the other hand, secondary rare diseases are caused due to exposure to a toxic substance.
Even though these diseases are rare in nature, they significantly affect the lives of patients and their families, impacting their physical, mental, and social well-being. In India, challenges related to rare diseases include a lack of awareness, social stigmas linked to these conditions, and high treatment costs.
A significant challenge faced by patients with rare diseases is getting timely and accurate diagnoses as well as the right care or treatment. Due to the scarcity of such rare medical cases and associated treatments, medical professionals may not be familiar with the unique signs and symptoms of such diseases, which could lead to delayed or incorrect diagnoses. As a result, patients might experience prolonged suffering and unnecessary testing and treatments before receiving an accurate diagnosis and treatment.
Out of the 7,000 rare diseases affecting millions worldwide, only about five per cent have FDA-approved treatments. This imbalance highlights the considerable challenges in creating drugs for these conditions.
Out of the 7,000 rare diseases affecting millions worldwide,only about five per cent have FDA-approved treatments.This imbalance highlights the considerable challenges in creating drugs for these conditions
Three main factors make this challenging: First, there's a limited understanding of how the diseases progress naturally. Second, there's a lack of clearly defined and measurable markers of success in clinical trials, which are commonly addressed as clinically meaningful endpoints. Lastly, the difficulties in proving therapeutic benefits and obtaining full regulatory approval further slow progress.
Regulatory challenges make developing drugs for rare diseases more complex. Unlike drugs for common conditions, clinical trials for rare diseases are complicated for several reasons. Firstly, rare diseases often have unknown biological mechanisms, making it harder to find effective treatments compared
to well-understood illnesses. The diverse nature of rare diseases requires unique protocols for each patient group, making research design more complex. Tracking outcomes across these diverse populations needs careful consideration and specialised approaches. Also, the limited number of patients makes recruiting for clinical trials challenging. This difficulty makes it tough to gather enough data for thorough analysis, leading to delays in potential progress.
The challenges mentioned highlight the need for creative approaches and technologies to bridge the gap and successfully treat rare diseases. This emphasises how new technological advances can offer advantages
over traditional methods for treating individuals with rare diseases.
While many rare diseases have genetic causes, not all of these causes can be directly targeted by medication. However, the rise of precision medicine offers renewed hope for these patients. This approach tailors treatments to individual patients based on their unique genetic makeup, lifestyle, and other factors. Instead of simply managing symptoms, precision medicine aims to address the root causes of the disease, potentially revolutionising treatment for rare diseases.
Several cutting-edge tools are emerging to support this approach. Artificial intelligence (AI) and machine learning help in analysing vast amounts of genetic data to identify potential treatment targets. Genomic analysis and next-generation sequencing provide detailed information about a patient's genes, aiding in diagnosis and treatment planning. Translational bioinformatics bridges the gap between basic research and clinical application, translating scientific discoveries into practical treatments.
CRISPR technology has great potential for treating rare genetic disorders by accurately editing genes. Its capability to fix underlying genetic mutations provides optimism for personalised therapies, tackling the root cause of rare diseases instead of merely managing symptoms. CRISPR introduces new possibilities for effective treatments and potential cures, revolutionising the approach to man-
aging rare conditions worldwide.
Digital twin technology is set to revolutionise clinical research by presenting a unique method to comprehend complex biological systems and enhance patient outcomes. This technology can offer a more detailed and comprehensive understanding of patient physiology, facilitating tailored treatments and contributing to advancements in precision medicine.
Automation and robotics enable quicker and more precise testing, enhancing quality control and expediting drug development. Big data analytics, through the analysis of extensive datasets, help identify biomarkers linked to specific rare diseases, allowing for earlier diagnosis and improved treatment options. Additionally, artificial intelligence holds promise in identifying personalised treatments tailored to the specific needs of individual patients.
By embracing these technologies, pharma companies can bridge the gap between scientific discoveries and their application in clinical settings. This improves the chances of patients receiving the care they need sooner rather than later.
