Express Pharma (Vol. 19, No. 7) June 2024

Indian pharma industryin 21st century– What has changed for domestic supply?

Demystifying Pharma Science: Batch v/s Continuous manufacturing

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CONTENTS

Chairman of the Board

ViveckGoenka

Sr.Vice President-BPD

Neil Viegas

Vice President-BPD

Harit Mohanty

Editor Viveka Roychowdhury*

Editorial Team

Lakshmipriya Nair

Kalyani Sharma

Kavita Jani

Neha Aathavale

DESIGN

Art Director

Pravin Temble

Senior Designer

Rekha Bisht

Senior Artist

Rakesh Sharma

Marketing Team

Rajesh Bhatkal

Ashish Rampure

Debnarayan Dutta

Production Co-ordinator

DhananjayNidre

Scheduling & Coordination

Pushkar Waralikar

CIRCULATION

Mohan Varadkar

MARKET

16 M&ATRENDS TO WATCH OUTIN PHARMA

20 INDIAN PHARMA INDUSTRYIN 21ST CENTURY– WHAT HAS CHANGED FOR DOMESTIC SUPPLY?

INTERVIEW

PRATIMAREDDY COUNTRYSPEAKER FOR MERCKINDIA& MD, MERCK

Express Pharma®

TECHNOLOGY

39 DEMYSTIFYING PHARMASCIENCE: BATCH V/S CONTINUOUS MANUFACTURING

41 TRANSFORMING MEDICALDEVICE ASSEMBLYWITH ACOPOS6D

Regd.With RNI No.MAHENG/2005/21398.Postal Regd.No.MCS/164/2022 - 24.Printed and Published byVaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press,Plot No.EL-208,TTC Industrial Area,Mahape,Navi Mumbai-400710 and Published at Mafatlal Centre,7th floor,Ramnath Goenka Marg,Nariman Point,Mumbai 400021.

Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Mafatlal Centre,7th floor,Ramnath Goenka Marg,Nariman Point,Mumbai 400021)

* Responsible for selection of news under the PRB Act.Copyright © 2017.The Indian Express (P) Ltd.All rights reserved throughout the world. Reproduction in anymanner,electronic or otherwise,in whole or in part,without prior written permission is prohibited.

CDSCO cracks down on export licenses, antibiotic approvals

India's central drug regulator continues to strategically close the loopholes and rejig India's drug regulatory protocols, focusing on state licensing authorities and their duties.

For instance, in a letter dated April 30, the Drugs Controller General (India) directed that CDSCO Zonal offices, and not the state/UT licensing authorities (SLAs), would be responsible for granting manufacturing NOCs in these cases.

Thus from May 15, fresh applications for NOC for manufacture of drugs meant solely for exports have to be routed online through CDSCO Zonal offices.

DCGI Dr Rajeev Singh Raghuvanshi's April 30 letter went a step further, requiring state/UT licensing authorities to hand over all NOCs issued from August 20, 2018 to May 14, 2024 to the respective CDSCO Zonal offices.

The letter specifies that all manufacturers of drugs meant for exports would be required to first obtain NOCs from the respective CDSCO zonal offices through the online SUGAM portal, before applying for manufacturing licenses from the state licensing authorities.

The move to streamline manufacturing licences for drug exports and make the process completely online is clearly the latest effort to closely track manufacturers tapping export markets. India's claim to be the 'pharmacy of the world' has been challenged over the past few years, with deaths of children in Gambia, Uzbekistan and other countries being linked to cough syrups and other medicines originating from India. Subsequent inquiries revealed that state authorities had consistently failed to crack down on manufacturing malpractices in many of these units.

It is hoped that applying through CDSCO's online SUGAM portal will serve the regulator's purpose of streamlining export licenses, while increasing scrutiny of manufacturers who have been habitual offenders of good manufacturing practices. A simple correlation with CDSCO's monthly alerts of brands/companies detected as spurious and/or as Not of Standard Quality could be a useful exercise in directing extra focus on the bad sheep in the fold.

Once the handover process is over, one hopes that the move could also cut down approval timelines for export-oriented manufacturers, as manufacturers with export-oriented units in various states who would have had to track pending NOCs in multiple states, now need to track just the online SUGAM portals.

Th next initiative is on controlling antibiotic resistance by controlling the manufacturing and sale of antibiotics and their irrational combinations. Since the CDSCO has now been tasked to conduct a six monthly review of fixed drug combinations of antibiotics marketed in states, DCGI has given state licensing

Can online courses and training programmes guarantee more effective regulation and better quality medicines?

authorities two weeks to provide the list of antibiotic combinations licensed by them for manufacturing and marketing in their states.

More significantly, the May 16 letter also requested the state licensing authorities to monitor and report the availability of unapproved antibiotic combinations in their states.

This crackdown on the approvals of antibiotic combinations and preventing their misuse is part of the overall mandate of an ICMR expert committee to create a pathway for strategic access of new antibiotics and to regulate against the overuse and irrational use of existing antibiotics in India.

These diktats from the DCGI represent steps along the journey to strengthen the regulatory system, an image makeover if you will. But to revamp India's reputation as a destination of quality affordable medicines, we need to have a credible regulatory system in sync with global regulations.

Recognising that credibility will have to start from within, the DCGI has asked all officials of state licensing authorities and CDSCO zonal and sub zonal offices to complete online certification courses from the CDSCOWHO-THSTI Regulatory Webinar Series. The webinar series has courses dealing with effective implementation of Good Review Practices, Good Regulatory Practices, and Quality Management System requirements for national inspectorates which are designed as per WHO specified standards. All officials need to complete the course, comprising a recorded lecture and a PowerPoint presentation, with an automated feedback mechanism. The e-certificates generated post completion of the courses need to be sent to the CDSCO.

It is significant that CDSCO and state licensing officials are expected to follow WHO-specified guidelines for all facilities, not just exports. Training workshops to gear up industry to follow the revised Schedule M also continue across the country, emphasising that there will be no leniency on implementing the deadlines to upgrade to these new norms.

While all regulatory reform is a continuous process, will measures like online courses guarantee more effective regulation and better quality medicines? It is the attitude and dedication to the cause of good quality that goes beyond certifications and inspections that will make the real difference.

VIVEKA ROYCHOWDHURY, Editor viveka.r@expressindia.com viveka.roy3@gmail.com

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M&Atrends to watch out in pharma

Aditya Patni,Partner; Achint Kaur and Siddharth Marwah,Counsels at Khaitan & Co decode and decipher factors spurring M&As in pharma and predict that intensified PE investment in the pharma sector is poised to fuel accelerated M&Aactivity

India’s pharmaceutical sector is on a growth trajectory. In 2023, while the deal volume declined, the deal value grew 1 , due to strategic megadeals in the pharma sector.

Pharma services have witnessed extensive innova tion from contract development and manufacturing organisation (CDMO), contract research organisation, pharma information technology (Pharma IT). The CDMO segment and Pharma IT have observed exponential growth, driven by Indian companies moving up the value chain building high-quality, low-cost manufacturing capability geared to deliver and bulk volumes and international pharma giants shifting away from China against global interest rates fluctuations and price pressures.

In the CDMO space, India is the world’s second largest CDMO player, just behind China, for small molecules 2 There has been a distinctive surge in India’s prominence over the last few years, propelled by India’s fast growing economy, low geo-political risks and disruptions, and companies keen on developing diversified supply avenues beyond China (which is facing sanctions), coupled with China’s inward-looking policy. India’s ability to manufacture medicines at 1/4th the cost and the existence of greater number of US FDA-approved manufacturing plants in India outside US3, and the presence of a resilient, English speaking, digitally enabled Indian workforce have reinforced this transition. India’s nine globally integrated CDMO facilities offer end-to-end manufacturing and development solutions. As a direct corollary, India today has an ever-expanding list of

Big pharma companies are engaging in divestitures to accumulate prolific dry powder from freed up capital permitting investment in their core focus areas.For e.g.Merck,GSKand Novartis have spun off their consumer groups

fast-growing CDMOs all of whom have robust order inflows from global MNCs.

India’s technological proficiency has aided health tech innovation backed by ‘innovation hubs’ by international pharma companies’ like Novartis, Merck, and AstraZeneca’s, India global capability centers.

Superior quality omnichannel interactions though video chat and integrated platforms and teams are being developed to propel a seamless experience across digital channels accounting for customer-driven requirements. Large pharma companies like GSK and Mankind Pharma etc. are rendering integrated services to promote economies of scale.

Digital transformation and generative artificial intelli-

gence facilitating use of new technologies have enabled greater performance with lesser headcount, increased quality, patient convenience, and customer experience by providing care at a single touchpoint. Digital health applications like e-diagnostics, e-pharmacy, telemedicine, wellness, and software as a service-based hospitals are growing.

Pharma sector has experienced an increased focus on innovative medical devices with strengthening of the regulatory requirements and quality checks, coupled with stringent price and margin caps. Covid-19 promoted India to the centre stage of global vaccines export as consumerisation of health providing an impetus for vaccines and prompt approvals.

Big pharma companies are engaging in divestitures to accumulate prolific dry powder from freed up capital permitting investment in their core focus areas. For e.g. Merck, GSK and Novartis have spun off their consumer groups.

Taking a cue from Pfizer’s acquisition of cancer drugmaker Seagen for $45.7 billion in 2023, there is compelling investor interest in medtech and biotech companies. With additional firepower, the pharma companies are looking to acquire innovative technologies specifically in precision medicine, cell and gene therapy, cancer and rare diseases, diabetes, auto-immune diseases, and weight loss which will hurl additional M&A activity.

While innovation and availability of medicines is essen-

tial, to ensure uniform access to vital life-saving drugs for all individuals irrespective of their socio-economic status, taking a cue from the judgement of the Supreme Court of India in the case of Novartis AG v. Union of India 4 (2013 (6) SCC 1), the Division Bench of Delhi High Court in the case of F. Hoffmann-LA Roche and Ors. Vs. Cipla 5 (ILR(2009)Supp.(2)Delhi 551) held that “public interest in greater public access to a lifesaving drug will outweigh the public interest in granting an injunction to the patent holder.”

