Three lessons from Pharmanovia’s ESG Report
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EXPRESS PHARMA TO HOSTMAIDEN
EDITION OF INDORE PHARMA SUMMITIN AUGUST
MARKET
P17: INTERVIEW
VIKRANTSHROTRIYA, CVP& MD, NOVO NORDISKINDIA
P22: INTERVIEW
FEDERICO FUMAGALLI,COMMERCIALDIRECTOR, STERILINE
CHIRANJEEVI KONDAPAKA,CEO,STERILINE ASIA
VISHESH PAREKH,MANAGING PARTNER,INCOME
36 THREE LESSONS FROM PHARMANOVIA’S ESG REPORT
P19: INTERVIEW
SYLVIAVARELA, AVPASIAAREA, ASTRAZENECA
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Of the 32 bills awaiting discussion during the ongoing 2023 Parliament Monsoon Session, the Drugs, Medical Devices and Cosmetics Bill, 2023 is one of 21 new draft legislations. Once passed, this will replace the Drugs and Cosmetics Act, 1940.
However, not everyone is on board with the proposed Bill. Pavan Choudary, Chairman, Medical Technology Association of India (MTaI) says that although the draft of the Bill has not been shared with stakeholders yet, they expect that it will incorporate several thoughtful provisions from the Medical Devices Rules 2017.
He points out that the regulation of Medical Devices currently operates under The Medical Devices Rules (MDR) 2017, a well-considered framework that emerged through extensive consultations between CDSCO and various stakeholders. Choudary further adds, that they strongly recommend that the industry is consulted and given an opportunity to submit their recommendations before the Bill is finalised. His point is that advancing the inclusive approach that the government has adopted so far, would help it avoid blind spots and enable the supply of quality products to continue uninterrupted.
From the pharma sector, Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance (IPA) reiterates that quality is fundamental, and this (the proposed Bill) will help to strengthen quality management systems in the country and take our industry to the next level.
Echoing these sentiments, Suresh Pattathil, President, OPPI comments, "...we find confidence in the thoughtful integration of provisions of the acclaimed New Drugs and Clinical Trials Rules, 2019 (NDCT), Medical Devices Rules 2017 (MDR) and the Cosmetics Rules, 2020. All these framed rules stand as a testament to the power of collaboration, arising from extensive consultations between CDSCO and diverse stakeholders. In nurturing this progressive legacy, the government's inclusive approach fosters a horizon of transparency and foresight. By removing blind spots, we pave the way for an uninterrupted flow of quality products, enriching the lives of those we serve. Together, we aim to uphold the highest standards of safety, efficacy, and accessibility, empowering healthcare for all."
In contrast, sources from the pharma MSME segment allege that while the stated purpose is quality and to replace the archaic Drugs and Cosmetics Act 1940, the real purpose of the proposed Bill is to ‘strangulate 8000-10000 small units and facilitate Big Pharma’. They allege that the proposed Bill is an attempt to unconstitutionally divest state drug regulators of powers, and aver that such changes cannot be made as long as medicines are on the concurrent List.
If this sounds familiar, that’s because it is. MSME players in any sector are bound to play the underdog card. Secondly, the centre-state power equation works well in theory, as a system of checks and balances. But practice has been anything but perfect. As drugs/medicines are on the concurrent list of the Constitution, the centre legislates and states implement the regulated manufacture and sale of medicines.
Supporting their argument, pharma MSMEs experts
single out the relevant sections in the new Bill like Section 41(5) of the proposed Bill which creates a Central Licensing Approving Authority, meaning that no unit can be licensed without its approval. Section 41 (6) of the proposed Bill empowers the Central Government to assume control of manufacture and sale of medicines by issuing a Notification. Similarly, Section 68(2) enables the Central Government to cancel any license.
They point out that this is the third attempt to centralise (pharma regulation), alluding to previous attempts in 2007 and 2013, which were stymied when the Parliament Standing Committees rejected the Bills. The 79th Report of the Standing Committee on Health and Family Welfare also reprimanded the Central Government for misleading the Parliament. Given past censure, these sources note that the new bill is not being sent to the Standing Committee this time.
It's easy to understand why pharma MSMEs are on the backfoot. Starting with cases in Gambia, the past year has thrown up multiple instances of MSME pharma exporters cutting corners on GMP, resulting in tragic deaths due to medicines containing non-pharma grade solvents. State drug authorities gave these companies a clean chit, even though some were multiple offenders.
Conceding that these incidents could be the trigger for this latest attempt to centralise pharma regulatory powers, pharma MSMEs claim bad policies force them to cut corners. They argue that the Central Government should own up responsibility as ‘the manufacturer alone is not the culprit’.
Blaming policies like tax holidays to hill states, followed by increasing excise burden to 30 per cent by levy of MRP excise, pharma MSMEs say they had to cut corners on quality to survive, ‘resulting in Gambia and Uzbekistan.’
They also allege that no more than 10 per cent MSMEs can comply with the inspection format and more stringent GMP norms which came into effect post 2005.
Pointing out that while India currently is fortunate to have a grid of skilled workers and technology to qualify as the Pharmacy of the World, they warn that if pharma MSMEs are closed down, the capacity to produce affordable drugs will be lost fo rever. In addition, the country loses employment to crores who make and sell drugs as part of the pharma MSME sector.
It is true that medical expenses push more Indian citizens below the poverty line each year, and pharma MSMEs create competition which keeps prices more affordable. However, maintaining quality standards is equally important.
While the blame game between centre and state regulators, as well as large and MSME pharma companies continues, let’s hope that legislators get a fair chance to debate the proposed bill and if not satisfied, ask for changes or defer it pending further discussion.
VIVEKA ROYCHOWDHURY, Editor viveka.r@expressindia.com viveka.roy3@gmail.com
The centre-state power equation works well in theory,as a system of checks and balances.But practice has been anything but perfect
Indore Pharma Summit 2023 will provide
opportunity
Express Pharma is organising a series of “Pharma Summits” across the nation's pharma centres to strategically leverage opportunities as well as find and apply new operating business models that support a value-driven approach to foster business growth.
Indore, with its strategic location, well-developed economic zones and industrial cen-
Indore Pharma Summit 2023 will provide the opportunity for professionals in the pharma sector to come together and exchange ideas on the most recent trends, challenges, and opportunities in the industry. It will offer an opportunity to network, learn, access policymakers, explore business opportunities, and stay up-to-date with the latest industry trends and developments.
tres, skilled workforce can emerge as a big pharma hub and significantly accelerate the growth of the sector and of the economy. The city, with its conducive environment is wellpositioned to add value and volume to pharma products.
Therefore, Express Pharma, is organising the maiden edition of the Indore Pharma Summit on August 25, 2023.