Though, advancements offer hope for faster development of effective treatments, addressing rare diseases requires more than technology. Patients and caregivers are closely connected with the rare disease community and play a critical role in advocating for improved treatments and raising awareness. For people with rare diseases, a better future can be created by combining technology, teamwork, and an emphasis on unmet needs, ensuring they get the support and care they require.
Dr Amit Pandit,School of Pharmacy & Technology Management,NMIMS,Indore & Shirpur Campuses,explores the imperative for the pharma industry to adopt eco-friendly practices; and discusses challenges,innovative solutions,and exemplary initiatives between all stakeholders to curb environmental footprint
In today's pharma industry, "sustainable pharmaceuticals" refers to practices that prioritise minimising environmental impact while promoting public health and social responsibility. This includes eco-friendly manufacturing, waste reduction, and responsible disposal. It underscores the need for companies to balance profitability with environmental and social concerns, aiming for a healthier, more sustainable future. Addressing environmental concerns in pharma is crucial due to the significant impact of pharma production, usage, and disposal on ecosystems and human health. This includes pollution from manufacturing processes, contamination of waterways, and the development of antimicrobial resistance. By prioritising sustainability in pharma, we can mitigate these negative impacts, protect ecosystems, and safeguard public health for future generations. In the wake of growing environmental awareness, concerns are mounting over the significant impact of pharma on ecosystems worldwide. From manufacturing processes to disposal, every stage of the pharma lifecycle presents potential hazards that necessitate urgent attention.
Navigating pollution, waste,and resistance: A call to sustainable action
The pharma industry is a major contributor to environmental pollution, with manufacturing processes releasing a plethora of harmful pollutants into the air, water, and soil. These chemicals, ranging from solvents to heavy metals, pose significant risks to both environmental and human health.
Another pressing issue is improper disposal of pharma products, including expired or unused medications. Often, these drugs find their way into water sources through sewage systems or landfill leachate, contaminating ecosystems and endangering aquatic life. The infiltration of pharma products into water bodies poses a grave threat to aquatic ecosystems. Accumulation of these drugs can disrupt the delicate balance of aquatic life, impacting species' health and behaviour and leading to ecological imbalances. Further, the rampant use and inadequate disposal of antibiotics contribute significantly to the development of antimicrobial resistance. Resistant bacteria, fuelled by pharma pollutants, pose a seri-
ous threat to public health, agricultural systems, and environmental sustainability. The urgency of addressing these environmental concerns cannot be overstated. Pharma companies, regulatory bodies, and consumers must collaborate to implement sustainable practices, reduce pollution, and safeguard ecosystems. Failure to act swiftly could have farreaching consequences for both environmental integrity and human well-being.
Driving environmental innovation: Green chemistry,waste management,and sustainable packaging in pharma
In the quest for a greener future, pharma companies are
embracing innovative strategies to minimise their environmental footprint. From manufacturing to disposal, these efforts aim to revolutionise the industry's approach to sustainability. Pharma manufacturers are increasingly adopting green chemistry principles. By using renewable resources, reducing hazardous chemicals, and implementing energy-efficient processes, they aim to mitigate environmental impact without compromising on product quality. Also proper disposal of pharma waste is a priority. Companies are focusing on ensuring the safe disposal of expired drugs to prevent contamination of water sources and ecosystems. Recycling programmes are being implemented to reduce waste generation, while advanced technologies are being employed to treat pharma wastewater effectively. Furthermore, the development of ecofriendly packaging is gaining momentum. Biodegradable materials are being utilised to minimise landfill waste, while efforts to reduce packaging and offer recyclable options are being prioritised. These initiatives not only reduce environmental impact but also cater to consumer demand for sustainable packaging solutions.
Lifecycle assessments are becoming standard practice within the pharma industry. By assessing environmental impacts from production to disposal, companies can recognise zones for improvement and apply targeted plans to improve sustainability throughout the product lifecycle. As environmental concerns continue to grow, the pharma industry's commitment to sustainability
has never been more critical. These innovative strategies not only demonstrate a dedication to environmental accountability but also cover the way for a more sustainable future for generations to come.