India’s other enabling processes like compulsory licences facilitate access and surge M&A deal-activity in the pharma sector, by removing a patent if the drug meeting the public health

Aditya Patni

Achint Kaur

Siddharth Marwah

MARKET

requirement is exorbitantly overpriced, thereby enabling generic drug manufacturers to develop the patented drug at a miniscule fraction of the price.

The Draft Patents Amendment Rules 2023 prevents evergreening of a patent which would not be granted unless the innovation causes a significant enhancement of efficiency in the product or the process, thereby providing opportunities for other players in the market.

Other policy initiatives aiding India’s medtech and pharma sectors are the National Medical Device Policy 2023 6, Make in India, production-linked incentive (PLI) scheme for encouraging

domestic manufacturing of critical key starting materials, drug intermediates and active pharma ingredients in India 7 as well as for medical devices, the creation of bulk drug parks, the research and development policy and innovation in pharma-medtech. Stringent drug safety norms by Central Drugs Standard Control Organisation have maintained the quality parameters thereby encouraging investors. Additionally, the Department of Pharmaceuticals, Government of India, directive requires strict compliance with the Uniform Code for Marketing Practices 2024. The pharma sector ranks among the top 10 sectors for foreign direct investment 8

For medical devices 100 per cent foreign investment is allowed under the automatic route. In greenfield pharma projects, 100 per cent foreign investment is permitted under the automatic route, while for brownfield pharma projects, foreign investment beyond 74 per cent up to 100 per cent require government approval. The 'Pradhan Mantri Bhartiya Janaushadhi Pariyojana' 9 promotes retail outlets to provide quality generic medicines at affordable prices.

There is record-breaking undeployed dry powder available in private equity (PE) owned pharma assets requiring monetisation. Intensified PE investment in the pharma

sector is poised to fuel accelerated M&A activity. All these trends consequently boost investor and consumer confidence, which is predicted to spur M&A activity in the pharma industry.

References

1. https://www.bain.com/insights/healthcare-and-life-sciences-m-and-a-report-2024/ 2. https://www.bain.com/insights/healthcare-innovationin-india/

3. https://www.fortuneindia. com/ long-reads/contract-manufacturing-pharmas-newgrowth-pill/116286#:~:text=India's%20ability%20to%20devel op%20drugs,at%20%24224.6%2 0billion%20in%202023.

4. file:///C:\Users\Achint.kaur\

Downloads\J_2013_6_SCC_1_2 013_3_SCC_Civ_227_2013_SC C_OnLine_librarydel_khaitancocom_20240508_202818_ 1_ 231.pdf

5. file:///C:\Users\Achint.kaur\ Downloads\F_HoffmannLA_Ro che_Ltd_and_Ors_vs_Cipla_Lt d_240420d090328COM901872. pdf

6. https://pharmaceuticals. gov.in/ policy/national-medicaldevice-policy-2023

7. https://pharmaceuticals. gov.in/ sites/default/files/ Gazettee%20notification%20of %20bulk%20drug%20schemes_ 0_0.pdf

8. C://Users/Achint.kaur/Downloads/ey-oppi-report-reimagining-pharma-and-healthcare.pdf

9. https://janaushadhi.gov.in/ pmjy.aspx

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Indian pharma industryin 21st century–

What has changed for domestic supply?

Dr Ashok Omray,Pharma Consultant,points out that despite significant advancements,the Indian pharma industry grapples with quality control issues.He highlights the need for stringent internal controls and adherence to CGMPstandards to maintain credibility and ensure public health safety

We are basking in the glory of NDAs, ANDAs, new molecules, biosimilars and technological advances coupled with quality optimisation and training at the global level at par with the Europe, US and Japan. Doubling and trebling international trade in next five years. Heartily enjoying the third or fourth ranking in the world in terms of volumes produced and supplied to world in addition to meeting our domestic medicines requirements. We seem to be making advancements in cancer research, autoimmune diseases, genetic disorders, nanotechnology and targeted delivery. We are writing 1000 research papers and 500 patents every day (needless to talk about the quality, authenticity and correctness). In all international and national scientific conferences, we collect a lot of applause and praise, this is the testimony of our intelligence, hard-work, resourcefulness and scientific aptitude.

I may sound very pessimistic/sarcastic and adhering/subscribing to the old systems of quality and manufacturing. Most shocking is the repeated and frequent reports of spurious, misbranded and substandard drugs being sold across the country (reports with names of drugs and companies are published in national, regional and local newspapers) reflect a very sad state of affairs. We are proud to call ourselves as “Pharmacy of the World” and with such news every alternate day what image and impression we are creating is a matter of concern. I receive at least three such published evidences and raids details every

The need of the hour is to evolve and create synergy amongst various medicine practices prevailing in the country. Science and evidence (composition, concentration,characterisation,clinical and therapeutic efficacy with consistency) based research is needed for better health and cure

day by state FDAs which exposes our approach, mentality and treating life very raw.

Such things give enough indications that our internal control on the quality for domestic products is very casual, loose, unattended and poor. We are happy for the lowest level of compliance as permitted by the monographs (viz. Assay 90per cent D.T. 15/30 minutes, Dissolution – comply at S2 stage at initial stage analysis etc.). Quite likely, the world and we ourselves are immune to such incidences of quality dilution/compromise/ non-compliance and our off shore customers know that the supplies for them will be manufactured efficiently in different manufacturing plants under the strict quality assurance, monitoring and compliance. Let the country (India) deal with its internal problems and our businessmen are also focused on multiple levels of quality compliance and now we are champions in maintaining dual rather multiple standards which are effectively supported by our scientific/technical and regulatory personnel also. We procure different grades of active materials, excipients and at times do not maintain recommended manufacturing and environmental conditions. The training and technical expertise are farfetched.

It's a pity that the Drugs and Cosmetics Act and Rules have been effective since 1940 and 1945 but the mentality of businessmen and supporting scientific and technical experts has been looking for the loopholes and gaps to meet the lowest level of standards rather than having strict in-

MARKET

house control and monitoring. As a result, the quality is still deteriorating. We have no respect for CGMP when it concerns the supply of drugs to our own population and also to few semi-regulated countries.

The drugs are treated like commodities (potatoes and onions, even these vegetables we pick up after selecting healthy pieces). In the name of cheaper generic medicines, the people are ready to compromise for the drugs manufactured by unknown or unheard type companies. I personally understand that the packaging and storage conditions must not be compromised for a particular molecule for the obvious concern for stability and efficacy. The primary packing must not be different whether it is a generic or branded generic product. The secondary and tertiary pack may be as per preference or supply requirements and transportation (logistics).

The experts in formulation of the drugs and packaging always talk big and how much the whole science and technology is respected needs to be seen and assessed for product performance. In several cases the storage and packaging (which may also be a means of administration) costs can be much more than the product itself, hence it is very critical for generic (for domestic market) manufacturers to be aware of this as well as use the correct materials and follow the right processes (Called CGMPCurrent Good Manufacturing Practices). Unfortunately, in India we still work like obedient workmen and follow CGMPs if the products are meant to be sent to Europe, North America, Australia, Japan and few more regions.

I have been thinking about this issue for more than two decades but nothing much has changed. This requires a complete blood transfusion and cerebral transplantation for the whole country. It is important to understand that every subject cannot be taught by bureaucrats and political leaders, they can definitely teach the economics, urban

and rural health issues, social factors and the supply matters.

In 2024 and the decade to follow, we are likely to make amazing progress in the areas of drug research for critical diseases. The money invested for R&D, both by the govern-

ment and entrepreneurs is phenomenal, therefore the expectations are that we have to be truthful and our focus must be success coupled with safety and acceptance by world regulatory bodies. The need of the hour is to evolve and create synergy amongst

various medicine practices prevailing in the country. Science and evidence (composition, concentration, characterisation, clinical and therapeutic efficacy with consistency) based research is needed for better health and cure. The government and

health authorities will have to sync to ensure that medicines and healthcare systems cannot be run per individual's likes or dislikes. National health and compliance to quality and current standards coupled with efficacy and safety are most critical.

INTERVIEW

Our aim is to tailor our oncology portfolio to address the most pressing needs in India

Pratima Reddy ,Country Speaker for Merck India & MD,Merck Specialties elaborates on the company’s partnerships with national payers and differential pricing schemes to facilitate access pathways to cancer therapies,to Viveka Roychowdhury. Excerptsfromtheinterview

What are the therapeutic focus areas of Merck's Oncology division? Do they match the unmet medical need in India for oncology treatment?

WHO states that cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, or nearly one in six deaths and is set to increase. This drives us at Merck to develop innovations that matter most to people living with cancer.

Merck’s oncology division is committed to addressing critical unmet medical needs globally, including in India. We prioritise innovation in areas such as immuno-oncology, precision medicine, and targeted therapies. Our goal is to develop treatments that not only extend survival but also improve patients' quality of life.

With the rising burden of cancer in India, there is a definite need to increase efforts towards awareness about early diagnosis and treatment options. Merck Healthcare in India has been instrumental in bringing globally acclaimed, timetested, precision-led medical treatment to Indian patients for several years. Our portfolio of therapy includes treatment options for head and neck cancer, colorectal cancer, bladder cancer and lung cancer.

In evaluating the alignment

Merck ranks fifth among the 20 largest pharma companies worldwide based on initiatives to advance global access to medicines in LMICs

of our therapeutic focus with the unmet medical needs in India, it's essential to consider the unique characteristics of

the Indian healthcare landscape. While significant progress has been made in oncology care, challenges such

as access to advanced treatments, affordability, and infrastructure limitations persist.

To ensure our efforts resonate with the Indian context, we collaborate closely with healthcare stakeholders, including physicians, patient advocacy groups, and regulatory authorities. Through these partnerships, we gain insights into the specific challenges facing Indian patients and healthcare providers.

Ultimately, our aim is to tailor our oncology portfolio to address the most pressing needs in India while upholding the highest standards of scientific excellence and patient care. By leveraging our global expertise and local insights, we strive to make meaningful contributions to the fight against cancer in India and beyond.

