Express Pharma (Vol.15, No.7) February 01-15, 2020

VOL. 15 NO. 7 PAGES 64

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PACKAGING

Future of packaging in 2030

IT@PHARMA

Vivek Vig, Vice President – Healthcare and Life Sciences, Cybage Software outlines how IT and digital technologies 1-15 FEBRUARY 2020, ` 40

CONTENTS

Chairman of the Board Viveck Goenka

FUTURE OF PACKAGING IN 2030

Sr. Vice President-BPD Neil Viegas Asst. Vice President-BPD Harit Mohanty Editor Viveka Roychowdhury* BUREAUS Mumbai Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Prabhat Prakash, Tarannum Rana New Delhi Akanki Sharma Bengaluru Usha Sharma DESIGN Asst. Art Director Pravin Temble Chief Designer Prasad Tate

Pharma packaging is an ever evolving yet challenging segment of the pharma industry.Business insights from the last decade will help the industryin visualising the need of the sector with high reliability,sustainabilitysolutions with low-cost methods.Express Pharma presents the industry’s views and understanding.Its preparedness for the next decade | P18

PRE EVENT

RESEARCH

INFRASTRUCTURE

Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma

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Digital Team Viraj Mehta (Head of Internet ) Photo Editor Sandeep Patil Marketing Team Rajesh Bhatkal, Ambuj Kumar Debnarayan Dutta Ajanta Sengupta E Mujahid, Nirav Mistry Ashish Rampure PRODUCTION General Manager BR Tipnis Production Co-ordinator Dhananjay Nidre Scheduling & Coordination Arvind Mane CIRCULATION Circulation Team Mohan Varadkar

INDIAN SOCIETY FOR CLINICAL RESEARCH TO HOST 13TH ANNUAL CONFERENCE IN MUMBAI

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IIT HYDERABAD RESEARCHERS UNRAVEL WORKING OF A PROTEIN THAT REPAIRS DAMAGED DNA

HR P25:INTERVIEW

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ACG APPOINTS ALEXANDER ROBERTSON AS THE NEW CHIEF MARKETING OFFICER

Dr Saurabh Singh, Associate Professor, Ayurvedic Pharmacy Department, Lovely Professional University

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ABB AND B&R LAUNCH FIRST FULLY INTEGRATED MACHINE-CENTRIC ROBOTICS SOLUTION

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INTECH ADDITIVE SOLUTIONS LAUNCHES NEW INDIGENOUS RANGE OF METAL 3D PRINTERS

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OPTIMA AND QUALITY MACHINES ENTER INTO A COOPERATION AGREEMENT

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SYSDIG CLOSES $70M IN SERIES E FUNDING

GENOMEASIA PROJECT TO SEQUENCE HIGH-QUALITY WHOLE-GENOME DATA FROM ASIA

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Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, 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.

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EDITOR’S NOTE

2019-nCoV: A wake-up call

W

e enter a new decade with yet another new virus slipping past our defences. The virus, detected last December, is a novel Coronavirus (2019-nCoV), and was traced back to wild animals sold in a 'wet market' in Wuhan City, in the Hubei province of China. A month later, the death toll of the virus is mounting.

By January 29, 132 deaths have been reported ; 6074 laboratory-confirmed cases, including 16 healthcare workers. Cases have been reported from four continents: 13 countries in Asia, eight from Europe, eight from the America (five in the US and three in Canada) and Oceania (five from Australia).

Our precarious handle on infectious diseases is compounded by the pharmaceutical sector's disinterest in researching and investing in this disease segment as such diseases mostly infect developing nations and are self limiting as opposed to lifestyle diseases. But SARS, MERS and now 2019-nCoV, all from the same family of Coronaviruses, do not need visas to travel across boundaries from developing to developed nations. Will the death toll be severe enough for governments and companies to start taking notice?

Two reports on pharma investments in R&D offer hope, but also show that the pace of the pivot has to increase. The 2020 Antimicrobial Resistance (AMR) Benchmark, finds that more companies are moving to discourage the overselling of their antibiotics and antifungal medicines to doctors and other healthcare professionals. Most companies have a strategy to prevent antibacterial residue being released in factory wastewaters. Furthermore, pharma companies are sharing more data on where drug resistance is emerging.

Outbreaks like 2019-nCoV underline the need for more R&D investment in infectious diseases

But the Access to Medicine Foundation, which publishes the AMR Benchmark study, points out that the low profitability of antibiotics is leaving the world precariously reliant on a dwindling number of pharma companies to develop and manufacture them. Since the 2018 AMR Benchmark, two more companies – Novartis and Sanofi – have retreated from new antibiotics R&D, while two companies – Achaogen and Melinta – have filed for bankruptcy.

It is heartening that a company from India - Cipla features as a leader in the 2020 report because it is one of three companies to reportedly fully decouple its sales agents' bonuses from sales volumes – a significant step in mitigating against overselling of antibiotics which leads to irrational antibiotic use and subsequently AMR. The AMR Industry Alliance report shows $1.6 billion annual investment (in 2018) in AMR-relevant R&D. While there is some sustained investment in early R&D and diagnostics for AMR-related products (including antibiotics, antifungals, vaccines), and major strides in responsible manufacturing of antibiotics, low levels of investment for later and more costly stages of R&D for AMR-related products may mean that many promising early-stage compounds will never reach patients unless governments put in place new mechanisms and incentives for antibiotic development.

Thus it is incumbent on both governments and the industry to experiment with commercial models to tackle AMR as well as disease outbreaks like 2019nCoV. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

INTEGRATED MACHINE VISION

More than embedded Complete portfolio: www.br-automation.com/vision

Expanding the field of vision 8

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UV

IR

PRE EVENT

Indian Society for Clinical Research to host 13th Annual Conference in Mumbai Leading up to the annual conference, six pre-conference workshops have been scheduled for clinical researcher professionals, investigators and students on January 23rd

B

eyond New Regulations - Increasing Participation and Enhancing Patient Safety is the theme of the 13th Annual Conference of Indian Society for Clinical Research (ISCR) to be held in Mumbai from January 24-25.

Held against the backdrop of the New Drugs and Clinical Trials Rules, 2019 launched around a year ago, the event will bring clinical research professionals from academia, healthcare institutions, not for profit organisations and the industry together to deliberate on the road ahead for clinical research in India, as well as new and emerging areas in clinical research.

Dr V G Somani, Drug Controller General India, CDSCO, will deliver the Chief Guest ad-

dress. Dr Gagandeep Kang, Executive Director, Translational Health Science Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology (DBT), Ministry of Science & Technology, Government of In-

dia, will deliver the late Prof Ranjit Roy Chaudhury Oration.

“This year’s Conference provides the right opportunity for clinical research professionals to reflect on the year that has gone by and look forward at what more we need to be doing

to move the clinical research agenda in the country forward so that our patients have access to treatment for the many unmet medical needs in our country,” said Dr Chirag Trivedi, President, ISCR. He further added, “India has 16 per cent of

the world’s population and 20 per cent of the world’s disease burden and yet less than 1.2 per cent of global clinical trials are done in India (source: www.clinicaltrials.gov).” The Conference has four tracks covering Clinical Operations, Medical Writing, Biostatistics and Data Management.

Leading up to the annual conference, six pre-conference workshops have been scheduled for clinical researcher professionals, investigators and students on January 23rd.

The workshops will cover Real World Evidence, Risk-based Implementation Strategy, PV Audits and Inspections and Enhancing Site and Investigator Capability among other topics.

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CARCINOGENS UNDER THE SCAN As trace amounts of cancer causing contaminants continue to crop up in certain medicines, pharma companies are upgrading their testing methods and equipment to meet increased regulatory scrutiny. The result? Safer medicines but even thinner margins

By Viveka Roychowdhury

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I

t is now one and a half years since the carcinogenic contaminant N-nitrosodimethylamine (NDMA) was first detected in sartans in June 2018. The fact that high blood pressure medicines are prescribed for long time use, on a daily basis added to the risk that life long use of NDMA, even in trace amounts, was definitely more harmful than the occasional exposure to the carcinogen from certain food and environmental sources.

While global regulators alerted companies and distributors, pharma companies withdrew their stocks from circulation.

Once tests confirmed the presence, batches were recalled. The presence was found to be an impurity in API supplied by a Chinese API manufacturer, Zhejiang Huahai and linked to a change in the process of synthesis.

It was almost action replay in September 2019, when trace amounts of NDMA were found in rantidine, an anti-ulcerant, commonly prescribed and available as OTC brands as well. Unlike sartans, ranitidine is not prescribed for long term use. And unlike sartans, the contaminant is not part of the medicine but thought to have been formed during the testing process, when the high temperature required for gas chromatography-mass spectrometry (GC-MS) caused ranitidine to react with itself and form nitrosamines.

Though the US online pharmacy Valisure which detected this felt that there was evidence to suggest NDMA formation under these conditions in the human body, the US FDA did not believe this was the case. The agency said that GC-MS was the suggested testing procedure for nitrosamine impurities in sartans, not in ranitidine. For the latter, the US FDA prescribed an alternative liquid chromatography-high resolution mass spectrometry (LC-HRMS) method, which showed much lower levels of nitrosamine impurities than Valisure. NDMA and N-nitrosodiethylamine (NDEA) have also been found in pioglitazone, used to treat type 2 diabetes mellitus.

The aftermath A lot has changed since June 2018. Today, the understanding is that nitrosamines are expected to be formed during the manufacture of sartans, under certain conditions with certain solvents, reagents and raw materials. They could also form due to contaminated equipment or reagents, either present as contamination from previously used equipment or reagents. Thus the onus is on manufacturers to control and remove these impurities during the manufacturing process itself.

Voluntary recalls continue, the latest being Mylan's voluntary recall of prescription nizatidine capsules on January 8 due to possible contamination with NDMA. While regulators seek to diffuse patient fears, they are raising the bar for manufacturers. For example, the European Medicine

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cover ) Agency (EMA) has given companies six months (on or before June 19 2020) for the risk evaluation and three years (on or before December 20, 2022) for remediation, if any.

In turn, formulation companies as well as API manufacturers have changed their processes to be in sync. Thus the next two years will be about testing all samples for the presence of such impurities. How are companies in India coping with these evolving standards and increased risk mitigation?

In December 2019, the sartan market in India was worth approximately Rs 5069 crore, while the ranitidine market was worth approximately Rs 662 crore, according to data from AIOCD Pharmasofttech AWACS. Glenmark Pharma's Telma was the market leader among sartans, followed by Mankind Pharma's Telmikind and USV's Tazloc. Among ranitidine brands, Cadila Pharma's Aciloc was the market leader, followed by GSK's Zinetac and J B Chemicals & Pharmaceuticals' Rantac.

According to Dr Milind Joshi, President-Global Regulatory Management, J B Chemicals & Pharmaceuticals, "Most API manufacturers have taken steps recommended by the US FDA to bring down NDMA levels considerably below the prescribed level. Similarly, formulation manufacturers have also adapted their process to ensure that NDMA presence, if any, does not increase during the formulation manufacture and hence are able to comply with the limits that have been set by regulators internationally."

Dr Joshi emphasises that the company has taken all required measures to comply with regulations for the safety of Rantac, stressing that it was not banned by the regulatory authorities, and has been deemed safe by the standards applicable to ranitidine, set by the regulatory authorities in India and US. Referring to the new

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Formulation manufacturers have also adapted their process to ensure that NDMA presence, if any, does not increase during the formulation manufacture and hence are able to comply with the limits that have been set by regulators internationally Dr Milind Joshi President-Global Regulatory Management, J B Chemicals & Pharmaceuticals

The quality of drugs manufactured in India will come into greater scrutiny. This will potentially bring in a slew of new regulations, which will make it even more costly for Indian generic pharma companies to comply with rigorous monitoring, testing and reporting regulations, ultimately squeezing profit margins Khushbu Jain Industry Analyst, Transformational Health Practice, Frost & Sullivan

We have hired the services of an external laboratory, which is an added cost of Rs 1.20 crores TS Prasad General Manager – TS, Saraca Laboratories

standards, he points out that on December 20, the EMA announced that they are reviewing the limit that was earlier set for NDMA in ranitidine formulations based on the dosage and the duration of treatment.

He estimates that the permissible levels are likely to change (increase) significantly based on the duration of the treatment. Based on a daily dose of ranitidine product for a year, the level of NDMA may be 4.256 ppm against 0.32ppm followed cur-

rently. The US FDA's permissible limit of NDMA in ranitidine at 0.32 ppm means is that if a patient takes ranitidine daily recommended dose for 70 years, then 1 out of 1,00,000 patients have the probability of getting cancer.

The NDMA issue seems to add to the perception that industry has been cutting corners and regulators have been caught unawares, yet again.

As Khushbu Jain, Industry Analyst, Transformational Health Practice, Frost & Sullivan analyses, “Unfortu-

nately the NDMA contamination issue which first came to light in 2018 continues to trouble us in 2020 and has led to recall of several sartans and some antacids. FDA suspects the origin of the problem to be the reuse of solvent and/or change in materials used during the manufacturing process of the drug and/or change in synthesis route to a cheaper and higher-yielding route, but a more toxic one.