Suggested topics
◆ Optimising pharma logistics for excellence
◆ Digital disruption in pharma
◆ Trends and disruptions redefining the pharma landscape
◆ Empowering pharma manufacturing: Driving efficiency and quality
◆ Accelerating innovation in drug development
◆ Regulatory compliance in the digital age
Schott Glass India: Type I is a special designation used in the ISO standards and Pharmacopeia to describe the quality of glass used for pharmaceutical primary packaging. Type I describes the highest quality and is generally recommended to be used for parenteral packaging. According to the definition in the current Pharmacopeia Type I glasses are Borosilicate glasses containing significant amounts of boric oxide, aluminum oxide and alkali and/or alkaline earth oxides. With this composition they offer a high hydrolytic resistance and a high thermal shock resistance. Whether glasses belong to the group of Type I glasses is determined with both the glass grain test and the container surface test, which are described in the pharmacopeia. Both tests evaluate the resistance of the glass against water attack at 121°C. The higher the resistance of the glass is the higher is its quality and the more it is a preferable packaging material.
Schott Glass India : A Type III glass usually is a soda-lime glass with a higher content of Alkali and Alkaline earth metals like Sodium (Na), Potassium (K), Barium (Ba), Calcium (Ca) and Magnesium (Mg). The glass is therefore softer and easier to convert. They have a CTE of higher than 9.0 10-6/K. This makes them more susceptible to thermal shock breakage and they are not recommended to be used for lyophilization processes, as also written in the Ph. Eur. Furthermore, due to its composition it also has a much lower hydrolytic resistance, therefore they are recommended and very well suitable for orals, cosmetics, etc., yet not for parenteral products.
For more information contact: santosh.jadhav@schott.com
the
for professionals in the pharma sector to come together and exchange ideas on the most recent trends,challenges,and opportunities in the industry
Indore Pharma Summit will provide a platform to network,learn,access policymakers, explore business opportunities,and stay up-to-date with the latest industry trends and developments
INTERVIEW
Tell us about the growth opportunities opening up in the pharma sector, globally. How is Novo Nordisk poised to leverage them? What are your current and future areas of focus? Why?
The pharma sector continues to present significant growth opportunities globally. Several factors contribute to this positive outlook, including increasing global healthcare expenditure, population aging, rising chronic diseases, technological advancements, and expanding access to healthcare in emerging markets. Research and Development (R&D) advancements in molecular biology, genomics, proteomics, and other fields are driving innovation in drug discovery and development. Targeted therapies, precision medicine, and personalised treatments are gaining prominence, presenting opportunities for pharma companies to develop novel and more effective drugs.
Today, chronic disorders have gained prominence. At Novo Nordisk, we are dedicated to tackling chronic diseases by driving change in diabetes, obesity, rare diseases- haemophilia, growth hormone deficiency, etc., cardiovascular diseases (CVDs), non-alcoholic steatohepatitis (NASH), and more. We are doing this by raising the innovation bar, harnessing the power of scientific excellence, and developing a leading portfolio of superior treatment solutions.
Can you tell us about Novo Nordisk's priority areas of growth in India in the
Vikrant Shrotriya,CVP& MD,Novo Nordisk India speaks about the growth opportunities in pharma sector and the company’s focus areas in India,in an interaction with Express Pharma
times to come?
Simplifying diabetes care, awareness around obesity and related complications, CVDs and rare diseases like haemophilia continue to be the focus areas for the Indian market. As a leading pharma company in India, Novo Nordisk India is dedicatedly working on three major aspects to shape a holistic healthcare ecosystem for the nation:
◆ Awareness (improved disease awareness and continuous dialogue with healthcare professionals and policymakers),
◆ Access (a bottom-up approach to enable early detection and a statespecific action-oriented approach starting at the grassroot level)
◆ Advancement (R&D and innovation for new and simplified product and therapy development addressing specific patient needs)
How important is India in the company's global strategy? What are the growth plans of the company for the next three years? What is the roadmap to achieve them?
India is a key market for the company’s global plans. In terms of diabetes alone, India houses over 100 million people living with diabetes. 1 This is expected to grow to over 125 million by 2045. 2 Additionally, the number of
people living with obesity in India is likely to be around 160 million by 2030. 3 These figures are alarming and underline the need for robust solutions, tailored to the needs of Indian population.
The company is planning on launching two important products in the coming years-
◆ potentially the world’s first once-weekly basal insulin icodec for type 2 diabetes care
◆ once-weekly injectable for obesity, Wegovy
How has diabetes care advanced? Can you share some key learnings from your expertise in diabetes drug discovery and development?
Over the last 100 years, Novo Nordisk has been part of an advancement journey for diabetes care. Ever since the discovery of insulin, there have been consistent efforts to bring insulin treatment as close to normal physiological levels as possible. Today, we can proudly say that new generation insulins mimic normal physiology to an extent that a person living with diabetes can live a diabetes-free life. Moreover, the introduction of GLP-1 RA in diabetes therapy has brought another significant development in diabetes care. It is important to acknowledge some pressing
unmet needs. These comprise adherence to treatment regimen, initiation of insulin therapy, regular monitoring of glucose levels, fear of needles, etc. At Novo Nordisk, we are working on developing solutions that cater to these needs and help simplify diabetes care for people, without disrupting their lifestyle. In this direction, we are developing revolutionary solutions for type 2 diabetes care-
◆ Insulin Icodec: potentially the world’s first once-weekly basal insulin. It has the potential to reduce treatment burden and to improve adherence via the once-weekly administration.
◆ Cagrisema: a fixed-dose combination investigational drug that combines cagrilintide and semaglutide. In Phase 2 studies, it has shown greater HbA1c reduction compared to semaglutide or cagrilintide alone.
Reference
1. Metabolic noncommunicable disease health report of India: the ICMRINDIAB national crosssectional study (ICMRINDIAB-17) - The Lancet
Diabetes & Endocrinology
2. Facts & figuresInternational Diabetes Federation (idf.org)
3. World Obesity Atlas 2023
Targeted therapies,precision medicine,and personalised treatments are gaining prominence,presenting opportunities for pharma companies to develop novel and more effective drugs
As this will be your first official visit to India following your appointment as the Asia Area Vice President, AstraZeneca what are your plans to grow the India market share?
AstraZeneca is committed to transform healthcare for billions of people. Pioneering science is accelerating our understanding of disease, helping us better predict clinical success, develop and deliver life changing medicines and increase engagement in the clinic and beyond.
We’re building success across our markets and our therapy areas by creating innovative medicines and improving access to them, with the aim of transforming the lives of the greatest number of patients with improved outcomes and a better quality of life. The pandemic showed the power of science, technology and public-private partnerships in driving innovation and we are applying the lessons learned to address future challenges.
India is unique and presents exciting opportunities. We recognise the opportunity to serve growing patient population and contribute to improving healthcare outcomes especially in the noncommunicable disease areas. With a high prevalence of conditions like cancer, diabetes, respiratory problems cardiovascular ailments and rare diseases, we are working with the ecosystem to ensure that we are able to deliver most effective medicines to patients in need. We are building
strategic alliances with government bodies, local healthcare institutions and diagnostic organisations which can help co-create tailored healthcare solutions and improve the overall access to care.
In terms of therapeutic focus areas, what will be the growth drivers for AstraZeneca in a post pandemic world, as revenues from COVID-19 medicines reduce?
