Express Pharma (Vol. 17, No. 7) June 2022

VOL. 17 NO. 7 PAGES 84

www.expresspharma.in

INTERVIEW Vinayak M Patankar Chief Operating Officer, SIP Division, Borosil Amit Saluja Senior Director and Head, NASSCOM CoE

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CONTENTS MARKET Chairman of the Board Viveck Goenka Sr. Vice President-BPD Neil Viegas Asst. Vice President-BPD Harit Mohanty Editor Viveka Roychowdhury*

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Delhi Akanki Sharma

Senior Designer Rekha Bisht Senior Artist Rakesh Sharma

BIOPHARMA ALLIANCES REACH $177.3 BILLION IN 2021

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POST EVENT

BUREAUS Mumbai Lakshmipriya Nair, Kalyani Sharma

DESIGN Asst. Art Director Pravin Temble

LOGISTICS

STRATEGY

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PHARMATECHNOL OGYINDEX, EEPC INDIA AND HARYANA GOVERNMENT HOST 12TH PHARMATECH EXPO 2022 & LABTECH EXPO 2022 VACCINE AND BIOLOGICS INDUSTRY LEADERS GATHER FOR IMAPAC'S 12TH ANNUAL VACCINES WORLD SUMMIT AND BIOLOGICS FESTIVAL

PACKAGING

VACCINE SUPPLY CHAIN: RISKS AND SOLUTIONS

TECHNOLOGY

P26:INTERVIEW Dr Mahesh Bhalgat COO, Syngene International

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P37:INTERVIEW Vinayak M Patankar Chief Operating Officer, SIP Division, Borosil

CHALLENGES IN PROCUREMENT OF "QUALITY ASSURED" GENERICS

Digital Team Viraj Mehta (Head of Internet) Marketing Team Rajesh Bhatkal Ambuj Kumar Ashish Rampure Debnarayan Dutta

P34:INTERVIEW

PRODUCTION General Manager BR Tipnis

Amit Saluja Senior Director and Head, NASSCOM CoE

Production Co-ordinator Dhananjay Nidre Scheduling & Coordination Arvind Mane CIRCULATION Circulation Team Mohan Varadkar

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Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Mafatlal Centre, 7th floor, Ramnath Goenka Marg, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world.

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EDITOR’S NOTE

Preparing for surprise inspections M

ay 27, 2022, marked an important milestone for Express Pharma: we presented our first offline industry meet post-COVID: the third edition of “Vizag Pharma Summit”. I am sure many of our readers would have followed the live updates from the venue on our social media channels and full coverage of the Summit will follow in the July print edition.

While delegates were happy to revert to face-to-face meetings after two years of virtual interactions, we also noticed that a fair number regretted that they could not attend “Vizag Pharma Summit” as they had to stay on site. They had long pending ANDAs in the inspection/approval pipeline and were expecting surprise site inspections from regulators.

This is only to be expected. During a virtual conference hosted by the Food and Drug Law Institute on 9th December, 2021, Elizabeth Miller, from the US FDA’s Office of Regulatory Affairs (ORA), had announced that they were resuming a pilot programme of unannounced inspections of drug manufacturing facilities outside of the US, starting with India and China.

While the US FDA aims to clear its backlog, will surprise site inspections be the end of a long wait? Or the start of another tunnel into non-compliance?

Senior pharma personnel, while relieved that they were finally at the end of a long COVID-induced wait, are also wary of the outcomes of these inspections. While rising COVID case numbers have meant that the pilot cannot be implemented at pharma sites in China, their counterparts in India are understandably on tender hooks.

In fact, an ICICI Securities (I-Sec) report dated 13th May asks if US FDA inspections will mean a 'Return of 'The Overhang?' It goes on to point out that while most Indian companies are waiting for the US FDA to begin physical inspections post-COVID, as they have many DMFs pending approval, the threat of adverse results like observations, Official Action Indicated (OAIs) and warning letters is the flip side of the coin. The top three companies with pending ANDAs are Aurobindo Pharma (225 pending ANDAs), followed by Dr Reddy's Laboratories (DRL) (116) and Sun Pharma (114). As per company data compiled in the I-Sec report, in FY22 till date, nine US FDA inspections have been conducted in India in FY22 (ending 30th September), which resulted in one OAI and two WLs. India Pharma Inc’s caution is only to be expected as the country is one of the top-four pharma exporters to the US (after Ireland, Germany and Switzerland).

Pharma is the second-largest category of imports from India into the US, after gems/diamonds.

As Indian firms increased ANDA filings over the past few years, especially for complex products, which warrant more scrutiny, the I-Sec report quotes data to show that warning letters from the US FDA to non-US companies have increased, with China and India facing the brunt. Consider that pre-COVID, the US FDA had issued 220 warning letters in FY20 versus an average of ~150 p.a. between FY15-FY20. As the number of foreign

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Will surprise site inspections be the end of a long wait? Or the start of another tunnel into noncompliance?

sites supplying to the US increased, so did overseas factory inspections, reflecting an increase in the number of ‘non-US’ countries in the defaulters list, from a fiveyear average of 52 to 70.

China and India, accounting for the largest number of sites exporting to the US, top the list of defaulters, together receiving almost half (~47 per cent) of total warning letters for the non-US segment in FY20, whereas the average between FY15-FY20 was ~60 per cent.

The uncertainties, arising out of factory inspections, are a sign of increasing regulatory scrutiny. While this is necessary to ensure medicine quality and benefits the patient-consumer, companies which are unable to speedily address these deviations could find their market valuations dipping. Combined with the existing woes of 'steep price erosion in the US market due to high channel inventories among other macro causes,' the I-Sec analysts now prefer companies with a focus on the domestic market.

Have pharma companies in India prepared enough for these surprise site inspections? Investments made in quality systems over the years will hopefully now pay dividends, in the form of no adverse consequences of these inspections. One hopes that companies have invested not just in equipment and technologies, but also training/upskilling of employees, which was sorely lacking in previous years.

And will the increasing cost of compliance become a reason to sell out as smaller companies prefer to exit? We are already seeing some signs of consolidation. The latest example is Medley Pharma, where the second generation pharma promoters are reportedly looking to sell out to more experienced players, with big Indian pharma companies and private equity players engaged in the bidding. Likewise, there are reports that Torrent Pharma and JB Chemicals are bidding for Curatio Healthcare, after four other pharma companies dropped out of the race.

Torrent Pharma's recent acquisition of four brands from Dr Reddy’s Labs to strengthen their presence in gynaecology and urology is also the latest example of strategic bolt-on acquisitions, a trend that we could see picking up, as many companies look to invest their COVID windfalls to pick up assets and plug gaps in their product portfolios.

Meanwhile, investor interest in select Indian pharma companies continues, and we should see more deals like the Abu Dhabi Investment Authority (ADIA) reportedly acquiring around three per cent in Intas Pharmaceuticals as the existing investor Temasek Holdings parts with some of its holdings. A challenge is an opportunity waiting to be won and India Pharma Inc has proved it can be done.

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

MARKET NEWS

Biopharma alliances reach $177.3 billion in 2021 In terms of deal volume, Q1 opened strongly as the most active quarter of the year with 300 transactions, as per the 2021 Deal-Making Roundup report dated March 2022, from Informa Pharma Intelligence

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iopharma alliances for 2021 reached a total Potential Deal Value (PDV) of $177.3 billion from 1,133 transactions (373 with disclosed values). In terms of deal volume, Q1 opened strongly as the most active quarter of the year with 300 transactions. In relation to PDV, Q4 was the highest at $64.5 billion, likely due to it having the greatest number of billion-dollar-plus deals (20) as well as the highest valued deal of the year (the latter making up 19 per cent of the Q4 total PDV), as per the 2021 DealMaking Roundup report dated March 2022, from Informa Pharma Intelligence.

In the largest alliance of both Q4 and the year, Recursion entered a 10-year collaboration, worth up to $12.4 billion, with Roche and its Genentech subsidiary to rapidly identify novel targets and develop therapeutic small-molecule programmes in a gastrointestinal cancer indication, and in key areas of neuroscience. The agreement will leverage the Recursion Operating System, which will be deployed to phenomically capture chemical and genetic perturbations in neurosciencerelated cell types and select cancer cell lines. Recursion is responsible for creating a certain number of PhenoMaps, which are massive relational databases of biological and chemical perturbatio phenotypes. Roche will have the option to use the collaboration images generated, and Recursion will also provide Roche with limited access to its preexisting human umbilical vein endothelial cells PhenoMap. For 2021, overall, transactions structured with an announced milestone component accounted for 79 per cent of

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the total PDV in the 260 deals in which the milestone was disclosed, while up fronts made up just nine per cent of the total PDV in the set of 259 for which the upfront amount was disclosed. There were 44 deals in all with disclosed potential future payments of a billion-dollarsplus; the Roche/Recursion deal was at the top with its up to $12 billion in possible milestones. Of the transactions with disclosed up fronts, only single deal exceeded a billion dollars: Takeda's agreement to transfer the assets, marketing rights, and, eventually,

marketing authorisations associated with a portfolio of select non-core diabetes products sold in Japan to Teijin Pharma for $1.25 billion.

Oncology was the most active therapeutic area for partnering during 2021 in terms of deal volume, with 408 deals (36 per cent of all partnerships) having at least one asset in this disease area. Oncology was followed by infectious disease (with 174 deals making up 15 per cent of the total), and neurology, with 141 alliances or 12 per cent of the aggregate.

Deals involving oncology

assets, together totalling $ 83 billion, also made up the greatest percentage (47 per cent) of aggregate potential 2021 deal value. Roche, in addition to its outlier neuro/oncology deal with Recursion, also penned a potential $3.3 billion eight-year alliance with Adaptimmune Therapeutics to develop and commercialise allogeneic offthe-shelf T-cell therapies for up to five shared cancer targets and development of personalised allogeneic T-cell therapies. Neurology/psychiatry-focussed deals brought in the next most dollars, with

$41.2 billion in aggregate PDV (23 per cent of the 2021 total).

One of the top deals in the neuro space also involved Roche, in a potential $3 billion partnership with Shap Therapeutics, which will apply its proprietary RNA editing platform RNAfix and AAVid technology for next-generation, tissue-specific adeno-associated viruses to develop gene therapies for certain Roche targets in Alzheimer's, Parkinson's and rare diseases. Deals for which no specific therapeutic area was specified were next at $18.2 billion, making up 10 per

MARKET cent of overall PDV. Although infectious diseases represented the second-most popular therapy area in terms of deal volume, the category accounted for $8 billion in aggregate deal value, just four per cent of total 2021 PDV. There were 54 alliances reaching or surpassing a billion dollars. In terms of deal volume, half of the partnerships in this subset of deals centered around an oncology asset, followed by alliances with one or more neurology asset(s).

During 2021, biopharma alliances to address SARSCoV2, the virus that causes COVID-19, impacted the dealmaking landscape with 111 partnerships signed in all; these were rather evenly split with 56 for therapeutics and 55 for vaccines. Collaborations involving a COVID-19 asset made up 64 per cent of the overall deal volume within the infectious disease category, and the 15 deals with disclosed values had an aggregate PDV of $1.1 billion, making up 14 per cent of the infectious disease total deal value. In the highestvalued COVID-19 alliance of the year, Verona Pharma and Nuance Pharma entered into a potential $219 million agreement granting Nuance the exclusive rights to develop and commercialise in Greater China Verona's ensifentrine (RPL554), an inhaled, dual PDE3/PDE4 inhibitor for chronic obstructive pulmonary disease (phase-III), and in phase-II for COVID-19 treatment, cystic fibrosis and asthma indications.

Biopharma acquisitions For the full year, biopharma M&A activity totalled $143 billion from 165 transactions, 82 of which had disclosed values.

The deal volume was the highest during Q1 with 44 transactions, dropping to 41 deals in Q2, but staying somewhat consistent quarter to quarter. Despite outlier CSL's definitive all-cash offer to acquire public specialty pharma Vifor Pharma for $11.7 billion - the second-highest M&A in the biopharma industry overall in 2021 - Q4 was the lowest quarter of the year in terms of deal

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For 2021, overall, transactions structured with an announced milestone component accounted for 79 per cent of the total PDV in the 260 deals in which the milestone was disclosed, while up fronts made up just nine per cent of the total PDV in the set of 259 for which the upfront amount was disclosed value, with only five deals hitting a billion dollars or more.

During 2021, an impressive 27 biopharma M&As had a deal value of one billion or more, while four of those exceeded the 10-billion-dollar mark. Thermo Fisher Scientific's $20.4 billion buy of publicly-traded Contract Research Organisation (CRO) PPD was the largest M&A for the biopharma industry overall during the year. Following the acquisition, PPD became part of Thermo Fisher's Laboratory Products and Services segment. PPD provides a broad range of clinical research and laboratory services such as

clinical development, peri- and post-approval, site selection and patient enrollment to clients in the biopharma, medical device, and other industries to enable acceleration of drug development productivity. The addition of PPD will enhance Thermo Fisher's offerings, bringing a proven drug development platform, patient recruitment capabilities, and other complementary laboratory services.

The main area of interest in terms of both deal volume and value for 2021 M&A deals exceeding a billion dollars was CROs/contract development

and manufacturing organisations (CDMOs), with six transactions in all of companies operating in this industry, for an aggregate $56.6 billion in deal value. Within the same billiondollar subset of deals, M&As of autoimmune/immunology-focussed companies accounted for the second most deals, with five transactions worth an aggregate $15 billion; Pfizer's $6.7 billion definitive agreement to buy Arena Pharma was at the top. Arena brings etrasimod, an oral, selective sphingosine 1-phosphate receptor modulator, currently in development for a range of immunoinflam-

matory diseases, which will complement Pfizer's capabilities in this therapeutic area.

Biopharma financings Total biopharma financing for 2021 reached $124.5 billion from 1,257 transactions. Q2 turned out to be the strongest quarter in terms of deal value, with an aggregate $43.4 billion (making up 35 per cent of the full year total), showing a steady increase from the first quarter's $35.3 billion. There was a significant dip during Q3 ($17.6 billion, just 14 per cent of the full year aggregate), but then fundraising rebounded to $28.2 billion in Q4.

In all, eight transactions met or topped the billion-dollar mark, most of those private placements of debt. The largest financing of the year was Organon's $5.6 billion senior notes offering, which closed with an added credit facility for total net proceeds of $9.5 billion. The women's health company will use the proceeds to repay one or more inter-company loans or notes owed to a Merck

MARKET & Co affiliate and to pay fees and expenses related to its spinoff from the Big Pharma, which was completed in June 2021.

Overall, biopharma IPO activity reached $21.7 billion from 128 completed transactions, with the average deal value at $173.5 million. The IPO category made up 18 per cent of all 2021 biopharma financing. Six of the top 10 IPOs were by China-based companies listing on Asian markets, including HKEX, Kosdaq and Shanghai stock exchanges. At the top, in terms of dollar value, was immuno-oncology-focussed BeiGene, which launched a $2.8 billion IPO on the STAR Market of the Shanghai Stock Exchange, followed by CDMO Asymchem Laboratories, which netted $939 million through its HKEX IPO in the second-highest deal.

Start-up firms - companies founded within the last four years - were well represented in completed IPOs during 2021.

A total of 31 biopharma startups raised a combined $4.4 billion in IPO proceeds, accounting for 86 per cent of the total 2021 IPO funding within this group (five medtech companies raised $722.3 million). In addition to China-based transcatheter valve developer MicroPort CardioFlow, which brought in the most in a $350.5 million listing on the HKEX, the other non-biopharma start-up firms completing IPOs were Olink ($246.2 million; proteomics products and services), Lucid Diagnostics ($65.1 million; oesophageal adenocarcinoma-focussed diagnostics), Movano ($45.7 million; devices to prevent and better manage chronic diseases), and Inspira Technologies ($14.7 million; respiratory devices). Going public is reasonable financing route for young companies with laterstage R&D programmes or with technology platforms that are generating more candidates than they can develop on their own with just venture capital funding.

Biopharma venture capital funding for the year totalled $37.4 billion; it was the category with the highest proportion of overall financing

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dollars, accounting for 30 per cent of the total across all deal types. There were 127 transactions of $100 million or more.

Series B rounds dominated in terms of deal value at $14.2 billion aggregate, accounting for 38 per cent of the total 2021 VC rounds (and 11 per cent of

funding across all financing types). EQRx led with a January 2021 $500 million Series B round it will use to accelerate development of late-stage cancer therapies and expand the company's pipeline. The company subsequently went public via a Special Purpose Acquisi-

tion Company (SPAC) merger that closed in December. The largest biopharma VC round of 2021 was a $700 million Series C raise by China-based startup Suzhou Abogen Biosciences (developing messenger RNA (mRNA) vaccines). In terms of deal volume, the most deals

(190, or a third of all VC funding volume) were completed by companies raising Series A funds, followed by Series B rounds at 161 transactions.

(Extracted from 2021 DealMaking Roundup, March 2022, Informa Pharma Intelligence)

POST EVENT REPORT

PharmaTechnologyIndex,EEPC INDIAand Haryana government host 12th PharmaTech Expo 2022 & LabTech Expo 2022 The event was held from 28th to 30th April, 2022, in Chandigarh (UT)

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harmaTechnologyIndex.c om, along with the Engineering Export Promotion Council of India (EEPC India) and the government of Haryana supporting as co-organisers, organised the 12th edition of PharmaTech Expo 2022 & LabTech Expo 2022 from 28th to 30th April, 2022, at Parade Ground, Sector 17, Chandigarh.

This year was encouraged by the response and feedback to the previous events with all enthusiasm and zeal to regain the defunct period of 2020 and 2021.

The concentration mainly was on to recover the lost active time and certainly was on the pharma machinery and equipment-manufacturing sector and pharma packaging, lab and analytical instruments, pharma formulations and nutraceuticals.

The exhibition was planned in the space of 7,500 square metres, with more than 250 exhibitors displaying machinery and equipment for producing drugs and pharma products.