Intensifying competition and thinning profit margins in generics prompts manufac-

turers to introduce these changes.”

Referring to regulators changing the goalposts, she says, “Even though there are regulations in place to monitor the safety of these changes, often, analytical methods used by manufacturers are not adequate to accurately measure impurities/toxicity (especially when present in lower concentration). To compound the problem, Indian pharma is infamous for data integrity and data reporting which can, in theory, bring such issues to light before they create public health havoc.”

Long-term impact Jain points out that there are micro and macro bearings of this incident. In the micro sense, some companies have faced a setback in their product sales because of drug recalls across North America and Europe but some others have enjoyed opportunistic price increase. For example, Lupin, Aurobindo, and Macleods have taken a hit and saw stock price decline immediately after the recall (but recovered later as these companies enjoy a wide product portfolio insulating them from episodes linked to singular drugs), but companies like Alembic increased the prices of their sartans fivefold.

But in the larger scheme of things, Jain expects, “The quality of drugs manufactured in India will come into greater scrutiny. This will potentially bring in a slew of new regulations, which will make it even more costly for Indian generic pharma companies to comply with rigorous monitoring, testing and reporting regulations, ultimately squeezing profit margins.”

Equipment manufacturers have responded to the situation by partnering with clients to ease their pain points. For example, Shripad Joshi, Director – India & South Asia, PerkinElmer India informs that their team of expert application specialists have

developed robust analytical methods in collaboration with customers to address the challenging need of NDMA testing and analysis. “For example, we have a method that offers a readymade seven minutes run time with high sensitivity and reproducibility, while adhering to all the regulatory compliance requirements of pharma.”

The PerkinElmer QSight 120 UHPLC-LCMS/MS provides a comprehensive solution to quantify the presence of NDMA impurity in ranitidine and meets the limits set

by USFDA of 96 ng/day. In addition, Joshi says that the PerkinElmer Clarus GCMS with Turbomatrix Headspace and Autosampler is also a proven technique for determination of NDMA in sartans

and other drug products.

Other solution providers too ahve stepped up to the challenge. V Umasankar, General Manager – Pharma, Waters Corporation says that his company has developed an LCMS/MS method to investigate the final API and formulated products for the presence of all listed nitrosamines (nine compounds) in a single method.

Beyond sartans and ranitidine As regulators are concerned that nitrosamine and other impurities might be found/formed in other medicines as well, they have expanded the search to all medicines. The attitude seems to be, 'Let's check all corners and clean out all cobwebs

once and for all.'

But these efforts obviously come at a cost. The risk mitigation strategy has forced manufacturers, both API and formulators, to re-look and change the manufacturing process to bring down NDMA levels below the prescribed level. These changes, and increased testing have added to the cost, the timeline of the manufacturer, and also required the purchase of new equipment.

According to Dr Joshi of J B Chemicals & Pharmaceuticals, most companies in India use the LCMS to check for NDMA since LCHRMS testing devices are not easily available. As he explains, “The control strategy for NDMA involves various process parameters like

temperature, humidity and extra purification, additional time cycles and such, during API manufacturing and similar stringent controls during formulation manufacturing.”

He agrees that this is an expensive process but they want to ensure quality medicines for their patients and do not compromise on the quality and patient safety.

Similarly, on the analytical front, Dr Joshi estimates that most manufacturers have procured LCMS systems to detect NDMA, which cost “around few crore rupees” and ensure that each batch is tested for NDMA before releasing the batch to the market so that the quality of the final product reaching patient is assured.

The cost of compliance The nitrosamine scare has also put the spotlight on API manufacturers, and the push back from regulators and clients has forced them to clean up their act. Hyderabadheadquartered SMS Lifesciences India is one such API manufacturer, which undertakes contract manufacturing of APIs, and advanced or basic intermediates. Praveen V Talluri, Senior Vice President, SMS Lifesciences India explains that there are are two possibilities to explain the presence of NDMA in the product. First, the route of synthesis (or manufacturing process and raw materials used). And second, the possibility of contamination. According to Talluri, SMS Lifesciences India uses validated

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cover ) methods published by US FDA, LC MS/MS instruments to check levels of NDMA in the final product, intermediates and raw materials.

He specifies that his company has been manufacturing ranitidine in dedicated equipment for the last 30 years in a robust process which was capable of controlling NDMA within limits. “With controls and few modifications, we are able to consistently release material with NDMA less than 0.02 ppm (US FDA limit of 0.32 ppm) for the majority of the batches.” He too concurs that new expensive equipment like LC MS/MS, increase in the cost of analysis and other controls have increased cost of production.

Saraca Laboratories, another Hyderabad-headquartered API manufacturer, too adopted the prescribed LCMS/MS method for estimation of NDMA in ranitidine hydrochloride and is hence investing in new equipment. According to T S Prasad, General Manager – TS, Saraca Laboratories, the company is procuring AB SCIEX 4500 Qtrap model LC-MS/MS equipment for this analysis, which costs approximately Rs 1.80 crores.

As procurement of instruments and establishing new methods takes time, to avoid delay in analysis, Prasad reveals that the company has hired the services of an external laboratory, which is an added cost of Rs 1.20 crores.

Commenting on how much the increased risk evaluation and testing will cost API and formulation companies Joshi of PerkinElmer India said it largely depends on the range of products offered by the API companies who may have to take the precautionary measure to mitigate the risk of nitrosamine formation or presence during the manufacture of all medicinal products containing chemically synthesised APIs. Estimating a price to these measures, he says, “While LC MS/MS itself – a highly

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The good news for pharma companies today is the availability of many innovative technologies that can detect and quantify the impurities/carcinogens at very low levels. It is to their advantage and to the advantage of consumers globally that these new and advanced technologies are utilised to help drive better health quality and safety Shripad Joshi Director – India & South Asia, PerkinElmer India

New expensive equipment like LC MS/MS, increase in the cost of analysis and other controls have increased cost of production Praveen V Talluri Sr. Vice President, SMS Lifesciences India

Waters Corporation has developed LCMSMS method to investigate the final API and formulated products for the presence of all listed nitrosamines (nine compounds) in a single method V Umasankar General Manager – Pharma, Waters Corporation

sensitive high throughout an instrument – typically requires an initial capital investment in the range of $ 200,000-250,000, the total investment would vary depending on various factors at the customer’s lab. A typical GCMS with headspace sampler and auto sampler could cost around $100,000150,000.”

Confirming the same, Umasankar of Waters also points out that these high sensitivity instruments need proper regular maintenance

and trained man power to operate the systems. This adds around $25000 every year towards regular complete maintenance and analytical method life cycle management.

Learnings from the NDMA episode Talluri of SMS Lifesciences India says, “There is a possibility of NDMA impurity (which is commonly present in foods, beverages) to be present in many more drugs in future and the limits are

based on extreme caution based on lifetime exposure.

Hence manufacturing products well within limits ensures patient safety. An NDMA limit of 0.32 ppm (0.000032 per cent) is control of impurities at extremely low level which has ensured we investigate the entire process in great detail and deliver a product with the highest quality than ever."

He also believes that constant process, quality and compliance improvements are important to meet any new guidelines that can be

implemented in future.

Commenting on the perception battle, he opines that effective control strategy in all products related to NDMA impurity can be reasonably implemented and hence negative perception of products and the industry is not prudent. He also mentions that there is an opinion that in general, the benefits of the medicine outweigh any theoretical risk associated with nitrosamine impurities.

Prasad of Saraca Laboratories too refers to the negligible risk. Quoting from the 2018 ICH Guidance M7 (R1), according to which if people consume 96 nanograms of NDMA daily for 70 years, the probable risk of cancer would be 1 in 100,000 patients. He points out that the risk factor in consuming ranitidine is negligible, as a peptic ulcer drug is normally used for a few days/weeks/months and not lifelong.

As for other learnings, Prasad says, “As of now, pharma companies are not identifying unknown impurities of less than 0.1 per cent by considering ICH Q3A. However, to understand impurities like NDMA, we have to seriously look at all these impurities, irrespective of the guidance.”

Second, ICH M7 principles on mutagenic impurities do not seem to be sufficient for nitrosamines. Third, routine traditional methods for estimation of impurities by HPLC or residual solvents by GC are not sufficient to estimate impurities like NDMA and it needs new methods like LCMS/MS etc. Quoting from an EDQM release, Prasad says that NDMA levels should be fixed based on importance/ usage/dosage of individual medicines.

In the long run, Jain of Frost & Sullivan believes the solution lies in the digitisation of operations, tamper-free handling of data (employing blockchain for example) and adoption of best practices in the supply chain will become the mandate and a

key differentiator. “This will allow continuous monitoring of every process, easier compliance with regulations and restore stakeholder confidence (regulatory agencies, providers and patients) in the Indian industry,” she says.

It is clear that an increase in testing and tighter controls is the new normal. As Joshi of PerkinElmer India predicts, “The NDMA issue will push pharma companies to bring even tighter controls around their processes. This is applicable not only for the API manufacturers and the finished pharma products (FPPs) but also to the thirdparty service providers who work with pharma companies.

Even the slightest possibility of NDMA contamination should be ruled out by appropriate tests during the process itself. The EMA has requested that all the FPPs should be evaluated for the possibility of NDMA being present in all products containing chemically synthesised active ingredients. The testing processes will only become more strict.”

Umasankar of Waters points out that the NDMA issue has led to stringent regulatory guidelines and audits on all genotoxic impurities (GIs) and probable genotoxic impurities (PGIs) based on functional group. Besides testing the final product upto the trace level, he advises that the QC department of API manufacturers should now develop GC /HPLC methods for routine monitoring of GIs and PGIs during synthesis and prove how these impurities are purged out from the synthetic process.

These efforts will also have to meet data integrity norms.

For instance, the UPLC system from Waters, with single quadrupole mass detector, reportedly creates data with 21CFR11 compliance, with strict audit trails to ensure data integrity.

Concluding on a positive note, Joshi of PerkinElmer India says, “The good news for

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pharma companies today is the availability of many innovative technologies that can detect and quantify the impurities/carcinogens at very low

levels. It is to their advantage and to the advantage of consumers globally that these new and advanced technologies are utilised to help drive

better health quality and safety.”

Thus while compliance with the new diktats comes at a cost, the nitrosamine

contamination episodes have proved that the cost of noncompliance is even higher in the long run. viveka.r@expressindia.com

PACKAGING

Future of packaging in 2030 Pharma packaging is an ever evolving yet challenging segment of the pharma industry. Business insights from the last decade will help the industry in visualising the need of the sector with high reliability and sustainability solutions with low-cost methods. Express Pharma presents the industry’s views, understanding and preparedness for the next decade.

By USHA SHARMA

Serialisation is the buzzword transforming pharma packaging industry P

harma packaging is one such pillar for business development which has evolved and is still evolving in an accelerated pace. The motive has been defined differently from time to time from containment and protection, to branding to user-friendliness.

Now is the era where the business perspectives are driven through regulatory compliance, customer focus and environmental sustainability. So maintaining the same packaging should also be designed with a purpose to meet the mentioned perspective as

Serialisation is the buzz word transforming pharmaceutical packaging industry.

Evolving Product Composition – Rethinking Primary Packaging These days the focus is on biologic drugs. Most biologic drugs being injectables; glass is the logical choice for primary packaging. However, some biologic drugs are found to interact with glass, delaminate it, causing flaking. So, it is necessary to keep this in mind while developing the primary packaging.

Regulatory compliance

Customer focus and intelligent packaging

Regulatory changes are driving packaging innovation globally.

Track and trace of the products throughout the supply chain to address the counterfeit issues.

An ageing population and increasing life expectancy provides room for packaging innovation. While digital medicine with in-built sensors is making

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Shivaji Chakraborty, Assistant General Manager-Packaging Development, Fresenius Kabi Oncology

inroads in compliance monitoring and connected care, features such as daily dose markings on the pack are common, advanced features such as digital timers

and alarms on packaging reminding patients of the time for next dose are the need of the hour.

Accurate dosing and dose monitoring: Dose monitoring features in packaging are increasingly playing an important role in abuse deterrence as well as patient adherence. Simple metered dosing systems to calendar-enabled closure technologies tracking and counting pills as they are dispensed and send the data to a smartphone. Unitdose packaging with key drug details incorporated in every dose is gaining popularity in hospitals and clinics as a convenient and safe option, driving allied trends in packaging.

Tamper protection and Child Lock: With a high contribution of pharmaceuticals unintentional childhood poisoning,

need for child locking mechanisms is critical. Packaging industries continue to incrementally innovate in striking the right balance between making it inaccessible to children but not too difficult for elderly patients.

Several innovative packaging mechanisms are evolving in pharmaceutical packaging, including braille printing for blind people Sustainability: Lot of packaging waste generated gets dumped into ocean, destroying marine life. In the process, it is destroying the ecological balance.