India's sustainable pharma agenda: Regulations,initiatives, and collaborative partnerships
The Indian government has taken several actions to address environmental concerns related to pharma. The first is rules for pharma waste management. The Central Pollution Control Board (CPCB) in India has formulated guidelines and regulations under the Biomedical Waste Management Rules, which govern the disposal of pharma waste. These rules mandate the proper segregation, collection, treatment, and disposal of biomedical waste, including pharma, to prevent environmental contamination. Government also launch national action plan for antimicrobial resistance (NAP-AMR). This plan aims to improve antibiotic stewardship, regulate antibiotic use in humans and animals, enhance surveillance of antimicrobial resistance, and promote research on new antibiotics and alternatives. Further, the Indian government has encouraged the adoption of green chemistry principles in the pharma industry to lessen the environmental impact of manufacturing processes.
Initiatives such as the Green Chemistry Cell at the Department of Chemicals and Petrochemicals support research and development in ecofriendly chemistry. Also the use of renewable energy sources in
pharma manufacturing facilities are been promoted by implemented various incentive schemes. It includes subsidies, tax benefits, and favourable financing options to encourage the adoption of solar, wind, and other renewable energy technologies. As a collaborative effort, the Indian government team ups with pharma industry associations, research institutions, and international organisations to address environmental concerns. Initiatives such as joint research projects, knowledge-sharing platforms, and capacity building programmes facilitate collaboration among stakeholders to develop sustainable solutions for the pharma sector. These actions reflect the Indian government's commitment to addressing environmental concerns in the pharma industry and promoting sustainable practices to safeguard public health and the environment.
Overcoming hurdles:
Addressing economic, technological,and awareness challenges in pharma sustainability
While the pursuit of sustainable practices in the pharma industry is gaining momentum, several key challenges must be addressed to pave the way for a greener future. The adoption of sustainable practices often encounters economic barriers, with high initial investment costs and potential impacts on profit margins. Companies face challenges in balancing sustain-
ability objectives with financial viability. Overcoming these barriers requires innovative financing mechanisms, strategic planning, and a long-term vision that recognises the intrinsic value of sustainability beyond short-term economic gains. The second challenge is applicability of new technologies. Despite advancements in green chemistry and renewable energy technologies, certain pharma processes still rely on resourceintensive or environmentally harmful methods. Overcoming these technological limitations necessitates continued research and development efforts, interdisciplinary collaboration, and investment in cutting-edge innovations. By leveraging emerging technologies, the industry can develop more sustainable alternatives and reduce its environmental footprint. Another significant challenge is lack education and awareness among stakeholders. Many individuals within the pharma industry, including manufacturers, healthcare professionals, and consumers, may not fully understand the environmental impact of pharmas or the importance of sustainable practices. Addressing this challenge requires comprehensive education initiatives, training programs, and public awareness campaigns to empower stakeholders to make informed decisions and advocate for sustainability.
Addressing these challenges requires collaborative efforts from industry stakeholders, policymakers, and the
broader community. By overcoming economic barriers, leveraging technological innovations, enhancing education and awareness, and integrating sustainability into R&D practices, the pharma industry can move towards a more environmentally responsible and socially conscious future.
Leading the charge:
Exemplarysustainable initiatives in the pharma industry
There are many inspiring success stories of sustainable initiatives from Indian pharma industries that have made a tangible difference. From implementing green manufacturing processes to launching recycling programs for pharma waste, these initiatives showcase the potential for positive environmental impact within the sector. Some are mentioned here –
1. Sun Pharma has been actively involved in various sustainability initiatives. They have implemented measures to reduce water and energy consumption in their manufacturing processes. Additionally, they have initiatives in place to reduce waste generation and promote recycling and reuse of materials. Sun Pharma also invests in community development projects focusing on healthcare, education, and environmental conservation.
2. Dr Reddy’s Foundation (DRF) has been working on several sustainability fronts. They have implemented green chemistry practices in their
manufacturing processes to reduce the environmental impact of their operations. The company also focuses on reducing carbon emissions and improving energy efficiency. Dr. Reddy's has initiatives for responsible waste management and recycling. They also engage in various social responsibility programs focusing on healthcare access and education.