This year, unprecedentedly, more than 6,500 business and industrial personnel visited the three-day event. With all the cooperation of the industry, this was the fourth consecutive event in Chandigarh, and there was 40 per cent growth in the exhibition area and about 50 per cent growth in the industrial visitors.

The Chief Guest, Sanjeev Kaushal, IAS, Chief Secretary, Government of Haryana, inaugurated the exhibition at Parade Ground, Chandigarh.

The Haryana Exporter's Conclave was organised by PharmaTech Expo jointly with the government of Haryana and

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A large number of industry representatives, entrepreneurs, government officials and academicians were present during the inauguration function

EEPC India on 28th April, 2022.

The inauguration was held on 28th April, 2022, at Hotel Shivalik View, in the presence of dignitaries - Sanjeev Kaushal, IAS, Chief Secretary, Government of Haryana; Dr G Anupama, IAS, Additional Chief Secretary and Chief Administrator, Trade Fair Authority of Haryana; Suvidh Shah, Joint Director General of Foreign Trade (DGFT), Ministry of Commerce

and Industry; Pradeep Kumar Aggarwal, Regional Chairman, EEPC India - who graced the occasion.

Further, at the Haryana Exporter's Conclave, lectures were delivered by Professor Anant Ramakrishna, CSIR-CSIO; Dr Gagan Sharma, Consultant, Pharmaceuticals Biotechnology, Invest India; Pradeep Ojha, Joint Director, MSME-Development Institute, Karnal; Sanjay Beswal,

Business seminar

Director, Andees Consulting LLP; Vijay Paul, Manager, ECGC and Deepak Gandhi, Head Sales, Drip Capital.

Apart from it, a seminar on "Quality and Regulatory Requirements of Pharma Export Business" Focus towards "Make in India" was organised by PharmaTech Expo jointly with the government of Haryana and EEPC India on 29th April, 2022.

Around 200 delegates from the industry attended the seminars and the following experts shared their views with partici-

pants on respective topics. ◆ Regulatory and quality issues in pharma sectors: Dr G S Pandey, Director, GAMP Technologies ◆ Regulatory requirements for COPP/WHO GMP: Sushant Sharma, Assistant Drugs Controller (I), Central Drugs Standard Control Organization (CDSCO) ◆ Current growing market for export: Dr Rakesh Suraj, Regional Director, EEPC India ◆ Export factoring - Collateralfree financing solution: Deepak Gandhi, Head, Outbound Sales Drip Capital ◆ Pharma marketing - New prospective: Dr Vinod Kumar Sharma, Pharma Business Coach, Leadership and CEO Coach.

Other dignitaries who visited the exhibition included Manmohan Taneja, State Drugs Controller, Haryana; Navneet Marwaha, State Drugs Controller, Himachal Pradesh; Sanjeev Kumar, Joint Commissioner (Drugs), Punjab; Pradeep Kumar Mattu, Ex-Joint Commissioner (Drugs), Punjab; N K Ahuja, Ex-State Drugs Controller, Punjab and Amneet P Kumar, IAS, Director General, MSME, Haryana.

A large number of organisations, including EEPC India, Laghu Udyog Bharti, Himachal Drug Manufacturers Association (HDMA), Ambala Scientific Instruments Manufacturers' Association (ASIMA), Drug Marketing and Manufacturers Association (DMMA) and other industry associations and industrial houses had given consent as support organisations/sponsors to the event.

Vaccine and biologics industry leaders gather for IMAPAC's 12th Annual Vaccines World Summit and Biologics Festival The Vaccine World Summit 2022 (co-located with Biologics Festival India) was held in Pune from 5th to 6th May, 2022

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he last decade has marked an era of growth in India's healthcare sector and the next promises exciting times for it. There is no other health intervention as simple, powerful and cost-effective as a 'vaccine.' Currently, more than two thirds of the total volume of the vaccines manufactured is exported, while the rest is utilised domestically. According to a new report by IMARC titled "Indian Vaccine Market Report and Forecast 2020-2025," the Indian vaccine market reached a value of Rs 94 billion in 2019.

As India shifts from being a low-cost generic vaccine supplier into an R&D power house, local vaccine manufacturers seek to fast track and gain greater access to the latest vaccine technologies through global partnerships. In recent years, there is a significant rise in global partnerships where international and local vaccine players come together to learn and complement one another's capabilities.

Currently, in its 11th year, the Vaccine World Summit 2022 (colocated with Biologics Festival India) in Pune, from 5th to 6th May, 2022, provided an opportunity for the "whole vaccine manufacturing value chain" to explore partnerships at various stages of the vaccine lifecycle, beginning with the fundamental research, and extending through to the licensing and production stages.

More than 530 participants from over 150 vaccines and biologics organisations came together to participate in the inperson conference.

The conference presented thought leaders the opportunity to exchange views on how industry players can link arms to build

As India shifts from being a low-cost generic vaccine supplier into an R&D power house, local vaccine manufacturers seek to fast track and gain greater access to the latest vaccine technologies through global partnerships a better future as well as scale up the next wave of innovation. With networking opportunities, presentations of case studies and discussions, the Vaccines and Biologics conference was the place to be! From market landscape to regulatory strategy, from recent invention of COVID-19 monoclonal antibodies to pandemic

preparedness, this event aimed to capture a holistic view of the issues challenging the industry.

The 2022 conference programme featured industry visionary presentations from DCVMN, Bristol Myers Squibb, Zydus Cadila Healthcare, Bharat Biotech International, Intas Pharma, PATH, Serum Institute

of India, Cadila Pharma, Bill and Melinda Gates Foundation, Sanofi Pasteur and many more.

Technology providers such as MR Sanghavi and Co, Pelican Biothermal, Marken, Ami Polymer, Sartorius Stedim Biotech Gmbh, Datwyler Pharma Packaging, West Pharma Services, Pall Life Sciences, EMBALL'ISO

were also there to showcase their latest solutions.

Alongside the conferences, IMAPAC's India Biologics and Vaccines Outstanding Industry Awards (BVOIA) 2022 facilitated vaccine R&D and biologics manufacturing excellence at enhanced speed, reduced cost and superior quality. Featuring top vaccine and biomanufacturing leaders in the industry, along with the latest advances in technologies and the best practices in R&D and manufacturing, the India Biologics and Vaccines Outstanding Achievement Award 2022 applauded the extraordinary leaders and trendsetters of today and inspired the innovators of tomorrow.

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As the world can't afford another Great Pacific Dump, the pharma industry needs to be responsible enough with its packaging methods and tools

By Akanki Sharma

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ackaging - one of the crucial aspects of the pharma industry - has been witnessing changes over years. With time, the demand for innovative packaging has risen, including innovative designs, security features, track and trace features, and so on and so forth. Currently, there are a number of sustainable packaging methods like metal tins, paper board packaging, HDPE and PP recyclable bottles that are being used in pharma companies.

A survey conducted by Edelman in 2020 had revealed that 88 per cent of investors believe that companies that prioritise Environment, Social and Government (ESG) initiatives represent better opportunities for long-term returns than companies that don't.

One of the emerging trends that intends to create an impact on the industry at the moment is green packaging - a sustainable mode that holds the potential to transform the future of pharma packaging.

Green packaging or sustainable packaging is using manufacturing techniques and packaging materials which reduce harmful impacts of packaging on environment, and also minimise the adverse impact on ecology and economy. "From pharma packaging perspective, it is a huge responsibility rather than demand," emphasised R Chandi Prasad, Head, Packaging Development, Aurobindo Pharma.

He also said, "Global pharma packaging market size was valued at $117.2 billion in 2021, and is expected to expand at a Compound Annual Growth Rate (CAGR) of 9.5 per cent from 2021 to 2030.

The two dominating factors that are influencing pharma packaging, apart from compliance with regulatory requirements for the last five years, are sustainability and usercentricity. User can be a patient, administrator or pharmacist. Sustainability is the major factor influencing sales of medicines as modern-day

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Many companies are developing novel sustainable packaging solutions like plant-based packaging that uses corn starch, sugarcane and cassava. The idea is to reduce the 300 million tonnes of plastic waste generated every year by the pharma industry, at least half of which includes single-use plastic Saransh Chaudhary Chief Executive Officer, Venus Medicine Research Centre

By streamlining shipments to customers, the company expects to save about 25 tonnes of plastic per year, while also lowering its CO2 footprint. In addition, the company is working in Sweden on a water conservation project Raghavendra Goud Vaggu General Manager, Cytiva South Asia

Many people think that cellulose or paper-based materials are better over plastics. However, we need to remember that we destroy more greens to get cellulose or paper and use more energy and resources to convert them in usable form Prabir Das Head, Packaging Tech Services, OSD, Mylan Laboratories

healthcare professional and individual customer demands convenient as well as sustainable product and packaging."

Regarding the usage of biodegradable plastic for pharma packaging, he said it is inevitable that plastics dominate pharma packaging as biodegradable plastics are not suitable for pharma products due to extended shelf-life of 24-to-48 months and beyond,

compared to FMCG, which is less than 60-90 days. "Manufacturers are associating with government and non-government organisations to collect pharma packaging for their disposal, segregation and recycling," he notified.

The growing awareness among consumers regarding sustainable packaging and the strict ban on the usage of single-use plastics are the major

factors fuelling the demand for green packaging, mentioned Saransh Chaudhary, Chief Executive Officer, Venus Medicine Research Centre. "Going by the estimates of industry experts, sustainable solutions account for 10-25 per cent of the total primary pharma packaging. Many companies are developing novel sustainable packaging solutions like plant-based packaging that

uses corn starch, sugarcane and cassava. The idea is to reduce the 300 million tonnes of plastic waste generated every year by the pharma industry, at least half of which includes single-use plastic," he said.

Last April, at a conference - PPL Conclave 2021 - held by Express Pharma, Professor Pierre Pienaar, President, World Packaging Organisation, had said, "Packaging is necessary. We can't do without it. But, it's what we do with the packaging after we have used the contents. That is what is important, and in what way can we reduce the impact on our natural resources. The World Packaging Organization sees a future without waste.

Those who are producing the packaging, must take responsibility of recovery and recycling. The world can't afford another Great Pacific Dump."

All that is happening Aurobindo Pharma is at the forefront of implementing green sustainable packaging solutions that are being followed by other big players in India. Apart from it, Cytvia, a global lifescience company, has also begun to remove unnecessary plastic packaging from its supply chain, as part of its sustainable growth strategy, among other improvements.

Speaking in this regard, Raghavendra Goud Vaggu, General Manager, Cytiva South Asia, said, "By streamlining shipments to customers, the company expects to save about 25 tonnes of plastic per year, while also lowering its CO2 footprint. In addition, the company is working in Sweden on a water conservation project."

According to Prasad, in primary packaging, Aurobindo Pharma implemented reduction of bottle sizes, removal of filler (cotton/rayon/polyester coils), downsizing of wall thickness of bottles and forming materials of blisters, thermoform blisters in place of 3/4 layers of coldform blisters which

reduces pack size by 60 per cent and material consumption by 80 per cent. In secondary packaging, the company replaced physical medication guides with electronic copy in agreement with the US Food and Drug Administration (FDA) and pharmacists providing print of electronic copy, as per patient demand.

Elimination of carton and reduction of leaflets by 90 per cent for tender orders of ARVs with regulatory permission saved 850 tonnes of paper annually, besides supply chain challenges.

Aurobindo Pharma also followed removal of shrink packing for bottles and cartons and replacing with banding for few products, as per market need and elimination of intermediate packaging.

"Another major project is shipping products to the US

A few contract manufacturing companies are also working in the direction of opting environmentfriendly packaging methods by stuffing of shippers in ocean containers with removal of wooden pallets. This resulted in transportation of 50 per cent more in a container saving one out of three. This reduces carbon footprint as 70 per cent are refrigerated containers using CFCs and HFCs; also saving of 35 tonnes of packaging materials such as plastic sheets, carry straps, corner boards and 15 tonnes of stretch wrapping material," Prasad further informed.

Similar to Aurobindo Pharma and Cytvia, Venus

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Remedies has also taken some steps towards sustainable packaging. It has replaced single-use plastic trays with paper trays for ampoule packaging, and has started using

eco-friendly UV-coated cartons instead of laminated ones.

"We have also started implementing biodegradable shrink films for shrink packag-

ing. The industry is still struggling to find a sustainable alternative to blister packaging.

The availability of sustainable packaging solutions from plant origin is limited. The

cost of the new solutions right now is prohibitively high in some cases, which comes to 50 per cent more than the solutions currently in use.

However,

cover ) increased adoption across all sectors will bring down the costs," suggested Chaudhary.

A few contract manufacturing companies are also working in the direction of opting environment-friendly packaging methods. Speaking in this regard, Yashna Garg, Chief Marketing Officer, ZeoNutra, Zeon Lifesciences, stated that choosing earth-friendly packaging supplies and processes will go a long way in minimising the waste and pollution that end up in landfills and oceans. Her company is working on sustainable packaging closely with its pharma packaging vendors, and trying to nullify hazardous plastics in the industry.

While some industry stakeholders are adopting the sustainable packaging methods, there are others who hold a different view and believe that the process of sustainable packaging causes more harm to the environment.

Prabir Das, Head, Packaging Tech Services, OSD, Mylan Laboratories, stressed, "Many people think that cellulose or paper-based materials are better over plastics. However, we need to remember that we destroy more greens to get cellulose or paper and use more energy and resources to convert them in usable form. Product safety and security is also compromised with such materials. Glass, metal and similar alternatives are often not favourable, considering technological advancement and change in lifestyle of people.

Composite materials are often considered difficult to recycle, reform and reuse. So, a balance is required while choosing an alternative."

He further advised, "Packaging design, from primary to tertiary, followed by palletization needs to be optimised, so that product per unit volume is maximum. Operations should be simple and linear, so that process cycle time is minimum. Wherever feasible, elimination of non-essential component like printed carton for each single unit, and digiti-

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Packaging industries are working hard on the easy source of green packaging at a reasonable cost. The Indian Institute of Packaging has been working on it for a long time Yashna Garg Chief Marketing Officer, ZeoNutra, Zeon Lifesciences

From user industry perspective, I strongly believe that future belongs to those who innovate on principles such as think beyond, make simple and value addition R Chandi Prasad Head, Packaging Development, Aurobindo Pharma

While some industry stakeholders are adopting the sustainable packaging methods, there are others who hold a different view and believe that the process of sustainable packaging causes more harm to the environment sation of product/patient information leaflet are few examples of reduced and simplified linear operation. Similarly, wherever feasible, direct printing on shippers/cases can be adopted instead of using an additional printed label and its application. Use of composite materials needs to be minimised as those are often neither recyclable nor decomposable."

Phasing out plastic: Easier said than done In line with the clarion call

given by Prime Minister Narendra Modi to phase out single-use plastic by 2022 in view of the adverse impact of littered plastic on both terrestrial and aquatic ecosystems, the Union Ministry of Environment, Forest and Climate Change had notified the Plastic Waste Management Amendment Rules, 2021, which prohibits identified single-use plastic items with low utility and high littering potential by 2022. Prior to it, various studies had predicted that plastic-based packaging would

be phased out by 2020. The goal, though, has not been achieved yet since the industry is still not able to afford sustainable packaging completely.

Agreeing somewhat with Das, Garg lamented that there should be a concrete alternate source, so that plastic-based packaging can be phased out.

"Packaging industries are working hard on the easy source of green packaging at a reasonable cost. The Indian Institute of Packaging has been working on it for a long

time," she revealed.

In line with the Plastic Waste Management Amendment Rules, 2021, Chaudhary stated, "The manufacture, import, stocking, distribution, sale and single-use plastic commodities, including polystyrene and expanded polystyrene, will be prohibited with effect from 1st July this year, thus marking a significant step in dealing with the environmental threat posed by non-biodegradable materials.

The adoption of sustainable packaging leaves a lot to be desired largely because of lack of awareness among small and medium scale industries and low volumes that lead to higher costs. Bringing down the cost of packaging to the same level as plastic packaging, if not lower, holds the key to facilitating this transition."

As per Prasad, usage of plastic-based packaging material in pharma industry is inevitable. "In fact, usage of plastics increased over the last decade replacing glass and metal for packaging of oral dosage forms, parenterals and semi-solids. The positive side of this is these plastic materials are easily recyclable and can be used for many applications except food packaging.

Plastics are not dangerous to the environment, if properly used, disposed and recycled.

However, single-use plastics need to be banned strictly, paper-based packaging should be used for food products, especially take away and online delivery, which is rampant now," he highlighted.

Predicting the future While pharma experts and stakeholders are constantly looking out for innovation, they also tend to take a peek into the future trends that might help them in implementing novel ways by using upgraded technologies for adding value to, and revolutionise the packaging segment.

"From user industry perspective, I strongly believe that future belongs to those

who innovate on principles such as think beyond, make simple and value addition.

With precise design, efficient strategy, applying advanced technology, automation and optimisation throughout supply chain, green packaging should be the mark of your brand. Personal medication, in future, can minimise packaging in pharma sector as it is manufactured, delivered to patient directly for immediate usage which reduces shelf-life drastically. Development of biodegradable plastics for pharma packaging, which can sustain product quality for longer periods of 24-to-36 months will immensely contribute to green packaging.

As an individual, I have huge responsibility to save our planet for future generations to live more safely and healthily and committed to follow green measures and use only green packaging.

Sustainability should be taught from secondary education level and engage them in green activities with reward and award."

Chaudhary predicts that the trend of biodegradable packaging will see a tremendous growth in the next decade. "Over the next 10 years, the trend of biodegradable packaging will grow like never before. The major factor that will shape the future of pharmaceutical packaging on sustainable lines is the need for alternative solutions that minimise the adverse impact on the environment. The alarming increase in pollution levels has accelerated the process of climate change and global warming, as evident by the rising temperatures and odd weather patterns across the globe. The increased awareness about this looming threat and the strong concordance between the government and the industry on curbing plastic waste through collaborative efforts and innovative solutions is making a big difference," he said.