As India is a price-sensitive market and most of healthcare needs are out-ofpocket rather than covered by insurance, what are the market access and affordability strategies that Merck has incorporated to stay ahead in the oncology segment?

Merck ranks fifth among the 20 largest pharma companies worldwide based on initiatives to advance global access to medicines in LMICs, improving from eighth place in the 2021 ATM Index.

More than 30 per cent of India's population lacks financial protection for health,

often termed the 'missing middle.' This segment falls between governmentsubsidised schemes and private insurance coverage, highlighting a critical gap in access to healthcare.

To address this challenge, Merck is committed to partnering with the government and related associations to foster impactful patient outcomes through sustainable access solutions. Our philosophy of "As One for Patients" underscores our dedication to developing noncommercial initiatives that strengthen healthcare systems and enhance patient access programs.

Aligning with the government's vision of universal healthcare, Merck Healthcare in India has pioneered the National Payers Partnership programme on cancer care. This innovative initiative collaborates with national payers such as the Employees State Insurance Corporation (ESIC) and the Ministry of Railways to facilitate access pathways for cancer therapies.

Additionally, we collaborate closely with state governments and other stakeholders to implement innovative, differential pricing schemes tailored to local market dynamics. These segmentation-based pricing strategies align with governmental programmes and prioritise affordability without compromising sustainability.

Patient access programmes are integral to Merck's approach, providing financial assistance to qualified patients in accordance with applicable local regulations. Through these initiatives, we ensure that patients who cannot afford our medications still have access to life-saving treatments.

Recognising the potential of digital healthcare, we are actively exploring partnerships to leverage telemedicine and ehealth solutions. Given India's extensive smartphone penetration and improving mobile connectivity, these digital platforms offer

promising avenues for expanding access to healthcare services.

Name one or two recent groundbreaking innovations and collaborations by Merck in the field of cancer care. What is the time lag between

their global and India launch?

One recent groundbreaking innovation by Merck in cancer care is the development of immuno-oncology therapies. These therapies, such as avelumab (Bavencio), focus on harnessing the power of the

immune system to combat cancer. Avelumab, for example, is a monoclonal antibody approved for the treatment of various types of cancer, including metastatic Merkel cell carcinoma and advanced urothelial carcinoma.

Additionally, Merck

collaborates with leading academic institutions, biotechnology companies, and research organisations to advance personalised medicine approaches in oncology. By identifying biomarkers and developing targeted therapies tailored to individual patients'

INTERVIEW

genetic profiles, Merck aims to improve treatment efficacy and reduce adverse effects.

Regarding the time lag between global and India launches of such innovations, it can vary based on regulatory approval processes, market access considerations, and healthcare infrastructure readiness. Merck endeavours to minimise this time gap by working closely with regulatory authorities and healthcare stakeholders in India to expedite access to innovative cancer treatments for patients.

How has India's clinical trials ecosystem evolved in terms of regulations, approvals etc?

India is a preferred destination for global clinical trials due to a high unmet need, with some of the highest disease burden globally, a heterogeneous patient pool, cost competitiveness, a skilled human resource and FDA audited sites, as well as rising costs in developed markets. Cost of clinical trials in India is 40-60 per cent lower than developed markets.

However, challenges such as regulatory complexities, lengthy approval processes, and varying ethical standards across different states have

CONTRIBUTOR’S CHECKLIST

been reported, impacting the efficiency and timeline of clinical trials.

Efforts are underway to streamline the regulatory framework for clinical trials, with initiatives aimed at harmonising guidelines, enhancing transparency, and expediting approval processes.

Collaborative efforts between government agencies, industry stakeholders, and research institutions are crucial for addressing these challenges and promoting a conducive environment for clinical research in India.

We continue to sustain dialogue and involvement of our key countries in all future clinical trials and seek support to ensure that countries like Taiwan, Korea, and India, where local patient inclusion in global studies is a key regulatory requirement for product registration, are always included in global clinical development programs.

India's intellectual protection (IP) protection has been framed in tune with the country's socio- economic situation. Are there any concern areas and how can they be addressed?

Intellectual property (IP) protection is essential for

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fostering innovation and encouraging investment in research and development. While India has made strides in strengthening its IP framework through legislative reforms and enforcement mechanisms, concerns remain regarding the effectiveness of enforcement and the resolution of IP disputes. Continued efforts are needed to enhance IP enforcement, streamline procedures for obtaining and enforcing patents, and address issues such as counterfeiting and piracy.

Stakeholder engagement and dialogue between government bodies, industry players, and IP experts can facilitate the development of balanced and effective IP policies that promote innovation while safeguarding public interests.

Have there been substantial improvements in the ease of doing business in India?

Improving the ease of doing business is a priority for India's government, as evidenced by various reforms aimed at simplifying regulatory processes, reducing bureaucratic hurdles, and enhancing transparency.

Despite progress, challenges persist in areas such as obtaining permits,

resolving commercial disputes, and navigating tax regulations, which can impact the business environment and investment attractiveness.

Efforts to address these challenges include digitalisation initiatives, regulatory reforms, and capacity-building measures to enhance administrative efficiency and reduce compliance burdens.

Continuous monitoring, evaluation, and stakeholder engagement are essential for identifying bottlenecks, implementing reforms, and fostering a business-friendly environment conducive to sustainable economic growth.

In conclusion, as India continues its journey towards enhancing the ease of doing business and fostering innovation, our recent launches of Tepmetko, Bavencio, and Pergoveris in the country over the last two years is a testament of the government's commitment to facilitating a conducive environment for pharma growth and healthcare innovation.

Are any of Merck's oncology medicines due to lose patent protection in the next four to five years? If yes, how is the company strategising for this

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loss of exclusivity and the price crash that will follow?

The natural progression of pharma innovation often leads to the emergence of generic competition as patents expire. This competition fosters a dynamic marketplace where multiple companies vie to offer cost-effective alternatives, ultimately benefiting patients by providing them with increased access to a diverse range of treatment options.

The prospect of generic competition signifies a step towards a more robust and competitive landscape. This competition incentivises companies to optimise their offerings, driving improvements in efficiency, affordability, and accessibility of medicines.

While this transition may lead to price erosion, it encourages companies to focus on enhancing the quality and efficacy of their medicines to maintain their competitive edge. By ensuring that patients have access to high-quality treatments at competitive prices, Merck remains steadfast in its commitment to meeting the evolving healthcare needs of patients. In essence, while competition in the pharma industry may initially seem daunting, it ultimately serves

The Editor, Express Pharma, Business Publications Division, The Indian Express (P) Ltd, Mafatlal Centre,7th floor, Ramnath Goenka Marg, Nariman Point,Mumbai 400021 viveka.r@expressindia.com viveka.roy3@gmail.com

June 2024

INTERVIEW

as a catalyst for innovation and progress. Through increased competition, patients stand to benefit from a broader range of treatment options that are both effective and affordable, thereby advancing the collective goal of improving healthcare outcomes.

What is Merck India's approach to cancer treatment and awareness, given the country's unique demographic and socioeconomic profile?

With scientific curiosity and dedication to patients, we strive every day to improve the futures of people living with cancer. Our efforts have led to new standards of care for multiple tumour types, and we are committed to bringing these innovative treatments to as many patients as possible.

Access and partnerships: Through our determination to maximise the impact of our standard-of-care treatments and pioneer novel medicines, we endeavor to create a world where more cancer patients can become cancer survivors.

Currently, we reach over 50 million patients a year with our healthcare portfolio in low- and middle-income countries (LMICs). One of our key priorities is to expand access to innovative medicine like Erbitux, in LMIC like India Head and neck cancer is one of the leading causes of mortality in India, contributing to ~30 per cent of overall cancer incidence with a mortality to incidence ratio of 56 per cent. Similarly, ~50,000 new cases of colorectal cancers (CRC) are diagnosed in India with ~31,000 deaths.

As per the Lancet study, ~90 per cent of the avertable cancer deaths were due to nonutilisation/lack of access to healthcare services and rest ~10 per cent due to poor quality of healthcare.

We are committed to helping 80 million patients in LMICs by 2030 by going deeper, wider, and faster to enable access in LMICs.

One of our flagship projects is Umeed – a Merck initiative to expand access for H&N and

mCRC patients in India

Overcoming barriers to access for underserved populations and communities in India in a businessintegrated and sustainable manner through focused interventions ranging from increasing awareness, prevention and diagnosis of

H&N and colorectal cancer; their early signs/symptoms and associated risk factors, in remote areas where access to information and literacy rate is low. Expanding screening coverage and building referral mechanism for early diagnosis and capability building by enhancing knowledge and

experience on treatment with targeted therapies. Create platforms for peer-peer exchanges and casemanagement protocols based on real-world experiences optimising patient outcomes. We also enhance treatment and quality care by helping reduce financial burden of

cancer treatment with patient assistance programme for Erbitux and building integrated care for cancer treatment with counselling support to ensure superior outcomes.

viveka.r@expressindia.com

viveka.roy3@gmail.com

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The Pharma and Med Devices Supply Chain Conclave brought together industry leaders and innovators to discuss strategies and best practices for building resilient,efficient,and sustainable supply chains

Special Address: Resilience in the pharma supplychain

Archana Jatkar, Associate Secretary General, IPA, delivered a special address at the Pharma & Med Devices Supply Chain Conclave, underscoring the urgent need for resilience and diversification in the pharma supply chain.

"In a world marked by unprecedented challenges and rapid change, our ability to adapt and thrive hinges on building a supply chain that is robust, agile, and diversified," she said.

Jatkar pointed out that recent years have underscored the critical importance of resilience in the pharma supply chain and emphasised the impact of the COVID-19 pandemic. She also noted that India has demonstrated remarkable adaptability by supplying medicines to over 200 countries, despite significant challenges.

She advocated enhanced transparency and collaboration across the

Archana Jatkar,Associate SecretaryGeneral,IPA

supply chain to swiftly identify risks and deploy effective contingency plans.