COVID-19 has exposed the vulnerabilities of health systems across the world. It has nudged us to adopt more resilient healthcare systems that can help address the underlying challenges such as the rise of non-communicable diseases. While COVID-19 has been a significant focus for us during the pandemic, we are invested in bringing down the burden of some of the biggest healthcare challenges today. Our strategy involves a balanced approach across all therapeutic areas we are present in to address unmet medical needs and deliver value to patients.
AstraZeneca continues to place a high priority on cancer. We continue to invest in research and development to advance therapies for conditions like lung, breast, and ovarian cancers. We have a solid portfolio of cuttingedge oncology medications. We expect considerable growth prospects in this therapeutic field as a result of the rising prevalence of certain diseases and the demand for personalised medical techniques.
Cardiovascular and
respiratory diseases continue to constitute significant worldwide health burdens. Asthma, chronic obstructive pulmonary disease (COPD), and heart failure are a few of the ailments for which AstraZeneca has a longstanding commitment to finding novel solutions. We expect sustainable growth by addressing the unmet requirements of people and healthcare systems in these areas.
Furthermore, globally we are actively pursuing advancements in the fields of immunology, neuroscience, and rare diseases. These areas present opportunities for AstraZeneca to leverage our scientific expertise and develop innovative therapies that can make a meaningful impact on patients' lives.
Additionally, our commitment to people and sustainability and addressing environmental, social, and governance (ESG) issues aligns with the growing focus on holistic patient care. We will continue to integrate inclusive and sustainable practices into our operations and leverage our capabilities to contribute to the overall well-being of patients and communities.
Most of India's population pays for healthcare out of pocket. What are the company's plans to make healthcare more affordable, accessible, and equitable, especially for families impacted by rare diseases? We understand the importance of making healthcare more affordable, accessible, and equitable for
India is unique and presents exciting opportunities.We recognise the opportunity to serve growing patient population and contribute to improving healthcare outcomes especially in the non-communicable disease areas
the Indian population.
AstraZeneca is committed to addressing these challenges through a multi-faceted approach. We strive to enhance accessibility by expanding our patient assistance programmes and leveraging partnerships with local healthcare organisations. These initiatives seek to close the accessibility gap between patients and the medicines they require, particularly for individuals impacted from uncommon diseases.
We continuously invest in research and development to advance scientific knowledge and develop innovative therapies for rare diseases. By expanding our portfolio in this area, we aim to address unmet medical needs and provide new treatment options for
patients.
We actively collaborate with healthcare professionals, researchers, and academic institutions in India to drive clinical trials and research activities with a focus on rare diseases. In addition to these efforts we recognise the importance of digital health technologies in improving healthcare access, particularly in remote areas. AstraZeneca is exploring partnerships and initiatives that leverage technology to enhance patient monitoring, remote consultations, and access to medical information, ultimately making healthcare more accessible and convenient for all.
Ultimately, we want to make sure that every patient can get the healthcare they
require, regardless of socioeconomic status or the rarity of their illness.We remain committed to working with important stakeholders, funding research, and implementing initiatives that drive affordability, accessibility, and equity in healthcare for the Indian population.
How does the company plan to partner with the Government of India to tackle public health pain points?
AstraZeneca is committed to working closely with the Government of India to address issues related to public health and improve access to care. We recognise the importance of publicprivate partnerships in
achieving sustainable healthcare solutions and building resilient healthcare systems and actively seek opportunities to collaborate on various initiatives related to access to care, innovation, upskilling and environment sustainability. Our collaborations with ISHIC (India-Sweden Healthcare Innovation Centre), ‘Skill For Scale’, an e-learning initiative that focused on upskilling primary care providers to equip them with hands on practical training to bridge the knowledge gap that exists in the management of NCDs. At the community level, we have designed programmes that complement government agenda of building mass scale awareness on diseases especially cancer. Through
our Ganga Godavari Programme, we have thus far touched more than 12,000 women and tested them for oral, breast and cervical cancer in many states of the country. Once identified atrisk or positive, beneficiaries are directed to nearest government facilities for further analysis and treatment direction.
AstraZeneca recognises the importance of empowering youth with disease knowledge so that they can make informed decisions about their health. Through our Youth Health Programme (YHP), we are working with adolescents to guide them about the illeffects of tobacco and alcohol so that we can raise awareness about various health issues
affecting youth and provide them with the necessary support and resources to lead healthier lives. By engaging with the government and right stakeholders, we strive to create a positive impact on youth.
These programmes represent a fraction of our broader commitment to collaborating with the Indian government to address pressing public health issues.
AstraZeneca is dedicated to advancing healthcare in India and enhancing the general health and wellbeing of its people by utilising our knowledge, resources, and international network.
As part of a small but growing cohort of women leaders in the pharma sector, what are the initiatives you have implemented to support gender diversity?
I believe it's important to have a strong support system, at AstraZeneca our employees are valued for their diverse experience and thinking as we are committed to creating a diverse and inclusive workplace where all employees can thrive. We empower our people to reach their full potential in a dynamic, inclusive and high performing working environment.
The company's initiatives and policies are helping to create a more equitable environment for women, and they are helping to attract and retain top talent.
◆ Network of Women:
AstraZeneca is passionate about developing a diverse and inclusive workforce, including a commitment to increase the presence of women in our leadership teams. One of the ways we to do this is through our Employee Resource Group (ERG) such as the NOW.
◆ Women as Leaders: The programmehas been designed to help womenin AstraZeneca develop to their full potential in leadership roles. The programme empowerswomenwithin the corporateenvironment
tobuild their ownpersonal brand through increased confidence, develop their ability to identify big picture opportunities,seek advancementby taking on moreresponsibilities and ultimately accelerate careers.
◆ Project iDEA: Encapsulates our commitment to helping gender diverse talent across STEM (Science, Technological, Engineering, Mathematical) to prepare for employment by bridging and engaging with students from
various backgrounds; giving them a glimpse of what we do with science in delivering life changing medicines for patients. This provides a structured development series for their first career, engage to know the career possibilities and exposure to
the pharma industry, thereby attaining experience through a case study-based competition to gain mentorship and internship in AstraZeneca.
Viveka.r@expressindia.com
vivekaroy.3@gmail.com
With an aim of enhancing their footprint on the Indian Subcontinent to become more responsive to the ever changing and evolving needs of the pharma industry,Steriline and INCOME recently announced their union.In an interaction with Express Pharma, Federico Fumagalli ,Commercial Director,Steriline Srl, Vishesh Parekh ,Managing Partner, INCOME and Chiranjeevi Kondapaka ,CEO,Steriline Asia talks about the objectives of this union and motivation behind this decision
Could you provide us with an overview of the union and the motivations behind this decision?
Vishesh Parekh: INCOME and Steriline had been working together since over a quarter century. It is natural that, after such a long association, the bonds which develop go beyond just a simple Agent – Principal relationship and become much deeper and stronger. We have decided to formalise these bonds so that the strengths of both the organisations can be leveraged to move ahead in a much faster manner.
Could you provide some insights into the potential benefits that the union will bring to both companies and the pharma industry as a whole?