Garg put emphasis on converting plans into actions.

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"Replacing virgin plastic with more sustainable materials is highly possible and highly effective in the next 10 years. We're already on the road to progress and putting

plans into action. We are ready to face the challenges and do our part in ensuring optimal health for every living being and providing a safer future for the planet,"

she said.

While it is indeed essential for the industry experts and stakeholders to look for green packaging methods, saving our natural resources is also

crucial as our future generations await a healthy and rich environment to breathe. akanki.sharma@expressindia.com journoakanki@gmail.com

STRATEGY I N T E R V I E W

Orphan drug development remains a specialised segment with limited players Recently, Syngene International was involved in the development of a drug for a rare disease that affects children. Dr Mahesh Bhalgat, COO, Syngene International, shares more details about the project, its impact, progress, potential and challenges in orphan drug development, evolving role of CROs in drug development and more, in an exclusive interaction with Lakshmipriya Nair How has the COVID-19 pandemic transformed the industry's approach to drug development? What are the imperatives that led to this change? What have been the lessons in drug development over the past two years?

Drug development has seen acceleration, partly due to the agility displayed by the regulatory bodies around the world. Regulators have put together the required machinery for swifter and parallel approvals. However, given the need of the hour, this has been more targetted towards COVID-related drugs.

So, has there been a broader benefit? Not quite as much, as the world was primarily focussed on fighting the pandemic.

While drugs related to COVID have benefitted from the acceleration, non-COVID drugs have two contributory aspects - firstly, organisations that didn't have the bandwidth to handle multiple programmes, have not been able to pursue non-COVID drugs at the same pace. We have seen some regulatory bodies around the world having to put things on hold; for example, FDA inspections of sites, which is a key step in the approval process, couldn't be pursued at the same pace.

Secondly, we have also witnessed pharma and biotech companies increasingly outsourcing their drug development activities to CROs in various parts of the world, India being one of the key markets. By outsourcing,

26 EXPRESS PHARMA June 2022

these companies could leverage the skills and expertise available in other markets to maintain their research pipelines.

Recently, you were involved in the development of a drug for a rare disease that affects children. Can you tell us more about the project?

I would like to use this

opportunity to delve deeper into our approach to drive programmes and projects.

Clients collaborate with us for our scientific expertise and approach, which includes our sharp focus on quality, infusion of cutting-edge technology and access to skilled scientists. As a strategic partner to our clients, often working as an extension of their internal

scientific teams, we continue to bring them innovative solutions for complex scientific challenges. This approach isn't specific to any disease, drug or client. It is who we are, and it remains uniform across the discovery, development and manufacturing spectrum.

Let me offer an example of what I mean by this particular rare disease drug, which is

approved for the treatment of pruritus in all subtypes of Progressive Familial Intrahepatic Cholestasis (PFIC). Similarly, Syngene has also received FDA approval to manufacture the drug Brexafemme (Ibrexafungerp tablets), which is useful for the treatment of life-threatening fungal infections. In both scenarios, the indications were different. The target population for a rare disease drug is different from that of a broad treatment targetting a therapeutic drug. For us, the approach is to ensure that we find the right solutions and get the drug through the next stage of the development pipeline or in the commercialisation pipeline, irrespective of the indication or target population it serves.

The approach to solutions we provide changes as per the science it needs and the patient population that is targetted. Given our broad expertise in many diverse areas, whether it is a small molecule or a large molecule, whether it is a peptide or protein or an oligonucleotide, whether it's an oral formulation or an injectable formulation, regardless of any of these modalities, Syngene is able to provide the required services through its scientific staff effectively.

How was the process of developing this drug different from the drug development of diseases that affect larger masses? What were the major challenges

faced and how were they overcome?

One of the key components related to the time required for developing treatments for rare diseases is getting the status of an orphan drug for accelerated assessment in the system. This status reduces the timeline for the regulatory approvals. For example, the EMA accelerated assessment means that the medicine is of major interest for public health. So, its time frame for review is 150 days rather than 210 days.

Therefore, as the manufacturing partner for this drug, Syngene had to produce limited quantities of the drug substance to support the trial and meet tight timelines. The opportunity to do so lies through finding the most optimal routes for synthesis and also flawless execution.

Since, with orphan drugs, the patient population is limited, the trial size is not as large as with other traditional drugs, making data generation more manageable.

What is the current landscape of orphan drug development? What are the key learnings you would like to share with the industry stakeholders to improve the current scenario and help advance potential treatments for rare diseases?

In my opinion, the whole area of orphan drug development is a specialised area. If a company is committed to a blockbuster drug being launched in the market, then it also requires selling a large volume of that drug, and, therefore, needs a combination of unit cost and

volume to meet its objectives.

Orphan drugs are produced in smaller volumes and yet need to be affordable, which calls for the application of innovative solutions to managing costs at low volumes. This is certainly a different challenge than what is faced for drugs being pursued for diseases such as cardiovascular, diabetes, neurology, oncology, bone disease, and so on. Patient recruitment is an additional challenge that needs to be addressed since the disease prevalence is low.

On the other hand, any company that decides to work on an orphan drug also benefits from lesser competition in this space. Once the drug receives the orphan status and gets a priority review, the approval and launch can be accelerated

leading to benefits for patients.

However, despite the pros and cons, this remains a specialised segment with limited players.

Are rare diseases finally gaining priority in the pharma industry's agenda?

Is it going to be a focus area for Syngene in the coming years?

At Syngene, our focus and commitment is to deliver cutting-edge science to our clients and help them advance their product pipeline. Our clients come to us knowing that we apply our scientific expertise to problem-solving and that we add value by critiquing and challenging their scientific ideas, bringing our own expertise to the table.

So, that's the opportunity, and it's also the marginal driver for

long-term growth. It's about the intellectual added value that we can bring, which segues perfectly.

This approach remains consistent for all areas of our work, it can be a drug for a rare disease or can be for a highly prevalent disease. So, I don't think there is really any change for us in the need to focus more on rare diseases because the toolkit is what we continue to equip well for bringing strong scientific contribution. Through this approach, we provide support to the complete stream of drug discovery, development and manufacturing aspects, leading to the launch of client products on the market for patients. lakshmipriya.nair@expressindia.com laxmipriyanair@gmail.com

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STRATEGY I N T E R V I E W

No one can stop Indian pharma exports Kamlesh Shah, President and Sandeep Modi, Joint Secretary, Federation of Pharmaceutical And Allied Products Merchant Exporters (FPME) explain to Viveka Roychowdhury why pharma merchant exporters are brand ambassadors for Indian pharma exports, and the policy changes required to tackle the challenges posed by countries like Bangladesh, Pakistan and Vietnam, which are getting stronger with a competitive edge What was the background and objectives behind the formation of the Federation of Pharmaceutical and Allied Products Merchant Exporters (FPME)?

The idea to form the association was cemented in June 2018, spurred by the improper attempts to implement Track and Trace (Barcode) system. After several meetings, the modalities of formation were finalised and the association was finally formed on 30th March, 2019 under the Companies Act with the Board of Directors comprising the two of us along with Ashish Shah, Abhay Shah, Yogesh Doshi, Niren Shah, and Hemil Shah.

The association sees merchant exporters as brand ambassadors for Indian pharma exports, who serve humanity by serving affordable medicines to the needy.

Today, FPME has more than 200 members, a strong managing committee, with Gujarat, Delhi and Chennai chapters operational.

An exclusive window for merchant exporters was created with the help of Pharmexcil during DAVA portal regime of bar code implementation. The association also has an active B2B WhatsApp group benefitting members.

FPME has worked with Pharmexcil to resolve the ban on various molecules, from paracetamol to remdesevir and enoxaparine during COVID times. They have also successfully represented MSME Ministry for inclusion

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Kamlesh Shah

of merchant exporters as MSMEs. They have represented Ministry of Chemicals and Fertilizers, Ministry of Finance for non-inclusion of the pharma sector under RodTep. They have also represented members to custom officials for timely issuance of drawback/IGST refund whenever it has been held for technical reasons.

The FPME also organised webinars to educate members on topics ranging from GST Refund, FEMA regulations, CBN Procedures for exports of narcotic and psychotropic substances and marine insurance/ECGC procedures.

A regular quarterly bulletin is published, and as a common platform, the FPME ensures a common quality control mechanism,

Sandeep Modi

affordable banking and affordable, effective, speedy logistic solution to members.

The FPME is trying to put together a mechanism for capacity utilisation and matching requirements of merchant exporters as well as a joint mechanism to authorise exports from reputed pharma companies.

The association aims to build a strong B2B/C platform exclusive for pharma trade, which will have international buyers also. FPME also aims to promote the Indian Pharmacopoeia (IP).

On the humanitarian side, FPME has organised Vitamin C, PPE and masks for customs and port workers.

What is the percentage share of India's pharma exports handled by

merchant exporters?

The total pharma exports for FY19 were $19132.5 million, out of which merchant exporters contributed approximately $6700 million.

Thus, merchant exporters account for around 35 per cent of the total exports. Even though there are more than 2,000 merchant exporters across India, there is no single representative body. Most merchant exporters have a distribution background or are startups who have quit the industry and require support.

What is India's rank as a global pharma exporter?

India is placed 12th in the world in terms of pharma exports.

Which are the areas where India is considered best

placed as a reliable and costeffective exporter?

Formulation is India's strength, as the world can rely on India for all the latest molecules, be it biosimilars, vaccines or the latest NDDS. India serves the world in a cost-effective manner without compromising quality. The recent development of quick COVID vaccine and its large-scale production is the best example. Having said this, the recent push for competitive API manufacturing, instead of imports from China, will take India to new heights.

While exports of Made in India COVID essentials, including medicines, were a humanitarian response during the pandemic, what were the challenges faced by

STRATEGY exporters, for instance, on the supply chain, availability front, etc.?

The inconsistent policies by DGFT like the ban/restriction imposed for export of certain COVID drugs, without taking exporters into confidence, was a major challenge. Costs of logistics went haywire in these days and it is still on the higher side. On the availability front, there was no big challenge, except for remdesivir, which was a challenge in April 2021.

Were those addressed in time?

Not exactly, but as we say in Hindi, der aaye durust aaye (better late than never).

What was the role of FPME and other associations in

addressing these concerns?

FPME, along with Pharmexcil, played an important role in taking up these issues to DGFT as well as CDSCO and the Department of Pharmaceuticals (DoP), which resulted in the removal of these restrictions.

What about some apprehensions on short supplies of these medicines in India, due to export commitments?

This is like doubting India's strength. As said earlier, none of the medicine was in short supply, with the exception of remdesevir and amphotericin-B in April 2021.

However, this was also regularised soon by India's manufacturers.

What is the outlook for pharma exports from India?

Pharma exports from India will grow multiple-fold postCOVID as the world has witnessed India's capacity to deliver affordable quality medicines in troubled times, especially where they have more faith in India than China.

The major challenge we foresee is that countries like Bangladesh, Pakistan and recently Vietnam, are getting stronger with a competitive edge. But, if we resolve to deliver and fill the loopholes, be it issues in the government policy or with individual exporters, no one can stop Indian pharma exports.

What are the policies which FPME is working on with

the government of India to encourage pharma exports?

FPME is working on major policies like promoting Indian Pharmacopoeia, as it should be made mandatory under every individual trade agreement with individual countries to accept goods manufactured under IP. Another policy matter we are working on is that bar codes, track and trace should be mandated only after universal implementation.

With no major incentives, the government should ask banks not to charge exporters for their foreign exchangerelated services. We feel that merchant exporters should benefit from the interest equalisation scheme.

Freight equalisation mechanism should be

developed in case of high volume, low value goods exports, or government should now interfere to reduce container as well as air freight.

FPME also suggests that to support MSMEs and enhance risk appetite, Export Credit Guarantee Corporation Limited (ECGC) or credit insurance premium should be minimalised and should be zero when supplying to international government agencies.

In the case of customs, FPME is working with the government on single port registration, lesser turnaround and avoiding duplication of documentation. viveka.r@expressindia.com viveka.roy3@gmail.com

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STRATEGY

Challenges in procurement of “QualityAssured”generics Dr Suresh Saravdekar, Ex-Assistant Director, Ministry of Medical Education and Health, State of Maharashtra and Ex-honorary consultant, Institute of Medical Sciences, Banaras Hindu University (BHU), analyses why procuring quality generic medicines is a challenge even in the 'pharmacy of the world' and suggests some policy changes to rectify this

H

aving worked as a medical supplies procurement head for more than three decades at the national and international level in public healthcare services, my responsibility was provision of generic medicines at the lowest price.

To obtain generic medicines at the lowest price is not a big task in India which is called the 'Pharmacy of the World of Generic Medicine.'' However, the main difficulty was finding a 'Quality Assured' generic medicine from a market flooded with 'Quality Assumed' generic medicines.

Believe me, this was a definitely a Herculean task. But, this quote of Kenneth Arrow, Nobel laureate in Economics kept guiding me: "If buyers know less about goods than the seller does, then the buyer suffers from Information Asymmetry or Handicap.'

I found this handicap very prominently in healthcare services, and to remove it, I had to constantly keep myself updated with changes in the national and the international market.

This led me to the study of the global pharma market which revealed that besides domestic market forces, global drivers also control the availability, accessibility and affordability of generic medicines within the domestic market in India.

Thus, there are direct as well as indirect challenges which need to be faced by providers of generic medicine.

Indirect market drivers constitute international policies that also affect the domestic availability and accessibility of generic medicines.

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Global challenges Skewed research priorities: Globally, technology has revolutionised all aspects of medical treatment with the adoption of Artificial Intelligence (AI), Machine Learning (ML) and Deep Learning (DL). Technology has revolutionised all concepts of medical treatment and health needs.

While there is an increased adoption of technology in healthcare, a lot needs to be done in the area of monitoring of essential drugs. As per WHO studies, there are many product gaps and delivery challenges. This is because the priorities in research are not 'need-based' but 'marketbased.' The reality is that there are about 10,000 diseases, world over, including orphan diseases, which are left untreated as medicines are unavailable.

Consequently, medicines are available only for 500 diseases which are prevalent mainly in rich and developed countries. Unfortunately, the present scale of technology development does not match the scale of people's need for better access to medicine, particularly in Low-Income Countries (LICs) and low-income groups in Middle-Income Countries (MICs).

Hardly any new drug is targeted for diseases prevalent in LICs except for infectious diseases, because they are common in both worlds. For example, COVID infections have shown us that for infections, there are no economic boundaries.

However, if we look at the list of new approvals in the pipeline in 2020, the number of

new drugs being invented for cancer are the highest (44), followed by 29 for neurological disorders like Alzheimer's, Parkinson's etc., 18 for diseases associated with endocrine disorders like diabetes.

But, there are no new drugs in the pipeline for old infectious diseases like tuberculosis, leprosy, leptospirosis. Artemether is the only new drug invented for drug-resistant malaria and that is by China. Thousands of children are dying each year in Bihar and few other parts of India, but there are still no effective medicines invented for diseases like Kala Azar, sickle cell anemia and Japanese Encephalitis, etc. In India, still we have around 450 orphan diseases without medicines.

IPR blocks Diseases cross all economic borders and spread equally in rich and poor countries. However, the entry of medicines for some diseases is blocked by an international visa called Intellectual Patent Rights (IPR).

The price of such patented medicines is governed by Trade- Related Aspects of Intellectual Property Rights

(TRIPS) formulated by the World Trade Organization (WTO) under the influence of "few international companies."

The only recent exception is COVID vaccine, as the vaccine was simultaneously developed in India and not exclusively by the MNCs. The only way to break the IPR and make essential and life-saving patented drugs available at low price is if the LICs and MICs have the capacity to manufacture generic versions of patented drugs.

However, under current situations, these countries have to operate compulsory and voluntary licensing procedures. But there is a strong resistance to these licenses by the companies and countries owning such patented medicines.

Till now, India has approved one compulsory licence to drug maker Natco Pharma on cancer drug Nexavar patented by Bayer. In 2011, Gilead offered voluntary licences for its patented hepatitis drug to local generic manufacturers of India, Malaysia and many more countries.

Natco Pharma got a compulsory licence for the sale of generic combination of valsartan and Secubitril, but, in November 2021, Novartis got a Delhi HC stay order on it. The price of this Novartis medicine is Rs 1,100 for 14 tablets, whereas Natco's generic version costs Rs 630 for 14 tablets.

Medicine research is, thus, globally dominated by 'few companies' from 'few countries' and done for 'few diseases' prevalent in rich countries.

Consider these statistics: ◆ 'WHO Findings - 2021-Access to Medicines and Report

on Disproportionate use of medicines 2020' report reveals that the world over, unequal and disproportionate expenditure/ consumption continues. ◆ 16 per cent of the world's population living in high-income countries accounts for over 80 per cent of global use on medicines. ◆ Remaining 84 per cent of world population accounts for only 20 per cent of pharma use/consumption. ◆ Globally, two billion people worldwide still live on very low incomes without access to medicine or robust health systems. (WHO Findings – 2021-Access to Medicines and Report on Disproportionate use of medicines 2020).

It should be, therefore, clear from the above discussion that accessibility, availability and affordability of medicines are not dependent only on domestic factors, but are also challenged by global market drivers.

Domestic challenges Inadequate fund allocation in public healthcare: There is always inadequate public fund allocation for procurement of generic medicines by the state, forcing poor patients to buy essential medicines out of pocket.

Secondly, due to unregulated promotion of non-essential generic medicines by the industry, they have to buy non-essential medicines at the cost of essential medicines.

Dichotomy in policies: There is a strong dichotomy between industrial policies for pharma and health policies for medicines in India. It is not decided by the same ministry. The National Pharmaceutical Policy is developed by the Ministry of

STRATEGY Chemicals and Petrochemicals (now Ministry of Pharmaceuticals) and the National Health Policy is designed by the Ministry of Health and Family Welfare.