Jatkar highlighted that the industry

needs to embrace advanced technologies like machine learning and artificial intelligence to enhance agility and

transparency. “Notably, companies like Cipla and Dr Reddy's have been recognised as Digital Lighthouses by the World Economic Forum for their use of these technologies to transform operations,” she added.

Jatkar also outlined several policy measures aimed at achieving supply chain resilience and diversification.

Jatkar concluded by highlighting the potential for India's pharma industry to grow from $50 billion to $120$130 billion. She called for embracing the challenge of redefining pharma supply chain management, ensuring it is resilient, agile, sustainable, and capable of delivering life-saving medicines globally.

In her closing remarks, Jatkar invoked the spirit of Vasudhaiva Kutumbakam , urging the industry to work collectively for the health and well-being of future generations.

Special Address: Shaping the future of supply chain management

At the Pharma & Med Devices Supply Chain Conclave, Anil Matai, Director General, OPPI gave an insightful Special Address which highlighted the complexity and global nature of pharma supply chains, involving a network of suppliers, manufacturers, and distributors. "The landscape of the pharma industry is rapidly evolving, and with it, the demand for secure, smart, and sustainable supply chains has never been more crucial," he emphasised.

"This event serves as a pivotal platform for industry leaders and experts to converge and delve into strategies and technologies that will shape the future of supply chain management in the pharma and medical device sectors," he said, lauding the Pharma & Med Devices Supply Chain Conclave.

Matai noted that the shift from traditional supply chain models to innovative approaches has enhanced resilience, efficiency, and sustainability. The COVID-19 pandemic underscored the vulnerabilities

Anil Matai,Director General,OPPI

in pharma supply chains, elevating their importance in public consciousness.

He stressed on the role of smart technologies in supply chain excellence and

cited examples such as blockchain-enabled traceability, IoT-driven predictive maintenance, and other advanced technologies like cyber-physical systems, big

data analytics, and artificial intelligence, which help stakeholders proactively identify risks and optimise operations.

Matai also stressed the need for ecofriendly practices, renewable resources, and ethical sourcing to address environmental concerns and evolving consumer preferences. He advocated the need to embrace circular economy principles, such as product lifecycle management and closed-loop systems, which can minimise ecological footprints while unlocking new revenue streams and enhancing brand reputation.

Matai emphasised the importance of resilience and informed that forwardthinking organisations prioritise risk management, diversify their supplier bases, and invest in contingency planning to ensure business continuity.

Further, Matai called for embracing emerging technologies, sustainable practices, and a culture of collaboration to navigate the complexities of an interconnected and uncertain world.

Special Address: Building resilient medtech supplychains

At the Pharma and Med Devices Supply Chain Conclave 2024, Dr Rajeev Chhibber, Joint Coordinator of Government & Public Affairs at AIMeD, delivered a Special Address which began by highlighting the newfound importance of supply chains at the management and organisational levels.

He discussed the government's vision of "Vikasit Bharat" and the pivotal role of supply chains in achieving affordability, accessibility, and availability. At the same time, he asserted that secure, smart, and sustainable supply chains are also essential to reach the next level of development.

Reflecting on the impact of geopolitical turbulence and the COVID-19 pandemic, Dr Chhibber reminded that significant shipment delays adversely

Dr RajivChhibber,Jt.Coordinator,Govt.& Public Affairs,AIMeD

affected critical and comorbid patients. These challenges underscored the necessity for resilient supply chains, which will be capable of withstanding such disruptions. Dr Chhibber detailed the complexity of creating medical devices, from sourcing materials to delivering final products to patients. He praised the National Logistics Policy (NLP), an initiative by the government, for facilitating policy shifts that enabled Indians to demand as well as supply on international platforms.

The address also highlighted India's progress from being import-dependent to becoming a significant exporter of medical devices. Further, Dr Chhibber revealed the proposal to create a National Stockpile of critical medical devices, a move supported by the government,

ICMR, and PMO. This stockpile will be based on disease patterns and market consumption, aiming to ensure the availability of critical medical devices during emergencies.

Dr Chhibber underscored the importance of strategic and innovative thinking in enhancing supply chain resilience and called for more boardroom discussions and out-of-the-box solutions. He advocated for a secure future through continued efforts and more collaborative initiatives, which he believes will ease business operations and shape India's healthcare landscape for 2030 and 2047.

Concluding his address, Dr Chhibber emphasised the need for convergence across the pharma, medical devices, and hospital sectors.

Panel Discussion: Decoding the dynamics of medical devices supplychain

At the Pharma and Med Devices Supply Chain Conclave 2024, a panel discussion discussed the future of the medical devices supply chain in India.

Moderated by Krishnan V, COO, Raman & Weil, the panellists for this session were Raghuveer Surupa, Founder, Stemtech Medical Devices; Sachin Hujare, Sr. Director, Operation and Manufacturing Systems, Philips India; Bhushan Rao, Associate Director, Supply Chain, Alcon; Gaurav Pandit, Sr GM - Supply Chain, Thermofisher Scientific; and Dr Ashish Negi, VP- Service Logistics, DHL Supply Chain India.

Krishnan opened the discussion with a reference to the Indian government’s goal to reduce dependency on imported medical devices by 50 per cent. He then asked the panel how Indian brands can stay locally relevant while expanding globally.

Dr Negi highlighted the need for infrastructure development in order to achieve global competitiveness. Adding onto it, Rao suggested a multifaceted approach, including regulatory harmonisation and skill development.

Further, Hujare discussed the importance of good investment in technology to increase affordability and access to care. He also spoke on the challenges of localising high-tech components, particularly for imaging devices.

The conversation then shifted to innovation within the supply chain, especially in light of recent global disruptions. Pandit emphasised the importance of c ontinuous inn ovation. Rao focused on using technology to improve customer service and transparency.

Surupa shared his own experience of launching his start - up and cited geopolitical issues and rising costs of imported components. Adding on to it, Dr Negi noted that DHL works with Indian startups to streamline their operations. "We bring them from chaos to clarity," he mentioned.

The panellists also shared their methods of monitoring supply chain performance. Surupa highlighted the importance of supplier performance

L-R: Raghuveer Surupa,Founder,Stemtech Medical Devices; GauravPandit,Sr GM-SupplyChain,Thermofisher Scientific; Krishnan V,COO, Raman & Weil (Moderator); Sachin Hujare,Sr Director - Operation,Manufacturing Systems,Philips India; Bhushan Rao,Associate DirectorSupplyChain,Alcon; Ashish Negi,VP-Service Logistics,DHLSupplyChain India

KEYTAKEAWAYS

◆ Amultidimensional approach is important to facilitate domestic production of med devices and build local supplychains.This,in turn will reduce dependency on export of medical devices

◆ Glocalisation of supplychains playa major role in mitigating risks,being cost effective and improving timelyaccess to critical medicines and medical devices

◆ Skilling,cross skilling and upskilling is vital to build effective,responsive and resilient supplychains

◆ End-to-end traceabilityand visibilitywith AI,data science and other emerging technologies will improve supplychain planning

◆ Making supplychains in medical devices more transparent will help manage evolving demands and serve patients in a better manner

◆ Qualityand timeliness of deliveries of medical devices is an imperative.Partners like DHLSupplyChain India can help bring in better efficiencies and clarityin med devices supplychain

◆ Efficient,agile,flexible,intelligent,resilient and passionate are the key attributes for highlyfunctional med devices supplychains

and timely delivery, particularly to Tier II cities. Pandit described dashboards as the "pulse" of operations, focusing on customer service experience and inventory management. Hujare men-

tioned using a Plant Manager Dashboard to track defects on arrival and material availability. Adding onto the discussion, Rao explained the use of OTIF dashboard to gauge operational

efficiency and customer demand fulfilment. Dr Negi, on the other hand stated that they work with different customers and hence have different dimensions to measure, highlighting business growth, customer promises, and innovation are some of the parameters to consider.

In his closing remarks, Krishnan V expressed optimism about India's trajectory in the medical devices sector. "India is at a cusp. Over the next 10 to 20 years, we are going to see a lot of things coming out of India. We are skilling people, embracing technology, doing a lot of development, and paralleling some amount of research, so that we can serve global customers along with local customers," he concluded.

The discussion highlighted that while challenges remain, strategic investments in technology, infrastructure, and skill development can propel India towards becoming a global leader in the medical devices industry.

Supplychain traceability: Atimelyintervention in the digital age

Harish Chandra Joshi, Global HeadStrategy and portfolio, Propix Technologies, showcased his company's latest advancements in supply chain traceability and digital transformation, emphasising the critical role of IoT, AI, and data science in modernising the industry.

Joshi introduced a suite of solutions including end-to-end track and trace systems, machine vision, robotics and automation, and software integrations leveraging IoT, Big Data, and AI/ML technologies. The Just Achieving Maximum (JAM) vision was a focal point of the presentation, emphasising the goals of maximising value, empowering disadvantaged populations, and increasing technology penetration. He also highlighted why pack-

Harish Chandra Joshi,Global HeadStrategyand portfolio,PropixTechnologies

aging is a key component in the ongoing digital transformation within supply chains.

The presentation detailed Propix’s secure, full-stack digital supply chain framework, which aims to enhance visibility and transparency, utilise real-time data to boost efficiency and productivity, apply big data analytics for trend analysis, forecasting, predictive modelling and implementing sustainable practices to reduce carbon footprints

It informed, for ensuring product validation and security, the company offers anti-counterfeiting measures, verified scanning and purchasing processes, geo-location mapping, loyalty programs, and statistical data for marketing insights

Adding onto this, Joshi mentioned

Propix's integrated command and control systems which provide real-time operational insights like overall equipment effectiveness metrics, an open, vendor-agnostic architecture, fully configurable solutions, granular architecture for detailed analysis, real-time business insights etc. He highlighted the The 4V model— Volume, Variety, Velocity, and Veracity— which underpins Propix’s big data strategy, ensuring efficient data management and analytics.

Joshi also underscored the potential of digital passports enabled by supply chain traceability to support future sustainability frameworks. The address showcaed Propix’s role in advancing supply chain management through secure, smart, and sustainable solutions.