Business will sustain with its people and mankind will sustain only with a safe and healthy environment. Packaging shall be designed in a way to meet the three main mantras Reduce, reuse and recycle.

Packaging has a profound impact across the entire supplychain T

he Indian pharmaceutical industry is undergoing significant growth. Even at current rates of seven to eight per cent CAGR, the industry’s annual revenues can grow to about USD 80 to 90 billion by 2030. As we enter in the new decade, pharma will continue to face the challenges from the past. Particularly, the globalisation of drug supply, delivering new product types, meeting demand from emerging countries, the rise of chronic lifestyle conditions such as obesity and diabetes, and the growing threat of counterfeit and falsified medicine.

To fullfil these requirements, the demand for pharma packaging products will rapidly evolve in the next three to seven years as portfolio diversification strategies translate to revenue realisation milestones.

This will drive expanded demand in several products categories across primary and secondary packaging.

uct safety and integrity 4. Increasing the focus on patient-centricity etc.

ANDA Filled by Indian generic companies – (December 2019) A- Solidoral doses B- Injectable C- Ophthalmic D- Others (Inhalation, topical, Transdermal etc.)

The above chart shows that about 85-90 per cent of the ANDAs held by Indian pharma companies are comprised of oral solids but there is a planned shift towards more complex molecules whose packaging is not only complex but also should be based on patient safety, patient compliance and patient convenience as well as patient-centric, intelligent and smart packaging for coming decade.

So, in the face of such disruption, we can expect some leading developments from Pharma packaging in the com-

ing decade.

A) Focus on patient safety, compliance and convenience The patient today has progressed from being the passive recipient of drugs to an active partner in the entire drug development process, right from the formulation type to the type of packaging. Digitalisation and

in drug delivery devices is a recent trend supplementing adherence packaging.

C) Device and self-administration

The global anti-counterfeit packaging is having significant demand due to strong growth in the pharmaceutical & healthcare sectors. The growing pharmaceutical and healthcare industry and an increasing number of counterfeit products in the market are the major drivers of the anti-counterfeit packaging market. The upcoming decade would be more dedicated to overt counterfeit options as the patient is the one who will demand genuine products.

Changing in hospital administration to self-administration process is increasing rapidly in the market. So, the medical devices are taking the leading role for the coming decade.

Soumyanath Mishra, General Manager- Packaging and Development, Mankind Pharma

awareness through social media have been the key driver of this change and the industry has been proactive in recognising the importance of ‘patientcentricity’, better to put as ‘customer-centricity’.

Some examples of patient safety, compliance and convenience pack ◗ Child-resistant packaging and Senior Friendly packaging ◗ Wallet pack ◗ Unit dose packaging with CR features. Unit dose packaging to avoid contamination of the drug product ◗ Child-resistant medication with timer or alarm caps

B) Smart Packaging and intelligent packaging

In the coming decade, there will be numerous changes within the pharma industry: 1. Increasing in the number of complex formulations 2. More active engagement in biopharmaceuticals 3. Increasing price pressure and competition within generics, regulatory changes and critical emphasis on the prod-

rised user tries to tamper with or force-dispense medication from the Smart Bottle, the device immediately neutralises the opioid.

Embedding advanced features into packaging such as sensing or wireless communication makes packaging ‘smart’ which can provide significant functionality. The packaging then becomes not only a way to protect and provide information on medicines but can add a whole host of extra functionality. The smart packaging can reduce supply chain losses through enhanced environmental monitoring and support improved patient adherence through smart adherence packaging.

For an example – Smart Bottle uses Biometric (fingerprint) authorisation to ensure that patients—and only patients—receive their prescribed doses of liquid opioid medications. If an unautho-

D) Connecting device A connected medical device can collect and store data about patient use and trace the effectiveness of a particular device and treatment to help them to do so.

Utilising connectivity in drug delivery devices such as injectors and inhalers, connected health solutions help pharmaceutical companies, healthcare professionals and patients, improve how people take their medication. In addition to medication tracking, these systems support patients through reminders, incentives and peer communities to improve disease management, medication adherence and, ideally, outcomes. Additionally to this, we hope the connecting device will be used for the emergency treatment of the patient in the coming decade with a secure channel.

E) Blow fill seal(BFS) for unit dose stérile product The inherent safety of the process, packaging sterile products under aseptic conditions without human intervention, has led the FDA to characterise Blow/Fill/Seal technology as an "advanced aseptic process", indicating its use as a preferred technology going forward for thecoming decade.

G) IoT (Internet of Things) Internet of Things (IoT) is gradually becoming an everyday reality in pharma, inventory and supply chain management being the biggest adopters. Amalgamation of IoT

H) Anti-counterfeit packaging

F) Serialisation and digitisation of the supply chain.

Serialisation is forcing businesses to move towards a more digital approach to data management as well as Anti-Counterfeit of drug products.

I) Optimisation of the cost and reducing the carbon footprint Packaging, while easy to overlook, has a profound impact across the entire supply chain.

It touches almost every aspect of the organisation. Most of the time it is never considered how packaging affects cost, handling, shipping, and more. Even the smallest of changes can save a manufacturer thousands of crores money per year while simultaneously reducing negative environmental effects. By taking a holistic approach to optimization through innovations that drive cost reduction and sustainability while maintaining the desired functionality.

In the era of globalisation, it would be a challenge for the Indian packaging industry to match the international standards, safety, patient compliance and quality. So the packaging industry has to upgrade more in research to have a holistic approach towards packaging that would go beyond the functional aspect of packaging.

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February 1-15, 2020

PACKAGING

Smart packaging which can communicate - an interesting avenue T

he past decade from 2010 to 2019 was phenomenal for the Indian pharma industry, which came out of regulatory and statutory challenges namely - increased and more stringent inspections by US FDA, issuing of warning letters and imposing import alerts.

Products-recalls due to quality issues mainly due to packaging errors. Serialisation requirements to start with DGFT followed by DSCSA, EUFMD and few other countries proposed.

This is a massive project for any organisation exporting to USA, Europe and Emerging Markets.

The Indian pharma industry triumphed from all these challenges and continued its reputation as ‘Pharmacy of World’. The quantum of role played in the implementation of serialisation by packaging technologists is commendable.

In the last decade, challenges gave ample experience and confidence to face the bigger challenges in the decade ahead. Some of the factors that will be influencing innovation in pharma packaging are: ◗ Diminishing patent expiry,

Chandiprasad Ravipati, Head – Packaging Development, Aurobindo Pharma

especially in solid oral and liquid oral dosage forms, but some bright scope in oncology therapeutic segment. ◗ Shift of focus to formulations of parenterals and other novel drug delivery systems where primary packaging and dose delivery packaging is big challenge. ◗ Sustainable packaging in its entire life cycle of package journey from initial designing, establishing safety, efficacy and cost-effectiveness. ◗ Followed by supply chain management, which includes

secondary and tertiary packaging meeting transportation until the final saleable pack is disposed. ◗ Catching the speed of IoT and using the technology for better information of the medicine, dosage, precautions. ◗ Instituting connectivity to each patient, retail and hospital pharmacists, understanding their needs and fulfilling them will play a pivotal role in making brand establishment by getting the patient loyalty. ◗ It’s a necessity to the pharmaceutical industry to dispel the bad propaganda done on the quality of drugs by Indian firms and infuse the confidence by practising of integrity and world-class cGMP. The challenges for the packaging industry will continue in the coming years as well and due to various demands. Reduction in manual interference and installation of more and more automation with corrected validation to completely eliminate packing and labelling errors. Increasing the speed of packing lines for better productivity will be addressed which needs accurate packaging

materials.

Meeting of US Pharmacopoeial standards <661> Plastic Packaging Systems and their Material of Construction effective from May 1, 2020 for packaging materials to meet overall perspective and establish with documented evidence that “The packaging system has been established to be safe by means of the appropriate chemical testing, such as extractables or leachables profiling, and toxicological assessment of the test data. This combination of chemical testing and toxicological assessment is termed “chemical safety assessment”.

It is one of the important responsibilities of pharma packaging technologists to facilitate 100 per cent transparency with packaging material vendors in translating the regulatory requirements and innovation.

They should play a role in participating in discussions with premier packaging academies who are nurturing future packaging professionals. The institutes should be aware of the needs and trends of pharmaceutical packaging. Another

important task is to develop pharmaceutical packaging engineering expertise in line with leading FMCG, as more and more automation with proven efficacy is the need of the future.

Another avenue is smart packaging which can speak to the patient and even able to listen. It will induce a level of psychological impact, wherein the same drug product can do wonders especially in a critical and prolonged illness. The current form of patient information or medication guides can be replaced by easy ways of audio-visual communication with advantage of smart phones.

Packaging can play a commendable part in e-pharmacy that is gaining popularity in India.

It’s going to be tough with so many geographical factors, millennials ruling world, technological advancement and ever-increasing regulatory demands, but there lays the beauty of the profession. Only those with heritable traits better suited to the environment will survive and not the strongest.

Use of AI and IOTconcepts for smart packaging will be on the rise P

harma Packaging is likely to go through a major transformation in this decade.

On the domestic front (Indian market), the shift is majorly towards affordable medicines for the masses in India.

With such a large population below the poverty line, the government’s efforts will be towards providing medicines at minimal costs to the masses.

This will call for cost-effective, simpler packaging. The shift will be towards Janaushadhi supplies, Government tenders, and institution supplies. These would also require some levels of traceability hence barcoding may be expected.

At the same time with India growing to be a major economy, there is a growing elite, educated patient population.

20 EXPRESS PHARMA February 1-15, 2020

Hence smart packaging concepts, use of AI and IOT concepts for packaging machines will be on the rise! Packaging that will help in patient compliance - a combination of digital solutions and smart packaging solutions will be essential to fulfil the needs of such customers.

Moreover Hospital tourism is a fast-growing area in India and hence doctors would need to communicate with patients across the world! This would call for the use of digital technology for patient compliance.

With the government becoming conscious of counterfeit and spurious medicine and wanting to curb the menace, the serialisation and traceability of domestic Pharma products also seems to be in the pipeline.

This increases the challenges

Tripti Nakhare, Sr. General Manager-Regulatory Affairs & PDD, FDC

for the Pharma industry. The service providers are however ready ad many vendors are now available for the same.

In the global scenario, serialisation and traceability are fast becoming the norm! Most countries are wanting this serialisation and traceability so having multiple software to fulfil each country requirement on each line is going to be a challenge and at some point will have limitations!

There will certainly be a shift towards automation and robotic controls. The continuous regulatory changes and demands of the inspecting authorities are leading to the growing need for lesser human interventions and increased automation. The regulatory requirements on packaging materials are increasing with the requirements like elemental impurities, recent USP chapter on plastics in packaging need

to be attended to. The vendors need to upgrade themselves to meet the growing regulatory requirements for packaging.

With the awareness to nurture the environment and reduce the damage already done due to the industrialisation, the reduction in the use of plastics will require the development of environment-friendly biodegradable packaging materials. With growing digitisation, need for Good Distribution Practices, the pharma supply chains will undergo a major transformation and hence will impact the packaging community.

Next decade – an era of ecofriendly, cost-effective, innovative Pharma packaging with an increased use of AI in the equipments!

PACKAGING

Markets have started accepting newer packages P

harmaceutical packaging is going to be a breadwinner next year. The Indian pharma industry has stedaliy grown year after year. The average growth of drug industry could also have been maintained due to certain factors like molecules going off patent, new markets opening up for manufacturers or some time it is addition or extension of product pipeline with genomics, cell therapy or biologics etc.

As the pharma industry is growing with a rapid pace, the packaging industry which is an integral part of this pharma business worldwide has to make a fortune. In most of the cases, the product goes with packaging and gives equal opportunity for growth, however, people/ manufacturers associated with hardcore packaging material, find this industry a challenge but at the same time, it is very interesting as well. As the world is coming closer, newer technologies worldwide are available to everyone. Still we find there are preferred packaging styles and requirements in each market. For example, in the US they prefer to have bottle packs whereas typical commonwealth nations in-

cluding the EU prefers blisters.

It depends on habits, distribution system and even the weather conditions prevailing there. However, as compared to the last decade, markets have started accepting newer packages, thereby reducing the cost and number of SKUs for the manufacturer.

In the coming decade, there is every possibility that the manufacturer can offer a single type of SKU for all markets depending on volumes and market penetration. Hospitals have started preferring unit dose blisters and this can be one of the areas where smaller or emerging markets, including Asian markets, adapt to this type of packaging with small batch manufacturing concept.

For example, Myanmar does not specifically ask for unit dose blisters or with cross perforations, however, they ask to print a batch detail with every tablet or capsule in blister.

In India, we already have a concept, as the chemist cuts a strip, even to single unit, as required by the customer and do not bother if remaining the part has the batch number printed on it. This concept of having batch identity on each pocket

Ajay Bapat, Pharma Packaging consultant

should pick up here as well. In my opinion, the coming decade may be the decade of compliances as regulators across the world are coming with newer guidance and complying to them will be a challenging job for packaging engineers, be it related to primary packing materials or labelling.