Ideally, both policies should be under the domain of the Ministry of Health. This dichotomy has created a total disconnect between these two policies and has greatly affected availability and affordability of essential medicines in India.

Lax regulation One of the important aims of regulation is 'public interest.'

This type of regulation arises from the need to rein in the free exercise of market forces and consumer and producer impulses in cases where such a display can act as an obstacle to the maximisation of societal wellbeing or to remove externally applied obstacles to market forces when their play is desirable.' (As quoted in Regulatory Management and Reform in India 1. Background Paper for OECD-This paper was prepared by Vijay Vir Singh, Fellow, CUTS International and Siddhartha Mitra, Director (Research), CUTS International) However, Indian drug regulatory authorities have miserably failed to achieve this aim.

Over the years, lack of 'public interest' and a 'callous approach' have resulted in regulators being too inclined towards liberalisation of industrial policies. This approach is now showing negative effects.

There is lack of complete coordination between Central and State FDA. The 59th Report of the Parliamentary Committee on working of CDSCO submitted on 08th May, 2012, has clearly pointed out these lapses. It had pointed out that the callous and casual approach of the Indian drug regulators and lack of central database of trade names has resulted in approving the same trade name to different medicines.

(See Box: Examples of Lax Regulation on brand names of medicines) Moreover, this lack of cen-

EXAMPLES OF LAX REGULATION ON BRAND NAMES OF MEDICINES (POINTED OUT IN THE 59TH PARLIAMENTARY COMMITTEE REPORT 2012)

◆ The brand name Lona is awarded for low sodium salt in one state and same trade name Lona is awarded for Clonazepam in other state. ◆ The trade name AZ has been awarded to three different contents of medicines, namely AZ for Azithromycin,AZ for Albendazole and AZ for Alprazolam by three different states. ◆ The recent example is the award of same trade name Medzole for five different contents - Itraconazole, Metronidazole, Isomeprazole,Albendazole and Pentaprazole!!!!!! ◆ (59th Report of Parliamentary Committee on working of CDSCO submitted to parliament on 08th May, 2012 and last one is from Market data available).

tral database means a drug declared substandard in one state can still get free access in another state.

Indian "Game of Brand Names'' - One Medicine, 100 names Currently, in India, the same medicine is sold by at least 100 companies masking its identity and labelling it with thousands of different names like branded, branded generics, mirror brands and combination of medicines called as Fixed Dose Combinations (FDC). Consequently, the market is flooded with lakhs of medicines and the same medicine is available at 100 per cent higher price and also at one tenth price of the other company's rate to the patients. (See Box: Branded Generics in India's Pharma Market).

Prices of brands are paradoxical: The top selling brand, amoxicillin + clavulanic acid (Tablet, 125/500 mg), is currently sold by 217 companies under 292 brands, with sub-

stantial price variation, ranging from Rs 40 to Rs 336 for a pack of six tablets.

Mirror brands: One company which manufactures amoxicillin + clavulanic acid (Rs125/500 mg tablet), sells two different brands at substantially lower prices; one at Rs18.27 and another at Rs 73.17, resulting in a price variation of 120 per cent. Another company has a glimepiride + metformin formulation, with one brand at Rs10 and the second at Rs 60 per pack of 10.

Fixed Dose Combinations (FDCs): A single drug is combined with other drugs and sold under different brand names. For example, the NSAIDs - pain killers and antiinflammatory medicines - are available in various permutations and combinations with 124 different combinations, sold by using 2,739 brand names.

The diabetic medicine metformin is available in various 25 combinations with other medicines and sold under 536 brand names.

BRANDED GENERICS IN INDIA'S PHARMA MARKET

◆ Only 10 per cent of the drugs in the domestic market are unbranded generics procured by public healthcare ◆ 87 per cent of drugs dispensed in India are so-called branded, branded generics, mirror brands, etc. ◆ 47,478 brands are available with 2,871 formulations ◆ On an average, there are 17 brands for every formulation.

About 235 drug brands are introduced each month, with a value of Rs 318 crores ◆ Annually, about 2,827 brands with a value totalling Rs 3,810 crores are introduced. ◆ Rosuvastatin (Tablet, 10 mg), a cholesterol-lowering agent, is marketed through 127 brands by 105 companies.

Source: MARKET STUDY ON THE PHARMACEUTICAL SECTOR IN INDIA (Key Findings and Observations: A Report by Competition Commission of India-18-11-2021)

Paradoxically, before the Dr Kokate Committee was constituted in 2014, most marketed FDCs were not approved by FDA. In 2016, the committee after studying the data on available FDCs, declared 344 FDCs as unsafe for human use. However, most of these FDCs are still in use as the decision is pending in Supreme Court.

Price variation between pure generics and branded generics: In the retail market, price variation across 54 molecules ranged from eight per cent to 190 per cent. In case of 45 molecules, it is more than 100 per cent. For example, the price received in public procurement for atorvastatin (10 mg) is Rs 0.21 and the lowest price in open market is Rs 5.1, a difference of 184 per cent. In the case of 19 molecules, it is in the range of 50-100 per cent.

Total failure of capitalistic economy: The main principle of a capitalistic economy is to make products available without restrictions, so that it will build strong competition, which, in turn, will reduce prices and make products affordable for the common man.

However, this theory has totally failed in the case of healthcare services and medicines. Currently, around 2,00,000 medicines are available in the market, marketed by around 10,000 firms, but the prices of most medicines are still unaffordable to poor people. Thus, the competition principle of capitalistic economy has totally failed in controlling prices of medicines.

Moreover, the market has turned more, not less, monopolistic. This is mainly because the customer in healthcare is blindfolded and the decision on which medicine to use is a ''third-party decision.''

In such a situation, if the decision maker (in this case, a doctor and pharmacist) is suffering from 'information handicap,' (as mentioned above) the seller rules the market.

Therefore, the role of regulator is crucial to control and make such a market favourable to consumers. But, the current situation shows that the regulator has totally failed. Or else, in a market where the prices of

most medicines are already 50 to 100 per cent higher, how can one allow a 10 per cent price hike every year, based on hike in Wholesale Price Index? This is like giving a rise in salary to a fat salaried government servant to mitigate inflation.

Incomplete information on proper and rational use of medicines This situation is further aggravated by the fact that there is disproportionate and incomplete dissemination of information on the proper and rational use of medicines in LICs and MICs. It has been observed that in developing and under-developed countries, only 30 to 40 per cent of information is disclosed on proper use of medicines. In India, package inserts giving information on proper use are not compulsory. All generic medicines are supplied without package inserts.

As a result, the abundance of medicines has resulted in 'over prescribing' and 'poly pharmacy.' This callous approach was recently seen during the COVID pandemic when irrational use and promotion of non-essential medicines was at its highest level.

Quality of generic medicines available in Indian market The quality of medicine, irrespective of branded or generic, differs depending on the licence under which it is manufactured. India has around 10,000 manufacturers, but only around 4,000 are in active marketing and have their "own'' manufacturing units.

Most companies get their medicines (branded as well generic branded) manufactured either on Loan Licence, or P2P (Peer to Peer) licence or on Third Party Licence from around 6,000 Small Scale Manufacturing units (SSI) at very low price and market it under their brand name at higher price.

Similarly, there are around 1,000 firms that do not manufacture any medicines at all, but only market it. They too get it manufactured from these SSIs at the lowest cost. Apart

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STRATEGY from zero capital investment on manufacturing, the main advantage of getting products manufactured from third parties is that the third party, being the actual manufacturer, gets prosecuted and the marketing firm escapes the net of drug laws if the medicine is declared of sub-standard quality.

It is then free to get it manufactured from another third party.

Secondly, as India gets half of its market share from exports, exporting Indian firms have to abide by international standards of Good Manufacturing Practices (GMPs).

There are three types of global regulatory standards. If a manufacturer wishes to export generic medicines to strict regulatory markets like the US, EU, Japan, Australia, etc, the firm has to abide by cGMP standards. The WHO/GMP standards are compulsory for exporting to developing and most Asian and African countries.

However, these strict standards are not mandatory for the domestic market. So, a particular firm could manufacture medicines of the highest standards for export to developed countries, middle standards for export to developing countries and the lowest or not updated standards for domestic and non-regulatory markets like Nigeria, Yemen, etc. Thus, the challenges in providing generic medicines of assured quality at the most affordable price are complex in nature and are affected at different levels and by many factors.

But, if we are able to remove the information handicap of a buyer, these issues can be sorted out effectively. For example, the issue of 'assurance of quality' of generic medicines was tackled effectively in Maharashtra during 2003, when I was procurement head of the state. We introduced pre-qualification criterion of ''WHO/GMP certification'' and ''own licence'' for participation in government supply. This helped us to make available export quality medicines at the most economic prices.

However, this was not without hurdles. This decision was challenged by SSI firms in high

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The main challenge to the pharmacist is the identification and substitution with the right generic when prescriptions are written in so many names of the medicines - original, branded, branded generic, pure generic and mirror brands and in multiple FDCs. In such a situation, incorrect brand substitution due to information handicap can result in dispensing wrong medicines court, but the court ruled in favour of the government stating that providing the bestquality medicines is in public interest.

Limited list of essential medicines: During the1960s, the WHO observed that there was dumping of non-essential medicines in third-world countries.

Based on the experience of Norway during 1970s, where use of medicines was needbased and not market-based, WHO introduced and propagated the concept of using ''only essential medicines'' by preparing a list of essential medicines.

In 1996, India introduced its National List of Essential Medicines (NLEM) based on priority healthcare needs of the country. All Indian states and public hospitals are supposed to prepare their list of essential medicines based on their health priorities. All state-run hospitals should pool their requirements to take advantages of bulk procurement. However, barring a few, most states have not yet even prepared their state list of essential medicines. They are still continuing with procurement of non-essential medicines with essential ones.

Price control on essential medicines: A failed concept?

The central government formed a separate agency called National Pharmaceutical Pricing Authority (NPPA). In May 2013, NPPA brought 348 medicines under price control.

However, this policy has not succeeded fully.

The analysis of total

pharma sales shows that price control covers only 18 per cent of annual sales, while 82 per cent is still not captured by price control.

It is not only price control, but based on the Wholesale Price Index (WPI), NPPA gives price rise too. Consequently, in July 2021, it allowed a one-time price hike of 50 per cent for three key drugs: ibuprofen, ranitidine and carbamezapine and recently, the NPPA has given a blanket price hike of 10 per cent for all 348 drugs in NLEM. If this is not enough, the annual blanket rise of 10 per cent is legally allowed for all branded medicines, and FDCs, which don't come under price control, are already high priced, as discussed above.

Price control at one end has successfully controlled the prices of scheduled medicines, but, at the other end, it has affected the availability of many life-saving essential medicines as big companies stop manufacturing these medicines once the drug is brought under price control.

This has, and still is, resulting in scarcity and dependence of procurement of many life-saving medicines from small firms whose capacity and standards of quality are many time, doubtful.

As a result, there are very few quality-conscious manufacturers who make life-saving and emergency injections like soda bicab, amonophylline, adrenaline, oxytocin, streptomycin, calcium carbonate, etiopylline + theophyline, all sulphonamides, penicillin, etc.

Making medicines affordable through Pradhan Mantri Jan Aushadhi Pariyojna The aim of these generic stores is making quality generic medicines affordable to all, creating awareness about generic medicines and generating employment by providing individual entrepreneurships.

This programme started in November 2008. And, as on 6.8.2021, 8,012 stores have been opened across India. The scheme is implemented by the Bureau of Pharmaceutical PSUs of India (BPPI).

The programme is well-accepted across India. However, there are a few gaps which need to be addressed. The list of medicines made available through generic stores is not integrated with NLEM. Consequently, it contains around 125 FDCs in the total list of 699 medicines. Fancy FDCs like Diclo + linseed oil + methylsalycilate cream, enzyme syrup mixed fruit flavour and appetite-enhancing syrups have also been included.

The main challenge to the pharmacist is the identification and substitution with the right generic when prescriptions are written in so many names of the medicines - original, branded, branded generic, pure generic and mirror brands and in multiple FDCs. In such a situation, incorrect brand substitution due to information handicap can result in dispensing wrong medicines.

Secondly, in the absence of proper regulation, in favour of substitution of generics by pharmacist, it is always a threat to the pharmacist to

attract law of negligence and prosecution. The message is clear: the current concept of promotion of generic stores is not to promote essential generic medicines, but only to make both essential and nonessential medicines affordable.

Summary Globally, the market drives the need, and it is not driven by real health needs of a country and patients. Hence, challenges to provide essential generic medicines exists not only at the domestic level, but are also at global level, which directly and indirectly influences the use of medicines by all stakeholders, namely, state, manufacturer, regulator, doctor and pharmacist.

At the domestic level, there is a 'total disconnect' between what is prioritised by the Ministry of Health (MOH) in its National Health Policy through NLEM and what is prioritised by the Ministry of Pharmaceuticals (MOP) in its National Drug Policy through promotion of industry and generic stores.

Consequently, the driving forces behind availability, accessibility and affordability of generic medicines at global and domestic levels are more or less the same.

To conclude, if we really wish to make all medicines available and affordable to all citizens, we need to adopt the following policies: Integration of national policies under MOH and MOP for the promotion of concept of essential medicines by all Indian states and also by all stakeholders' adequate fund allocation to public healthcare services for provision of all essential medicines free of charge. The firms should not be allowed to escape from price control by using various names for the same medicine and should not be allowed to stop manufacturing of essential drugs placed under price control. There should not be double standards of quality of generic medicine like higher standards for export and diluted standards for domestic use. Generic stores should be allowed to sell only essential medicines from NLEM.

LOGISTICS

Vaccine supply chain: Risks and solutions Hersh Shah, CEO, Institute of Risk Management, India Affiliate and Prasanna Bharatan, Global Head, Assurance and Risk management, Wockhardt, explain the various types of risks associated with the supply of vaccines and the solutions to tackle those

T

he sheer scale of global efforts to tackle the novel corona virus pandemic through vaccines - a tool that humanity has historically been relied upon, for over 200 years, to reduce the death tolls from infectious diseases has a lot to say.

Despite the swift development of the vaccines within less than 12 months after the pandemic began, there were myriad challenges when it came to effective production, distribution and delivery of these vaccines, which threatened the operational success of the vaccination programme.

Given the heavy reliance of successful and effective vaccine programmes on efficient supply chains, it is essential to understand, actively assess and mitigate the risks involved.

What are the major supply chain risks?

Planning-stage risks: At the planning stage, a delay in communication about the exact specifications and quantum of requirements can seriously affect supplies, and, eventually, the availability of vaccines. There is also the risk of inadequate planning when it comes to the quantity of raw materials needed to meet demand - this can seriously jeopardise the supply of vaccines and lead to a domino effect of delays further down the supply chain.

Sourcing-stage risks: At the sourcing stage, there are several vendor-specific risks that can emerge, putting the entire vaccine supply chain in danger. On the vendor side of things, engaging with just a single vendor for certain raw materials may entail a concentration of risk if that particular vendor fails to deliver.

Furthermore, putting capacity constraints on vendors may end up hampering assured supplies.

Further, more often than not, out of specification supplies and quality issues can hamper the

Hersh Shah

timely receipt of raw materials.

One also has to take into account unforeseen vendor plant shutdowns due to myriad possible reasons, such as maintenance, outage, bankruptcy, natural disaster or global pandemic, that can affect the ability of a

terms of availability of vessels/containers at ports, or port congestion, which could eventually delay shipments.

Outsourcing stage-risks: The outsourcing stage is one of the most crucial stages in the vaccine supply chain. Risks such as failure to maintain the vaccine shipment at the appropriate temperature, inefficient route planning, not ensuring availability of surface transport for all routes and destinations, and lack of planning and scheduling/slotting of outbound ocean fleets can affect timely delivery. Infrastructure constraints at ports and closure of transport routes due to conflicts or carrier embargoes can also affect supplies. Another possibility is sub-optimal fleet size or underutilised fleet space, and unforeseen events such as accidents, arson or theft, that could destroy entire shipments.

Prasanna Bharatan

important for the agencies sourcing the vaccines to have alternate manufacturers supplying them.

Vaccine manufacturers should establish alternate vendors, preferably across geographies, and enter into committed

Effective mitigation strategies to tackle vaccine supply chain issues include managing all key stakeholders and taking into account potential risks on multiple fronts vendor to supply requirements fully or on time. Vendors could also face financial constraints that can impact the manufacturing and delivery of raw materials. A war impacting the vendor's geography, or denial of transportation through other conflict zones can also affect supplies of raw materials, leading to expired and unfit materials being used in vaccine production.

There is also the remote, yet real, possibility of unscrupulous vendors acting in unison to cause shortages and sharp price increases for their material gain.

Other possible risks include the denial of supplies due to retaliatory or unilateral trade sanctions, and logistical challenges in

In-transit damage to shipments due to poor packaging design or materials, or rough transportation and handling are also real risks.

What are the solutions?

Effective mitigation strategies to tackle vaccine supply chain issues include managing all key stakeholders and taking into account potential risks on multiple fronts. Clear contracting of specifications and scheduled location-wise delivery dates should be based on the urgency of the situation and practicality given the manufacturer's infrastructure. Additionally, supply contracts must factor in non-deliveries due to events beyond a manufacturer's control. It is also

long-term contracts to seek continuous supplies from these multiple sources. This will help to avoid the risk of concentrating supplies in the hands of a single vendor. Manufacturers should also have a reasonable estimate of lead times, vendor capacity constraints and shut-down schedules, which should be factored into their planning for sourcing and calendaring the manufacturing pipeline. Rigorous vendor audits must be conducted to ensure vendor processes adhere to GMP and standards of quality, and a continuous process for discovering new vendors should be established, in order to keep supply lines open, reduce dependencies on the existing vendors and

counteract cartel behaviours.