Federico Fumagalli: The idea behind any such joining of hands is always to make the resultant is bigger than the sum of the individuals! Each organisation had its own inherent strengths and drawbacks. I believe that the inherent strengths get multiplied and the weaknesses neutralised.
Our customers can certainly expect much better offerings from us in terms of products and services. These will come from a major recruitment drive we are undertaking presently where we are actively looking
for a large number of Software Engineers, Mechanical Engineers, Design Engineers.
Response time to customers are expected to further improve with such a large team
in place. Software support, which used to happen from Italy and was a challenge due to
different time zones will now become a local support.
Overall, I believe, Steriline
Asia will be able to rise not only to, but beyond customer expectations in many ways.
With the merger, what changes can employees and stakeholders expect? Will there be any restructuring or realignment of roles?
Chiranjeevi Kondapaka: they say, the only thing Permanent in Life is Change!
changes are certain to be expected, but I believe these would be positive changes which will lead to growth and development of not only the organisations, but individuals too.
member of a Pan European organisation which will bring in some of the best HR practices followed by them worldwide.
realignment of roles as new team members join in, but this would certainly be for creating value offerings to all stake holders
Looking ahead, what are the long-term goals and aspirations?
Kondapaka: that India has a great potential to become a global hub for
manufacturing and services for almost any sector, with Pharma leading.
Steriline Asia is uniquely positioned to leverage this potential of India and become a proud part of the country’s growth story.
As a first stage, Steriline
Asia shall cater to the service and support needs of all our clients, not only in India but pan Asia. We hope to move ahead and utilise the “soft power” of India to customise softwares and the development of AI for our machines. Design and manufacture, we believe would
follow as a natural step.
Where does India fit into the company's global vision? Any big tie-ups or investments, in the offing?
Fumagalli: I believe the above answers clearly indicate that India is a priority in our Global
ApplicationsforSolid
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Shin-EtsuChemicalTyloseIndiaPvt.Ltd. OfficeNo.B,7thFloor,DBuilding,MBCPark, GhodbunderRoad,Kasarwadavali, Thane(West)-400615India.
Tel.:+912262833001Email:pharmaindia@setylosein.com
Plans. At the moment we have a subsidiary in the USA, but this is just limited to sales and support for our US based customer. Our operations in India are envisaged to grow much beyond supporting local Indian customers as I explained earlier. August
Our customers can certainly expect much better offerings from us in terms of products and services. These will come from a major recruitment drive we are undertaking presently
By Lakshmipriya Nair
The Indian pharma industry is in the midst of a paradigm shift from volume-based to valuedriven strategies. Recognising the significance of this transition, Express Pharma is organising a series of "Pharma Summits" across the country's key pharma centers. These events are strategically designed to unlock new opportunities and navigate the intricacies of this evolving landscape. From cost and competitive pressures to cutting-edge scientific advancements and digital innovations, the summits examine factors driving value in the pharma ecosystem.
The latest in this series, Chandigarh Pharma Summit 2023 was successfully hosted by Express Pharma recently. Under the theme, "Volume to Value Leadership: Opportunities and Challenges for India Pharma Inc”, it provided a platform for industry leaders and game changers to converge and engage in an exchange of ideas, insights, and experiences pertaining to the latest trends, challenges, and opportunities in the pharma sector. It also showcased why Chandigarh, with a conducive business climate, access to skilled manpower, and good infrastructure, presents an opportunity for pharma companies to expand their horizons.
In this article, we delve into the highlights of the Chandigarh Pharma Summit 2023, and showcase the key takeaways and insights from the presentations and discussions at the event.
Chandigarh Pharma Summit 2023 commenced with a very impactful inaugural address by Dr Sanjit Singh Lamba, Managing
Partner, Trillyum Consulting and Advisory.His address shed light on the immense growth potential of India Pharma Inc and emphasised India’s crucial role in the pharmerging markets. To harness this
Future readiness of pharma facilities will be determined by compliance, quality and automation.Digitalisation will enable progress across all these areas
Head-Pharma of Laghu Udyog Bharati and President of the Himachal Drugs Manufacturers Association, delivered a compelling keynote address at the Chandigarh Pharma Summit 2023, offering valuable insights from the regulatory perspective.
In his address, Dr Gupta highlighted the regulatory challenges faced by the pharma industry and emphasised that regulatory compliance plays a vital role in ensuring the safety and efficacy of pharma products. Proper documentation and effective data management were underscored as essential to build and sustain a culture of quality and compliance within the industry.
The session shed light on how disparities in manufacturing practices and varying quality standards, coupled with ineffective documentation and lack of transparency in communication, were hindering the industry's growth. To overcome these hurdles, Dr Gupta advised leaders to collaborate closely with regulatory authorities and proactively address compliance issues. He accentuated that this approach is crucial to maintain trust and credibility among stakeholders.
potential effectively, Dr Lamba stressed the importance of a value-driven approach, which can be achieved through strategic investments, key collaborations, intellectual property creation, and a patient-centric focus.
Dr Lamba also spoke on the significance of a qualityoriented approach, substantial investments in research and development, and fostering an inn ovation- driven mindset for sustained progress in this industry. He also highlighted the impor-
tance of building health infrastructure, skill development, regulatory compliance, diversifying product portfolios to mitigate risks, and promoting training and awareness programmes.
A key message from his address was that leaders need to be open to change and perceive disruptions as opportunities for growth, rather than obstacles. Dr Lamba also advocated the need to instill a culture of continuous learning within organisations to adapt successfully in an ever-changing business landscape.
The central take away from his session was that transformation of Indian pharma companies from a volume-driven approach to value-driven progress requires focus on quality, innovation, collaboration, and specialisation.
Dr Lamba's insights provided guidance for India Pharma Inc's continued success and leadership in the global pharma market.
Dr Rajesh Gupta, All India
During the address, Dr Gupta also brought attention to the issue of non-standard quality (NSQ) products, which have been negatively impacting the industry's global standing. He stressed that regulatory compliance, transparent communication, and strict adherence to guidelines are vital to uphold India Pharma Inc's reputation in the international arena.
Dr Gupta's address served as a reminder for leaders to take proactive measures in aligning with regulations and fostering a culture of quality and transparency to drive the industry's progress and success.
Dr Prahalad Singh Maan,
India will play a significant role in pharmerging markets.But,we need to make strategic investments,grow key partnerships,create more IPand be patient-centric as we strive to become more value-driven
Dr Sanjit Singh Lamba Managing Partner, Trillyum Consulting and Advisory
Dr Prahalad Singh Maan
Global QMS and Quality Compliance Director, Reckitt Benckiser Group
India Pharma Inc needs to document our data better,balance quality and cost,as well as improve continously to enable regulatory compliance and maintain its growth momentum
Dr Rajesh Gupta
All India Head-Pharma, Laghu Udyog Bharati, President - Himachal Drugs Manufacturers Association
Global QMS & Quality Compliance Director at Reckitt, delved into the crucial topic of nurturing quality leadership amidst disruption. Participants gained valuable insights on tackling challenges posed by disruptions and honing effective leadership to elevate quality standards in their organisations.