Comprehending the future of healthcare supply chain: Digitalisation,Technology& Sustainability

At the Pharma & Med Devices Supply Chain Conclave, Dhruv Thakkar, VP-Business Development, India, DHL Supply Chain India, outlined the future of the healthcare supply chain with an emphasis on digitalisation, advanced technologies, and sustainability in his address.

He informed that DHL Supply Chain India boasts over 17,000 employees, 140+ locations, a 2,000-strong fleet, 160+ customers, and over 13 million square feet of warehousing space. In his presentation, he detailed its offerings like comprehensive solutions across the supply chain, from manufacturing and raw materials to export/import activities, primary and secondary movement, distribution centers, B2B and B2C distribution, and after-sales services. He also spoke of the MySupplyChain solution that integrates services, enhancing efficiency with warehouse management systems, transport management systems, and customer order management systems.

DhruvThakkar,VP-Business Development,India,DHLSupplyChain India

Thakkar highlighted the shift towards healthcare consumerism, discussed the evolution of therapies from simple molecules to complex biopharma products, and addressed

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importance of collaboration in healthcare. He said, “Supply chain orchestration, involving 4PL, control towers, and business support centres, plays a crucial role in this collaboration.”

Next, he pointed out that the pandemic prompted a reevaluation of supply chain structures to handle external shocks and ensure resilience. He informed that the healthcare sector is addressing disruptions, managing alternating shortages and excesses, and keeping up with global trends to evolve delivery models. Notable examples include enabling nextday deliveries for prescription glasses, urgent delivery of heart valves and stents, and maintaining six temperature zones for various customer needs.

Thakkar, at the end, also outlined key services for adapting to industry trends, including shared pharma warehouses, cold chain part truck loads, lead logistics partnerships, control towers, business support centers, service logistics, packaging solutions, and customs-bonded warehouses and free trade warehousing zones (FTWZ).

The Editor, Express Pharma, Business Publications Division, The Indian Express (P) Ltd, Mafatlal Centre,7th floor, Ramnath Goenka Marg, Nariman Point,Mumbai 400021 viveka.r@expressindia.com viveka.roy3@gmail.com

Panel Discussion: From fragile to agile: Building resilience in pharma supplychain in the face of disruptions

The second panel discussion at the Pharma Med Devices and Supply Chain Conclave was titled “From fragile to agile: Building resilience in pharma supply chain in the face of disruptions.” Industry experts gathered to discuss the challenges faced by the pharma supply chain and ways to strengthen the industry. Led by Ryan Viegas, Management consultant, the discussion brought together esteemed panellists who provided insights on making the pharma supply chain more resilient and agile. Viegas was joined by Arindam Bhattacharya, VP-Supply Chain Excellence, Amneal Pharmaceuticals; Kaifeel Shaikh, VP-Domestic Distribution & Global Logistics–EXIM, Indoco Remedies; Avinash Kumar Talwar; VP - MRO & Pkg. Material Sourcing (Strategic & Plant), Dr Reddy’s Laboratories; Deepak Khurana, VP-Procurement & SCM, Suven Pharmaceuticals; and Bharat Bhushan Rathi, Head-Distribution and Logistics, Mankind Pharma.

The discussion centred on some key themes like glocalisation of supply chains, technology adoption, risk management strategies and sustainability, among others. It started off with experts highlighting the importance of building strong connections with supplier partners to gain agility in the pharma supply chain. Viegas emphasised, “Building a relationship with the supply chain members is based on mutual trust, transparency and shared concern.” Stressing on promoting glocalisation to balance between local and global imports, they underscored the need to develop native resources and collaborate with local players for growth and flexibility of pharma supply chains.

The experts urged the industry to build a resilient pharma supply chain by embracing technological interventions, and incorporating them at every stage of the supply chain process. The panellists also discussed high risk factors faced by the pharma supply chains due to geopolitical events, changing market demands, policy changes, growing regu-

L-R: DeepakKhurana,VP-Procurement & SCM,Suven Pharmaceuticals; Avinash Kumar Talwar,VP- MRO & Pkg.Material Sourcing (Strategic & Plant) and Global SupplyChain Management,Dr.Reddy's Laboratories; Ryan Viegas,Management Consultant (Moderator); Arindam Bhattacharya,VP-SupplyChain Excellence,Amneal Pharmaceuticals; Kaifeel Shaikh,VP-Domestic Distribution & Global Logistics–EXIM,Indoco Remedies; Bharat Bhushan Rathi,Head-Distribution and Logistics,Mankind Pharma

latory scrutiny and environmental issues among other factors. They were emphatic that a structured risk

KEYTAKEAWAYS

management process is crucial to build a strong and balanced pharma supply chain.

◆ Building sound relationship with supplier partner is vital to attain agilityin the pharma supplychain

◆ Developing local resources and collaborating with them is crucial for growth and balance in pharma supplychains

◆ Self-sufficiencyis veryimportant for the growth of pharma supplychain

◆ Technological interventions gives lead time for better management of distribution network

◆ Structured riskmanagement process can help in attaining a balanced pharma supplychain

◆ Supplier selection and auditing,green packaging,life cycle assessment and collaboration are some of the ways to attain sustainabilityin pharma supplychain

Another key issue discussed was sustainability, a major concern of the pharma industry, as it is a significant contributor to global emissions. Strategies to cut the carbon footprint and make conscious decisions for the future was emphasised. Waste reduction, recycling, eco-friendly packaging materials, life cycle assessment, supplier selection and auditing, water management, are some of the areas of opportunities and improvements for the industry.

The experts were unanimous in their opinion that growth is a result of keeping up with the latest trends and technology and implementing such changes into practice. Technological integration and sustainable practices will be paramount to build a supply chain for the future.

Panel Discussion: Supplychains of tomorrow: Secure,Smart,Sustainable

The last panel discussion of this event - ‘Supply chains of tomorrow: Secure, smart, sustainable.’ The aim of this discussion was to discuss ideas and strategies for a future-ready pharma and med-devices supply chain. To provide a balanced view, it included a mix of experts from the medical devices and the pharma sectors.

Aruna Nayak, MD, Getinge; Anil Damle, Sr President – Corporate Projects and Supply Chain, Bharat Serums and Vaccines; Ashish Sabnis, VP-Strategic Buying & Compliance, USV; and Mihir Rachh, Sr GM - Supply Chain, Encube Ethicals were the esteemed panelists for this session. It was moderated by Viveka Roychowdhury, Editor, Express Pharma & Express Healthcare.

Exploring the multifaceted role and significance of secure, smart, and sustainable supply chains, the experts rooted for the adoption of advanced technologies to enable real-time monitoring, predictive analytics, waste reduction, optimisation of operational costs, risk management etc.

The discussion kick started with the experts acknowledging the need for better strategies for supply chains to cope with uncertainty and volatility in the market. Sharing her perspective from a med-tech point of view, Nayak asserted that it is vital to simplify med devices production, make them quicker to assemble, as well as more sustainable (without compromising their functionality).

Putting forth his views from the pharma perspective, Sabnis informed that sustainability in pharma supply chains can be achieved by moving away from high energy resources to attain a more environment-friendly ecosystem. Speaking about agility and resilience, Sabnis stated, “The ability of the supply chain team to change challenges into opportunities will determine the resilience of the supply chain.”

Damle shared how the urgency during Covid-19 was challenging but also proved to be a learning opportunity that led to innovative thinking and most importantly, localisation and self-reliance in supply chains.

L-R: Aruna Nayak,MD,Getinge; Viveka Roychowdhury,Editor,Express Pharma & Express Healthcare (Moderator); Anil Damle, Sr President – Corporate Projects and SupplyChain,Bharat Serums and Vaccines; Ashish Sabnis,VP-Strategic Buying & Compliance,USV; Mihir Rachh,Sr GM - SupplyChain,Encube Ethicals

KEYTAKEAWAYS

◆ From medtech industrypoint of view,sustainabilitycan actuallylead to an opportunityand sometimes newproduct development

◆ Pharma industryis nowmoving awayfrom high energyresources to attain an environment friendlyecosystem

◆ The abilityof the supplychain team to change challenges into opportunities will determine the resilience of the supplychain

◆ Having a good product is the first step to sustainabilityin the med devices sector.

◆ Eco-friendlyproduct design,use of sustainable materials,optimising packaging, etc are some of the keysteps to achieve sustainabilityin pharma and med devices supplychain

◆ We need to train,skill and upskill our supplychain teams to make them futureready.This will make our supplychains more efficient,productive and agile

Another learning from the pandemic days was focusing on mutually beneficial collaborations. Rachh emphasised that rather than looking at it as a mere outsourcing of a job, companies must strive to build strategic

and long-lasting connections within the industry. This change in outlook will help the industry grow as a whole.

Thus, the discussion looked at how advanced technologies like AI, IoT, and blockchain will make supply chains increasingly smart and automate decision-making. Sustainability was a core focus, with the experts urging companies to adopt eco-friendly practices. They also stressed on the importance of collaboration by all stakeholders, from manufacturers to consumers, to drive transparency and resilience, fostering a more efficient and responsible global supply network.

The panel also underscored that upskilling people to make the workforce adept with the advancing technology will result in a smarter and efficient workforce and make the industry future-ready.

Supplychain leaders honored at Pharma & Medical Devices Conclave 2024

Champions of Change initiative seeks to acknowledge and applaud the sterling role played by supply chain leaders in ensuring safe,efficient,and timely delivery of critical medications and devices to patients

The inaugural edition of the Pharma & Medical Devices Conclave 2024, hosted by Express Pharma, also recognised and celebrated leaders and innovators transforming supply chains in the pharma and medical devices sectors as Champions of Change.

The evening commenced with a welcome from Viveka Roychowdhury, Editor of Express Pharma and Express Healthcare, who took the stage to provide insights into the vision and mission of the Champions of Change initiative.

Highlighting the importance of the event and the role of supply chain leaders in improving healthcare outcomes, she informed that the Champions of Change initiative seeks to acknowledge and applaud the sterling role played by supply chain leaders in ensuring safe, efficient, and timely delivery of critical medications and devices to patients. She also emphasised the significance of recognising those who are pioneering advancements in supply chain management within the pharma and medical devices industries.