It is also vital for vaccine manufacturers to safely and securely maintain appropriate inventory reserves to counter supply outages due to unforeseen events. In a scenario where supplies are hit due to trade wars or regional conflicts, they should communicate proactively and transparently with customers about the inability to meet delivery schedules, and also provide regular updates.

For moving the vaccines, there should be long-term agreements for contracting ocean fleet or freight capacities to secure timely delivery of materials.

Once again, it is prudent to engage with diverse freight companies, to ensure that the failure of one does not impact the entire supply chain.

With the advent of many new technologies, cold-chain logistics providers are now able to use IoT-based monitors to ensure temperature conditions are met throughout the transit period, and provide end-to-end visibility while enroute to the destination.

The use of blockchain also ensures the integrity of the shipment, and prevents tampering or pilfering. Efficient automated planning tools, backed by AI, help to support superior and efficient supply chain planning, load and route optimisation, and scheduling.

The vaccine product and packaging should be designed for minimum possible damage in transit, and to eliminate any scope of wastage while administering the vaccine doses. To avoid perceptions of nepotism or favouritism, vaccine manufacturers must publicise location-wise vaccine-availability schedules. And, lastly, since it is impossible to be impregnable against all possible threats, vaccine manufacturers must invest appropriately in insurance.

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TECHNOLOGY I N T E R V I E W

Digital roadmap defines the success of technology initiatives Amit Saluja, Senior Director and Head, NASSCOM CoE, explains the role of technology in pharma manufacturing, while also shedding light on the Smart Manufacturing Forum for MSMEs, in an exclusive interview with Akanki Sharma

There are numerous examples where digital solutions have failed to create an impact, which makes leaders feel these don’t work for them. However, the real cause of failures is lack of structured roadmap in bringing technology to the organisation

34 EXPRESS PHARMA June 2022

In what ways can technology adoption be the key for pharma manufacturing transformation? Tell us about the role played by NASSCOM CoE in this regard.

NASSCOM CoE is part of the ‘Digital India’ initiative of the Ministry of Electronics and IT, in collaboration with state governments, and is focussed on accelerating adoption of digital technologies in industries. We have built the largest ecosystem in the country to bring together enduser enterprises, solution providers and academia to cocreate solutions that can help in solving complex business issues. Pharma being a large industry is an important sector, both for global and Indian manufacturers. We understand that the challenges and needs vary with the size of the companies and our programmes are aligned to meet their requirements. In the past two years, we have been running innovation challenges in healthcare and manufacturing sectors where large enterprises share their complex problems for which deep-tech startups propose solutions. The winning startup works with the enterprise to deploy the solutions. We also have long-term industry partnership programmes in case an enterprise has multiple use cases for finding technology-based solutions.

For a pharma manufacturer, the quality of drugs and compliance with Global Manufacturing

Practices (GMP) are the most essential. Pharma units need to focus not only on agile and integrated supply chain, but also on seamless operations to drive reduction in the use of raw material, human resources and the risk of lowquality products.

Digitalisation has the potential to transform supply chain, boost productivity and improve manufacturing operations. It includes adoption of Industry 4.0 solutions for areas such as production, quality, compliance, procurement, logistics, R&D and workforce development. Digital solutions for paperless operations can digitise the data recording and generate insights from analytics to optimise processes. Condition monitoring of critical equipment prevents them from unwanted breakdowns.

Computer vision-based quality inspection of drugs can highlight defects and missing drug in the packaging.

Augmented Reality-based virtual plant visits can drive customer and partner engagements, in addition to AR/VR solutions helping in remote collaborations and workforce training. Smart warehousing and supply chain solutions provide drug monitoring, theft security and movement tracking solutions.

While building a smart manufacturing roadmap, what are the aspects that a pharma organisation must keep in mind? Give reasons

to support your answer.

Digital roadmap defines the success of technology initiatives in an organisation.

There are numerous examples where digital solutions have failed to create an impact, which makes leaders feel these don’t work for them. However, the real cause of failures is lack of structured roadmap in bringing technology to the organisation. Many times, we have seen enterprises have deployed ad hoc solutions without thinking long-term and that’s when problems take place. While building plans for smart manufacturing, we suggest enterprise to start with the digital maturity assessment of the plant to understand current state of infrastructure, processes and organisation structures to support future growth. These findings are then mapped to cost structure of the enterprise and business objectives for next three-tofive years. The recommendations that come from this exercise help in ensuring an integrated digital plan gets defined that will align with current challenges and future objectives. Design thinking approach can also be used to ensure proposed solution is human-centric and gets developed using agile methodologies.

NASSCOM CoE has launched the Smart Manufacturing Forum.

Kindly give us details on the same. How is it going to benefit pharma

manufacturers, especially Micro, Small and Medium Enterprises (MSMEs)?

In the new normal, where large pharma industries are moving towards digital-led growth, Micro, Small and Medium Enterprises (MSMEs) are falling behind and struggling to understand how technology can help. This disparity in technology adoption between large and MSME pharma units will create more challenges as supply chain needs global, Indian and MSMEs to work together. We met with lot of pharma MSME leaders and found lack of digital awareness is the biggest reason for the lack of technology adoption. Seeing the gaps between MSME and large pharma companies increasing, we launched the Smart Manufacturing Forum to make 100 MSMEs digital, so that they can become role models and inspire other MSMEs to replicate their success. Through this initiative, we aim to address the awareness, accessibility and affordability challenges that manufacturing enterprises face in technology adoption.

Smart Manufacturing

Forum will help enterprises through skill and capacity building, hand-holding for digital journey, and branding and market reach.

research reports, webinars and thought leadership sessions is made available to forum members with roundthe-clock access.

What are the various digital skills that are required for smart manufacturing? Tell us how this forum will help in this regard.

The skills needed the most are understanding the applications of digital technologies to improve manufacturing productivity and efficiency. Manufacturing workforce don’t need to know how to develop the applications, but they should be able to identify areas where technologies can help. The good part is it is not so difficult to learn, considering we have domain skills already available with the workforce.

The Smart Manufacturing Forum will help to develop digital awareness across all levels of an organisation.

These include interactive masterclasses for business and functional leaders and capability building sessions for managers. A knowledge bank comprising case studies,

Skill building needs to be followed by solution adoption. How do you plan to provide handholding to pharma MSMEs looking to make their plants smarter?

We are keen to have forwardlooking pharma MSMEs to be part of the forum, as we would like to work with them to make them digital champions. This will happen through handholding that includes digital maturity assessment for understanding gaps in current processes and identifying opportunities for saving costs.

Post this, we will conduct design thinking workshops by bringing together leadership and workforce to define the challenges, along with possible solutions. The outcome will enable us to build technology roadmap for MSMEs for which implementation will be done through co-creating solutions along with deep-tech startups.

Our team will connect with both MSME team and startups

to define requirements and oversee the implementation.

The objective of our handholding is to create success stories that show that productivity and efficiency in plants can also be improved through software and give confidence to more MSMEs. We will also be inviting MSME leaders to present their success stories at the national level and give them a chance to establish themselves as thought leaders.

What are the current manufacturing trends in pharma MSME? How will these evolve in the future when compared to today’s scenario?

Manufacturing in pharma MSMEs is currently being driven by regulatory and compliance requirements.

Majority of the MSMEs are manufacturing drugs for exports, and, hence, for them, processes to align with certifications and the quality are of prime importance. We are making world-class drugs irrespective of whether they are produced in large or small plants, but the bigger question

is - are manufacturing practices in small plants costefficient? The answer is a big ‘no.’

While we have automation in place in every small pharma unit with processing equipment, processes are still manual. Records are maintained in registers, as not all units have ERP systems available, the inspection process is manual. All of these lead to inefficiencies as historical data is not available for analysis, inventory levels are high and there is a huge dependence on worker skills for doing quality inspection.

These systems will not work in the long run as we need to be cost-competitive to operate in a global environment. Future systems will need to be integrated where man and machine talk to each other through data, and for this to happen, we need digital infrastructure. R&D is another area where small pharma units will need to invest and that cannot happen without technology adoption. akanki.sharma@expressindia.com journoakanki@gmail.com

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant. ❒ We welcome information on new products and services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value

Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph.

Preferably in colour, postcard size and with a good contrast.

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

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PACKAGING I N T E R V I E W

Funding for lifescience research is set to grow and so will the demand for products Vinayak M Patankar, Chief Operating Officer, SIP Division, Borosil, speaks about his company's growth plans for the Indian market, impact of the pandemic on business strategies and priorities, emerging focus areas and more, in an interaction with Lakshmipriya Nair From an evolutionary point of view, how has COVID-19 impacted the pharma packaging sector?

India plays a key role in the global pharma industry. The pandemic saw an unprecedented urgency to ramp up critical drugs, especially injectables. The industry in India came together and did a remarkable job of responding to the crisis. However, even though we seemed to have overcome the worst and life seems to be getting back to normal, there have been disruptions to the supply chain and the biggest impact on players like us in the glass primary packaging industry has been the rise in input costs. Most injectables come specified with a particular brand of glass tubing, and there, we are constrained to the cost and supply. The rising costs have impacted the margins and end cost to the consumer.

The COVID-19 pandemic has brought about significant shifts across businesses. What were the major transformations that Borosil witnessed?

We are a business that is built on close daily contact with scientists and chemists in laboratories. With realworld physical contact getting abruptly disrupted, we had to find new ways to reach out to scientists.

Overload of online meetings also led to fatigue at both ends. How we engage with our customers with content and approach required a lot of retraining and re-skilling

across all levels of the organisation.

It was also a rude awakening on how we approached and prepared for force majeure. We’ve relooked at the business operationally to make it more robust and resilient.

What kind of new opportunities and challenges did the pandemic bring about for your organisation? How did you deal with them?

Our major customers are laboratories in the pharma sector. It meant that we had to answer the call of duty to be able to meet the demands of an essential services player. Safety and the livelihood of our own employees were our first priority. Even with our best efforts, we did lose some of our people to the pandemic, we are proud that we did not have to lay off a single employee. We also took a people-first approach as to how we dealt with both emergencies and at the policy level. It was very heartening to see employees across the organisation coming together beyond the call of duty.

During the pandemic itself, the approach was not about exploiting the opportunity but to play our part in the pushback. We absorbed costs and burnt the midnight oil to meet demands. This approach did not go unnoticed, we were able to get accelerated approvals for primary glass packaging and also got into a number of strategic

partnerships overseas for our lab business.

What has been the growth in the lifesciences segment, globally and in India?

Which are the geographic markets promising growth?

What are the growth drivers in these markets?

What is your market share in the products and services for this division?

Of course, the pandemic showed an unusual spike in the demand for lifescience products and it also made global businesses look at their operations and supply chains. The pandemic has also led to a lot of public spending, which, in turn, led to the expansion of capacities. While everyone would like to prepare for exigencies in the future and look for new alliances, there is also some scepticism about the utilisation of the expanded capacities. One thing that is evident is the need for an improved healthcare infrastructure across the globe. This will definitely lead to more countries looking to have the ability to access life-saving

drugs and therapeutics for their citizens. Funding for lifescience research, both by public and private enterprises, is definitely set to grow, and so will the demand for products. NA, EU, Japan and China are the markets that will lead in consumption and demand.

Our exports from scientific products have been growing steadily for the past decade.

We now export to over 70 countries. The export contribution is over 12 per cent of the total revenues.

How does Borosil score over its competitors in the lifesciences sector?

Borosil has been the undisputed leader in laboratory glassware for decades, three out of four volumetric glassware used anywhere in India is a Borosil product. Over the years, our logistics have evolved wherein we are able to fulfil almost 96 per cent of any order received the same day.

We also manufacture and develop most of our portfolio in-house. This gives us arbitrage to offer to our customers. In-lab equipment and lab tools, which our markets depend heavily on imports, our ability to offer high-performance products without the customer having to compromise on quality or service expectations gives us a definite edge over the competition.

Where does India fit into the company's global strategy for the future?

Borosil has always been an India-first company with life-

long associations with leading research, industry and education institutions.

India will continue to remain the company’s primary market. In the last few years, we’ve expanded our offering from laboratory glass to primary glass packaging and laboratory equipment. The laboratory glassware and primary packaging are stable growing businesses where we are among the leading suppliers. Our focus now is on laboratory equipment and process chemistry where we see a clear space to emerge as a credible Indian player in domains dominated by imports.

What are the revenue targets, growth targets for Borosil’s lifesciences business in India, and what are the strategies to achieve these targets?

After the uncertainties at the end of FY19-20, the scientific and industrial business was able to display a robust and swift bounce back. The pandemic made us relook and realign the way we did everything. It has been a catalyst to improve efficiencies and redefine roles and responsibilities.

The market presents growth opportunities and we are optimistic about double-digit growth as our continual investments bear fruition.

The opportunity exists to emerge as the most significant player in the space, just like successful companies in the west. lakshmipriya.nair@expressindia.com laxmipriyanair@gmail.com

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205 & 206 Hill View Industrial Premises, Amrut Nagar, Ghatkopar (W), Mumbai - 400 086, India.Tel.: 022-2500 4576 E-mail : sales@mksilicone.com

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Blue Heaven

QM 002

RTIFIED

M

INDIA

CE

Quality Products

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Continuous Coating

Coating, Drying and Laminating the basic functions of the «KTF-S»

The system is available in a powder-coated steel or full stainless steel version depending on customer requirements

The use of a production machine is not financially viable for research and development purposes The most economical solution is our continuous coating system of modular design for various materials such as paper, textile, copper, aluminum and plastic foils

Market leaders are using Mathis technology

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EXPRESS PHARMA OsmoTECH® XT Single - Sample Micro-Osmometer Now available!

Best-in-class osmolality performance, designed with you in mind.

HIGHLIGHTED FEATURES:

®

®

®

Offers the widest range of osmolality testing (0 – 4000 mOsm/kg H2O) Supports 21 CFR part 11, GMP and EU Annex 11 compliance Meets Pharmacopeia osmolality testing guidelines 3 Level user access and password protection Storage: unlimited data storage for access Audit trail: Preserve unlimited results and events Database backup, protects your data with automatic or manual backup

No. 127, Bussa Udyog Bhavan, Tokershi Jivraj Road, Sewri West, Mumbai-400015, Maharashtra, Landline : +91 022 - 24166630 Mobile : +91 9833286615

Non-Agitated type Nutsche Filter with cleanable SS316L filter disc for filtration of pharmaceuticals in sterile rooms

Most of our assemblies are custom designed to suit the product being manufactured with respect to cake height, liquid hold-up, CIP/SIP requirements etc.

We can retrofit your existing Agitated Nutsche filters & Dryers (ANFD) with our cleanable filter media. Hastelloy C22 filter media also can be offered for corrosive product applications. Filter discs as large as 2.6 m diameter can be offered in a single piece or as segments.

Contact us for further details

All nozzles are provided with TC type sanitary connections, ‘O’ Rings are offered with special PTFE encapsulation which are compatible with a variety of solvents. Other features like Sight / Light glass, spray balls etc. are provided as per the customer’s needs.

Superior quality castor wheels are provided for easy mobility. The internal surfaces are electro-polished & offered with 320 grit finish to comply with cGMP. With countless satisfied customers, our Nutsche filters are preferred as a standard by all major API & Bulk drug manufacturers. Experience our superior levels of customization by getting in touch with our technical experts.

Kumar Process Consultants & Chemicals Pvt. Ltd. 4 & 5, Bhagtani Enclave, Sonapur Lane, Off. LBS Marg, Bhandup (West), Mumbai - 400 078. INDIA. Tell. : 911 - 222 - 35552 35562 Mobile: 90047 06047, 98923 12343 email: info@kumarfilter.com www.kumarfilter.com

www.siddharthads.com

Kumar process has designed unique Non-agitated type Nutsche Filters which can be used for filtration of antibiotics, vitamins & pharmaceutical products in sterile rooms. Conventional Nutsche filters use PP /Polyester cloth, which could release fibers leading to product contamination. We offer cleanable, non fiber/particle releasing Sintered SS316L filter discs.

This is a major advantage in applications requiring filtration of antibiotics, vitamins etc. in sterile rooms where ordinary centrifuge cannot be used and use of conventional filter cloth is ruled out.

Clear solutions for your filtration problems since 1978 54

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The Power of Stationary Phase Selectivity How one of the most powerful parameters in LC method development can be explored using AVANTOR® ACE® novel stationary phase chemistries Introduction During LC method development, a range of method parameters are typically assessed to achieve the desired separation. One of the most powerful parameters that can be varied is stationary phase selectivity.

By varying the stationary phase chemistry, differing mechanisms of interaction with analyte molecules can be exploited to optimise the separation selectivity. This article will briefly describe the key parameters that affect separation selectivity and how novel stationary phase chemistries from the Avantor® ACE® portfolio can be utilised during method development to achieve better separations.

other parameters must also be considered when developing methods, to provide suitable resolution between analytes.

Resolution can be described using Equation 2, where W

the selectivity parameter is clearly the most powerful parameter that affects resolution. This is often the case for typical LC separations, and it is therefore highly recommended that column chemistry is explored during method development to optimise the separation selectivity.

procedure ensures that residual silanols are minimised, which improves peak shape by reducing potential secondary interactions between functionalised analytes and the silica surface.

The Avantor® ACE® reversed-phase portfolio (Table 2) was designed and engineered with the aim of producing a

Selectivity Analyte retention time (tR) is described as the time taken for an analyte to elute from the column. Retention factor (k) describes the analyte elution from the column, taking into account the column void volume (t0). Selectivity (α) is the ratio of retention factors of two adjacent analyte peaks (Equation 1) and describes the degree of separation between two adjacent peaks.

An α-value of 1 indicates coelution of the two analytes.

The combination of the column and elution conditions prohibits the separation of those peaks, regardless of the column efficiency. This therefore indicates further work must be performed to improve separation.

Many method and instrument parameters can affect the separation as described in Table 1.

Column stationary phase (and the various mechanisms of interaction) is a powerful parameter to explore when developing methods.