One of the major compliance is going to be related to serialisation or a job related to anticounterfeit issues. The supply chain needs to be made more secure and packaging plays the most important role in making it more difficult for counterfeit-

ers to eat in our product share.

As such in major markets, serialisation, in one or other format is being worked out and in a regulated market, it is already been implemented.

The coming decade will have a major say in the aspect of how to make it more secure and whether the digital identity that is recognised as of today is enough or to have a combination of technologies of physical identity along with existing digital technology will make it perfect security. Making use of big data from serialisation with blockchain technology should be helping in a secured supply chain.

The coming decade is going to be dominated by devices; a packaging suitable and complimentary to these new devices will be a challenging job.

All of us have already started working on patient-centric packaging and as a medium of communication; it is packaging, which is going to play a major role.

With customer-centric features of the new decade and pharma companies as customers, even the packing material manufacturers will have to work on very attractive, sus-

tainable and at the same time a cost-effective options. With the growing availability of information and awareness of intellectual property, the new material being developed in this decade will surely be covered under IP. Worldwide, next decade, the buzz word is going to be sustainability, and what else other than pharma packaging is going to make it happen.

Of course, FMCG or retail markets with e-commerce will attract most volumes but pharma is not going to be lagging behind.

More and more companies have started working on automation and increase in productivity. The material that is being used also has to support these functions. So a chalta hai attitude will have to be kept aside and all of us will have to work with most precise and perfect material development.

With all these aspects in mind, a pharma packaging engineer or personnel involved in material development will have the most interesting, challenging and a decade demanding them to use the best of the skills, knowledge and aptitude.

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PACKAGING

Anicelypacked product can become USPfor marketing T

he pharma industry itself is undergoing radical changes since beginning, more so since the last two decades.

Naturally, in the coming decade, 2020-2030, there are going to be very fast and innovative changes in therapies, products, formulations, technology and consumer awareness, government rules, regulatory and digitalisation etc.

These changes are bound to have an impact on pharma packaging rapidly. Hence, the road ahead is challenging and equally interesting.

Obviously, in these revolutionary days, every pharma company will need to define its own road map depending on its vision, goal, size, capabilities, consumer base and policy to accommodate/adapt changes.

And yet will need to be in line with above mentioned innovative changes in their products as well as packing.

Vision for policy decisions Scientific, technological and socioeconomic changes will revive the industry’s fortune in the coming decade. To capitalise on these trends, companies will need to make crucial decisions and prepare their own growth plan, considering their strengths and weaknesses.

When we peep in the vision window, it is seen that the mar-

ket is going to be double in the coming decade of 2020-2030. If we look at India’s pharma market, the existing market will increase plus, we will explore new market places like China, Japan and uncovered countries. To cope up with this high-speed demand, pharma packing also has to be in place.

At the same time, packing systems will have to be actively capable in operations. Thus, the need will be to quickly design, develop, improve and implement the pack as per changing demands from global market. Artificial intelligence with medical robotic devices will also be in practice for perfection.

As perceived, the following factors will dictate packing types, forms, styles, designs etc. – ◗ New molecules — Looking at the current ongoing research on health issues and remedies, new products may not be only in conventional forms. New forms like dermal patch strip, sublingual tablets, new product delivery systems etc. can be innovated by researchers.

This will lead to the development of suitable primary and secondary packing, for every new formulation and dosage. ◗ Innovations in packing material — Though existing packing materials may continue, as an evolution process, innovative materials will be intro-

The formula for those who formulate the pharmA sector.

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EXPRESS PHARMA

February 1-15, 2020

ture recorders used, will also be suitably changed while packing the product

Challenges to pharma packing

Mohan Mone, Consultant, Pharma & Vaccine Packing Systems and Innovations

duced considering new regulatory requirements, costs, pack cosmetics, sustainability, etc.

New packing machines for more productivity, styles will define pack type and material to use. ◗ Increasing consumer expectations — Patient-centric marketing trend will be fundamental, for adopting product suitable packing. Consumer demands like easy-to-use/ handle, informative, the economical yet attractive pack will continue forever. ◗ Regulatory requirements, government rules and digitalisation — Health awareness and researches are compelling regulatory authorities to revise the rules suitably. In turn, the primary packing material, printed Matter, type of track and trace systems, tempera-

◗ Industry focus is likely to change from treatment to prevention. Time has come to have quick inline testing and approvals of developments in packing material and systems; maybe in collaboration with regulatory. ◗ Regulatory authority and Q.A. concerns for reusable/ recycled packing material will have to be considered during developments. Changes anticipated are something like, usage of non-plastic, non-hazardous, environment-friendly packing materials. QMS Guidelines will be more stringent with primary packing material manufacturers like rubber, glass, aluminium, plastic items. ◗ Pharma co-vigilance systems are rapidly changing all over the globe. A pack look is the first point to create faith in the product. This necessitates proving genuineness, correctness in pharma packing material. Perfect identification of product will be a must. ◗ To develop and standardise process for quick changeovers and maintain balancing between flexibility, reliability, consumer friendliness and cost will be one of the major headaches in the decade.

Aspiration for pharma packaging It is rightly said that every challenge is an opportunity to grow. Challenges can be converted into an opportunity if you rightly and timely handle them. ◗ Growing market — If the packaging is up to the standard or better and meet the demand, a pharma company can grab more share and increase the company’s turn over. Veterinary products, vaccines are the fast-growing segments in the market place. ◗ Packing machines / material innovations - If you are the first bird in a new introduction, you can increase productivity and also attract doctors and patients. ◗ Smart packaging — This does not mean only more productivity or innovative pack; but also includes compatibility with digitalisation, meeting regulatory requirements and other things that will make your product superior to other products from the range.

A nicely packed product can become USP for marketing. To conclude, those pharma companies, who accept and overcome the challenges in most appropriate originality, have high chance to offer real value to their customers and be successful in this competitive world.

Express Pharma has been the backbone of this sector since 20 years. It is what the experts look to when the entire industry looks to them.

That is because the magazine contains a potent mix of innovative ideas, cutting-edge analyses and expert insights. It’s no wonder then that the finest in the field trust the foremost in the field.

For any queries, call 022-67440000/22022627 or email at healthcare@expressindia.com.

IT@PHARMA I N T E R V I E W

'To harness the full value of digital transformation there must be a structured methodology in place' Cybage Software, a global technology consulting organisation is partnering with the life sciences organisation to spur a enterprise-wide digital transformation. Vivek Vig, Vice President â&#x20AC;&#x201C; Healthcare and Life Sciences, Cybage Software outlines how IT and digital technologies will be crucial for progress in this sector and details how to harness the full value of these transofmrational technolgies and the role that Cybage can play in this tech-driven era, in an exclusive interaction with Lakshmipriya Nair

As the pharma industry evolves to meet changing consumer needs and stringent regulations, tell us how will investing in IT and digital technologies become essential for sustenance and growth?

New age digital technologies can make immense impact on each step of the drug discovery process. We already see a lot of niche start ups trying out AI driven solutions in the early drug discovery process specifically focusing on information aggregation, synthesis for target identification, deep learning strategies for compound screening, and lead identification.

Investing in IT and digital technologies will only increase the efficiency and reduce the time to market by using machine learning techniques for subject identification in the clinical trials, ensure deploying AI solutions on risk based clinical trial monitoring and intelligent interventions.

Likewise, use of mobile platforms for patient engagement and data collection (e.g. apple research kit) will further enhance proficiency in the patient

reported outcome process.

Similarly, application of digital technologies will be prominently evident on other aspects of pharma industry including manufacturing and supply chain, regulatory compliance, marketing and outreach, human resources, finance, patient engagement.

The right governance model could prove to be the single most important contributing factor towards the success of a digital transformation initiative

What are the crucial steps to navigate and effectively harness the full value that digital technologies can bring to the pharma sector?

To harness the full value of digital transformation there must be a structured methodology in place. The first step which any pharma or life sciences organisation should do is perform a comprehensive digital audit. This involves understanding the business vision, auditing the existing technology landscape, and considering the companyâ&#x20AC;&#x2122;s digital initiatives. Once the gap is identified, then the next step is prioritising the areas of investment. Post prioritisation an overall digital transformation roadmap can be created, with clearly defined milestones.

Having said that, the right governance model could prove

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IT@PHARMA to be the single most important contributing factor towards the success of a digital transformation initiative.

This entire initiative needs to be backed by the CXO office with clearly defined milestones, complete ownership and accountability.

Regular review with course corrections will steer the initiative in the right direction.

Finally, pharma companies must focus on building the right infrastructure (cloud, analytics, IoT etc.) to execute the plan. It is very important that at all stages, pharma companies ensure that they always own their data and that it is not locked in proprietary vendor systems.

How can Cybage collaborate with the pharma sector to drive the trend of valuebased medicine? Which are your major areas of focus?

Value-based medicine as an economic/risk sharing model is witnessing a lot of interest from all stakeholders. It is in the nascent stages and is incredibly tricky to implement.

That is because success or the value impact of a given medicine depends on a myriad of factors including the genetic profile of the patient (pharmacogenetics), the severity of disease, patient behaviour, social determinants (geography, ethno-economic profile etc.) and so on. There are a lot of unknowns making it a controversial subject in medical fraternity.

We at Cybage, believe that the paradigm of value-based medicine is best suited to personalised medicine where all contributing factors from genealogy to social determinants of health have been taken into consideration.

That said, we acknowledge that pharma organisations will face pressure from insurance organisations to have a portion of payments tied to their performance. This is mostly observed for high cost drugs or for a care episode in an acute care setting.

To help thrive in the valuebased era, Cybage can guide pharma companies towards building up the right tool sets.

This includes implemented statistical modelling, MLbased solutions to implement predictive risk or pricing models, patient engagement platforms, m-health applications, and data interoperability pipelines with hospitals amongst others.

There are reports which reveal that investments made in emerging technologies are yet to see substantial benefits.

What is your take on this issue? To what extent is it deterring the adoption of these technologies in the life sciences industry?

Yes, the investments made in emerging technologies are yet to show substantial results, however, there are some patterns and learnings which can be leveraged. The most important of them is the novelty vs utility aspect. It is

when the novelty of the solution gets more importance than the practical utility of it.

It is more like a solution waiting for a problem. A prime example in this case is the Proteus digital pill. While the technology is undoubtedly cool, its use case is not strong enough for adoption.

The next issue is preparedness. It includes the organisations, the partners, and the entire ecosystem. For e.g. blockchain based supply chain solutions. Undoubtedly it is a futuristic smart technology, but successful implementation needs technological maturity across the value chain, which is difficult to implement.

The other issue is the limited advancements in basic science. As much as technology can make an impact, it still is largely constrained by advancements in basic science and clinical research. And a clear case of this is Theranos, where science did not support the idea to carry multiple tests with a single drop of blood.

Pharma organisations recognise that innovation is the way ahead, so we don't see any long-term deterrence in its adoption.

Can you elaborate on the cost advantages that could be generated annually through adoption of digital technologies?

The cost advantages of adopting digital technologies

depend on the profile of the pharmaceutical organisation and their ecology of operations. In certain cases, it could be tricky to calculate.

A cost advantage sometimes could be as simple as direct savings due to operational efficiency introduced. Say gains due to supply chain optimisations or just-in-term pricing. You could benchmark the current operational costs against the previous reporting period and easily arrive at cost benefits and consequently calculate the ROI. But let’s take the example of the compliance management system. An investment in a robust compliance management system that uses ML-based intelligence to identify potential noncompliance hot spots will greatly reduce the risk. But evaluating the reduced risk often leads to an academic exercise.

That said, it is very important that all IT investments are tied to concrete business outcome parameters. The least that a pharma organization should have is a defined metrics to capture process efficiencies, business outcomes, and IT investments.

What are the factors which will drive the future IT trends in pharma? How is Cybage poised to drive these trends and leverage the growth potential and

opportunities that would arise?

One of the primary trends is ‘personalised medicine’. With the advancement in omics, we have now a better understanding of biopathways of medicines and how they impact diseases. Particularly in high impact therapeutic areas like Oncology where companies like Novartis have made remarkable advancements in creating personalized intervention therapies. Pharma companies will continue to leverage advancements in omics research throughout drug discovery and delivery value chains.

It will be fair to say that pharma organisations have embraced the centrality of data in any digital transformation initiative. We expect to continue to see inhouse investments in clinical and non-clinical data repositories, big-data technologies, ML solutions and so on. Similarly, there will be continued focus on figuring out best data-driven strategy to engage patients using mobile, IoT and other emerging technologies.

Cybage with its technology and domain expertise is best poised to not only build technology solutions for pharma organisations, but also offer consultation services in deciding the right IT strategy for the right trade-offs. lakshmipriya.nair@expressindia.com

Express Pharma has been the backbone of this sector since 20 years.

It is what the experts look to when the entire industry looks to them. That is because the magazine contains a potent mix of innovative ideas, cutting-edge analyses and expert insights. It’s no wonder then that the finest in the field trust the foremost in the field.