He pointed out that technological advancements have empowered consumers, granting instant access to expert data with a single click. Consequently, early warning systems play a pivotal role in promptly addressing quality issues, enabling organisations to remain responsive and proactive.
Maan's session also underscored that repeated disruptions can erode the culture of quality in organisations due to shifting priorities, rapid changes, and evolving expectations. To counteract this, quality should be a leadership priority, integrated into decision-making and actions.
A key takeaway from his session was the significance of leaders "walking the talk" on quality, setting powerful examples for their teams and fostering a culture of excellence and continuous improvement. Leaders should also prioritise evaluating and recognising employees' contributions to quality, reinforcing their commitment to maintaining high standards.
Girraj Tripathi, Sr GM, and Site Quality Head at Sun Pharma shed light on the evolving regulatory landscape, stressing the importance of proactive compliance measures. Leaders must prioritise adherence to guidelines, transparent communication with regulatory bodies, and continuous improvement to ensure product safety and efficacy while staying ahead of changing regulations.
The session addressed the
regulatory challenges faced by the pharma industry, including evolving guidelines, complex approv al processes, and global variations in regulations. He said, collaboration
between industry stakeholders, proactive compliance strategies, and leveraging technology for streamlined regulatory submissions and tracking can help overcome
these challenges.
Tripathi emphasised the crucial role of management and leaders in maintaining product quality, compliance, and fostering a culture of ex-
cellence. Data integrity and reliability were highlighted as critical aspects, requiring proper protocols, training, and oversight to safeguard accurate information within
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organisations. The session also emphasised the importance of embracing technological advancements, regulatory harmonisation, and promoting cooperation among regulatory bodies.
The key message conveyed was that the industry must adopt a proactive approach to keep pace with evolving regulatory requirements, and process automation can greatly aid in streamlining compliance efforts.
Embracing innovation in pharma packaging is vital become future
Shivaji Chakraborty, Asst. General Manager, Fresenius Kabi Oncology spoke on the topic, ‘Shaping the new normal of pharma packaging’, which focused on the evolving trends and advancements in pharma packaging.
He identified and elaborated on factors driving the evolution of pharma packaging, including changes in consumer behavior, shifting market dynamics, aging
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Girraj Tripathi Senior General Manager and Site Quality Head, Sun Pharmapopulation, inclusive packaging to cater to diverse demographics, and a growing focus on sustainability. He emphasided that pharma packaging has undergone significant changes to align with shifting market dynamics, and serves various key functions including protection, containment, branding, brand protection and sustainability.
He concluded the session by informing the audience that the future of pharma will be characterised by tamperevident features, authentication measures, and improved communication with consumers. It will also serve as a reminder to promote medication adherence and emphasise sustainability through eco-friendly materials and practices.
An important message from his session was that innovative pharma packaging can meet the changing needs of the industry. Creative packaging solutions can enhance product safety, extend shelf life and improve patient experience.
Products,Value Add),Pharma Packaging and Pharma Technology Review sections.Related photographs and brochures must accompany the information.
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Tamper evidence,inclusivity, sustainability,patient-centricity and authentication will be some of the trends that will drive growth in pharma packaging
Shivaji Chakraborty Asst. General Manager, Fresenius Kabi Oncology
The cost of poor quality and regulatory non-compliance is huge.They cause loss of time,money and reputation. Fostering a culture of quality is key to enable and ensure regulatory compliance
The Chandigarh Pharma Summit 2023 provided valuable insights and learnings on various pivotal topics ranging from regulatory compliance and manufacturing capabilities to product solutions and quality leadership. During the summit, industry professionals exchanged ideas, addressed regulatory hurdles, and explored innovative breakthroughs.
Each session highlighted critical aspects for success in the industry. It also showcased the sector's potential for growth by embracing value-driven strate-
◆ Strategic location: Chandigarh's prime location in North India provides easyaccess to major markets like Delhi,Punjab,Haryana,and Himachal Pradesh,opening doors to increased revenues and market expansion for businesses.
◆ Skilled workforce: Abundant renowned educational institutions in the cityensure a highly skilled and competent workforce.
◆ Business-friendlyenvironment: The government offers attractive subsidies and incentives for the pharma industry,including taxexemptions,land allotments,and capital investment subsidies.
◆ Robust infrastructure: Chandigarh boasts of well-developed transportation, communication,and utilityinfrastructure,streamlining business operations.
◆ Upcoming bulkdrug park: The upcoming bulkdrug parkin Una district,just 126 km from Chandigarh,promises high-qualityrawmaterials and reduced manufacturing costs, providing a competitive edge to pharma companies.
◆ Qualityof life: Chandigarh's modern amenities,excellent healthcare facilities,and green environment make it an attractive destination for talented professionals,making it easier to attract and retain top talent.
challenges, embrace change, and position their organisations for success in the dynamic pharma landscape. It is to be hoped that the event will spur more efforts toward a future defined by value-driven leadership with a focus on research, innovation, and strategic collaborations.
Mark your calendars for the next 'Pharma Summit' by Express Pharma . It will be held on August 25, 2023, in Indore. Leaders will come together again to ensure that India Pharma Inc remains at the forefront of innovation and manufacturing excellence. Stay tuned for more
+919900674407|info@srico-labworld.com|www.srico-labworld.com
The recently hosted Chandigarh Pharma Summit 2023 focused on delivering sessions and presentations tailored to the life sciences industry.This event,organised by Express Pharma, brought together valuable insights into various products and solutions pertinent to the pharma sector.Here is a summary of the presentations at Chandigarh Pharma Summit 2023
Dr Abhijit V Gothoskar, a Formulation Expert from Sigachi Industries, discussed the significance of improving pharma manufacturing capabilities to enhance efficiency, reduce costs, and increase product quality and remain competitive in the market. He also discussed the importance of reducing the number of unit operations in drug manufacturing to enhance productivity.
Dr Gothoskar further delved into the role of multifunctional excipients in boosting productivity, effectiveness, and efficiency throughout drug
Pavankumar Pasupulati highlighted the role of smart manufacturing in achieving sustainable compliance. Adopting digital solutions and paperless processes not only enhance efficiency but also ensure accurate data recording, leading to improved compliance with regulatory requirements. Smart manufacturing can streamline operations and minimise errors, driving operational excellence.
He also made a case for going paperless and elaborated on the advantages of moving away from the use of paper records in favor of completely depending on digital technologies for storage, management,
and analysis of data. He pointed out that going paperless:
◆ Enables a properly validated system
◆ Does not allow deviation
from compliance
◆ Ensures strict adherence to defined workflows or
development and manufacturing processes. He highlighted the advantages of using coprocessed excipients over single excipients, as they offer a range of benefits. Co-processed excipients enable greater functionality, maintain balanced properties, enhance convenience, ensure consistent performance, and adhere to Quality by Design principles.