Selectivity is important, but

corresponds to the peak width of the adjacent peaks.

A minimum resolution value of 1.5 for the critical pair (i.e. closest eluting pair in the chromatogram) is recommended for most chromatographic separations. The resolution equation can also be expressed according to Equation 3. This new equation can be used to understand the influence of efficiency (N), selectivity and retention factor on resolution.

From this equation, resolution can be improved by varying either k, α or N. The impact of each variable on resolution can be assessed by fixing 2 parameters and varying the third, as demonstrated in Figure 1. In this case, fixed values of 5000 for column efficiency, 5 for retention factor and 1.05 for selectivity were used. In this case,

Figure 1: Effect of efficiency (N), selectivity (α) and retention factor (k) on resolution for fixed values of 5000 for N, 1.05 for α and 5 for k.

Common Reversed-Phase Interactions Avantor® ACE® columns are manufactured using modern ultra-inert, base-deactivated type-B silica, which increases batch-to-batch reproducibility.

The tightly controlled bonding

broad array of functionalities offering orthogonal selectivity.

The complementary phases cover a range of retention mechanisms, namely hydrophobic, Π− Π interactions, dipole-dipole, hydrogen bonding and shape selectivity.

Hydrophobic retention is the dominant retention mechanism for alkyl ligand stationary phases, such as C18, C8 and C4. Whilst the C18 phase remains the most commonly utilised in reversed-phase LC, other mechanisms of interaction, provided by different stationary phases, are often advantageous.

The Avantor® ACE® C18-AR contains an electron-rich ring attached to an extended alkyl chain, combining the hydrophobicity of a C18 phase with additional aromatic selectivity. The chromatograms in Figure 2 compare the selectivity of the C18, Avantor® ACE® Phenyl and Avantor® ACE® C18-AR with toluene, trinitrobenzene, dinitrobenzene and nitrobenzene. The Avantor® ACE® C18-AR and Avantor® ACE® C18 provide similar retention of the hydrophobic marker, toluene. However, the Avantor® ACE® C18-AR shows stronger retention of the nitrosubstituted aromatic analytes, along with a different elution order and successfully provides full resolution of the analytes.

The Avantor® ACE® C18PFP combines hydrophobicity from the alkyl chain with shape selectivity, dipole-dipole and Π− Π interactions, provided by the electron deficient pentafluorophenyl ring. The Avantor® ACE® C18-Amide contains an extended alkyl tail to increase hydrophobic retention, whilst the embedded amide moiety is ideal for analytes able to hydrogen bond, such as acidic, phenolic and amino analytes.

The terminal polar CN group on the Avantor® ACE® CN-ES utilises a polar and dipole mechanism whilst, again, the alkyl chain enhances hydrophobicity. Figure 3 demonstrates how the combined hydrophobic and cyano functionality provide different selectivity to standard C18 and

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PHARMA PULSE selectivity.

Alternatively, differences in selectivity can be practically demonstrated using a selectivity screen and the Neue selectivity approach.[2] Using this approach, gradient retention times of a diverse set of 41 analytes, with different physicochemical properties, are determined on each stationary phase.

A linear regression analysis of the plotted retention times

cyano phases. Finally, the Avantor® ACE® SuperC18 is a hydrophobic C18 phase utilising unique encapsulated bonding that is stable using low, mid and high pH eluents.

Figure 4 shows a selection of acidic, basic and neutral analytes, chroatographed on a reversedphase gradient, using five of the Avantor® ACE® reversed-phase columns detailed in Table 2. The data clearly shows that the different stationary phase chemistries provide substantially different selectivity to one another. The elution order of the seven peaks is different for each of the columns. This example clearly demonstrates how powerful stationary phase chemistry can be for exploring separation selectivity. If one stationary phase chemistry fails to resolve a critical peak pair, as-

60 EXPRESS PHARMA June 2022

sessing the separation on a variety of phase chemistries offering complimentary selectivity can help rapidly identify a more suitable column for the separation.

for any column pair combina2 tion provides an R value from which a Selectivity value (S) is determined, according to equation 4. The S-values quantify the difference in selectivity offered by the column pair. An

Understanding Selectivity Differences Between Columns Established column characterisation protocols, such as those devised by Tanaka or Synder and Dolan, can be used to understand the relative contributions of different retention mechanisms to analyte retention, such as hydrogen bonding capacity, ion-exchange capacity and hydrophobicity. Various databases are available which contain characterisation data for columns from different vendors. These can prove invaluable for identifying orthogonal stationary phase

S-value close to 0 indicates similar retention for the 41 analytes and therefore identical selectivity. S-values between 6 and 8 indicate that the two columns are similar to one another, with small observable differences in selectivity.

Higher S-values indicate that the two columns are orthogonal and possess substantially different selectivity.

Table 3 shows the S-values determined for the six

PHARMA PULSE substantially different selectivity can be obtained for a given separation. The Avantor® ACE® reversed-phase portfolio has been specifically designed to offer a range of complimentary stationary phases. Quantitative data has been presented which demonstrates that these phases provide valuable selectivity differences which can be exploited to help develop optimised LC separations.

Avantor® ACE® phases using mobile phases containing both acetonitrile and methanol.

Significant S-values were obtained between the majority of Avantor® ACE® column combinations, indicating meaningful selectivity differences between all six phases.

Importantly, the data also revealed significant selectivity differences between methanol and acetonitrile for all six phases (data not shown, see reference 3 for further details). This indicates that the use of the six Avantor® ACE® phases with both organic modifiers provides a powerful tool for fully exploring selectivity during method development.

References

Conclusion This short article has demonstrated that stationary phase chemistry is a powerful parameter to explore during reversedphase method development. By varying the stationary phase,

Table 3: Experimentally determined S-values for the six AVANTOR® ACE® stationary phases, in mobile phases containing either methanol (A) or avantor® ace® tonitrile (B). Adapted from reference 3.

1. Adapted from “Introduction to Modern Liquid Chromatography”, 3rd Edition, Snyder, Kirkland, Dolan, 2010, p.29, Wiley & sons 2. U. D. Neue, J. E. O’Gara, A. Méndez, J. Chromatogr. A 1127 (2006) 161-174 3. M. R. Euerby, M. Fever, J. Hulse, M. James, P. Petersson, C. Pipe “Maximization of Selectivity in Reversed-Phase Liquid Chromatographic Method Development Strategies”; LCGC Europe, January (2016) 8-21.

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LUBRITAB® - Aversatile excipient from natural origin Being a solid lipid, LUBRITAB® has various applications pertaining to pharmaceuticals

T

o design a pharma or nutra formulation, excipients are selected according to their properties, advantages, risks, regulatory status and many more attributes. Due to the benefits of low safety concerns, lipids have become an interesting and promising category of excipients for multiple purposes.[1] The term "lipid" describes a family of products with diverse physicochemical properties. Their composition includes oils, fats, waxes, fatty acids and their derivatives, and biosynthetically or functionally-related substances to these compounds.[1] Naturally occurring lipids are typically triglycerides (triacylglycerols or triglycerides, TAGs), esters of glycerol and three fatty acids.

Image 1: Structure of a Triglyceride

The nature and compositions of three fatty acid chains of a TAG molecule, defined as R1, R2 and R3, determine its chemical property. An important characteristic of TAGs is their crystallisation behaviour.

The crystallisation behaviour (crystallisation rate, crystal sizes and their network, crystal morphology and crystallinity) of the TAG is directly influenced by polymorphism, and by several external factors such as temperature, pressure, solvent, rate of crystallisation, impurities, etc. Due to the conformation differences, they present different melting points.[1] This difference helps in identifying particular TAG grade (eg Glyceryl monostearate and distearate, Hy-

62 EXPRESS PHARMA June 2022

drogenated vegetable oil Type I and Type II, various grades of Polyoxylglycerides). This phenomenon is also important to define applications and process of specific TAG moiety.

In pharmaceutics, short chain and unsaturated long chain fatty acids (liquids, semisolids and solids) are approved for use in creams, ointments, emulsions, dispersions and suppositories. Long chain triglycerides, which have no practical ability to self-disperse, are digested rapidly in the intestine (lipolysis). Furthermore, their fatty acids and monoglycerides digestion products are solubilised by bile salt - lecithin mixed micelles, which are then absorbed. The lipid excipients used in pharma development are derived predominantly from the food industry where they are used as additives for emulsification, solubilisation, stabilisation and lubrication since long. Besides, lipid excipients have been refined and fine-tuned for the pharma industry to provide solutions to drug delivery challenges including drug solubility, drug dissolution properties and also to resolve manufacturing issues. Over the last four decades, naturally occurring triglycerides have been modified physicochemicaly to develop excipients suitable for the development of drug delivery systems.[1] In like manner, solid lipids became more and more interesting as pharma excipients for solid dosage forms. They are normally crystalline in nature and have melting ranges or melting points determined by their chemical structure (and composition).[1] They are chemically inert and their properties such as high hydrophobicity, high melting point and low density can be used ● to lubricate pharma dry powder blends ● as sustained release agent ei-

ther alone or in combination mask bitter-tasting drugs ● to solubilise lipophilic drugs [1] Furthermore, solid lipids used as sustained release agents provide different biopharma properties compared to polymers. Fundamentally, the drug release mechanism is different and this provides formulators with broader options for controlling drug release scope to develop innovative dosage forms.[1] They can be used either alone or in combination with other agents.

Several processing methods could be applied using solid lipids, such as ● Direct compression ● Dry and wet granulation ● Melt granulation ● Melt pelletization ● Molding ● Spray congealing ● Hot melt coating Choosing the appropriate TAG for the use in pharma process requires an understanding of their physicochemical properties and its as● to

Image 2: SEM image of LUBRITAB® [4]

TYPICAL PROPERTIES [5] Structure

Refer to Image 1; R1, R2 and R3 are mainly C15 and C17

Acid value

Max. 2.0

Iodine value

Max. 5

Melting range

57° to 70°C

Loss on drying

Max. 0.1 %

Saponification value

175 to 200

sociated effect on lubrication efficiency, API release and taste-masking effect.[1] Hydrogenated vegetable oil is a mixture of triglycerides of fatty acids. The two types defined in the USP-NF are characterised by differences in their physicochemical properties like melting range and Iodine value. LUBRITAB® complies with Hydrogenated vegetable oil Type I. It is made from the seeds of varieties of Gossypìum hirsutum (L) or other Gossypium species by refining, and hydrogenation.[1][2]

Applications LUBRITAB® is used in food products and oral pharma formulations, and is generally regarded as a non-toxic and non-irritant excipient. As discussed in previous section, being a solid lipid, LUBRITAB® has various applications pertaining to pharmaceuticals.

Lubricant: The primary function of lubricants in tableting is to reduce the force required to eject the compressed tablet from the die cavity. In capsule filling, where a plug is formed, lubricants perform essentially the same function by reducing

PHARMA PULSE the force required to transfer the plug from the dosators into the capsule. Without lubricants, these processes would be difficult or impossible and would result in significantly shorter tooling lifespan. LUBRITAB® is used as a lubricant in oral solid dosage forms at a concentration range of 1 - 6 % w/w. It acts as a liquid film-lubricant. It can be used alone or in combination with other commonly used lubricants.[2][3] Sustained release matrix: LUBRITAB® is additionally used as the matrix-forming material in lipid-based controlled-release formulations; it may also be used as a coating aid in controlled-release formulations. It has also been investigated in hydrophobic melt agglomeration. This application may find more rele-

vant space, where usage of traditional polymers is restricted or limited due to patent or percentage level (regulatory) constraints.[2] Taste masking: Being hydrophobic lipid in nature, LUBRITAB® does not dissolve into oral cavity. Hence, it can be used as a barrier to mask bitter and/or unpleasant taste of APIs by various methods like melt granulation, hot melt coating and spray-congealing where drug particles can be entrapped in wax matrix or covered by wax layer.

Viscosity modifier: Hydrophobic nature and miscibility with various oily materials, its use as a viscosity modifier in the preparation of oil-based liquid and semi-solid formulations is unique. It imparts this useful property during manufacturing of suppositories, to

reduce the sedimentation of suspended components and to improve the solidification process; and in the formulation of liquid and semisolid fills for hard gelatin capsules.[2] Wax nature of LUBRITAB® makes it a suitable alternative to hard waxes in cosmetics and topical preparations.[2] Binder: LUBRITAB® may be used alone or in combination as a binder in dry and wet granulation processes. It helps to solve capping and lamination during tableting.[3]

Summary LUBRITAB® is a plant-derived excipient made by hydrogenation of cottonseed oil.

It serves as a lubricant in tablet and capsule formulations. It can also be used as a binder, a taste-masking agent, and in controlled release ma-

trix tablets. It is used in oily liquid and semi-solid dosage forms to alter viscosities.

References [1] Petrovick, G.F. (2015) Orodispersible Tablets Containing Taste-Masked Lipid Pellets with Metformin Hydrochloride for Use by Elderly Patients. The Faculty of Mathematics and Natural Sciences, The Heinrich Heine University in Düsseldorf.

[2] Sheskey, P.J., Cook, W.G., Cable. C.G. (2017) Handbook of Pharmaceutical Excipients, 8th edition, Pharmaceutical Press, 1007-1009.

[3] LUBRITAB® | Hydrogenated Vegetable Oil- JRS Pharma (https://www. jrspharma.com/pharma_en/pro ducts-services/excipients/lubricants/lubritab.php) [4] SEM Images Lubricants-

JRS Pharma (https://www. jrspharma.com/pharma_en/ resources/sem-images/ lubricants.php) [5] United States Pharmacopoeia, USP 43-NF 38 (2019).

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

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Accelerated hassle-free removal of high-boiling solvents with fully automated Biotage® AB V-10 Touch solvent evaporation system The Biotage® V-10 Touch evaporation system is a unique system which operates through a combination of IR heat, fast rotation and internal vacuum that completely evaporates and dries hard-to-evaporate solvents and solvent mixtures

E

vaporation of any kind of solvents, including low boiling water, mediumto-high boiling solvents is an unavoidable step in chemical synthesis workflow. The age-old Rotary Evaporator remains instrumental for evaporating solvents even though a chemist may be restricted by many of its shortcomings like use of high boiling solvents such as DMF, DMSO, NMP, solvent mixtures containing water, cross contamination associated with too much bumping, longer evaporation times for medium-to-high boiling solvents, limited throughput, low rotational speed and frequent emptying of collection flasks.

In recent years, the development of biomolecules as drugs such as DNA, RNA, proteins, peptides, peptidomimetics have garnered a lot of attention in the pharma sector due to their increased target specificity and fewer side effects in the body.

For instance, in solid phase peptide synthesis workflow from concept to final compound, several evaporation steps become necessary-the evaporation of corrosive cleavage mixture, evaporation of purified prep HPLC or Flash Chromatography fractions consisting of CH3CN/H2O mixture and evaporation of high boiling DMF or DMSO. Even though the actual peptide synthesis time can be dramatically reduced with the advent of automation, electromagnetic heating techniques, multi-channel parallel peptide synthesisers for library synthesis, purification and repeated evaporation steps still remains the bottleneck in peptide synthesis workflow.

The Biotage® V-10 touch Solvent Evaporator, a walk up, walk away evaporation system manufactured by Biotage® AB, Sweden, speeds up the evaporation process of synthetic workflow.

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Fig. 1 A representation of peptide synthesis workflow, emphasising the need of several evaporation steps, which can slow down the overall production time.

The V-10 Touch may be used as a base unit for single solvent evaporation or can be upgraded to a fully automated system with the attachment of a 16-position carousel for high throughput, the solvent manger for evaporating large volumes of solvent placed in 1,000 mL conical flask and connecting it to a Gilson liquid handling robot for direct evaporation of HPLC fractions (Fig 2). The user can aim for all three or any one or two of the automation upgrade options.

This system combines a sophisticated IR heating technology capable of providing a temperature range of 200C to 700C with an in-built vacuum pump (2 mbar) and high-speed rotation (3,000 to 8,000 rpm). Further, the system can accommodate scintillation vials of multiple sizes ranging from 4 mL to 30 mL. The system is controlled by a large touch screen with in-built ready-to-use pre-programmed conventional methods. The typical evaporation times of different solvents using pre-programmed methods is depicted in Table 1: Now, let us analyse in depth by taking the peptide synthesis workflow as example about how this system can overcome a major bottleneck in the peptide synthesis workflow process. The peptide cleavage cocktail in Fmoc solid phase chemistry usually consists of TFA/TIPS/water.

It is important to completely evaporate this mixture to ensure complete precipitation with cold ether. The complete solvent

Fig. 2 The V-10 Touch evaporation system is an option rich unit. The user can opt for the base system that can be used as standalone unit for evaporation of single solvent or the user can automate the system by connecting a 16-position carousel for high throughput, solvent manger for evaporation of large volumes of solvent and a Gilson fraction collector for automated evaporation of purified HPLC fractions

Table. 1 Evaporation performance of Biotage's V-10 Touch Evaporator with hard-to-evaporate solvents

cocktail removal in a traditional rotary evaporator requires higher temperature and very long time, along with a strong likelihood of cross contamination due to bumping. Overcoming these limitations is simply a matter of speed and vacuum strength. The speed of traditional rotary evaporator is around 250-280 rpm. With lower rotational speed and smaller

surface area, rotary bubbles form spontaneously on the surface of vessels and when these bubbles explode, bumping occurs. In contrast, spinning the sample at a high speed forces the solution to form a very thin film along the sides of the vials, which prevents bumping. The rotation speed of V-10 Touch evaporator is between 3,000 to 8,000 rpm which means this system can

reach a speed up to 8,000 rpm.

This, in combination with an internal vacuum pump (capacity 2 mbar), allows fast and complete evaporation of TFA cocktail.

Moreover, to withstand TFA vapours, a chemically resistant upper vial face seal is provided.