She said, “It is my honour to welcome you to the inaugural edition of the Pharma & Med Devices Supply Chain Conclave. This Conclave takes forward the efforts of the Group to spotlight the achievements, and growth of each sector. In 2017, we expanded from print to events with the successful launch of networking

platforms like Formulation And Drug Delivery Conclave for FR&D scientists and Pharma Packaging & Labelling Conclave for packaging professionals. Now in their seventh editions, these initiatives have grown into much awaited gatherings of their respective fraternities. The vision behind these endeavors is to create a platform for senior members of these crucial sections of the industry to meet, discuss and brainstorm, share best practices and learnings. Today, it is our honour to take this vision forward with the inaugural edition of the Pharma & Med Devices Supply Chain Conclave.”

Following Roychowdhury, Daara Patel, Secretary General of IDMA, delivered a special address. Sharing insights into the current state and future prospects of the industry, he highlighted the development of supply chain infrastructure in India from its past, signifying how the country has come a long way in terms of building the supply chain from the ground-up, implementing technology and advancing along the way. He commended the supply chain experts for being driven to make developments and to ensure that the industry progresses according to global standards. He also spoke on harnessing the power of emerging technologies, significance of localised production to reduce transportation time and cost, circular-economy practices, and meet

Daara Patel,SecretaryGeneral,IDMA

evolving demands of the pharma market, while reducing environmental impact.

Next, the Roychowdhury and Ptel presented the citations to some leaders . The recipients of the Champions of Change citations were:

◆ Arindam Bhattacharya

◆ Kaifeel Shaikh

◆ Pramod Pandit

◆ Avinash Kumar Talwar

◆ Deepak Khurana

◆ Gaurav Suchak

◆ Nihar Medh

◆ Anil Damle

◆ Ashish Sabnis

◆ Shayam Tiwari

◆ Peeyush Kaushik

◆ Ganesh Sabat

◆ Aruna Nayak

◆ Sachin Hujare

◆ Bharat Bhushan Rathi

◆ Krishnakant Parab

The Pharma & Medical Devices Conclave 2024 successfully highlighted the critical role of supply chain leaders in the healthcare industry. By honoring the Champions of Change, the event not only celebrated their achievements but also aims to inspire future innovations in pharma and medical device supply chains.

The event concluded on a celebratory note with dinner and cocktails, allowing for further networking.

GLIMPSES OFPHARMA& MED DEVICES SUPPLYCHAIN CONCLAVE 2024

GLIMPSES OFPHARMA& MED DEVICES SUPPLYCHAIN CONCLAVE 2024

TECHNOLOGY

Demystifying Pharma Science: Batch v/s Continuous manufacturing

Indu Bhushan, CEO & Director,STEERLife explores the distinctions between batch and continuous manufacturing in the pharma industry,highlighting their respective advantages, challenges,and impact on efficiency,product quality,and cost

The Indian pharma sector has a significant influence on human well-being and continues to play a key role in supplying drugs and vaccines to millions around the world. The industry is poised for sustained growth and is expected to reach $65 billion in 2024 with forecasts pointing toward a remarkable growth of around $139 billion by 2024 and $450 billion by 2047. (Source: EY).

India is a major exporter of pharma, with over 200+ countries served by Indian pharma exports. India supplies over 50 per cent of Africa’s requirement for generics, ~40 per cent of generic demand in the US and ~25 per cent of all medicine in the UK. ( Source: Invest India ) India currently commands over 20 per cent of the global generics supply by volume and addresses approximately 60 per cent of the worldwide demand for vaccines. (Source: EY).

Over years, India has undergone a remarkable transformation in this sector and have evolved into a dynamic powerhouse of healthcare advancements worldwide and will continue to shape the trajectory of healthcare in the times to come. The sector is poised for further expansion and transformative shifts with significant opportunities and several challenges that lies ahead. The government supported production-led incentive schemes, not just for formulations but also bulk drugs, drug intermediates, and the medtech sectors are the rising sectors of our economy. Beyond its global impact in improving health outcomes, the Indian pharma industry plays a pivotal role in

propelling the country's economic growth and generating employment.

In this article, on "Demystifying Pharma Science," let’s dive a little deeper to understand batch manufacturing and continuous manufacturing and which approach best fits your business needs.

Understanding batch manufacturing

In batch manufacturing, drugs are produced in discrete steps or batches. This process involves mixing the ingredients, processing them, and then packaging the final product. Each batch is made separately, with its own set of equipment and conditions. While it has been the norm for decades, it comes with certain limitations: 1. Inefficiency: This happens

between the start and stop of any particular batch

2. Quality variability: Each batch may vary in quality due to differences in equipment usage and operator techniques

3. Scale-up challenges: Scaling up is complex and timeconsuming, requiring adjustments to equipment and processes to maintain product consistency

4. Inventory management: Batch processes lead to large inventories of intermediate and finished products, which may lead to potential expiration or obsolesce

5. Costs: Costs of labour, power, and production times are significantly higher

6. Environmental impact: BM may result in higher energy consumption and waste generation than continuous

processes.

Despite its limitations, batch production has a wide adoption rate because of its familiarity, lower equipment cost, and relatively lower failure rates.

The shift

Continuous manufacturing revolutionises the pharma industry by enabling a seamless flow of production from raw materials to finished products without the need for batch intervals. In this approach, ingredients are continuously fed into the production line where multiple stages of production occur in a continuous stream. The constant flow allows for real time monitoring and control of various parameters such as temperature, pressure and composition ensuring consistent product quality and uniformity.

Key components include integrated processing units interconnected by automated control systems that regulate critical process parameters within a narrow range of operation.

Continuous manufacturing revolutionises the pharma industry by enabling a seamless flow of production from raw materials to finished products without the need for batch intervals. In this approach, ingredients are continuously fed into the production line, where multiple stages of production occur in a continuous stream. The constant flow allows for realtime monitoring and control of various parameters such as temperature, pressure and composition, ensuring consistent product quality and uniformity.

Key components include integrated processing units in-

terconnected by automated control systems that regulate critical process parameters within a narrow range of operation.

Significant advantages of adopting continuous manufacturing

◆ Improved product quality: Due to only nominal changes required in continuous manufacturing there is greater quality control leading to improvement.

◆ Improved efficiency: Continuous manufacturing eliminates the need for batch setup and cleaning, leading to reduced downtime and increased production efficiency.

◆ Consistency: The continuous nature of the process ensures that each batch of product is consistent in quality, with minimal variation.

◆ Real-time monitoring: Continuous manufacturing systems are equipped with sensors and monitoring devices that allow for real-time monitoring of critical parameters such as temperature, pressure, and flow rates. This enables rapid detection and correction of any deviations from the desired conditions.

◆ Flexibility: Continuous manufacturing systems are highly flexible and can easily accommodate changes in production requirements or formulations.

◆ Reduced waste: Continuous manufacturing generates less waste compared to batch manufacturing, as there is no need to discard leftover materials between batches.

◆ Cost saving: Continuous manufacturing reduces downtime and increases production efficiency by eliminating the

TECHNOLOGY

need for batch setup and cleaning. This results in cost savings and faster time to market for pharma companies.

On the other side of the ‘benefit’ coin lie the challenges. Everything comes with a set of challenges. For continuous manufacturing, they are:

◆ Initial investment: The initial investment required to im-

plement continuous manufacturing can be significant, as it involves the installation of specialised equipment and infrastructure.

◆ Regulatory approval: Regulatory agencies may require additional validation and documentation for continuous manufacturing processes, which can prolong the ap-

proval process.

◆ Transitioning from batch to continuous: Transitioning from batch to continuous manufacturing may require reevaluation of existing processes and workflows, as well as staff training on new technologies.

◆ Risk management: Continuous manufacturing systems are highly automated, which in-

creases the risk of system failures or malfunctions. Robust risk management strategies are essential to mitigate these risks.

With its promise of faster, more cost-effective production, continuous manufacturing will continue to evolve and gain acceptance. More pharma companies will keep adopting it for the

production of a wide range of drugs, nutraceuticals, and food products. Despite challenges, continuous manufacturing is poised to revolutionise the pharma industry. Its ability to improve efficiency, consistency, and flexibility makes it an attractive option for pharma companies looking to stay competitive in today's fast-paced market.

Comparison Chart: Batch Manufacturing vs Continuous Manufacturing

Transforming medical device assemblywith Acopos6D

The invent of ACOPOS 6D for pharma manufacturers was to create possibilities in new areas of application,opening new market opportunities for machine builders and manufacturers

The medical device assembly sector is poised for significant expansion, extending its reach into new territories alongside its manufacturing and assembly facilities. This dynamic industry is expanding and driving daily growth, thanks to its exceptional adaptability and commitment to innovation.

As per estimates by the Government of India, the sector is growing at a rate of 28 per cent to reach a size of $50 billion by 2030. To aid this growth, leaders in medical device assembly are preparing solutions previously unattainable, enabling the fabrication of end-to-end product types with unparalleled flexibility and efficiency. This new breed of smart and adaptive machine solutions are remarkably good at adjusting to changes in a dynamic environment. The medical device assembly present primary challenges revolving around enhancing Overall Equipment Effectiveness (OEE) and profitability for customised small batch production. Overcoming such challenges involves automating repetitive and manual tasks and reducing production costs and process wastages. Manufacturers always look toward latest innovation in their quest to accomplish all their goals in less time, with minimal machine footprint, and with

higher productivity. This facilitates the implementation of a compact and adaptive machines in the manufacturing eco system, making process simple and efficiently maximising the production.