Dr Gothoskar concluded his presentation with an assurance that Sigachi offers a wide array of co-processed excipients and is a dependable formulation partner for the pharma industry.
guidelines
◆ Avails latest version of templates or procedures for execution
◆ Provides complete traceability and ownership of the activities performed
◆ Offers risk mitigation and built-in controls
◆ Facilitates process harmonization and continual improvement
◆ Allows periodic review of data and refining the process and controls
He emphasised that going the digital route to maintain data will make pharma companies future ready in terms of regulatory requirements, operational efficiency and automation.
Upendra Singh Bisht, Manager-Business Development, Ami Polymer, gave an informative presentation on critical product solutions for the pharma industry at Chandigarh Pharma Summit 2023.
He began by sharing details about his company and its offerings. Further, he shed light on the crucial role that polymer solutions play in pharma manufacturing. He emphasised that different drugs often require specific types of polymer, tubings and hoses to ensure the integrity and efficiency of the production process. He also helped the audience understand the significance of selecting the appropriate materials tailored to the unique characteristics of the drugs being manufactured.
Throughout the presenta-
tion, Bisht also elaborated on the wide-ranging applications of these polymeric tubings and hoses in the life sciences industry and showcased how these components are instrumental in drug formulation. He also explained how the choice of suitable polymeric materials is criti-
cal to meeting stringent industry regulations and ensuring the safety and efficacy of pharmaceutical products. Bisht concluded the presentation by reiterating Ami Polymer's expertise and commitment to providing tailored solutions to the pharma industry.
During the Chandigarh Pharma Summit 2023, one noteworthy technical session was conducted by Matteo Masi, Product Sales Manager from Romaco S.R.L. The focus of his session was on aseptic and ophthalmic filling line and secondary packing solutions.
Matteo Masi's presentation shed light on the latest advancements in filling line and secondary packing technologies, emphasising their critical role in ensuring product safety and maintaining high-quality standards in pharma operations. He also pointed out how these technologies have a significant impact in ensuring compliance with regulatory guidelines. The session demonstrated the importance of investing in such technologies to enhance
safety and quality of products, reduce wastage, and optimise production processes, thereby leading to cost savings and better resource utilisation.
Matteo Masi also touched upon the significance of the new Annexure 1 guideline in the pharma industry. This guideline has made liquid filling processes increasingly signifi-
cant, albeit more complex. Consequently, there is a growing need for specialised filling machines that can meet the strict requirements outlined in Annexure 1. He assured that Romaco can be a reliable partner, providing cutting-edge packaging solutions tailored to the specific needs of the pharma sector.
Neeraj Shukla began his presentation by giving an overview about his organisation, Optel and its track and trace solutions. Then, he went on to discuss the importance of traceability in pharma to ensure product integrity and authenticity, safety, regulatory compliance, sustainability and brand reputation.
Then, he went to elaborate about Optchain, an outcomedriven intelligent supply chain solution suite. He informed that the Optchain platform acts as a supply chain control tower, capturing and connecting granular data along the supply chain to provide greater visibility and transparency. Optchain’s traceability capabilities allow the user to optimise the performance and sustainability of their supply chain while complying with local regulations and international standards.
Apart from offering product identification and tracking for
traceability and compliance, Shukla also informed how the solution enables sustainability by monitoring and providing visibility of the supply chain’s environmental and social impact. He explained how the solution helps with real-time production and supply chain efficiency through better operational intelligence.
The traceability journey begins with smart digital transmission. Invest in the right tools for the right job
ESG has been topping the pharma agenda for some time, but recently, there’s been a step change, with growing momentum.
Individual businesses are moving away from working in silos, adopting a collaborative approach, sharing insights and learnings to benefit from the whole pharma industry’s ESG credentials. Greater emphasis is also being placed on ESG in tender and investment decisions - a cause for optimism.
This new phase in pharma’s ESG journey is an opportunity for the sector to make new inroads towards more sustainable, inclusive and responsible practices. Just as ESG cannot be shouldered by one department in any business, meaningful change will be acceleratediforganisations worktogether and exchangelearnings.
Pharmanovia has long been committed to doing business responsibly.Back in 2021, we set out to formalise our approach to ESG and launched our first sustainability report last year. This included integrating our ESG strategy into our business strategy, applying greater rigor to how we measured our carbon footprint and
setting science-backed stretch targets, challenging us to rethink how we do business.
One year on, our second report shares the results of novel pilot schemes and what we’ve learned so far.
The pharma industry is not historically a strong performer in
terms of sustainability. The sector is a bigger polluter than the automobile industry, estimated to directly generate about 52 mega tonne of CO2 emissions. The operative word here is ‘directly’.
Indirect - Scope 3 – emissions from pharma’s value chains haven’t been factored into this figure and for a nonmanufacturing company like
Pharmanovia, these emissions account for a significant proportion of its carbon footprint.
To put this into context, Scope 3 emissions accounted for 99 per cent of Pharmanovia’s CO2 emissions in 2022. Yet, a recent industry report found just 16 of the 500 pharma companies polled currently measure their entire Scope 3 emissions. Under-
standing your carbon footprint across the supply chain is the first step towards a more sustainable business, but many aren’t accounting for the indirect impact they are having in their measurements.
We believe it’s our responsibility to hold our partners to the high standards we expect of ourselves and to choose to work with responsible, valuealigned third parties.Continual monitoring of third-party progress and commitment to ESG initiatives, must form a significant pillar of pharma’s ESG strategy. Holding partners accountable for how they conduct business and helping those falling behind to develop plans for improvement, offers pharma an opportunity to influence meaningful change.
After measuring our Scope 3 emissions in 2021, we recognised that global transportation was having one of the biggest impacts on our carbon footprint, so we challenged ourselves with mapping out a pathway to manage these emissions.
Neeshe Williams,General Counsel and Head of ESG at Pharmanovia opines that the pharma industry has renewed its focus on sustainability and this new phase in pharma’s ESG journey is an opportunity for the sector to make new inroads towards more sustainable,inclusive and responsible practices
Last year, we launched a pilot programme to understand the impact transitioning from air to sea freight could have, focussing on our Spain-to-Australia freight route.
The pilot successfully avoided an estimated 470,000kg in potential CO2 emissions in 2022, equating to an 18 per cent reduction in our Scope 3 upstream transport emissions.
The innovative pilot not only delivered benefits in terms of carbon, but in waste and cost reduction, too.
Air freight is reportedly responsible for up to 80 per cent of all temperature excursions in the pharma industry, requiring medicines to be destroyed. During our pilot, no sea shipments experienced temperature excursions, thus reducing waste.
The transition also presented the opportunity for us to
re-evaluate the expiry period of our medicines. Following testing, we were able to successfully increase the shelf-life of some products, once again mitigating and reducing waste, all while continuing to serve patients around the world. We have now made a landmark pledge to divert 40 per cent of our air shipments to sea in 2023, and 75 per cent by the end of 2028.
Employees have the power to drive change
Sustainability shouldn’t be something we just talk about but something that we do. According to the World Economic Forum employees play a vital role as advocates and enablers of ESG strategies.