The stimulant for those who stimulate the

pharma www.expresspharma.in

24 EXPRESS PHARMA February 1-15, 2020

. sector

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RESEARCH I N T E R V I E W

â&#x20AC;&#x2DC;Asava is a well-known traditional fermented biomedicine in Ayurvedic pharmaceutical sciencesâ&#x20AC;&#x2122; With Asava now becoming sugar-free, it will open the doors for diabetic patients in India to benefit from these Ayurvedic medicines, informs Dr Saurabh Singh, Associate Professor, Ayurvedic Pharmacy Department, Lovely Professional University to Akanki Sharma Share a brief about the sugar-free Ayurvedic Asava for diabetics that you have developed. When did the process start and end?

The 'novel sugar-free Ayurvedic Asava' is a new fermented biomedicine developed for diabetics.

Asava is a well-known traditional fermented biomedicine in Ayurvedic pharmaceutical sciences. It forms the base for several Ayurvedic medicines for treating large human body systems like the nervous system, blood circulatory system, respiratory system or even excretory system.

However, diabetic patients are reluctant to use these products due to the higher percentage of sugar/jaggery and honey present in them. In India, the diabetic Mellitus disorder is found among 72.9 million people. Considering a large number of diabetic patients, we decided to conduct several studies and developed the novel sugar-free Ayurvedic asava formulation which is suitable to them.

The fermentation process of sugar-free asava formulation and composition is completely different from the traditional asavas. It has been prepared using anti-diabetic herbs as its fermenting initiators instead of sugar, jaggery or honey, which makes it safe for consumption by diabetics. The formulation can be directly consumed by

Sugar-free Ayurvedic Asava has been prepared using antidiabetic herbs as its fermenting initiators, instead of sugar, jaggery or honey, which makes it safe for consumption by diabetics

conducted? What was the size of this trial? How many people were involved, what were the conditions, etc.?

Clinical trials were not required as the chosen ingredients are clinically safe on the basis of an official compendium like - Ayurvedic Pharmacopoeia of India, Ayurvedic Formulary of India and the traditional texts of Ayurveda.

However, we conducted the pre-clinical trials using streptozotocin-induced antidiabetic models on Albino Wistar male rats. The biochemical tests related to kidney, liver and pancreas function were performed and the formulation was found to be very effective. The experimental protocol was approved by the Institutional Animal Ethics Committee of the School of Pharmaceutical Sciences, Lovely Professional University.

patients with or without water.

With Asava now becoming sugar-free, it will open the doors for diabetic patients in India to benefit from these Ayurvedic medicines. The formulation will be beneficial for diabetic management and other associated problems like weakness, fever, cough, cold and headache.

We started this research in 2012 and filed a patent to protect the IPR. After that, we

What challenges came your way during the process and how did you overcome them?

We faced challenges during the fermentation process of the formulation. It was difficult to get the required amount of alcohol without adding the traditional fermenting initiators like jaggery/sugar.

However, we succeeded in generating the required amount of alcohol with the help of anti-diabetic herbs which makes this formulation

focussed on the major area of research work which includes product development, process validation, finished product analysis and pre-clinical trials.

We completed all of these activities within three to four years. In August 2019, the Government of India has finally granted the patent after completing the examination.

When and where was the clinical trial for this product

different from traditional asava and arista.

For commercialisation of this product, which pharma companies are you in touch with? Which regions are you targetting?

We are in talks with a few Ayurvedic/pharma companies like Multani Pharmaceuticals, New Delhi; Shree Dhanwantari Herbals, Amritsar, Punjab; Shree Ayurved Sevasadan, Firozabad, Uttar Pradesh and Sri Herbasia Biotech, Amritsar, Punjab for the commercialisation of our product.

What will be the cost of this product? And, can there be any side effects, too?

The cost of 225 ml novel sugarfree Asava formulation will be approximately Rs 140. As far as side effects are concerned, we used only natural ingredients to make the formulation and there were no side effects reported during the pharmacological evaluation.

What all steps are you taking to validate your research?

Any support from the Government of India?

The Government of India has granted the patent to Lovely Professional University for novel sugar-free asava formulation and its process of preparation. akanki.sharma@expressindia.com

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RESEARCH

IITHyderabad researchers unravel working of a protein that repairs damaged DNA Researchers are seeking to understand the workings of the DNA damage repair proteins. Certain types of chemicals produced naturally in the body can cause damages in DNA and, if not fixed fast, may trigger cell death RESEARCHERS at Indian Institute of Technology Hyderabad have unravelled the working of a protein that repairs damaged DNA. Nature has evolved techniques to not only protect DNA, but also to repair damaged DNA so that catastrophic damage can be averted. In humans, one such repair mechanism involves activation of a special class of proteins called ‘DNA repair proteins.

With increasing awareness of the impact of DNA damage on almost all diseases and maladies, there is a worldwide effort to understand how these repair proteins work, both as an academic exercise and as the foundation for therapeutic interventions.

The research team is headed by Dr Anindya Roy, Associate Professor, Department of Biotechnology, IIT Hyderabad. The Research was funded by Science and Engineering Research Board (SERB), Department of Science and Technology, Government of India.

The results of the study, conducted in collaboration with Dr Arun Goyal, Professor, Department of Biosciences and Bioengineering, IIT Guwahati, has been published recently in the reputed peer-reviewed journal Nucleic Acid Research. The published paper has been co-authored by Dr Anindya Roy, Dr Arun Goyal and research scholars, Monisha Mohan, Deepa Akula and Arun Dhillon.

What makes matter a living being, be it a bacterium or man is the DNA. DNA is the blueprint of the life-form and encodes the directions that the life-form must take in order to become a bacterium, rose, lion

26 EXPRESS PHARMA February 1-15, 2020

or man. It is thus essential for the survival of every cell and is usually kept well protected within the nucleus of cells, and in some non-nuclear parts like the mitochondria.

Any damage to DNA can result in outcomes that can range from unperceivably mild changes, such as the sudden appearance of a harmless mole, to serious diseases, such as cancer. The retention of DNA integrity is therefore essential for proper function and survival of all organisms. Protection of DNA is daunting because of the possibility of dam-

age by external sources and the intrinsic instability of DNA itself.

“Our laboratory at IIT Hyderabad seeks to understand the workings of the DNA damage repair proteins. Certain types of chemicals produced naturally in the body can cause damages in DNA and, if not fixed fast, may trigger cell death”, explains Dr Roy. A doctoral student in his laboratory, Monisha Mohan, discovered the mechanism by which these DNA repair proteins assemble when DNA is under threat. They studied

the action of one specific protein called alkB homolog 3, or ALKBH3. It has been known that ALKBH3 repairs alkylated DNA containing 1-methyladenosine and 3-methylcytosine through oxidative demethylation, but the mechanism has hitherto remained unclear.

Dr Roy and the research team have unravelled the mechanism by which ALKBH3 brings about demethylation.

“We have found that ALKBH3 has a direct protein-protein interaction with another protein called RAD51C and this inter-

action stimulates ALKBH3-mediated repair of methyl-adduct located within 3'- tailed DNA”, adds he said on the technical aspects of their discovery. The team is fascinated by the universality of the mechanism – it is just as applicable to the bacterium as it is to human beings.

“The knowledge gained from our studies might, in the long term, be beneficial from a cancer therapeutic perspective”, hopes Dr Roy as his team proceeds with work on understanding how DNA repair works.

EP News Bureau

RESEARCH

GenomeAsia project to sequence high-quality whole-genome data from Asia Study conducted under the project provides a useful genomic resource which will facilitate genetic studies in Asia including India HUMAN GENETIC studies taking place across the world have minimum representation from Asian population groups.

Most of these studies have been performed on people with European origin. Now, discovery and genetic association found from the European population can not necessarily be translated to non-European population group. This limits the researchers in understanding human diseases accurately for the non-European population, including those from Asia (which represent 60 per cent of the global population). Recently, there has been slight improvement in non-European studies but still, it remains highly underrepresented. The goal of the GenomeAsia consortium is to sequence highquality whole-genome data from Asia and make it available free for the scientific commu-

nity and industry.

As part of the pilot project, GenomeAsia 100K consortium has published a research study covering 1,739 individuals of 219 population groups from 64 countries across Asia. The samples included 598 from India, 156 from Malaysia, 152 from South Korea, 113 from Pakistan, 100 from Mongolia, 70 from China, 70 from Papua New Guinea, 68 from Indonesia, 52 from the Philippines, 35 from Japan and 32 from Russia.

This study provides a useful genomic resource which will facilitate genetic studies in Asia including India. More than 20 per cent of genetic variants identified in this study are not reported in previous studies. For eg, HBB variant (chromosome 11: 5248155 c.92+5G>C) associated with ß-thalassaemia is found in south Asians and is at a lower frequency in southeast

Asians. This study will also improve the identification of pathogenic variant for the rare diseases more accurately. The complex history of Asian populations and population structure has also been reported in this study. The population group from India, Malaysia and Indonesia consists of multiple ancestral populations as well as

multiple admixed groups.

In several clinics globally, the recommendations for dosing of certain drugs are guided by apparent or self-reported population identity. In this study, the authors assessed the allele frequencies of key pharmacogenomic variants in the GenomeAsia dataset to identify inter-population differences that have potential implications on drug testing and treatment.

Interestingly, the study has identified drugs such as carbamezepine, clopidigrel, peginterferon and warfarin as the drugs with the largest impact on genetic variation related to ethnicity, and has predicted adverse drug responses in several population sub-groups. For example, a genetic variant in HLA-B gene is associated with risk for development of Steven Johnson syndrome in patients treated with carbamazepine

was found to occur at an increased frequency in Austronesian group people (~400 million) from Indonesia, Malaysia and the Philippines. Also, the study assessed the allele frequencies of key pharmacogenomic variants to identify inter-population differences that have potential implications on drug testing and treatment, and these novel findings can help the Pharma industry to reduce time and investment in their research while assessing the efficacy and toxicity of new drug development. In addition, the GenomeAsia has deeply catalogued population-specific genetic variants in “very important pharmacogenes” (VIP genes) such as VKORC1, IFNL3, CYP2B6, CYP2D6 and CYP2C19, affecting dosage, efficacy and toxicity of associated FDA approved drugs.

EP News Bureau

New possible strategy for treating chronic pain due to burns may help sufferers including veterans This research suggests that burns cause changes to neurons in multiple parts of the spinal cord, even far from the injury site, which can contribute to chronic pain and other long-term complications NEW RESEARCH shows how second-degree burns cause hard-to-treat chronic pain, and this understanding may be key to treating these complications, common in war veterans This research, published in Physiological Reports, suggests that burns cause changes to neurons in multiple parts of the spinal cord, even far from the injury site, which can contribute to chronic pain and other longterm complications.

Second-degree burns initially only affect layers of the skin, specifically the top and second layers. More than 11 million individuals per year around the world suffer burn injuries severe enough to require hospitalization and longterm care.

Treatment of burns normally entails localised treatment at the site of the burn, but this doesn’t address problems that the burn may cause in other parts of the body, such

as the central nervous system (brain and spinal cord), which is crucial for fully treating the burn and possible neurological complications, such as neuropathic pain.

Siraj Patwa and his colleagues at Yale University and the US Department of Veterans Affairs studied spinal cord neurons in a burn injury mouse animal model and found that the skin injury affected the structural connections between neurons. They

also identified an important molecule in this problem called PAK1, which is involved with regulating these changes in the spinal cord.

An exciting discovery from this work was the identification of an existing clinical drug targeting PAK1, called Romidepsin, which is already used in cancer treatment. One promising avenue of study is looking at “re-purposing” this drug for targeting chronic pain associated with burn injuries.

Andrew Tan, senior author of the study said, “This research has exciting potential to provide a new avenue for speeding up the development of new treatments for long-lasting complications that often follow burn injury. Having a treatment that would not only treat the acute injury, but long-lasting complications could have a big impact on clinicians’ treatment of burns, including battlefield injured-veterans."

EP News Bureau

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INFRASTRUCTURE VENDOR NEWS

ABB and B&R launch first fully integrated Machine-Centric Robotics solution Fully integrating ABB’s robots into its automation systems means that B&R will now be able to supply machine builders with machine automation and robotics from a single source

B

&R, a unit of ABB’s Robotics and Discrete Automation business, announced the integration of ABB robots into its automation portfolio. With the ability to offer unprecedented levels of machine flexibility and precision, merging robotics with machine control into one unified architecture will enable manufacturers to embrace the trend of mass customization and optimize their lot size one processes.

Fully integrating ABB’s robots into its automation systems means that B&R will now be able to supply machine builders with machine automation and robotics from a single source.

Machine builders will be able to buy their robots from B&R along with all their control, I/O and drive components.

“The integration of ABB’s robot fleet into the B&R portfolio makes us a true one-stopshop. We are the only company to offer industrial automation customers the entire range of integrated hardware and software solutions around control, actuation, robotics, sensing and analytics and electrification. Our strength lies in our ability to combine ABB and B&R products into one solution, supported by our deep application expertise. This will help manufacturers increase their flexibility, at all levels including machines, to support shorter product cycles and to make much smaller lots of greater variety,” said Sami Atiya, President of ABB’s Robotics and Discrete Automation business.