Adaptive manufacturing is innovation’s best

Adaptive manufacturing opens completely new avenues for solving problems that would be hard to tackle with a traditional method. The constraints of traditional manufacturing techniques become clear as we see production batches shrinking to batch sizes of one. Product variations are difficult for these lines to handle; product customisation and changeover happen too

slowly to achieve a production level that is economically feasible. To achieve greater output in less time, a production unit needs to become extremely adaptable at this point and lay the groundwork for cuttingedge technology. With the launch of ACOPOS 6D, the manufacturers are dawning their hands to put this remarkable innovation to use. The invent of ACOPOS 6D for pharma manufacturers was to create possibilities in new areas of application, opening new market opportunities for machine builders and manufacturers. The mechatronic innovations of B&R hold the best of technology, after services and programming made easy via mapp6D. The

market has already witnessed that adaptive machine supports digital business strategies with the ability to deliver cost-effective, automated, make-to-order mass customisation for the first time ever.

Mobilising made easywith ACOPOS

6D

Advancements in technology are streamlining processes and reducing time consumption. Machine manufacturers are embracing practical innovations that yield consistent results. The latest generation of hygienic and aseptic shuttles for ACOPOS 6D enables profitable small-batch production across various sectors. These magnetically levitating ACOPOS 6D shuttles glide silently and precisely, adhering to stringent cleanliness standards while remaining easy to maintain. Customers seeking a sterile environment can opt for this hygienic and aseptic version. In cleanroom applications, our planar product transport system simplifies the setup of processing stations, maximising production within a smaller footprint. To further streamline operations, the newly launched ACOPOS 6D LaunchPad assists automation engineers in designing transport system paths and optimising process flows without additional software tools or programming. This intuitive graphical workspace allows users to drag and drop destinations and waypoints, defining key locations for the shuttles. An underlying algorithm efficiently plans the connections, detecting and resolving potential collisions or deadlocks. Changes are easily accommodated by adjusting waypoints, and the 6D LaunchPad seamlessly integrates with the controller, becoming an essential part of the entire machine. For machine builders, integrators and users, it becomes not just a design tool, but an integral part of the entire machine lifecycle as an intuitive, graphical hub for data-driven process optimisation and all types of value-added services.

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ACOPOS6Dallowsyoutomoveproductsfreelythroughan openmanufacturingspaceunboundbythelimitsofonedimensionalproductionflow.Magneticlevitationprovides sixdegreesoffreedomforunprecedentedprocessing densityonafractionofthefloorspace.

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Ensuring pharma compliance with testo data measurement technology

Testo being a market leader in testing and measurement sector provides the best in class data loggers and data monitoring systems for the pharma division

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 of which, it becomes essential to store pharma products, vaccines, laboratory samples or units of blood at the right temperatures to ensure that they remain ef-

data loggers and data monitoring systems. Testo's data loggers are EN 12830 and 21 CFR Part 11 compliant which ensure 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.

fective and that quality is maintained. Another reason for the pharma division to ensure safety measures and controlled environment is stringent regulations and inspection of the facilities. This elementary need for climate control can only be ensured with right data monitoring systems. Testo being a market leader in testing and measurement sector provides the best in class data loggers and data monitoring systems for the pharma division.

Ensuring end to end climate monitoring – Testo Data Loggers

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.

Temperature and humidity data loggers are often used in pharma industries to monitor

the conditions in which drugs, medicines, vaccines are kept.

Not only storage, but 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 logger 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 for ensuring 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 applica-

tions. These instruments are the most convenient and pocket friendly solution for all pharma application areas.

The testo Saveris 2 WiFi data logger system is the simple, flexible and reliable solution to humidity and temperature monitoring in cold storage area like blood banks. This innovative monitoring system is ideal for high product quality and eliminates manual work of reading out or documenting measurement data. With a secure online storage of all readings in Testo Cloud the data can be managed and analysed online by the user via smart phone, tablet or PC anywhere and anytime. In case of crises and deviations, it is provided with an alarm by e-mail, or optionally by SMS.

Another important and crucial application of a pharma industry involves validation of sterilisation 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 with testo 190 data logger solution that has innovative data loggers for temperature and humidity, smart software and accessories.

Data compliance for audits and inspections

Testo offerings are majorly related to the data security along with comprehensive analysis and evaluation of all the recorded measurement data. Testo data loggers ensure continuous monitoring of temperature and relative humidity of pharma products during production, storage or transit of goods. Real time data monitoring is important for the quality of pharma goods and also enables the supplier to improve the life of the goods. Transportation trucks, warehouses, cold rooms etc. can now be remotely monitored via Testo

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, non-contact type temperature (infra red thermometer, thermal imager). In fact, it is the first and only lab in India to get NABL accreditation for dew point temperature as well.

For more details, login to our website www.testo.com or write back to us on info@testo.in

PHARMA PULSE

Choosing right TOC sensor for pure and ultrapure water applications

METTLER TOLEDO TOC sensors provide a powerful solution to effectively manage water quality and offer unique features to benefit both the fabricator and end user

As end users continue to refine, update or replace processes to be more efficient, meet new regulations and deliver improved product quality to their customers, they demand more from their utilities team, especially for water quality and confirmation of the absence of all contaminants. This process control is even more critical for users of pure and ultrapure water—pharma, microelectronics and power—as any deviation in water quality can have major impacts on the water system and the final product/energy generation. A critical contaminant that is controlled as part of this effort is total organic carbon (TOC).

Need for increased speed and tighter control of water quality

As the utility teams address the critical need of TOC control for end users, system engineers and fabricators of water purification skids also need to find analytics solutions that are efficient and cost-effective. In order to achieve this, system fabricators often employ solutions that can support:

◆ Use of industry-accepted suppliers

◆ Reduced overall project costs

◆ Ease of integration, startup and operation

◆ Advanced features that offer distinct advantages

◆ Ease of service and maintenance

Water requirements in the pharma industry

In the pharma industry, companies must adhere to local and/or global pharmacopeia compendial regulations that dictate the chemical composition of water allowable for use in manufacturing products.

This could be the United States Pharmacopeia (USP), European Pharmacopeia, Japanese Pharmacopeia, Chinese Pharmacopeia, Indian Pharmacopeia or the pharmacopeia of other relevant countries. One of the key contaminants to control as per the regulatory requirements is TOC, and it needs to be controlled not only during the water purification process but also in the water loop with the points of use. The USP encourages the use of online TOC instrumentation in Chapter <643> for product control and for additional process and system control.

METTLER TOLEDO TOC sensors for water projects

As leaders in pure water analytics, METTLER TOLEDO Thornton has engaged with industry heads and influencers as well as regulatory bodies to contribute technical expertise while also collecting feedback from discussions on monitoring needs. This has driven innovation at METTLER TOLEDO to develop products that meet user needs and provide valueadded features. These inn ovations include TOC sensors and associated transmitters that address the critical client needs mentioned

above with the addition of innovative features that ease the integration of analytics into the overall system design.

METTLER TOLEDO Thornton’s series of TOC sensors support on-line, real-time monitoring to ensure a full picture of the water quality trend. Using UV oxidation and industry leading conductivity measurement technologies, the sensors accurately measure the TOC content in water. They do not require any reagents or chemicals for operation, and have few moving parts. This reduces cost of operation and maintenance for the sensors. They are designed to meet specific customer technical and budget needs, to effectively address the requirements of various measurement points across industries. While other TOC analytical equipment available to system fabricators provide a measurement every six minutes, the METTLER TOLEDO Thornton series of TOC sensors provide a measurement response in 60 seconds and updates every second. This allows for an unprecedented level of transparency regarding the water quality, and the ability to react quickly to any out of specification event.

These sensors are paired with either the M300 or the M800 transmitters, depending on the capabilities required.

The M800 transmitter can accept up to four sensors on one transmitter. While other manufacturers may require a separate transmitter or specific programming for each type of sensor, Intelligent Sensor Management (ISM®) technology in the M800 transmitter allows for plug and play capability for virtually any combination of pH/ORP, conductivity, DO or TOC sensor inputs on a single transmitter. The M800 transmitter is also available with Profibus DP communication capabilities, which reduces cabling costs and streamlines data collection. This reduces the overall footprint of the analytics solution, allowing for a more efficient design and lower project cost.

Conclusion

METTLER TOLEDO TOC sensors provide a powerful solution to effectively manage water quality and offer unique features to benefit both the fabricator and end user:

◆ Use of industry-accepted suppliers with technical expertise and high accuracy measurement

◆ Reduced overall project costs with a variety of solutions offered to meet technical and budget needs

◆ Ease of integration, startup and operation with TCT software and plug and play simplicity

◆ Advanced features that offer distinct advantages to meet clients’ objectives, including ISM technology

◆ Ease of service and maintenance with ISM predictive diagnostics

In addition to these advanced capabilities, METTLER TOLEDO provides technical and after-sales support globally, with trained service experts available to support the system fabricator team through all stages of the process — installation, commissioning, preventive maintenance and troubleshooting. This ability, combined with TOC sensors tailored to meet water system design needs, allows METTLER TOLEDO to be a valuable and reliable partner aligned with system fabricator goals.

To know more, visit: www.mt.com/TOC Email – sales.sales@mt.com

Call toll-free – 1800 22 8884 & 1800 1028 460

PHARMA PULSE

DockShelters from Gandhi Automations –Safe and environmentallyfriendly

Dock Shelters seal the gap between the building and the vehicle in such a way that when the Sectional Overhead Door is opened,goods and personnel are protected against the harsh weather conditions outside

India’s No. 1 Entrance Automation and Loading Bay Equipment Company, Gandhi Automations, offers a complete range of Dock Shelters available for every requirement and environment.

Dock Shelters are installed mainly to seal the gap between the building and the vehicle in such a way that when the Sectional Overhead Door is opened, goods and personnel are protected against the harsh weather conditions outside.

Dock Shelters provide a seal between the internal and external environments, thus assisting in the reduction of energy consumption. The savings in energy costs are considerable.

Retractable DockShelters

The retractable PVC front panels Dock Shelter is commonly used. With its simplicity and efficiency, it guarantees a constant return on investment. These are available for docklevel installation or for groundlevel installation for the protection of doors without docks. The front panels are made of high-resistance black PVC reinforced with a double weave of polyester that works like a spring in order to seal the vehicles of different shapes. The flaps are flexible and have very high wear and tear resistance. Designed to retract under the shock of any possible wrong maneuvers of the docking vehicles and extend when the vehicle drives away.