To engage our people with our strategy, we wrote ESG goals into employees’annual performance objectives, with every-
one across our global officestied to ESG targets. This was an important move to encourage proactivity and ensure a sustainable lens was applied to our dayto-day work. We also have four employee groups designed to drive new initiatives in support of our ESG goals.
We can confidently say that we have seen first-hand how empowering employees can lead to great strides. Employees
achieved a 98 per cent completion rate of compliance training, which included ESG modules.
It’s an approach that we will continue to adopt with new targets set for all employees each year.
The climate crisis is often badged as the challenge of our time and Pharmanovia has made rising to this challenge and sharing learnings its mission. The health of the planet is intrinsically linked to the health of its citizens, which is why baking ESG into every layer of our business is so important to us.
The strategies we have piloted have yielded great success, defining novel pathstowards a more sustainable sector.This is not box ticking exercise though and there’s far more to be done. In the spirit of striving for continual improvement, we now look forward to new ambitious targetsand working with our partnersto deliver a healthier planet.
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We launched a pilot programme to understand the impact transitioning from air to sea freight could have,focussing on our Spain-to-Australia freight route.The pilot successfully avoided an estimated 470,000kg in potential CO2 emissions in 2022, equating to an 18 per cent reduction in our Scope 3 upstream transport emissions
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“Pharmaceuticals and life sciences industries have been complying with so many regulatory guidelines that at some point, tasks become mechanical. There is a lack of motivation and intent. In such scenarios, even if the guidelines are met precisely, are we justifying the big picture – safeguarding human well-being?”
APQR (Annual Product Quality Review), a resonating term in the pharmaceutical industry originated in the ’70s. First proposed on February 13, 1976[1], APQR initially faced objections across the industry as companies refrained from preparing written summaries for each product. FDA, after considering the views of numerous industry experts published the requirement as final current good manufacturing practices (cGMP) regulations for drug products under 21 CFR 211.180(e).
APQRs assess the quality standard of drugs and the consistency of manufacturing processes while also ensuring the appropriateness of prescribed specifications and establishing control procedures. According to FDA, the preparation of these review reports must be an annual affair so that drug manufacturers identify the trends and need for any changes required during the manufacturing process.
As everyday tasks often become routine, they lose their essence.
The same is true for the APQR process too. As it is an annual requirement, every company that comes under scrutiny deploys a team specialized in the process. This sometimes involves assigning team members from crucial departments. Transitioning tasks demand a change of focus and time to adapt to the process.
Once things are settled, the team begins the actual job of
preparing the annual product quality report. Since this is an annual process, it has a predefined set of tasks levelled down to get the desired review report in a prescribed format. However, is only pushing the data into a format enough to derive value out of the report? Obviously, the answer is NO.
APQR is a concept that presents an organization’s commitment to quality in all its manufacturing operations. It needs to be understood in terms of the value it is going to deliver to the industry. Mechanically pulling out data and feeding it into the formats is a trivial thing to do.
Nowadays life sciences and pharma organizations have generously accepted the digitalization trend. Realizing its benefits and vitality in today’s competitive era, companies have begun to automate their APQR processes. However, the ques-
tion remains – Is Compiling an APQR enough?
Although APQR software automates the entire process, which really saves time and maintains accuracy throughout, it isn’t contributing to the bigger picture. Let’s try and understand the essence behind APQRs.
◆ The core aspect: If we think of APQR as a concept, it might have definitely arisen from a perspective– a perspective of creating a way to provide an uncompromised system that aims at keeping a check on the consistency of drug products manufactured.
◆ AGILITY: Times and technology are changing fast. APQRs must possess the agility to quickly adapt to these changes.
◆ FLEXIBILITY: Every organization operates differently and has different organizational structures. APQRs must allow
for functional flexibility for user convenience.
◆ ACCURACY: Data is the foundation of an APQR, and it undeniably should be accurate. The system must empower organizations with correct data to ensure integrity in reports.
◆ ACCESSIBILITY: Today everything needs to be instant. However, APQR is usually an annual affair. This still has a possibility of compromising on the consistency of processes. As the review is annual, year-long manufacturing and the products can suffer a delayed notice of deviations or inconsistencies. The APQR must also be instantly available for a quick glance.
◆ ACCOUNTABILITY: A process holds worth only when it is accountable for its performance. APQR is a critical process and must be entirely accountable for all the efforts and time
that go into its preparation.
If you are still wondering whether there is an APQR that fulfills all of the missing elements, the answer is affirmative! CaliberAPQR is a revolutionary product and the first of its kind in the industry. Defying all the odds and setting new horizons for the regulated industry, CaliberAPQR brings immense possibilities to add value to the mandatory ritual of preparing APQRs. It rightly transforms the way these review reports have been generated until now. The APQR system promotes agility, flexibility, accuracy, accessibility, and accountability.
CaliberAPQR –
◆ Reduces months’ efforts to a single click
◆ Enhances traceability
◆ Displays trends instantly
◆ Analyses data aptly
◆ Provides statistical calculations
◆ Promotes ANYTIME feature
◆ Includes attachments for ready reference
“Quality Review Can Never Be Routine, It is a Culture That You Build.”
We need to think beyond marking all items in the dossier. In the life sciences and pharmaceuticals, quality has a distinct nature. It is a concept and has a focused perspective behind it. When an APQR meets convenience and usability, it is worth all the effort and adds more value to the entire process.
CaliberAPQR is a powerful entrant in this sector and is already taking the industry by storm. It is developed for valuedriven, technically-sound enterprises of tomorrow. It is time we rethink our quality reports with a quality mindset. Afterall, APQR is meant to be a constructive review process!
APQR is a concept that presents an organization’s commitment to quality in all its manufacturing operations.It needs to be understood in terms of the value it is going to deliver to the industry
Cellulose, a natural polymer found abundantly in plant cell walls, has found diverse applications across various industries. In pharmaceuticals, powdered cellulose has emerged as a versatile and essential ingredient, revolutionising drug formulations and manufacturing processes. This article explores the various properties of ARBOCEL® (Powdered cellulose, Ph Eur / NF / JP/ E460 (ii) / FCC), offered by JRS Pharma in the pharmaceutical industry and highlights its key benefits and applications.