Machine builders will be able to choose from a wide

28 EXPRESS PHARMA February 1-15, 2020

range of ABB robots, including articulated arm, SCARA, delta and palletizer robots in various sizes and with various payloads. This is particularly important for machine applications where a high degree of synchronization with other components is required, for example with picking solutions. With ABB robots integrated into the machine automation system, customers will benefit from an unprecedented level of synchronization between robotics and machine control. Since the robot will no longer require a dedicated controller, all interfaces between the machine and the robot are eliminated, while the fact that all axes and sensors will now communicate on a common network increases precision to the previously unimaginable microsecond range.

Integrating robotics and automation also means only one controller and one engineering system will be needed for development, diagnostics and maintenance, so there will no longer be a need for an extra control cabinet just for the robot, which will save floor space.

More user-friendly programming is another decisive advantage that comes from combining robotics with machine control. Instead of programming a robotics application in one development environment and a machine application in another, there will only be one application and one development environment. This will help to reduce development times significantly. With the ready-made software components of mapp Technology, developers can quickly set up and configure

the machine application, including robotics, without any knowledge of special robotics languages.

“Our newly developed integrated solution enables us to support machine builders, enhancing their processes and future-proofing their automation investments. Traditionally, the robot is a self-contained system, with its own controller and its own control cabinet. Engineering, diagnostics and maintenance are all performed using dedicated systems, and with specific robotics language, you often need a specialist programmer,” said Hans Wimmer, Managing Director of B&R. “With the incorporation of ABB robots into one simple architecture we create a fully integrated automation system.

For machine developers, it now makes no difference

whether they must integrate a single motion control axis or an entire robot into the machine.”

Synchronization between sensors and robot motion will also become easier with integration. For example the result of a quality inspection with a B&R vision camera can be converted into a control command for the ABB robot in less than a millisecond, so defective workpieces can be removed from the production process without manual intervention or slowing the manufacturing process.

Since the machine builder no longer needs to use separate hardware, communication networks and applications, he is able to achieve much tighter synchronization between the robot and other machine components. The movements of the robot and all of the machine's motion control axes can be coordinated with unprecedented microsecond precision, boosting the productivity of the machine and the output of the process.

The robots are programmed in B&R's universal engineering environment just like all other automation components, while in the digital twin the user can simulate and optimize the machine's entire motion sequence, including the robotics, before the machine is built. This makes engineering and development both faster and cheaper, which in turn lowers the threshold for machine builders looking to implement robotics in their production machinery and increases their return on investment.

Intech Additive Solutions launches new indigenous range of Metal 3D Printers The iFusion series of innovative, cutting edge technology Metal 3D Printers is being showcased at the ‘IMTEX FORMING 2020’ exhibition at Bangalore from January 23rd-28th, 2020 INTECH ADDITIVE Solutions, the Pioneers and Industry experts in Metal Additive Manufacturing in India, announced that they have designed, developed and delivered to the Indian manufacturing Industry a true ‘Made in India’ technological solution, with the launch of their new range of Metal 3D Printers.

The newly launched iFusion series of Metal 3D Printers- the iFusion SF1 and the iFusion LFMulti, designed and built at Intech Additive Solutions’ facility in Bangalore, is a significant milestone in the innovation journey of Intech and Metal Additive Manufacturing in India.

These innovative, cutting edge technology 3D Printers are being showcased at the ‘IMTEX FORMING 2020’ exhibition being held at Bangalore from 23rd to 28th January, 2020.

Intech Additive Solutions has been a pioneer in the Metal Additive Manufacturing in India

providing end to end solutions starting from concept design to fully functional Production parts for various industries such as Aerospace, Automotive, General Engineering and Medical Market segments in India and Abroad.

“The iFusion series of Metal

3D Printers, based on the Selective Laser Melting technology and the first of its kind in India, are designed for high precision, stability, reliability and to deliver unmatched performance with higher build rates,” said Sridhar Balaram, MD & CEO of Intech Additive

Solutions. “These cost-effective machines are part of Intech’s 3D ecosystem with software bundled in for machine parameter optimization and build process being sold as a package. The overall target of Intech is to reduce the cost of acquisition, cost of operations

and first time right with a quick 'go to market'.”

The iFusion SF1 is a smaller format machine dedicated to R&D Laboratories, Universities, Institutions and academies. The iFusion LFMulti is a Large format Multi laser machine with extensive features designed for the Industrial use of Metal additive Manufacturing.

“These machines are a culmination of more than 30000 man-hours of research, development and innovation spread over the past 36 months. We have 3D printed more than 800 parts for a variety of industries in different materials. Along with our in-house developed Software AMOptoMet and the upcoming AMBuilder we aim to create a full-fledged ecosystem for Additive Manufacturing fueling the industrialization of AM in India” added Sridhar Balaram.

LANXESS joins World Business Council for sustainable development World Business Council for Sustainable Development is a global, CEO-led organization working together to accelerate the transition to a sustainable world LANXESS RECENTLY announced that it has joined the World Business Council for Sustainable Development (WBCSD) in January, 2020 to enhance its commitment to sustainability The WBCSD is a global, CEO-led organization working together to accelerate the transition to a sustainable world. At the core of the network are its six work programs, for example on climate and energy or circular economy, targeting the realization of the United Nation’s Sustainable Development Goals (SDGs). The WBCSD’s approx-

imately 200 member companies represent 19 million employees and USD 8.5 trillion in sales.

Matthias Zachert, CEO – LANXESS said, “Sustainability bolsters our business objectives in many different ways –

whether by ensuring greater resource efficiency, good relationships with our stakeholders, greater risk awareness or longtime beneficial cost structures. I am delighted to have joined the World Business Council for Sustainable Development where, together with other member companies, we will be able to make a business case for sustainability.”

“WBCSD is pleased to welcome LANXESS as our newest member. We are dedicated to working towards a transformation of the key systems across society, and LANXESS – as a

provider of sustainable solutions for a wide range of areas – will strengthen the collaboration we aim for and help accelerate the transition to a sustainable world,” said Peter Bakker, President and CEO – WBCSD. In the last few months, LANXESS has focused its business activities even more on sustainability. The specialty chemicals company announced in November 2019 that it will become climate neutral by 2040. In December, LANXESS linked the interest rate terms of its main revolving credit facility to sustainability criteria.

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INFRASTRUCTURE

OPTIMAand Quality Machines enter into a cooperation agreement This initiative is part of Optima's comprehensive globalisation strategy OPTIMA DO Brasil has entered into a partnership with the Brazilian mechanical engineering company Quality Machines based in Campinas.

This initiative is part of Optima's comprehensive globalisation strategy. Both companies' customers will benefit from the cooperation. The new alliance was presented at an Open House Show at Optima do Brasil at the end of November, where both partners' machines were on display. More than 160 Quality Machines and Optima customers availed themselves of the opportunity to talk to the companies and to experience the latest machine technologies first-hand.

“Our close partnership now means that manufacturing companies in the pharmaceutical and consumer sectors can access a wide range of solutions from a single source," says Rolf Geissinger, Managing Director of Optima do Brasil,

about the new alliance.

In Brazil, Quality Machines has gained a reputation as a reliable partner for cost-efficient mechanical engineering projects for the South American market. Optima do Brasil is distributing Optima Group's

technology for the pharmaceuticals, consumer goods, medical devices and paper hygiene market segments throughout South America. Market-specific machine solutions are manufactured directly on site.

The OPTIMA CP4NG Case

Packer, the OPTIMA FM1 Filling Machine and the OPTIMA CM1 Closing Machine are a particularly important part of the portfolio.

OPTIMA do Brasil provides support with OPTIMA Total Care, the integrated Life-

Cycle Management Program Optima do Brasil will be supporting Quality Machines, particularly in After Sales. Within the framework of OPTIMA Total Care Life Cycle Management, Optima ensures safe and reliable production of the systems installed in South America long after commissioning.

A part of the Life-Cycle-Management Program is Basic Services and Smart Services. Basic Services include, for example, support during commissioning, retrofitting and upgrading, training of plant operators, embedded engineers and the production of spare parts directly in Brazil. Smart Services are digital solutions that provide the best possible support in terms of plant efficiency, predictive maintenance, knowledge management and solutions to problems for example with remote support using augmented reality eyewear.

Waters to acquire AndrewAlliance The acquisition of Andrew Alliance broadens our technology portfolio to include advanced robotics and software that will positively impact our customers’ workflows: Waters Corp WATERS CORPORATION announced recently that it has entered into a definitive agreement to acquire Andrew Alliance, an innovator in specialty laboratory automation technology, including software and robotics. Andrew Alliance’s cloud-native software platform and modern interface dramatically improves the use of automation technology, enabling more scientists to realise the advantages of repeatability and performance for both routine and complex laboratory workflows.

“The acquisition of An-

30 EXPRESS PHARMA February 1-15, 2020

drew Alliance broadens our technology portfolio to include advanced robotics and software that will positively impact our customers’ workflows across pharmaceuticals, life sciences and materials science markets,” commented Chris O’Connell, Chairman and Chief Executive Officer of Waters Corporation. “This move also demonstrates Waters’ commitment to deploy capital to growth-oriented acquisitions that reinforce our specialty strategy and enhance our core business.”

Andrew Alliance has ap-

proximately 40 employees in Switzerland, France and the United States.

“We are thrilled to join the Waters family,” commented Piero Zucchelli, Chief Executive Officer of Andrew Alliance.

“We have found the right partner to bring our vision of connected laboratories to life.

Waters’ combination of instruments and chemistries will help us accelerate the delivery of our innovative software and hardware technologies to customers as mass spectrometry increasingly moves into the hands of more and more users.”

INFRASTRUCTURE

Sysdig closes $70m in Series E Funding Investment will fuel the company’s leadership as the most advanced Kubernetes security tool to embed security, maximize availability, and validate compliance SYSDIG RECENTLY announced that it has raised $70 million in Series E funding led

by Insight Partners with participation from previous investors, Bain Capital Ventures and Accel. Glynn Capital also joined this round, along with Goldman Sachs, who joined after being a customer for two years. Sysdig’s total funding to date is $206 million. Sysdig will use the funds to extend market presence and leadership in enabling enterprises to confidently run cloud-native workloads in production. The Sysdig Platform addresses both DevOps security and IT operations spaces. IDC forecasts the worldwide DevOps software tools market will reach $15 billion in 2023.

In the healthcare sector, Sysdig helps clients like Cota Healthcare more efficiently operate and protect the software and systems that serve its business. As a result of selecting Sysdig, Cota has a single solution that helps reduce costs and ensures the data hosted with Docker and Kubernetes is secure, reliable, and available. Cota builds solutions for healthcare that analyze, visualize, report, and manage real-world evidence and deliver precision medicine.

It has an important mission, merging technology and medicine to improve the lives of cancer patients. The company takes a big data approach to increase treatment effectiveness and lower healthcare costs.

And, because the company is entrusted with millions of patient records, visibility and security are paramount to its business.

As Cota Healthcare moved to Kubernetes on Google Cloud, it chose Sysdig for Kubernetes monitoring and container security. With Sysdig, Cota accelerates healthcare service development, improves capacity planning, fixes issues

rapidly, and strengthens its security posture.

“Containers and Kubernetes development is disrupting the way organizations deploy and run containers, but when you look at the history of major technological changes, Kubernetes is still early. We invest in high-growth companies that are disrupting the old way of doing things, companies that will lead this decade-long transition. Sysdig’s novel approach of providing a single source of truth for both security and monitoring for container-based applications has proven more effective, more scalable, and higher ROI,” said Richard Wells, Managing Director at Insight Partners.

“As a customer, we are impressed with Sysdig’s technology and the company’s open source approach to security.

We look forward to Sysdig

joining our investment portfolio and seeing their continued growth as a leading Kubernetes security vendor,” said Soumya Rajamani, Vice President of Merchant Banking at Goldman Sachs and Sysdig Board Observer.

“Containers and Kubernetes will take over the world.

Over the last year, we have seen competitors partner in an attempt to deliver capabilities similar to ours, but the reality is, these approaches cannot provide the level of visibility and security that we can, even when they use multiple tools. As Kubernetes adoption increases, CISOs will continue to recognize that their IT teams and security tools need to adapt. In 2020, we look forward to partnering with more Global 2000 organizations in their cloud-native journeys,” said Suresh Va-

sudevan, Chief Executive Officer at Sysdig.

Kubernetes is the de facto operating system of the cloud; however, as organizations move workloads into production, security and visibility are the biggest barriers. Traditional tools and processes leave enterprises blind because they do not provide visibility with application context for these environments. To reap the benefits of the agility that containers and Kubernetes provide, enterprises need an approach that integrates security and compliance into DevOps workflows.

This approach is often referred to as secure DevOps or DevSecOps. According to Gartner, “By 2021, DevSecOps practices will be embedded in 60% of rapid development teams, as opposed to 20 per cent in 2019.