Cushion DockShelters

Due to its high insulation factor, the Cushion Dock Shelter is the ideal solution for controlled temperatures. The three cushions are made of elastic polyurethane foam and covered with PVC-coated polyester fabric, supporting the vehicle pressures and perfectly sealing the three sides, including the space between the opened rear doors and sides of the vehicle. The two vertical cushions have continuous overlapped anti-friction

limpets, allowing for the upand-down heavy friction of the vehicle on its suspensions during the loading. It is available with a fixed or adjustable horizontal top cushion, adjustable to the different vehicle heights.

Inflatable DockShelters

Inflatable Dock Shelter is the best solution for insulating and improving the working environment. It can be rapidly inflated with a fan, and it creates perfect insulation between the vehicle and the loading bay, sheltering

Dock Shelters provide a seal between the internal and external environments, thus assisting in the reduction of energy consumption. The savings in energy costs are considerable

from cold, rain, wind, dust, and humidity. The Inflatable Dock Shelter is made of polyester fabric, PVC-covered, a material resistant to hot temperatures and bad weather conditions. Inflatable Dock Shelters provide the most versatile seal available to service the widest variety of truck and trailer configurations. Contrary to other types of dock shelters, the vehicle does not push towards the shelter; instead, the shelter is inflated around the vehicle.

For more information, please contact: Gandhi Automations Pvt Ltd Chawda Commercial Centre, Link Road, Malad (W), Mumbai – 400064, India. Tel: +91 22 66720200 / 66720300 (200 lines) Fax : +91 22 66720201

Email : sales@geapl.com

Website: www.geapl.com

PHARMA PULSE

PROSOLV® EASYtab: All-in-one excipient

Developed using the PROSOLV® technology, PROSOLV® EASYtab is the first lubricated high functionality excipient on the market. It effectively combines four individual components –

◆ Microcrystalline cellulose (filler/binder)

◆ Colloidal silicon dioxide (glidant)

◆ Superdisintegrant

◆ Lubricant

SOLV® EASYtab requires only blending as compared to conventional granulation techniques. This leads to less dust generation and significantly lower cleaning and change over gaps between batches.

◆ Better flow properties

Favorable particle morphology imparts excellent flow property when compared with physical mixture and blends.

◆ Better coating process and film

uniformity

No possibility of segregation of individual excipients due to the composite nature. The porous surface helps adhesion of micronized API particles and hence improves uniformities in blend and finished formulation.

Following table shows results of low-dose API (0.6%) formulation with direct compression process, which shows

As compared in above image, PROSOLV® EASYtab is not a simple physical blend. Instead, it is spray-dried, uniform, lubricant-coated high functionality excipient composite. Compounding with PROSOLV® technology leads to homogenous distribution of individual components throughout the particle and on its surface. All the excipients maintain their chemical identities while synergistically providing increased physical and functional performances due to significantly increased surface area.

Due to this unique combination and favorable particle morphology, it is perfectly suited for dry mixing / direct compression applications. Advantages of using PROSOLV® EASYtab discussed in brief in subsequent section.

Benefits of PROSOLV® EASYtab

Process benefits

◆ Simple process steps

Processing with PRO-

satisfactory uniformity of dosage throughout the compression cycle.

◆ Improved compactability

Excellent compaction and lubrication attributes generated due to spray-drying manufacturing process result in tablets with good hardness, less friability at lower compaction forces.

◆ Smaller tablets

Lower excipient level needed when formulated with PROSOLV® EASYtab grades as compared to using individual excipients, which result into tablets with smaller shape and size.

◆ Rapid and consistent disintegration

adhesion to core

Its unique surface structure makes it ideally suited for film coatings, resulting in better film adhesion and crisp logo definitions.

◆ Blending robustness

If longer mixing times are required in order to ensure a good blend homogeneity, there is no risk of overmixing or segregation. This provides robustness in terms of blending times due to its all-in-one unique structure.

Formulation benefits

◆ Excellent blend and content

Intricately entrapped superdisintegrant particles ensure rapid and uniform disintegration and ultimately dissolution.

◆ Improved surface for coatings

Smooth unique surface helps to get tablets devoid of coating defects and uniform films for aesthetic and functional purposes as well.

◆ Better suited to pressure sensitive APIs, Enzymes and Probiotics

Mechanically robust tablets with lower friability produced at comparatively lower compaction and ejection forces when formulated with PROSOLV® EASYtab. This helps to get a better hardness for tablets with APIs exhibiting sensitivity towards hardness for disintegration and dissolution. It also supports to maintain viable cell counts for probiotics. There is no significant reduction in enzyme activity when Enzyme tablets are compressed with PROSOLV® EASYtab.

Cost benefits

◆ Low setup

Due to easy process of direct compression, there is no need of comparatively complex and energy consuming equipment line setup.

◆ Single inventory management

Being composite of four excipients, only single inventory to be maintained instead of multiple individual grades. The cost is also saved on raw material quality testing.

◆ Accelerated product and process development

PROSOLV® EASYtab is most suitable for direct compression applications; Hence, lesser process and formulation parameters needed to be optimized to finalize formulation and take it to market.

◆ Less number of batches for same output

When formulated with PROSOLV® EASYtab, batch size is proportional to blender size unlike equipments for conventional granulation methodologies. This leads to higher

SEM images of tablet surfaces.A.MCC,B.PROSOLV® EASYtab

Effect

hardness

Particle morphologyof Physical blend of individual excipients and PROSOLV® EASYtab

PHARMA PULSE

batch size resulting in less number of batches for same output; results in lower time, lesser testing.

◆ Higher outputs

Simpler process as compared to wet and dry granulation results in shorter processing time and higher production. It also shows lower die-fill depths due to better flow and density properties. This makes PROSOLV® EASYtab a choice of excipient for high volume formulations.

◆ Improved yield

Lesser number of unit operations results in much lower

process loss at every step.

◆ Low risk of batch failure

Converting conventional granulation process to dry mixing step minimizes person and process variables, which significantly reduces the risk of batch failure.

◆ Prolonged tooling and equipment life

With PROSOLV® EASYtab, sufficient tablet hardness can be achieved at lower compaction forces, which leads to prolonged life of tooling and equipments.

◆ Best suited for continuous manufacturing

Because of its all-in-one structure, blending uniformity and blending robustness, PROSOLV® EASYtab is best suited for continuous manufacturing process.

Other benefits

◆ Patient compliance

Smaller tablets formulated with PROSOLV® EASYtab may show better patient acceptability.

◆ Complete regulatory support

QnQ composition revealed for all PROSOLV® EASYtab grades. USDMF is available along with complete regulatory support.

Conclusion

Excipients have come a long way since powdered cellulose, particularly with the introduction of all-in-one excipients such as PROSOLV® EASYtab. Designed for direct compression, this excipient can achieve excellent functional tablet properties that cannot be achieved when adding the same components individually to a formulation. PROSOLV® EASYtab has some special benefits when used in continuous manufacturing applications too.

AUTHOR Krishnakumar Patel Manager, Technical Services, JRS Pharma, India Krishna.Patel@jrsindia.com

Combating HumidityChallenges in the Pharmaceutical Industry

Bry-Air’s Desiccant dehumidifiers ensure optimal conditions regardless of external environmental factors.Besides,they provide efficient dehumidification and meet the stringent GMPrequirements of the pharmaceutical industry

In the pharmaceutical industry, maintaining air quality is crucial for ensuring the safety, efficacy, and quality of products. Uncontrolled humidity can lead to numerous issues such as organic corrosion, biochemical reactions, and the germination of unwanted microorganisms. These problems can impair the accuracy and uniformity of pharmaceutical formulations and significantly impact the shelf life and effectiveness of medications.

During processes like powder milling and tablet compounding, excessive moisture can prevent effective grinding and alter chemical reactions. In tablet compression and coating, humidity can cause lumping, caking, and unsatisfactory coatings, which compromise the integrity and appearance of the final products.

Moist environments can affect the storage of sensitive materials like aluminum, leading to moisture entrapment. During packaging, especially in the fill-

During packaging,especially in the filling of dry powders and vials,moisture can cause adherence to conveyors and disrupt operations.Maintaining a controlled humidity is essential to ensure that the final packaged products retain their intended quality throughout their shelf life

ing of dry powders and vials, moisture can cause adherence to conveyors and disrupt operations. Maintaining a controlled humidity is essential to ensure that the final packaged products retain their intended quality throughout their shelf life. Bry-Air’s Desiccant dehumidifiers offer a robust solution to these challenges. These systems ensure optimal conditions regardless of external environmental factors. Besides, they provide efficient dehumidification and meet the stringent GMP requirements of the pharmaceutical industry. By integrating the dehumidifiers, pharmaceutical facilities can achieve consistent and reliable control over humidity, enhancing product stability and extending shelf life. This level of control is particularly crucial in the manufacturing of diagnostics, nutraceuticals, and injectables, where precise humidity conditions are required to prevent the degradation of highly reactive and hygroscopic materials.

Margo: Edge interoperabilityinitiative to unlockIndustrial IoT

Margo will define mechanisms for interoperability between applications,devices and orchestration software at the edge of industrial ecosystems

Arecently established open standard interoperability initiative called 'Margo' that aims to remove the main obstacles to digital transformation. ABB Process Automation and ABB Machine Automation (B&R) are among the founding group of industrial automation solution providers that are driving the initiative. Margo aims to unlock interoperability at the edge, a key layer of Industrial IoT ecosystems where plant data is transformed into AI-powered insights to drive efficiency and sustainability.

Margo initiative draws its name from the Latin word for 'edge' and will define mechanisms for interoperability between applications, devices and orchestration software at the edge of industrial ecosystems. It will make it easy to run and combine applications from any ecosystem member on top of the hardware and runtime system of any other member. Margo aims to deliver on its interoperability promise through a modern and agile open-source approach, which will bring industrial companies increased flexibility, simplicity and scalability as they undergo digital transition in complex, multi-

B&R Industrial Automation (A

Fig:

interoperabilityat

edge of industrial automation ecosystems,Margo will address keyroadblocks to unlockdigital transformation at scale

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