3. Cipla Foundation has a strong commitment to sustainability and corporate social responsibility (CSR). The company has implemented several eco-friendly initiatives in its manufacturing facilities, such as water and energy conservation measures and waste management practices. Cipla is also involved in various community development programs, including healthcare access, education, and skill development.
4. Lupin has been actively working on sustainability initiatives across its operations through the Lupin Human Welfare & Research Foundation (LHWRF). They have implemented measures to reduce water and energy consumption and minimise waste generation. Lupin also focuses on green packaging solutions to reduce the environmental impact of its products. The company invests in community welfare programs, including healthcare services and education, to contribute to social development.
5. Biocon has been integrating sustainability into its business strategy. They have initiatives to reduce greenhouse gas
emissions, optimise energy usage, and minimise water consumption. Biocon also focuses on sustainable sourcing practices for raw materials and implements waste reduction and recycling measures. The company is involved in various CSR initiatives, including healthcare access, education, and environmental conservation.
These are just a few examples, and many other Indian pharma companies are also increasingly recognising the importance of sustainability and implementing initiatives to reduce their environmental footprint and contribute to social development.
In conclusion, the detailed discussion underscores the pressing need for sustainable practices within the pharma industry. From highlighting environmental challenges to showcasing real-life success stories and potential for scaling up initiatives, it's evident that sustainability is increasingly becoming a priority for pharma companies. The examples provided demonstrate that through innovation, collaboration, and commitment to sustainability, significant strides can be made in reducing the industry's environmental impact while maintaining operational efficiency. As stakeholders continue to embrace these practices and drive systemic change, the pharma sector is poised to play a pivotal role in shaping a more sustainable future for generations to come.
Vineet Agarwal,MD,Transport Corporation of India emphasises the pivotal role of efficient and productive logistics in propelling India towards a $5 trillion and eventually a $10 trillion economy. He highlights the need for a comprehensive approach,focusing beyond cost and addressing key drivers such as infrastructure,digitisation,and skill development within the logistics sector
As India moves towards its goal of a $5 trillion economy, the need for the industry to be aggressive, competitive, and productive will be the key to driving the country beyond. For this, the imperative would be to improve the ease of doing business and one of the most important components of this plan would be logistics. Though the recent announcement by DPIIT that India’s logistics cost ranged from 7.8 - 8.9 per cent of GDP for the year 2021-22 seems to be significantly lower than expectations, there is now a need to focus beyond cost.
Countries measure their logistics effectiveness through the World Bank’s Logistics Performance Index (LPI) which covers aspects of infrastructure, competence, traceability, and several other factors as its component.
In the last several years, India has moved up the ranks considerably and is now positioned at number 38. However, we have a long way to go and focusing more on the drivers of performance and productivity will ensure our products are domestically and globally competitive against other nations.
The country has made immense progress over the last decade when it comes to
logistics efficiency.
As per an IIMC-TCI study in 2014-15, the average speed of a truck in India was just 35 kmph which is now closer to 50 kmph. Better roads and highways, expansion of port capacity, digitisation of trade documentation and digital transactions including the use of fastags for tolled roads have all contributed to a significantly robust logistics ecosystem.
The National Logistics policy, now in its sophomore year, has clearly illustrated the need to increase multimodal logistics, lean heavily on digitisation and build
national standards.
At a macro level, logistics infrastructure must be built with a long-range perspective of 20 years and more. Shift towards seamless multimodal logistics, not just for cost benefits but to reduce carbon emissions, should be incentivised. The 22 million people employed in this sector need a very strong skilling ecosystem for current and future skills and national recognition for their contribution to society.
At the ground level, process improvements for users and service providers will provide significant upside to productivity growth. Trucks stand for days at factories and warehouses for loading and unloading of cargo, companies insist on physical proof of delivery (POD) and physical invoices from providers vs digital, shift from ‘head load’ to palletisation of cargo, increased discipline around supplier credit, deep focus on quality and several such rudimentary yet ignored measures need urgent focus.