By 2023, more than 70% of enterprise DevSecOps initiatives will have incorporated automated security vulnerability and configuration scanning for open-source components and commercial packages, which is a significant increase from fewer than 30% in 2019.”

To date, Sysdig is the only security company to support a secure DevOps approach by integrating monitoring and security into a single platform.

Cloud teams can embed security, maximize availability, and ensure compliance. By integrating security into the DevOps process, teams can realize the business goals in their transition to cloud native.

Open by design, Sysdig provides the scale, performance, and usability enterprises demand. Sysdig customers include: Goldman Sachs, Steelcase, and Worldpay from FIS.

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INFRASTRUCTURE PRODUCTS

Better vision for Pharmaceuticals PHARMACEUTICALS RANKS higher in the minds of consumers owing to the constant need for medication for remaining fit or recovering from ailments. Thus, consumption of medicines is almost a never-ending saga for any age group. Quality, effectiveness and safety of these medicines is of utmost importance so as not to compromise on consumerâ&#x20AC;&#x2122;s health. Pharmaceutical industry is a highly regulated industry with extremely high quality requirements.

Conventionally for inspections of quality, determination of package integrity, batch numbers, expiry dates, and other aspects factories had to rely on human inspection or invest heavily in separate solutions for inspection. Manual inspection certainly has limitations and in order to improve quality and to deliver safe and secure medicines, use of image processing system in pharmaceutical production lines is increasing. Such measures ensure high manufacturing quality thus meeting FDA compliance norms. Today, machine vision systems are widely used in nearly every stage of pharmaceutical manufacturing process.

Machine vision systems are automated inspection systems based on an image technology, such as sensors, cameras or scanners. Whether testing color of pills, filling level of syrup, identification of missing components in packaging or blisters, identification of codes on boxes or labelling, manufacturers are using machine vision to improve line productivity and quality and thus reduce wastage and risk. In addition, such vision and allied systems are in place for ensuring efficient track and trace mechanism where individual blisters can be tracked to the package, carton, and exact batch based on a barcode or serial number.

B&R has incorporated ma-

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Machine vision system is automated inspection systems based on an image technology, such as sensors, cameras or scanners

chine vision into its automation system with an unprecedented level of integration. The cameras, intelligent image processing algorithms and innovative lighting portfolio are an integral part of B&R control system. Automation engineers are now able to implement a large portion of machine vision applications on their own.

The core of vision solution are intelligent cameras: Smart Sensor and Smart Camera.

Smart Sensor is designed to implement a single machine vision functionality, such as QR code reading or position detection. Unlike many other devices in its class, there is no need to install dedicated hardware for each function.

Scalable hardware In cases where more than one functionality is required, it is easy to switch to a more powerful Smart Camera. The existing application software, pa-

rameters and models can continue to be used. Whichever camera type is selected, installation is very easy: Simply hook the camera up to the machine network, and it automatically obtains all the settings it needs from the controller.

These smart cameras are based on the powerful Ethernet POWERLINK network which is the backbone of the entire B&R portfolio. Thus, a vision system is in the same network as of I/Os, drives, sensors and actuators. This enables the machine builder to reduce costs in laying separate networks, improve diagnostics and reduce maintenance.

Full flexibility If desired and enabled in user management system, all variables and parameters can also be adjusted in real time during operation. It is also possible to add new models for object recognition or code types and

other search criteria at runtime. Both camera types feature multi-core processors and integrated FPGA image preprocessing. This enables sophisticated functions such as text recognition based on deep learning algorithms.

Optimum image quality Each hardware variant can be equipped with one of three image sensors, ranging from 1.3 to 5 megapixels. All three sensors are characterized by their large pixel size, high light sensitivity and low noise. This guarantees optimum image quality â&#x20AC;&#x201C; even in high-speed applications.

Housing variants are available with either an integrated lens or a standard C mount.

The C mount supports lenses from B&R or third parties â&#x20AC;&#x201C; for example when telecentric lenses are required.

A special cover is available for C-mount lenses from B&R

to retain IP67 protection. The integrated lenses have electronic focus adjustment and are available in focal lengths from 4.6 to 25 mm. All B&R lenses are specially optimized for the image sensors used to achieve maximum sharpness and optimal imaging performance.

One cable is all you need The camera only needs a single cable. The camera is integrated into the machine network via an M12 hybrid connector which also supplies the necessary 24 VDC power. A second hybrid connection enables daisy-chain cabling with lighting elements.

Optimum lighting for every situation B&R has developed and patented an innovative lighting system for its vision solution.

Lighting control is synchronized with the automation sys-

INFRASTRUCTURE tem in the sub-μs range. The modular barlights and backlights ensure optimum results even in difficult lighting situations.

As integral parts of the automation system, both cameras and lighting are easy to synchronize with other sensors, motor positions and events in the machine application. Lighting control with microsecond precision is even guaranteed when synchronizing multiple cameras and light sources.

Each light has an integrated flash controller, so no external hardware is required. The controller ensures a precise pulse current supply to the powerful LEDs. This enables light pulses of at least one microsecond duration at maximum intensity.

The B&R vision system can therefore also be used for highspeed applications without any problems.

Just the right light The flexible barlights are available individually or arranged as ringlights in groups of 4, 6 or 8. There are also two different sizes of backlights. Each light can feature up to four different LED colors. The spectrum ranges from white and various visible colors to infrared and ultraviolet. This makes it possible to achieve just the right contrast, color, illumination and intensity for any application.

Many machine vision applications require very precise alignment of the light source to achieve good results. B&R's barlights are therefore available in a version with electronic angle adjustment from 0° to 130°. When producing multiple products on the same machine, the lighting angle can be optimized between batches – simply set it once and save it as part of the batch recipe.

Ringlights with electronic angle adjustment make it possible to optimize the light cone to avoid scattered light.

Configuration at runtime Just like the angle of the barlight, all other lighting parameters can be configured at runtime to adapt to new products. Combining LEDs of differ-

Machine vision system can be mounted over a single machine, robot or on production line to visually inspect products in real time without operator intervention

Integrated lenses of machine vision system have electronic focus adjustment and are available in focal lengths from 4.6 to 25 mm

ent colors makes it possible to adjust the wavelength at runtime to optimize contrast. Diagnostic data can be read from the lights at any time thanks to their network connection.

mapp Vision The full range of mapp Vision functionality is available with the upgrade to Automation

Studio 4.6. When the Technology Package is installed, the correct firmware is automatically installed on all required components. This simplifies configuration considerably and prevents errors.

B&R has integrated the HALCON machine vision library directly into mapp Vision. The algorithms have

proven themselves over many years to enable robust, highperformance solutions for detecting position, checking completeness and evaluating quality as well as measurement and identification. Some of the functions are identification with over 40 different code types; OCR reading which manages character

recognition with deep learning algorithms; blob analysis, which is model-based surface detection with comprehensive analytics; matching, which manages flexible object recognition and metrology, which enables powerful, precise measurement instrument.

Source: B&R Industrial Automation

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INFRASTRUCTURE

Selecting loading dock levellers DOCK LEVELLERS bridge the gap and height difference between the dock and the trailer. They also compensate for the up and down float of the trailer bed during loading. A dock leveller includes a ramp (hinged along its rear edge) and a lip (hinged at the front of the ramp). When not in use, the dock leveller is stored in its neutral position, flush with the loading platform floor. To use a dock leveller, the operator raises the ramp and the lip swings out. With the lip extended, the operator lowers the ramp until the lip rests on the truck.

Distribution operations Achieve efficiency with the right loading dock equipment: When your facility handles high trailer volumes, you need reliable equipment designed to take a constant beating to ensure your loading dock keeps running smoothly. Regardless of your market segment or facility size, the right loading dock equipment can help you maximize operational efficiency through greater trailer turnaround, improved scheduling, improved communications, and improved equipment sequencing and utilization.

Gandhi Automations loading dock equipment can also enhance security and minimize downtime due to service issues or accidents.

Industrial operations Extreme loads call for heavyduty dock equipment: Heavy industrial facilities that handle large, weighty products such as pulp/paper, automotive or steel, have unique needs. It’s not about the footprint of the space, but the size and weight your equipment can handle within highvolume traffic flows. For these extraordinarily heavy loads, you need heavy-duty industrial dock equipment that can stand up to extreme loads while also providing operational efficiency and safety.

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General warehousing Cost-effective dock solutions for smaller operations: Just because you have a smaller operation doesn’t mean you don’t face similar security, safety and operational issues as larger operations. The dock solutions that work best for your facility will vary depending on the frequency of use. Conventional non-powered dock equipment will typically work well for those docks processing a low volume of trailers daily, but powered dock levellers are recommended for moderate users as they provide a lower lifetime cost of ownership.

And if you’re working in a leased space, you may have special equipment needs.

Food & beverage Dock products that provide safety & performance: Food & Beverage operations, regardless of warehouse/loading dock footprint, are often the most rugged of

environments. Heavy loads, larger gross vehicle weight, high traffic volume, high productivity demands, higher need for flexibility and high load frequency are just some of the challenges these operations face. In addition, Food & Beverage facilities often require low maintenance and more regulatory demands, such as wash down, AIB, FDA and EN 1398. As a result, these dock products are recommended:

Operational efficiency Create efficiencies for your workers & your bottom line: One of the biggest challenges facing companies is how to effectively respond to continually changing market forces in a cost-effective manner. Companies can often achieve operational efficiency by minimizing redundancy and waste while leveraging the resources that contribute most to their success and utilizing the best of their work-

force, technology and business processes. Streamlining the core processes in your warehouse and loading dock is a vital piece of that puzzle. Picking the right loading dock equipment can help you: ◗ Lower your lifetime cost of ownership of equipment ◗ Improve trailer scheduling ◗ Reduce cycle time of trailer loading/unloading ◗ Improve trailer management within the yard ◗ Effectively sequence loading dock equipment and dock doors

present. However, a variety of Gandhi Automations products can improve environmental conditions and visibility and protect workers from dangerous situations.

Gandhi Automations dock levellers continue to feature innovations that are stronger, longer-lasting and more dependable for a more productive workplace. From economical mechanicals and economically efficient manual dock levellers to high-capacity hydraulic units, there’s a Gandhi Automations leveller for every loading dock.

Safety & security

Contact details: Gandhi Automations Chawda Commercial Centre, Link Road, Malad (West), Mumbai - 400064, Tel: +91-22-66720200 / 66720300 (200 lines) +91-22-66720201 For enquiries via e-mail sales@geapl.co.in Customer Support customercare@geapl.co.in

Key products to keep your workers safe: Creating and maintaining a safe work environment is the keystone of any successful warehouse and loading dock operation. The mixture of personnel and machinery in hectic, fast-paced environments means the opportunity for accident and injury is always

INFRASTRUCTURE VALUE ADD

Push Packs from Romaco Siebler – Sustainable packaging technology made in Germany Andreas Detmers, Head of Technical Solutions, Romaco Pharmatechnik GmbH writes about how Romaco Siebler and Huhtamaki are adopting new approaches to primary packaging for pharmaceutical solids with innovative push-through strips

Romaco_Siebler_HM-1-350_cmyk

CLIMATE-FRIENDLY, material saving, affordable, customisable and ultra-thin – Romaco Siebler’s Push Pack manufacturing technology for push-through four-sided sealed strips heralds in a new era in primary packaging for solid pharmaceutical products. The leading global supplier of strip packaging machines got together with Huhtamaki, the

Finnish film and foil specialist, to develop its Push Pack product family. Romaco Siebler is currently the only machinery supplier in the market with the capability to process the new, ultra-thin, PVC-free Huhtamaki foils into safe and absolutely tight pharmaceutical packs.

The push-through strip packs in the Push Pack product

family are Romaco and Huhtamaki’s alternative to the established blister packaging forms presently available in the market. Push Packs provide equivalent barrier properties to blisters and are opened in the same way: you simply press the tablet out of the Push Pack with your thumb just as you would normally do with a blister. Push Packs are also similar

in appearance to conventional blister packs: for example, the standard Push Pack version can be combined with transparent foil for an unobstructed view of the contents.

Up to 60 per cent cost saving compared to aluminiumaluminium blisters Since Push Packs are sealed all round with two foils, far thinner aluminium barrier lay-

ers can be realised than with cold formed blisters, namely between 9 and 25 μm depending on the primary packaging’s barrier specifications. With aluminium-aluminium blisters, on the other hand, the fact that the aluminium is deep-drawn means that very thick foil is inevitable. That is why a cold formed aluminium-aluminium blister weighs more than twice

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INFRASTRUCTURE as much as a high-barrier Push Pack produced on a Siebler strip packaging machine.

This markedly lower material consumption goes hand in hand with significant cost economies: a potential saving of up to 60 per cent is possible compared to standard aluminium-aluminium blisters.