In general, high boiling DMF and NMP are the solvents of choice in peptide synthesis and often peptides are stored in biological assay solvents like DMF and DMSO. By connecting V-10 Touch to an external vacuum pump, one can evaporate these solvents at a rate of almost 1 mL /min (see Table 1).

Another tedious procedure in peptide workflow is evaporating the water/acetonitrile mixture; very often the user needs to combine fractions corresponding to different peaks for analysis. This is made easier through direct connection of the Gilson fraction collector. With the help of software, the system can automatically mark, pool and concentrate the pooled fractions corresponding to the desired peak in a single vial. Hence, it not only reduces the evaporation time of ACN/water mixture, but also reduces the manual labour time of individually pooling and transferring fractions into vials.

The reader must be wondering is there any other unique system like Biotage® V-10 Touch available in the market? Well, in recent years, few parallel evaporation systems to overcome the limitations of rotary evaporators have emerged. However, compared with V-10 Touch, these systems are not fully automated and will still require manual filling of solvent before a run, and very often overnight runs are needed. Unlike V-10 Touch, possibility of cross-contamination remains a significant threat in these types of evaporators. Balancing with an empty vessel is another requirement which is not applicable with V-10 Touch.

PHARMA PULSE In summary, the Biotage® V10 Touch evaporation system is a unique system which operates through a combination of IR heat, fast rotation and internal vacuum that completely evaporates and dries hard-to-evaporate solvents and solvent mix-

tures. Thus, chemists are not restricted by the choice of solvents they want to use for their reaction, work-up and purification procedures. For instance, many starting materials are only soluble in DMF. But, traditionally, chemists must distil out the

DMF from their reaction mixture. However, we have seen DMF can be concentrated easily and in a very short time with V-10 Touch. Similarly, procedures like evaporation of samples in silica before loading in the actual flash column can be

also performed. Thus, this system can be a powerful lab tool for increasing the overall efficiency of a chemical synthesis work flow.

For more info, check www.biotage.com

For any queries, mail at india@biotage.com Contact Details: BIOTAGE INDIA 211 2nd Floor, DLF Tower B, Jasola District Centre Jasola, New Delhi- 110025

Imafit® DB Hose: Platinum cured silicone Double Braided hose from Ami Polymer Imafit® Double Braided hose fits perfectly for high pressure fluid transfer as the construction of hose is such that it provides strength, flexibility, pressure resistance and solution to many problems

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ne of the major challenges and critical parameters in pharma and biopharma industry is to maintain the high-pressure requirements with absolute ultimate quality and ensuring smooth bioprocessing. The Imafit® Double Braided silicone hose is fabricated with double braided polyester yarn with a silicone layer along with it which can withstand high pressure fluid transfer comes with minimum burst pressure.

Imafit® Double Braided hose fits perfectly for high pressure fluid transfer as the construction of hose is such that it provides strength, flexibility, pressure resistance and solution to many problems.

As the Imafit® DB hose is braided twice reinforcement by polyester yarn and a silicone plies whereby has a tremendous performance quality.

Material and its composition Imafit® Double Braided hose is manufactured under stringent quality parameters in the facility of ISO Class 7 clean room. All assembly and final packaging of Imafit® DB hose is performed in an ISO Class 7 clean room. The inner liner made of platinum cured silicone certified by the National Sanitation Foundation for food equipment materials (NSF-51).

Imafit® DB hose conforms to USP Class VI, FDA CFR 177.2600, ISO 10993 and European Pharmacopoeia 3.1.9 standards. Full BPOG standardised

extractable test protocol has been performed on the hose liner by a fully-accredited, thirdparty test lab and the silicone resins which is used in manufacturing hose is certified by NSF51.

Technical Details

Sterilisation methods ◆ Autoclave ◆ Ethylene oxide gas ◆ Gamma radiation

Key features ◆ Offers high pressure resistance compared to single braided hose. ◆ Provides excellent flexibility than wrapped hose and commensurate working pressure ratings. ◆ Better bend radius performance over fabric or wired hose ◆ Imparts no taste or odour during critical media transfer. ◆ Withstand maximum temperature range up to +180°C. ◆ Manufactured from low volatile grade silicone resin. ◆ Available with SS 316L triclovers end fittings having Ra Value < 0.5 at bore. ◆ Coloured outer layer and custom colour coding available on request.

Certifications ◆ FDA 21 CFR 177.2600 ◆ USP Class VI ◆ NSF-51 ◆ ISO 10993 ◆ European Pharmacopeia EP 3.1.9 ◆ GERMAN BFR ◆ FRANCE ARRETU ◆ TSE/BSE Free ◆ Full BPOG standardised

extractable test protocol available on request ◆ Phthalate free

Applications ◆ High pressure fluid transfer in

pharma, bio-pharma, food, cosmetic and chemical industries ◆ Media bulk transfer ◆ Food dispensing ◆ Critical liquid transfer ◆ Stages of bio-processing, drug formulation, upstreaming and downstream process ◆ Analytical lab food and beverages

Standard dimension and specification Above mentioned pressure data is tested at room temperature, increase in temperature of 100°C

will decrease the pressure rating by 20 per cent. Products should not be used for continuous steam application.

For more information, visit: www.amipolymer.com

Ami polymer works exclusively for its clients

Get a sneak peek look at Ami polymer’s facility: https://www. youtube.com/watch?v=SeNlSTVBDOE

◆ Customised laser printing for lot traceability. ◆ Customised colour coded outer cover options available upon request. ◆ Customised molded and over molded assemblies. ◆ Free samples for testing / trails are available upon request. ◆ Complete validation package available upon request.

Ami polymer believes "Be in business with ethics" and assure quick development, fastest delivery, ultimate quality and also very competitive rates.

For techno-commercial quires: europe@amipolymer.com Article by: Manisha Boga International Marketing Representative - EU (MBA in Marketing - NMIMS)

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First time in India – Fast,precise and efficient calibration of multi-channel micropipettes!

State-of-the-art proprietary software is used to calibrate pipettes with minimal human intervention

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ppendorf India has added a new capability at its Pipette Calibration Facility in Chennai with the installation of ‘Speedcal mobile,’ the first-ever installation in India, to calibrate 8-channel or 12-channel micropipettes in less than 30 minutes.

This patented and unique pipette calibration system includes 12 weighing systems for fast, precise and efficiently calibrate multichannel pipettes up to 12 channels. State-of-the-art proprietary software is used to calibrate pipettes with minimal human intervention. There is absolutely no possibility for data correction or manipulation. Eppendorf can support calibration of all brands of micropipettes.

About Eppendorf India Eppendorf India, the Indian arm of Eppendorf SE was established in 2003 to cater and be closer to the customers of the sub-continent and continue being an expert partner in lifesciences laboratories.

Started as a sales and service organisation with a team of 13, it is now a strong committed family of 180, spread across the country. Headquartered in Chennai, it has offices in all major cities.

Most of its employees have a sci-

ence, engineering or commercial background and every employee is an Eppendorf representative dedicated to supporting its customers. In the field, sales, product management and service personnel help customers select

solutions that best address their specific needs and provide comprehensive post-sales support.

Meanwhile, customer service, logistics, marketing, finance and administration team-members provide strong support to keep

customers well-informed and help ensure products and services are available efficiently. Beyond the sub-continent, Eppendorf India is also associated with markets of Bangladesh, Sri Lanka, Nepal, Maldives and Bhutan

working very closely with various dealers in these countries, providing pre-sales and postsales support.

Visit https://www.eppendorf.com/ IN-en/ to learn more

Eppendorf India to distribute products of Stilla Technologies to offer complete digital PCR workflow solution With this partnership, the companies will offer an optimised workflow for a wide range of applications, including liquid biopsy, sentinel pathogen testing, infectious disease assays, overall cancer research and drug discovery

E

ppendorf India and Stilla Technologies recently announced that Eppendorf India will distribute the products of Stilla Technologies in India, Bangladesh, Nepal and

66 EXPRESS PHARMA June 2022

Sri Lanka. The agreement allows Eppendorf India to offer the sample preparation systems and digital PCR on the six-color naica® system. With this partnership, the compa-

nies will offer an optimised workflow for a wide range of applications, including liquid biopsy, sentinel pathogen testing, infectious disease assays, overall cancer research

and drug discovery.

The six-color naica® platform is being quickly adopted, with end-users developing high multiplex dPCR assays that have been previ-

ously unattainable. This adds to the growing body of evidence for the need to study more molecular targets per sample to provide actionable insights.

PHARMA PULSE

Gandhi Automations's Porto and Max Vista - Automatic Sectional Overhead Doors: Ideal for industrial and commercial needs Gandhi Sectional Overhead Doors provide heat insulation and sound proofing, thus, improving the working conditions on the premises and saving energy

P

orto Sectional Overhead Doors (SODs) are ideal for all industrial and logistics needs. The design and different solutions offered ensure the door to be aesthetically pleasing and perfectly suited to any architectural environment - from modern and traditional industrial buildings to fine commercial buildings.

As these doors slide vertically, stopping in the proximity of the ceiling, they blend in with the architectural features of the building. Porto doors are built to ensure the highest ease and flexibility of use, which, in turn, ensures a quick, hasslefree and accurate replacement of old doors. Their compact size ensures more available space both inside and outside the premises. Depending on the structure of the building and the requirement, a choice can be made from a standard lift, vertical lift, horizontal lift, low headroom or inclined lift.

Porto range comprises a wide series of track systems, panel options and safety features.

Special glazed doors provide excellent lighting and vision into the building where required.

Max Vista Sectional Overhead Doors are ideal for industrial and commercial buildings.

The doors are made with a combination of aluminium panels and transparent acrylic, grilled or meshed windows, giving it a distinctive look, and enhancing the look of a building. Max Vista Doors make the environment bright and pleasant to work in as it allows natural light to pass through the large clear areas.

Gandhi Sectional Overhead Doors provide heat insulation and sound proofing, thus, im-

proving the working conditions on the premises and saving energy. The products are affixed with a CE mark making them reliable and safe.

Key features: ● Reliable and low-noise operation ● Extreme robustness ● Safe operation in compliance with safety requirements ● Design-oriented surfaces and optimum light solutions ● Minimal bulk for more space indoors and outdoors ● Easy and practical to open and operate ● Energy savings and more comfort ● Bright indoor environment and attractive design ● Pre-painted, galvanised steel, sandwich panel, thickness 40 mm ● The gaskets, made of a special non-ageing rubber, seal the perimeter of the door opening ● They produce a perfect seal,

preventing water, air and dust infiltration ● Minimal bulk for more space indoors and outdoors ● Easy and practical to open and operate ● Energy savings and more comfort ● Bright indoor environment and attractive design ● Sectional Overhead Doors can be customised as Gas Tight Ripening Room Doors ● Opening - Closing speed = 0.2 - 0.4 m/s. ● Sizes available: Width (max) = 15,000 mm ● Height (max) =10,000 mm For more info, Gandhi Automations Chawda Commercial Centre, Link Road, Malad (W), Mumbai - 400064, India.

Tel : +91 22 66720200 / 66720300 (200 lines) Fax : +91 22 66720201 Email : sales@geapl.co.in Website : www.geapl.co.in

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PHARMA PULSE

Validation of weighing processes: Are you up-to-date?

The weighing experts from Mettler Toledo help design weighing processes, qualify weighing equipment and continuously monitor it to ensure reliable product quality and avoid unpleasant surprises during audits

G

ood Manufacturing Practice (GMP) guidelines are continuously revised to consider technological changes and current practices in pharma manufacturing.

Process validation is a key requirement of all regulations.

The weighing experts from Mettler Toledo help design weighing processes, qualify weighing equipment and continuously monitor it to ensure reliable product quality and avoid unpleasant surprises during audits.

Process validation contributes significantly to ensure drug quality, but it also places a heavy burden on pharma manufacturers. It requires significant effort and resources that result in additional costs.

Pharma production, and the validation of such a process, is a complex task that needs to consider many aspects, including weighing. Weighing has a significant impact on quality, both in production and in the laboratory. Therefore, weighing equipment must be qualified and critical weighing processes need to be validated.

must be qualified and critical weighing processes need to be validated. Mettler Toledo's Good Weighing Practice™ (GWP®) provides outstanding support in three main stagesweighing process validation, equipment qualification and continuous process verification.

About Mettler Toledo Mettler Toledo is a leading global supplier of precision instruments and services. The company is the world's largest manufacturer and marketer of weighing instruments for use in laboratory, industrial and food retailing applications. Mettler Toledo also holds top-three market positions in several related analytical instruments, and is a leading provider of automated chemistry systems used in drug and chemical compound discovery and development. In addition, the company is the world's largest manufacturer and marketer of metal detection and other end-of-line inspection systems used in production and pettler Toledo can be found at www.mt.com

Weighing processes in pharma manufacturing Weighing occurs at various stages of the pharma manufacturing process. Nowadays, scales are built into complex machinery, such as filling machines or reactors. They also can be connected to Human Machine Interfaces (HMIs) or computers running software that guide operators through production processes. Initially, scales are used in material receiving to verify incoming or outgoing components and reconcile inventory. Next, scales and balances are found in dispensing areas to weigh components according to pre-defined formulations. Then, scales are used when checking for completeness or monitoring pro-

68 EXPRESS PHARMA June 2022

duction yield. Finally, weightbased quality control confirms the weight of tablets using the principle of mass uniformity or vial fill level is qualified using Statistical Quality Control (SQC) software. In quality con-

trol labs, balances belong to the most widely used equipment for standard preparation, assays and impurity profiles.

Weighing processes are critical to high-quality products and the performance of

the scale is a Critical Process Parameter (CPP).

Process validation contributes significantly to ensuring drug quality. Since weighing has a significant impact on quality, weighing equipment

For more information, visit: www.mt.com/GWP Verification Call Toll Free -1800 22 8884 / 1800 10 28460 or Email-sales.mtin@mt.com

PHARMA PULSE

Next-generation tablet coater - Totallyadjustable batch sizes from 10 to 100 per cent Tablet coater TP R Optima perforated coating pan from Romaco Tecpharm provides fully automatic adjustment of all parameters during the coating process for an impressive batch size range from 10 to 100 per cent filling volume with one and the same drum

C

oatings are applied to tablets for different purposes. Amongst other things, they make tablets easier to swallow, protect them from light, air and moisture or mask an unpleasant taste when they are taken. Film coatings are additionally used to control the release of the active ingredient in the human body.

The TP R Optima coater enables tablet coatings of all kinds to be produced fully automatically for a wide range of batch sizes. The recipe with the predefined process parameters can be accessed by the machine operator on the HMI and is then running automatically. Parameters like the spray distance or angle no longer have to be adjusted (or readjusted) manually and nor do the exhaust air flows.

The parameters are monitored continuously during the coating process and automatically adapted by the system to the recipe. The operator is no longer required to be present throughout and is freed up for other assignments. This highly automated coater delivers absolutely reproducible results and optimal process control is guaranteed, because all manual intervention during the coating process is eliminated. For example, sampling can take place directly without having to stop coating and open the machine.

Sonar system measures batch volume and tablet bed inclination The key to the TP R Optima tablet coater's ability to adjust the parameters fully automatically during the coating process lies in a sonar: acoustic wave sensors measure the complete tablet bed continuously and then use this information to determine the batch volume. The tablet bed inclination, which

varies according to the turning speed of the drum, is measured in the same way.

Therefore, the new perforated coating pan from Romaco Tecpharm allows ultra-precise application of the spray liquids over the entire batch size range from 10 to 100 per cent. This is achieved thanks to the interaction between the sonar's realtime data and a nozzle arm with a three-point extension mechanism, which automatically adjusts the spray angle and distance without interrupting the coating process. The nozzle arm's long reach ensures that the suspension is always applied to the tablets exactly as per the recipe, even with very small batch sizes.

The GMP conform in-wall design of the TP R Optima tablet coater provides for a strict separation between technical and production area

Efficient spraying and drying process enables shorter processing times Drying is a particularly important step in the tablet-coating process, which begins while the spray liquid suspension is being applied. The inlet and exhaust air temperature and flow rate are crucial to the efficiency of the spraying and drying process, as is correct air flow behaviour in relation to the batch size. Near loss-free application of the suspension and rapid drying will otherwise be impossible. It is also extremely important to adjust the drying air, to prevent the product in the coater from becoming too moist, causing individual tablets to stick together.

The TP R Optima tablet coater uses a bypass to adjust the supply of process air. The vacuum that is created inside the drum can be varied according to the batch size; it stabilises the air flow and diverts the air towards the automatic air exhaust flaps. These flaps can be opened individually and continuously in a controlled way, so that the process air is guided

through the product directly.

The coater's high spraying and drying efficiency thus achieved, is reflected in short processing times - generally between one and three hours depending on the product - as well as lower energy usage.

The precise control of the air flow inside the drum also means accurate application of the coating suspension to the product for any batch volume between 10 and 100 per cent. In other words, the system prevents that the liquid just runs over the tablets and is discharged without being applied. Together with the high spray accuracy which results from the automatic adjustment of the spray arm, this adds up to significantly lower consumption of coating suspension - and a material saving of up to 60 per cent compared to other coating methods, depending on the application.

Detection and automatic clearance of clogged spray nozzles Automatic extendable spray arm with self-adjusting movable spray nozzles allows for variable batch sizes from 10 to 100 per cent

Continuously opening flaps control the air flow and path and thus enable precise coating and drying processes according to the respective batch size

The coating technology from Romaco Tecpharm includes a system for automatically detecting and clearing clogged spray nozzles. The risk of such blockages occurring is actually very low in practice but increases the higher suspension's viscosity. Directly downstream of the peristaltic pump, the coating pan has a load cell that measures the amount of spray liquid being pumped. If the load cell registers that liquid is no longer exiting from one of the nozzles, the coater initially attempts to unclog that particular nozzle by building up maximum pressure.

If this is not possible, an individually-configurable mechanism takes over: depending on the product being processed, either the coating process continues and the system simply issues an

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PHARMA PULSE alert or the process is interrupted immediately. The coating pan's response to nozzle blockages can be fine-tuned to the product in question in this way.