As our country integrates into global supply chains, logistics can be that value driver to propel us towards a $10 trillion economy. The era to move towards efficient and productive logistics has begun.
LeistritzwithitslinesinGMPdesign isthemarketleaderinthedemanding fieldofpharmaceuticalextrusion.
NANO16
usedfortestingtheextrudabilityofsmallestbatches
-forcontinuousextrusionprocessesforbatchesof20-100g/h
-equippedwiththemicro-plungerfeeder
-torqueof42Nmallowsfortheprocessingofhighlyviscousmaterials
ZSE12HP-PH -twinscrewextruder
-easyhandling,simple(dis)assembly,goodcleanability
-suitableforthroughputsof50to1,000g/h
-innovativecooling/heatingsystem
-horizontallysplitbarrelsfacilitatelookattheprocess
ZSE18HP-PH -twinscrewextruder labandsmallbatchextruderfor200g/h-5kg/h
-idealasatestingandproductionsystem
-suitableforthroughputsof200g/hto5kg/h
-polishedsurfacesforeasycleaning
ZSE27HP-PH -twinscrewextruder labandproductionextruderfor1-25kg/h
-parametersofaproductionmachine
-productionofsmallquantities
-veryeasytoclean:processanddrivepartsseparatedbyasubdividingwall
ZSE40HP-PH -twinscrewextruder productionextruderforupto100kg/h
-pureproductionmachine
-productionofsmallquantities
-designfulfillsallrequirementsinthepharmaceuticalindustry
ZSE50HP-PH -twinscrewextruder productionextruderforupto200kg/h
-productionmachineforlargethroughputs
-universallyadaptablefortheactualprocesstask
-useofhigh-gradesteels
Thesystemisavailableinapowder-coatedsteel orfullstainlesssteelversiondependingon customerrequirements
Coating,DryingandLaminatingthebasicfunctionsofthe«KTF-S»
Theuseofaproductionmachineisnotfinancially viableforresearchanddevelopmentpurposes
Themosteconomicalsolutionisourcontinuouscoating systemofmodulardesignforvariousmaterialssuchas paper,textile,copper,aluminumandplasticfoils
MarketleadersareusingMathistechnology
Nowavailable!
Best-in-classosmolalityperformance, designedwithyouinmind.
HIGHLIGHTEDFEATURES:
Offersthewidestrangeofosmolalitytesting(0–4000mOsm/kgH2O)
Supports21CFRpart11,GMPandEUAnnex11compliance
MeetsPharmacopeiaosmolalitytestingguidelines
3Leveluseraccessandpasswordprotection
Storage:unlimiteddatastorageforaccess
Audittrail:Preserveunlimitedresultsandevents
Databasebackup,protectsyourdatawithautomaticormanualbackup
No.127,BussaUdyogBhavan,TokershiJivrajRoad,SewriWest,Mumbai-400015, Maharashtra,Landline:+91022-24166630Mobile:+919833286615
The advantages of aseptic connectors are not only that they provide more robust sterility assurance,the connectors also permit the operation to be conducted within a lower classification for the surrounding cleanroom
There is a wide range of processing technologies aseptic connections, they can be supplied as either discrete components or more often as pre-validated, pre-sterilised single-use systems – ready to open and use. They are used to connect single-use fluid paths – these fall into two basic categories based on how the connection is achieved: those that connect by welding or fusing together two fluid paths and those that mechanically couple two components installed in the fluid pathway.
The advantages of aseptic connectors are not only that they provide more robust sterility assurance, the connectors also permit the operation to be conducted within a lower classification for the surrounding cleanroom (for example, where a traditional connector would require ISO class 5 / EU GMP Grade A, and ISO class 7 / EU GMP Grade B area could be used).
Sterile connectors for aseptic processing (commonly referred to as ‘aseptic connectors’) enable two lines of tubing to be joined while maintaining a sterile fluid pathway. Each line of tubing is pre- connected to one connector end. At the end of the connector is a removable membrane which facilitates the two pieces of tubing to connect (mechanical coupling). Once the two connectors ‘connect’ the membrane is removed.