“Push Packs not only help pharmaceutical companies reduce their carbon footprint; they also let them produce much cheaper," explains Rolf Izsak, the Product Manager responsible for Push Pack development at Romaco Pharmatechnik GmbH. The standard and high-barrier Push Pack versions are manufactured from a five-layer, laminated PE or Surlyn, aluminium and PET foil from Huhtamaki. The foil’s pushthrough function is achieved by perforating the outer PET layer. In the standard version, Push Packs have an aluminium barrier layer just 9 or 12 μm thick. High-barrier Push Packs, which have to meet very high light, air and moisture tightness requirements, are made using 25 μm aluminium foil.

Thanks to the tear-resistant PET film, children find it extremely difficult to open Push Packs whereas elderly people can press the tablets out without any problem. And since the relatively small cavities in the Push Packs also mean smaller air pockets, the medicines have a longer shelf life. What’s more, unlike many blister forming foils, Push Packs contain zero PVC – a material considered harmful to health and the environment alike.

Strip packaging machines with unique heat-sealing technology

Romaco_Siebler_Push-Packs_cmyk

Romaco_Siebler_Push-Packs_opening_cmyk

The world’s first recyclable unit dose packaging for pharmaceutical solids With their PVC-free design and lower material usage, both standard and high-barrier Push Packs already have a much better eco-balance than blister packs, yet Romaco and Huhtamaki have now gone one step further – with the world’s first recyclable strip packaging for pharmaceutical solids. The eco Push Pack version consists of polyolefin laminate, which can be disposed of as recyclable material; an impressive 70

36 EXPRESS PHARMA February 1-15, 2020

per cent or more of it can be recycled back into the material loop. The key lies in the unique structure of the Huhtamaki foil: recyclable Push Packs comprise over 90 per cent polyethylene and polypropylene, which belong to the same material class.

Extensive test series at the Romaco technology centre The Finnish packaging manufacturer’s special new foils were extensively tested by Ro-

maco and Huhtamaki on a Romaco Siebler HM 1-230 strip packaging machine at PacTech, the Romaco laboratory in Karlsruhe (Germany). The optimum sealing conditions for these ultra-thin Huhtamaki foils – in other words, the ideal processing temperature, pressure and time – were determined in a large number of test series and the foils subjected to various leak tests, for instance using the blue dye method. “We decided to develop our new, push-through foils in partner-

ship with Romaco because we’d already worked together very closely and effectively in the past. Romaco and Huhtamaki are two companies with complementary expertise”, reports Fabio Daidone, Senior Sales Manager at Huhtamaki. “We really enjoyed bringing the idea for our foils to maturity in collaboration with Romaco because we both pull in the same direction and the project teams at Romaco and Huhtamaki are passionate about what they do.”

Romaco Siebler’s strip packaging machines are designed to process a very wide range of heat-sealable materials – from paper-aluminium foils through plastic to polyester. To enable safe and absolutely tight pharmaceutical packaging to be manufactured from the new Huhtamaki foils, the Siebler heat-sealing technology was specially adapted to handle laminates with an aluminium foil thickness of between 9 and 25 μm. “Our heat-sealing machines are currently the only ones in the market capable of processing Huhtamaki’s ultrathin foils into primary packaging in line with the pharmaceutical industry’s safety and tightness requirements – and of doing so using recyclable materials”, says Rolf Izsak proudly. “The secret is our unique heat-sealing process: the precise temperature distribution means we can coordinate all of the sealing parameters optimally with one another and ensures air, light and moisture-tight seams for the foursided sealed strips.”

Push Packs are manufactured on the Romaco Siebler HM 1 series of vertical heatsealing machines, which can pack up to 7000 tablets per minute. The HM 1-350 and HM 1-600 models (with a maximum foil width of 350 or 600 mm) are also suitable for this purpose in addition to the HM 1230 type with a maximum foil width of 230 mm. The product is fed vertically into the heatsealing machine regardless of the model which is chosen, then passes through the rotary sealing system between the foil webs, so that it is sealed all round. In the next step, blades perforate the product web lengthwise and crosswise and cut it to size according to the customer’s requirements.

In future, it will be possible to produce Push Packs on heatsealing machines in the Romaco Siebler HM 2 series too.

HM 2 machines are designed to pack medical devices like prefilled syringes or eye drops in unit doses, which have to be fed

INFRASTRUCTURE horizontally due to their geometry.

designed to process smaller batches with different pack sizes and enables more flexibility if the strip layout or stack height varies. Romaco Promatic cartoners and case packers can then be used for the secondary and final packaging.

In short, Romaco customers reap all the benefits of a complete production line all from one source.

Also suited for die-cut packaging formats Not only standard strips but also freely selectable packaging formats – so-called design strips – can be realised on Romaco Siebler’s strip packaging machines. The machine can be equipped with a continuous cutting station for this purpose at the customer’s request. Two servo-driven punches then cut strips out of the foil layer with a drawing cut. “Round or starshaped, stylised hand, ‘thumbs up’ look or just about any other format under the sun – you name it, our machines can do it”, Izsak comments. “The ability to customise shapes and sizes in this way helps pharmaceutical and healthcare companies give their primary packaging an attractive and distinctive appearance with high recognition value, so that they set themselves even more clearly apart from their competitors.” Push Packs simultaneously offer several compelling arguments from a marketing perspective: the new Romaco packs can be printed on both sides and have a larger print area for targeted marketing messages than is possible with blister packs.

First Push Pack product tests underway for leading manufacturers The first product tests with standard and high-barrier Push Packs are currently underway at PacTech, the Romaco technology centre in Karlsruhe (Germany), on behalf of various leading pharmaceutical customers – and the first project enquiries for the brand new recyclable Push Packs have meanwhile been received by Romaco. The recyclable version was officially unveiled to a wider audience at the CPhI trade show in Frankfurt (Germany) at the beginning of November. Interested visitors had a chance to see for themselves in live demonstrations how Huhtamaki’s recyclable foils are processed into Push Packs on an HM 1-230 from Romaco Siebler. Rolf Izsak: “The huge interest displayed by attendees at the fair in our Push Pack product family, and particularly in the recyclable strip packs, is confirmation that ‘sustainability’ is now also top of the agenda in the pharmaceutical industry when it comes to primary packaging.

That’s why we’re committed to further optimising our Push Pack technology in the future and to moving forward decisively with sustainability initiatives in other product segments too.”

Romaco_Siebler_design-strips_cmyk

Even fragile effervescent tablets can be packed in Push Packs Tablets and capsules in umpteen different shapes and sizes can be packed in Push Packs on heat-sealing machines from Romaco Siebler – even large effervescent tablets, which react very sensitively to humidity owing to their hygroscopic properties and thus require a specific line configuration, can be processed in this way.

A tablet press must be installed upstream of the heatsealing machine in order to make effervescent tablets. The tablets are fed to the Siebler HM 1 on conveyor belts and packed directly in Push Packs following the compression process. “We advise our customers to consider one of Romaco Kilian’s tablet presses for manufacturing effervescent

Romaco_Siebler_Push-Packs-Eco_cmyk

tablets, because they’re finetuned for use with Romaco Siebler strip packaging machines," Izsak continues.

Romaco Siebler proposes two alternative solutions for

transferring the strip packs to the modules positioned downstream: belt transfer with Siebler FixTrans is especially appropriate for large batches with identical pack widths and

impresses with a high transfer speed, reliable processes and cost-efficiency. Siebler FlexTrans, the servo-driven transfer solution, features a pickand-place system that is

For further information, contact: Susanne Silva Market Communications Romaco Group Am Heegwald 11 76227 Karlsruhe Germany T+49 (0)721 4804 0 F+49 (0)721 4804 225 E: susanne.silva@romaco.com

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Continuous processing of pharmaceutical masses Leistritz with its lines in GMP design is the market leader in the demanding field of pharmaceutical extrusion.

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HR

ACG appoints Alexander Robertson as the new Chief Marketing Officer Robertson has worked for global agencies including Ogilvy & Mather, Brand Union and most recently held the position of Executive Creative Director at Landor in Mumbai

A

CG Group recently announced the appointment of Alexander Robertson as the new Chief Marketing Officer for the Group. In his role, Robertson will be responsible for continuing to drive ACG’s marketing initiatives and current growth across the group’s global focus markets. He will be based at the company’s Mumbai head office.

With more than two decades rich experience across the spectrum of B2B and B2C marketing, branding communication, design and advertising, Robertson is a true brand specialist. He has worked for global agencies

including Ogilvy & Mather, Brand Union and most recently held the position of Executive Creative Director at Landor in Mumbai.

He takes over from Peter Neve,

who has decided to move back to his home country following three successful years at ACG. On Alex’s appointment as ACG’s new Chief Marketing Officer, Karan Singh, MD, ACG, said, “We are very excited to have Alex on board. With his rich experience in narrating successful brand stories, we are confident that ACG will chart newer heights under his leadership. I also wish to thank Peter Neve, who helped ACG create a new identity and will be remembered for his work on OneACG.” EP News Bureau

OBITUARY

Dr M K Bhan: The man behind India's first rotavirus vaccine DR MAHARAJ Kishan Bhan, the man who developed India's first rotavirus vaccine, passed away last month. A former secretary in the Department of Biotechnology (DBT), the 72-year old had been battling with pancreatic cancer for some time.

Dr Bhan had played a significant role in Indian healthcare. Amidst all his achievements, the most important – the rotavirus vaccine development – helped lower the cost of vaccination for diarrhoea, a major cause of death among children below five years in India. The three-dose vaccination course of Rotavac vaccine for full immunisation costs

Dr Kiran Mazumdar-Shaw honoured with Australia’s highest civilian honour The award was given for her significant service to advancing Australia's bilateral relationship with India, particularly in promoting commercial and educational links BIOCON CHAIRPERSON and Managing Director Dr Kiran MazumdarShaw has been awarded the ‘Order of Australia’, Australia’s highest civilian honour, for her significant service to advancing Australia’s bilateral relationship with India, particularly in promoting commercial and educational links.

Dr Mazumdar-Shaw was appointed an Honorary Member (AM) in the General Division of the Order of Australia

by Australia’s High Commissioner to India, Her Excellency Harinder Sidhu, at a ceremony in Bengaluru recently. The ceremony was attended by representatives from Indian and Australian business and diplomatic corps, amidst family and friends of Dr Mazumdar-Shaw.

Honorary appointments in the Order of Australia are made to foreign nationals who have made an outstanding contribution to Australia or humanity at large.

Dr Mazumdar-Shaw is the fourth Indian citizen to be awarded Australia’s highest civilian honour.

58 EXPRESS PHARMA February 1-15, 2020

“It is an absolute privilege for me to be conferred the ‘Order of Australia’. I am deeply grateful to the Australian Government for this great honour. I do hope that technology will be the great economic connector in the future as we together build a sustainable world where bush fires and floods, diseases and pollution are no longer life threatening; but challenges that we learn to manage and mitigate through responsible behaviour and innovative technologies.” Dr Mazumdar-Shaw said.

Her honour follows the conferment of batsman Sachin Tendulkar in 2012,

former Attorney General of India, Soli Jehangir Sorabjee in 2006 and Mother Teresa of Kolkata in 1982.

Congratulating Dr MazumdarShaw, Australia’s High Commissioner to India, Her Excellency Harinder Sidhu, said, “The Australian Government has chosen to bestow this honour on Dr Kiran Mazumdar-Shaw for her immense contribution in advancing Australia’s bilateral relationship with India. She is a tireless champion of Australia-India commercial, educational, government and people-to-people links.

She is a pioneer, an inventor, a bio pharmacist-par-excellence, a philanthropist and an international role model for women in STEM. On the basis of her longstanding commitment and support in advancing Australia-India relations, Dr Mazumdar-Shaw is worthy of recognition with an appointment as an honorary Member in the General Division of the Order of Australia.”

EP News Bureau

Rs 180, whereas the two other WHO-approved vaccines available in the market cost around Rs 2,500 per course.

Dr Bhan had also set up several institutions that enabled the collaboration between the biotechnology industry and academia.

Born just three months after India got its independence, Dr Bhan completed his MBBS from Armed Forces Medical College, Pune and later got an MD from the Post Graduate Institute of Medical Education and Research (PGIMER) in Chandigarh. Thereafter, he went on to conduct a comprehensive research for his post doctorate at the All India Institute of Medical Sciences (AIIMS) that focussed on the role of micronutrients, especially zinc. In the year 1990, he was awarded the prestigious Shanti Swarup Bhatnagar Prize for Science and Technology.

Apart from starting many new initiatives as the DBT Secretary between 2005 and 2012, Dr Bhan also initiated Translational Health Science and Technology Institute (THSTI) with centres dedicated to vaccines and infectious diseases, paediatric biology, biodesign and drug development. His other contributions include bringing international funding by establishing partnerships with the US-based Bill & Melinda Gates Foundation and the UK-based Wellcome Trust.

EP News Bureau

REGD.WITH RNI NO. MAHENG/2005/21398, POSTAL REGD. NO. MCS/164/2019 – 21, PUBLISHED ON 5TH / 20TH EVERY FORTNIGHT, POSTED ON 5TH, 6TH, 7TH & 20TH, 21ST, 22ND OF EVERY FORTNIGHT POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE, MUMBAI – 400001