GMP-compliant in-wall design The TP R Optima tablet coater was designed in conformity with Good Manufacturing Practice (GMP) standards. All productcontacted parts on the inside of the coater are easy to clean using Washing In Place (WIP) procedures and readily accessible, so that cleaning validation is totally straightforward. No dead spaces exist where product residues could accumulate, leading to cross-contamination. The design of the spray arm particularly rules out such critical spaces due to its extendable and retractable mechanism.

Furthermore, the tablet coater's in-wall design enables strict separation between the "grey" area and the production

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Blocked spray nozzles are automatically being detected and cleared on the spot

area in the cleanroom. If servicing is required, the work can be carried out without having to enter the cleanroom and decontaminate it again afterwards.

What is more, the batch being processed does not necessarily need to be disposed of following a service assignment in the "grey" area and can be processed further once the work is completed.

Advanced sensors and actuators take processing automation to a new level Romaco Tecpharm's new perforated coating pan combines very high flexibility with premium product quality and a previously unattainable level of automation in tablet coating. The spray arm and its three-point extension mechanism are patented.

Peripherical systems of the TP R Optima tablet coater for inlet and exhaust air as well as for cleaning

Nevertheless, the system still allows individual parameters to be adjusted manually, if required. The TP R Optima tablet coater, which is available in seven different sizes, is thus equally suited for product development with laboratory-scale batch sizes and for scale-ups to larger production volumes.

The machine is also ideal for

suppliers producing under contract who need to run a wide range of batch sizes on one line and therefore often face "last batch" challenges, especially during campaign manufacturing.

Author Jordi Carrera, Sales Director, Romaco Tecpharm, S. L.

PHARMA PULSE

Ensuring pharma compliance with testo data measurement technology Testo data loggers can be used to test the optimum conditions for specific products or surroundings

D

ue to the crucial necessity and its direct impact on human health and welfare, pharma is probably the most important and critical sector, among others. As a consequence of which, it becomes essential to store pharmaceuticals, vaccines, laboratory samples or units of blood at the right temperatures to ensure that they remain effective and that quality is maintained. Another reason for the pharma division to ensure safety measures and controlled environment is stringent regulations and inspection of the facilities. This elementary need for climate control can only be ensured with right data monitoring systems. Testo being a market leader in testing and measurement sector provides the best-in-class data loggers and data-monitoring systems for the pharma division.

Ensuring end-to-end climate monitoring Testo data loggers Pharma goods must be stored well in every situation as any deviation in the ambient temperature or humidity values may lead to deteriorated quality of the product. Testo data loggers can be used to test the optimum conditions for specific products or surroundings. Temperature and humidity data loggers are often used in pharma industries to monitor the conditions in which drugs, medicines and vaccines are kept. Not only storage, but during the transit of goods, testo transport data loggers are useful to measure the transport conditions. The range of data loggers is very extensive. A temperature and humidity logger such as 174 T guarantees continuous monitoring in a storage or warehouse. Further, data loggers with multi channels for con-

necting external sensors and thermocouples, like testo 176 are available for ensuring secured work process in labs.

These data loggers are also critical for production quality assurance where the temperature has to be frequently checked at various points in production processes. Using thermocouple probes, data loggers can also record data in the kinds of extreme temperature ranges. The probe's fast response also contributes in the validation processes and quality standard optimisation in QA units and clean room applications. These instruments are the most convenient and pocket-friendly solution for all pharma application areas.

The testo Saveris 2 WiFi data logger system is the simple, flexible and reliable solution to humidity and temperature monitoring in cold storage area like blood banks.

This innovative monitoring system is ideal for high product quality and eliminates manual work of reading out or documenting measurement data. With a secure online storage of all readings in

sure continuous monitoring of temperature and relative humidity of pharma products during production, storage or transit of goods. Real-time data monitoring is important for the quality of pharma goods and also enables the supplier to improve the life of the goods. Transportation trucks, warehouses, cold rooms, etc. can now be remotely monitored via Testo data loggers and data-monitoring systems. Our data loggers are EN 12830 and 21 CFR Part 11 compliant, which ensure complete documentation of parameters, be it humidity, temperature or absolute pressure. They come with professional software where the data recorded cannot be modified and the audits can be easily complied with.

Service and calibration made easy

Testo Cloud, the data can be managed and analysed online by the user via smart phone, tablet or PC anywhere and anytime. In case of crises and deviations, it is provided with an alarm by e-mail, or optionally by SMS. Another important and crucial application of a pharma industry involves validation of sterilisation and freeze-drying processes. Not only that, validating cleaning and disinfecting equipment is equally necessary. In order to allow a seamless operating procedure, the validation

process and the documentation work must be as efficient and smooth as possible which could be easily achieved with testo 190 data logger solution that has innovative data loggers for temperature and humidity, smart software and accessories.

Data compliance for audits and inspections Testo offerings are majorly related to the data security, along with comprehensive analysis and evaluation of all the recorded measurement data. Testo data loggers en-

Testo also has an established state-of-the-art NABL-accredited service and calibration LAB in accordance with the standard ISO/IEC 17025:2017, that takes care of the after-sales support locally from Pune. Testo service and calibration facility is highly cost-effective as it delivers international standards very conveniently within a week's time. Instruments of any brand/make can be calibrated and serviced locally maintaining necessary standards. The accredited parameters include humidity, pressure, absolute pressure, contact type temperature, non-contact type temperature (infra red thermometer, thermal imager). In fact, ours is the first and only lab in India to get NABL accreditation for dew point temperature as well.

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

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PHARMA PULSE

Waters and Universityof Delaware announce official opening of Immerse Delaware Lab Lab opening milestone is part of multi-year Waters-UD research partnership to collaborate on projects with biopharma industry stakeholders About the University of Delaware (www.udel.edu)

W

aters Corporation and The University of Delaware announced the opening of Immerse™ Delaware, a new Waters innovation and research laboratory. As part of their multi-year research partnership announced in October 2021, the lab opening is the first step on a journey to collaborate with biopharma scientists both in industry and academia to advance industrial processes for making and characterising biotherapeutics.

Located at the University of Delaware Science, Technology and Advanced Research (STAR) campus, Immerse Delaware is a fully functional, fit-for-purpose, bioprocess laboratory enabling a dedicated focus on the entire manufacturing process from clone selection to Quality Control (QC) of drug substances. It will give students, faculty and industry researchers access to use and evaluate state-ofthe-art analytical technologies from Waters as well as novel analytics, consumables and software that will enable the next generation of biotherapeutics.

“Our mission to address some of the biggest challenges in the development and manufacturing of biotherapeutics requires an immense amount of work, collaboration, and diversity of thought. Immerse Delaware will enable us to tap into an ecosystem of talent and expertise in biological manufacturing, coupled with Waters’ experience in analytical technologies, to advance and accelerate the delivery of high-quality medicines to patients,” said Dr Udit Batra, President and CEO, Waters Corporation.

“As a research institution,

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Immerse Delaware, A Waters Innovation and Research Lab at The University of Delaware (Photo: Business Wire)

Waters selected University of Delaware as a partner due to its leadership in chemical and biological manufacturing research as well as its active support of and close proximity to the National Institute for Innovation in Manufacturing Biopharmaceuticals the University of Delaware has a long history of advancing new discoveries and innovations that make our world safer, healthier and more vibrant,” said Dennis Assanis, President, UD. “Today, the Immerse Delaware partnership with Waters Corp is another exciting opportunity to extend our research impact and continue building on our successes in educating the next generation of leaders in the field of biopharmaceutical manufacturing.”

Waters selected the University of Delaware as a

partner due to its leadership in chemical and biological manufacturing research as well as its active support of and close proximity to the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a collaborative effort amongst industry, academia and regulators.

Notable attendees at the lab opening included Dennis Assanis, PhD, President, University of Delaware; Udit Batra, PhD, President and CEO, Waters Corporation; Chai Gadde, CEO, BioTek reME-

Dys; Kelvin Lee, PhD, Director, NIIMBL and Gore, Professor Biomolecular Engineering; Levi Thompson, PhD, Dean, College of Engineering, University of Delaware; and Michael Flemming, President, Delaware Biosciences.

Additional Resources

◆ Learn more about Immerse Delaware, a Waters Innovation & Research Lab ◆ Learn more about the University of Delaware’s STAR Campus ◆ Connect with Waters via Twitter, Facebook and LinkedIn

The University of Delaware, located in Newark, Delaware, traces its beginnings to a small private academy established in 1743. Today, UD is a researchintensive, technologically-advanced institution offering more than 150 academic majors across nine colleges, serving more than 23,000 undergraduate and graduate students. The university's distinguished faculty includes internationally renowned authors, scientists and artists. The Carnegie Foundation for the Advancement of Teaching has classified UD as having very high research activity—a designation accorded fewer than three per cent of the US colleges and universities. The University’s Science, Technology and Advanced Research (STAR) Campus in Newark is a growing centre for innovation, blending cutting-edge research, top-notch academics and thriving businesses in one location.

Delaware has 21 varsity sports teams that compete at the Division 1 level in the Colonial Athletic Association and the Football Championship Subdivision.

About Waters Corporation (www.waters.com) Waters Corporation (NYSE:WAT), a global leader in analytical instruments and software, has pioneered chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials and food sciences for over 60 years. With more than 7,800 employees worldwide, Waters operates directly in more than 35 countries, including 14 manufacturing facilities, and with products available in more than 100 countries.

PHARMA PULSE

Virosil Pharma: Arevolutionary,eco-friendly fumigant Virosil Pharma has proved to be effective in controlling aerial bacteria and fungus present in sterile rooms.The area becomes completely sterile within 60 minutes of spraying without causing any irritation to the eyes, nose and skin - unlike conventionally used formulations ABSTRACT In the past years, the pharma and healthcare industry has witnessed tremendous growth and there have been tie-ups with a number of multinationals for production and R&D facilities to be nurtured in India.

Organisations are applying for ISO standards and upgrading themselves to the latest norms related to health and hygiene.

Microbial contamination and pollution play a significant role in the pharmaceutical industries. Control of microbes has always been the biggest challenge to these industries.

A load of microbes are present in areas such as production, storage/packaging, R&D, Q.A/Q.C., filling etc. They are present everywhere in the air, surface, water, instruments, linens etc.

Hence the disinfectant used should be so precise that it should not only take care of the microbial contamination but also be user and eco-friendly.

Virosil Pharma meets all the required standards for the pharmaceutical industry.

strict regulations imposed by European Health bodies.

PRODUCT DISCRIPTION Virosil Pharma is a multicomponent fumigant and disinfectant. The oxidizing agent used is hydrogen peroxide, which is bonded with stabilizing agents to form a complex solution. A long-lasting effect is ensured by the addition of silver, which acts as a catalyst in trace amounts. The bactericidal effect of silver is based on the fact that the monovalent silver

ion Ag+ binds very firmly to bacterial proteins by a covalent or co-ordinate bond, and thus inactivates or precipitates these. ◆ Its effectiveness against bacteria, viruses, amoebae, fungi and algae; i.e. its extremely wide range of application makes it easy to handle for the end user; i.e. only one product is needed, where so far 2, 3 or various products were necessary. ◆ Owing to the good stability of the product, a long storage

Clean Area Classification

Microbial limit Cfu / 10 cu.ft.

Microbial limit Cfu / 10 cu.m.

100

< 1a

< 3a

1000

<2

<7

10,000

<5

< 18

100,000

<25

<88

a = samples from class 100 environments should normally yield no microbiological contaminants

WHO 2002 MICROBIAL LIMITS Grade

Max. no. of microorganisms permitted / m3

A

Less than 1

B

5

C

100

D

500

EU GMP 2002

ABOUT US Sanosil Biotech, a Mumbaibased company, has launched a range of multipurpose disinfectants which are eco-friendly, chlorine-free and completely biodegradable and have applications in the pharma and healthcare industry as well as in the food processing industry.

It is manufactured in India in technical collaboration with SANOSIL AG of Switzerland.

SANOSIL AG in Switzerland is the patent holder and has joint venture agreements in more than 15 countries such as France, Italy, Spain, Holland, Norway, South Africa, Australia, Saudi Arabia, Oman, the UAE, etc. The product is being used in various countries by reputed institutions and has been thoroughly tested under

USFDA DRAFT GUIDELINES

ADVANTAGES

PROPERTIES

# Eco- friendly - It is totally biodegradable since (H2O2) breaks down into water & oxygen # Chlorine free # Non-toxic (no irritation to skin or eyes # No effect on pH # Non carcinogenic and non mutagenic # Excellently rinseable with no remains

# Can easily be dosed # Does not foam # Decomposes into water and oxygen # It is excellently rinseable with no remains # Treats any other material with consideration

Grade

Air sample cfu / cu.m.

Settle plates (90mm) cfu / 4 hours

Contact plate 55mm cfu / plate

Glove print Cfu/glove

A

<1

<1

<1

<1

B

10

5

5

5

C

100

50

25

-

D

200

100

50

-

time can be guaranteed. As the product remains stable at high water/air temperatures, and as its effectiveness is even increased at high temperatures. ◆ Due to its long-term effectiveness and pronounced characteristics to prevent recontamination, this product is perfectly suited for disinfection of drinking water and wells. ◆ Virosil Pharma is ecologically harmless. Its principal constituent - hydrogen peroxide - does not pollute waste wa-

ter, because it breaks down into water and oxygen (H2O and O2), i.e. it produces no noxious by-products. ◆ The two basic substances (H2O2 and Ag) enhance their advantages (*synergism). The bactericidal effect comes into action quicker and more intensively than if either substance was used on its own.

Fumigation with Virosil Pharma, the perfect Salternative to Formalin Fumigation is one of the most

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PHARMA PULSE important factors associated with pharma industries, it plays a vital role in maintaining the sterility of areas and is directly related to production.

Sanosil Biotech is the first company to pioneer the novel concept of eco-friendly fumigation. The company has great respect for human health and the environment. The CEO, Dev Gupta, an MBA from the Bentley Graduate School of Business, Boston, has been actively marketing the brand nationally. According to Gupta, "Virosil Pharma has simplified the lives of so many people who work in the pharmaceutical industry as they are guaranteed sterility with the minimum risk exposure". As there was a high risk to the staff involved in the use of Formaldehyde/Glutraldehyde for sterilization and disinfection.

Owing to the stringent integrated micro contamination control and biosafety requirements, it is desirable to have micro-contamination control procedures and methods that could be monitored, evaluated and assessed periodically, which are convenient, cost-effective and safe.

A glimpse at the standards put down by various would monitoring agencies would help an individual or an organization help decide on choosing the most appropriate control procedure/methods. The important microbial limits which have been prescribed by various agencies is as follows: To meet those requirements aerial disinfection (fumigation) with formaldehyde was the most convenient method. With the regulatory having restricted the use of formaldehyde and also putting into place the monitoring levels of formaldehyde after fumigation makes it a procedure with its own limitations.

Formaldehyde is a known carcinogen (IARC & NTP).

Formalin is toxic by inhalation, toxic if swallowed, may be fatal if swallowed, causes eye burns, may cause blindness, strong sensitizer, causes irritation to skin, eyes, and respiratory tract. Repeated or prolonged exposure increases the cancer risk.

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COMPARISON VIROSIL PHARMA

FORMALIN

Eco-friendly, Non-toxic

Highly toxic

Room gets sterilized within 1 hour after fumigation

Requires overnight fumigation

Requires no de-fumigation

Requires de-fumigation

Person can be present during fumigation

Causes skin, eye irritation even after next day of fumigation

Time Saving

Time consuming

Multiple Applications

Application restricted

Virosil Pharma has been a direct alternative to Formalin Fumigation. Virosil Pharma has proved to be effective in controlling aerial bacteria and fungus present in sterile rooms. The area becomes completely sterile within 60 minutes of spraying without causing any irritation to the eyes, nose and skin - unlike conventionally used formulations. Virosil Pharma can even be successfully used in AHU which are responsible for optimal and steady air exchange in production facility, of which the ducts, air shafts, humidificator, filters, etc. are often contaminated with loads of bacterial and bio-films.

The main aim of Virosil Pharma is to increase productivity by cutting down disinfection time while at the same time providing a totally microbe-free environment.

Virosil Pharma is also very effective in disinfection of all critical surfaces that come in contact with pharma products.

There is no requirement to rewash equipment and surfaces disinfected with Virosil Pharma since it is H2O2 based and decomposes into water and oxygen.

Virosil Pharma has been tested by several reputed and renowned institutions in India with respect to its disinfection and fumigation applications in Pharmaceutical Industry Because of all these factors, Virosil Pharma has attained maximum satisfaction of the customers in controlling the microbial contamination in their respective applications.

The introduction of an ecofriendly, non-carcinogenic and totally biodegradable versatile product, like Virosil Pharma,

A GRAPHICALVIEW ON DISINFECTANT EVALUATION DATA - VIROSIL PHARMA

Organism Type S.AUR

B.CER

E.COLI

P.AER

C.ALB

2.50%

429.83

397.4

418.15

289.38

0

3.00%

514.44

502.4

440.92

349.48

0

4.00%

615.44

683.14

490.625

404.5

0

5.00%

669.32

1063.07

580.77

452.16

0

has not only brought an end to the era of conventional biocides but has completely solved the disinfection requirements which these healthcare industries were prone to.

Targets Sanosil Biotech is marketing this disinfectant under the 'Virosil Pharma' brand name and is targeting the entire industrial belt of India. The com-

pany has already set up a distribution and infrastructure network having establishments in Maharashtra, M.P., Hyderabad, Chennai and Delhi.

REGD.WITH RNI NO. MAHENG/2005/21398, POSTAL REGD. NO. MCS/164/2022 – 24, PUBLISHED ON 5TH EVERY MONTH, POSTED ON 9TH, 10TH, AND 11TH EVERY MONTH POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE, MUMBAI – 400001