Through the act of connection, the process line is maintained as closed and sterility ideally assured.
Furthermore, whereas the risk with traditional connectors includes the operator and hence finger plates are typically taken, the aseptic connector does not require finger plates to be taken as the impact of the operator and the level of bioburden carried on gloved hands will not af-
fect the assurance of sterility as the connection is made.
Traditional biologics like vaccines and mAbs as they have been early adopters of aseptic connectors and single-use technologies (SUT) overall. Some of the main benefits that led to SUT adoption are:
◆ Cost- Reduced manufacturing cost by elimination of cleaning and sterilisation steps
◆ Speed – Time and labour savings during setup and between operational cycles
◆ Sterility – Elimination of cross contamination between batches
To create an aseptic connection between the two lengths of complementary thermoplastic tubing, sterile tubing welders were built. Two ends of tubing from the same module are firmly inserted into the tube clamp mechanism as part of the welding process configuration. Sterile tubing welders make connections quickly and safely while maintaining a functionally closed system, whether dry tubing or wet tubing is being attached.
Cross-contamination is limited because each wafer is thrown after a single-use. A functionally closed system is maintained by the ideal sterile welder.
A general question that can arise is how to determine if you should use a tube welder or an Aseptic connector. Tube welders are commonly used when a small number of connections are to be made per day and when only one dimension of tubing is used. As the number of connections increase use of aseptic connectors is preferred as they provide more flexibility of using multiple tube sizes and take less time as tube welding takes more time.
Aseptic connectors are available in both gendered and genderless versions.
Gendered connectors are composed of two different connectors (typically male and female component) connected together to create a fluid pathway.
In Genderless connectors two components brought together to make a connection are identical. Genderless connector offers various significant advantages over gendered connector leading to time saving, reduced
inventory, increased operational and design flexibility.
Assemblyconsiderations
A single-use assembly provider should be flexible when working on a client's design that includes sterile connectors. Tubing types, methods of securing tubing onto connectors (i.e., cable ties, barb locks), and willingness to use customer-specified components (i.e., those of their competitors) are aspects that should be considered when customers are selecting suppliers. Other factors to consider are sterilisation options, gender-specific assemblies, and pricing.
Typically, two options are available for sterile connectors. The manufacturer may provide the connector on an assembly that has been pre-sterilised by gamma irradiation. Alternately, connectors may be autoclaved along with assemblies made inhouse.
Testing needs and documentation expectations
Various tests should be performed on Aseptic connectors to ensure connector has been challenged using worst case condition for proper selection and to mitigate risk.
Some of the common tests performed are:
Bacterial challenge: The bacterial challenge test typically is done by exposing the connector mating surfaces to a bacterial solution (by direct soiling or by aerosol) with a minimum colony forming unit (CFU) concentration, assembling the connection, passing sterile media through the connection, and collecting it. After incubation of the collected sample, absence of microbial growth confirms prevention of ingress of a contaminant. Proper controls must be demonstrated.
Pressure and temperature tests are other important tools in validating components for
use within specific applications. Bubble leak testing is performed to verify the integrity of these components in a variety of temperature and pressure conditions potentially found in certain bioprocessing applications.
Another key assessment for components utilised for bioprocessing are bioburden and endotoxin particulate tests, which are designed to validate that components are free of a range of living organisms (bioburden) and gram-negative bacteria (endotoxins) that could compromise a system.
End users are responsible for evaluating the functionality and performance characteristics of a connector or component before integrating it into a bioprocessing application.
Training in the use of these consumables is highly recommended to ensure they provide an integral connection. Implementing these products involves a number of steps and some require careful attention to avoid such mishaps as over- or underactuation, misalignment, displacement of o-rings, and interference with membranes (i.e., peeling them off inappropriately).
Conclusion
Sterile connectors make operation easier and faster than other methods of connections in an aseptic environment, such as open manipulations, while completing the path of a sterile closed system. Nonetheless, due diligence is required to ensure that an appropriate connector type is selected and tested to satisfy the user, product requirements, system integrity, and safety.
Prabhat Balyan
Asst. Manager - Business Development
Ami Polymer prabhat.b@amipolymer.com
With a range of temperature and humidity loggers,including transport data loggers,testo guarantees end-to-end monitoring in storage,transit,and production processes
Due to the crucial necessity and its direct impact on human health and welfare, pharma is probably the most important and critical sector among others. As a consequence, it becomes essential to store pharmaceuticals, vaccines, laboratory samples or units of blood at the right temperatures to ensure that they remain effective and that quality is maintained. Another reason for the pharma division to ensure safety measures and a controlled environment is stringent regulations and inspection of the facilities. This elementary need for climate control can only be ensured with the right data monitoring systems. Testo being a market leader in the testing and measurement sector provides the best-in-class data loggers and data monitoring systems for the pharma division.
Pharma goods must be stored well in every situation as any deviation in the ambient temperature or humidity values may lead to deteriorated quality of the product.Testo data loggers can be used to test the optimum conditions for specific products or surroundings. In particular, temperature and humidity data loggers are often used in pharma industries to monitor the conditions in which drugs, medicines, and vaccines are kept. Not only for storage but also during the transit of goods, testo transport data loggers are useful to measure the transport conditions. The range of data loggers is very extensive. A temperature and humidity loggers such as 174 T guarantees continuous monitoring in a storage or warehouse. Also, data loggers with multi-channels for connecting external sensors and thermocouples, like testo 176 are available to ensure a secured work process in labs.
These data loggers are also critical for production quality assurance where the temperature has to be frequently checked at various points in production processes. Using thermocouple probes, data loggers can also record data in the kinds of extreme temperature ranges. The probe's fast response also contributes in the validation processes and quality standard optimisation in QA units and clean room applications. These instruments are the most convenient and pocket-friendly solution for all pharma application areas.
Thetesto Saveris 2 WiFi data loggersystem is a simple, flexible and reliable solution to humidity and temperature monitoring in cold storage areas like blood banks. This innovative monitoring system is ideal for high product quality and eliminates the manual work of reading out or documenting measurement data. With secure online storage of all readings in Testo Cloud, the data can be managed and analysed online by the user via smartphone, tablet or PC anywhere and anytime. In case of crises and deviations, it is provided with an alarm by email, or optionally by SMS.
Another important and crucial application of the pharma industry involves the validation ofsterilisation and freeze-drying processes. Not only that, validating cleaning and disinfecting equipment is equally
necessary. In order to allow a seamless operating procedure, the validation process and the documentation work must be as efficient and smooth as possible which could be easily achieved withtesto 190 data loggersolution that has innovative data loggers for temperature and humidity, smart software and accessories.
Testo’s offerings are majorly related to data security along with comprehensive analysis and evaluation of all the recorded measurement data. Testo data loggers ensure continuous monitoring of the temperature and relative humidity of pharma products during production, storage or transit of goods. Realtime data monitoring is important for the quality of pharma goods and also enables the sup-
plier to improve the life of the goods. Transportation trucks, warehouses, cold rooms etc. can now be remotely monitored via Testo data loggers and data monitoring systems. Testo's data loggers are EN 12830 and 21 CFR Part 11 compliant which ensures complete documentation of parameters, be it humidity, temperature or absolute pressure. They come with professional software where the data recorded cannot be modified and the audits can be easily complied with.
Service and calibration made easy
Testo also has an established state-of-the-art NABL-accredited service and calibration LAB in accordance with the standard ISO/IEC 17025:2017, that takes
care of the after-sales support locally from Pune. Testo service and calibration facility is highly cost-effective as it delivers international standards very conveniently within a week’s time. Instruments of any brand/make can be calibrated and serviced locally maintaining necessary standards.
The accredited parameters include Humidity, Pressure, Absolute Pressure, Contact Type Temperature, and Non-Contact Type Temperature (Infra Red Thermometer, Thermal Imager). In fact, testo has the First and Only Lab in India to get NABL Accreditationfor Dew Point Temperature as well.
For more details, login to www.testo.com or write to oninfo@testo.in