Manufacturing process
ARBOCEL® is manufactured by the purification and mechanical size reduction of acellulose obtained as a pulp from fibrous plant materials. [3]
Biocompatibility
ARBOCEL® is considered as safe and biocompatible, making it an ideal choice for pharmaceutical applications. It is non-toxic and does not interact with the body's physiological processes, ensuring patient safety. Powdered cellulose is widely used in oral pharmaceutical formulations and food products and is regarded as a nontoxic and nonirritant material. It is not absorbed systemically following oral administration and thus has little toxic potential. [3]
Chemically inert
ARBOCEL® is chemically inert and hence is not metabolized by the human body. As ARBOCEL® is not digested, it has no functional caloric value.[3]
Low moisture absorption
In the dry form, it absorbs lesser amount of moisture, when compared to other diluents. This low moisture absorption assures better shelf life, especially with moisture sensitive active ingredients in pharmaceuticals. [3]
Versatility
ARBOCEL® fibers come in different forms, including fine powders and granules, making them versatile for use in diverse manufacturing processes and products. It finds applications in a wide array of industries, including food, pharmaceuticals, cosmetics, and industrial manufacturing. [3]
Eco-friendly and sustainable
One of the appealing aspects of ARBOCEL® is its eco-friendliness. Being sourced from renewable plant-based materials, it reduces the carbon footprint and contributes to a more sustainable future. Moreover, its biodegradability ensures that it will not linger in the environment for extended periods, fur-
good binding properties, ARBOCEL® grades are used as fillers in oral formulations like tablets and capsules. Due to finer particle size, ARBOCEL® M80 and ARBOCEL® P290 are suitable for wet / dry granulations, while ARBOCEL® P290 and ARBOCEL® A300 can be used in dry mixing and extragranular applications because of improved flow characteristics. Excellent flow and low dusting improves handling and weight uniformity in capsule formulations. It can also be used as a filler in sachet formulations and dry syrups. It is commonly used as an alternative to lactose, when the target population is lactose-intolerant patients. [1][3]
Famotidine dry suspension is one of such formulation.[6]
◆ Food applications: Powdered cellulose is also widely used in food products in various applications. Its ability to absorb moisture and coat ingredients in a fine powder makes it the perfect additive for anti-caking applications. Shredded and grated cheeses, powdered drink mixes and spice mixes are some of the examples.
Because cellulose binds and mixes easily with water, it is often added to increase the fibre content of drinks and other liquid items when the gritty texture of regular fibre would be undesirable.
Typical properties and benefits
Natural
◆ Extracted from wood source / No animal origin /
Vegan
◆ During manufacturing process, no organic solvent is used
◆ No allergens
◆ Biodegradable
◆ Clean label-friendly
◆ Recognized as GRAS [1][3]
Swelling properties
Another notable feature of ARBOCEL® is its impressive absorbent capabilities. In the food and cosmetic sectors, it can be used in products like animal feed and facial masks, thanks to its ability to absorb liquids effectively. This property makes it an asset in various personal care and food applications.
ther reducing its impact on the planet.
Physical parameters
ARBOCEL® is available in various grades, bifurcated based on PSD and other physical attributes [3]
Applications
◆ Filler/Diluent: Because of their fibrous structure and
◆ Oily suspension: Due to its fine PSD and higher surface area, ARBOCEL® M80 may be used to reduce the sedimentation rate of oily suspension. This property can be explored to decrease the sedimentation in oily fills in soft-gel capsules and in oil based oral suspensions as well. It may also be used as suspending agent during the processing of suppositories. [1]
◆ Aqueous suspension: It is also used as a suspending agent in aqueous suspensions for oral delivery. It helps to form flocculated suspension which is easily re-dispersed upon shaking. [1] Amongst the grades, ARBOCEL® M80 is most suitable due to its fine PSD and higher surface area.
Cellulose has become a popular bulking agent in diet foods. Because it is indigestible to humans, it has no caloric value. Eating foods with high cellulose content allows dieters to feel full without consuming too many calories.[2]
◆ Animal food: ARBOCEL® is used as a part of food for livestock and other pet animals to improve digestion and gut health.
Summary
ARBOCEL® is a highly versatile and eco-friendly material that offers numerous benefits across various industries. Its sustainable nature, coupled with its ability to enhance product quality and safety, makes it an attractive choice for manufacturers and
ARBOCEL®,powdered cellulose,offered by JRS Pharma is a highly versatile and eco-friendly material that enhances product quality and safety and presents a promising solution to reduce environmental impact and promote a more sustainable future in the pharma industryImage 1: Manufacturing process of ARBOCEL® [3]
consumers alike. As a renewable resource, ARBOCEL® presents a promising solution to reduce environmental impact and promote a more sustainable future.
[1] Sheskey P.J., Cook W.G., Cable C.G. (2017) Handbook of Phar-
maceutical Excipients, 8th edition, Pharmaceutical Press, 201203.
[2] How Cellulose Is Used in Food (thespruceeats.com)
(https://www.thespruceeats.com
/what-is-cellulose-1328464)
[3] Arbocel_GB (jrspharma.com)
(https://www.jrspharma.com/ph arma-
wAssets/docs/brochures/br-arbocel.pdf)
[4] JRS Pharma Media Library
(https://www.jrspharma.com/ph arma_en/media-library/)
[5] United States Pharmacopoeia, USP 43-NF 38 (2019).
[6] DailyMed (nih.gov) (https://dailymed.nlm.nih.gov/d ailymed/)
Author Krishnakumar Patel Technical Services – Pharma JRS Pharma, India Krishna.Patel@jrsindia.com
Eppendorf has introduced Centrifuge 5427 R – the first Eppendorf microcentrifuge with hydrocarbon cooling to contribute to an even more sustainable laboratory environment. With this offering, customers can now perform various molecular and cell biology applications while using a refrigerated device that contains a natural cooling agent with a GWP of almost zero. To protect your samples – and the planet.
Natural cooling agents, like R290 (propane), have a similarly low global warming potential (GWP) as CO2 (<3), while conventional refrigerants such as R134a have a GWP of 1430 and thus have a disproportionately greater im-
pact on global warming when released into the environment.
The ACT label certification of Centrifuge 5427 R makes it even easier for customers to choose a more sustainable product, since this label gives a clear, third-party verified information about its environ-
mental impact (e.g. manufacturing, energy and water usage as well as packaging and product end-of-life).
However, the new Centrifuge 5427 R scores not only with its reliable propane cooling: Due to its compact footprint and the dual-row rotor
FA-45-48-11 for up to 48 x 1.5/2 mL tubes, it is the optimal solution for laboratories with a high sample throughput. Due to its large rotor selection, it is also a good choice for areas where many users share the instrument: the nine rotor options, consisting of fixed-angle
and swing-bucket rotors, cover a wide range of applications in the field of molecular and cell biology.
More information about the Centrifuge 5427 R can be found at https://eppendorf.group /5427R
Customers can now perform various molecular and cell biology applications while using a refrigerated device that contains a natural cooling agent with a GWPof almost zero.To protect your samples – and the planet
The ACTlabel certification of Centrifuge 5427 R makes it even easier for customers to choose a more sustainable product,since this label gives a clear,thirdparty verified information about its environmental impactImage 3.1: SEM image of ARBOCEL® M80 [4] Image 3.2: SEM image of ARBOCEL® P290 [4] Image 3.3: SEM image of ARBOCEL® A300 [4]
Due to the crucial necessity and its direct impact on human health and welfare, pharma is probably the most important and critical sector among others. As a consequence of which, it becomes essential to store 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.
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. Testodata loggers can be used to test the optimum conditions for specific products or surroundings. Temperature and humidity data loggers are often used in pharma industries to monitor the conditions in which drugs, medicines, vaccines are kept. Not only storage, but during the transit of goods, testo transport data loggers are useful to measure the transport conditions. The range of data loggers is very extensive. A temperature and humidity logger such as 174 T guarantees continuous monitoring in a storage or warehouse. Also, data loggers with multi channels for connecting external sensors and thermocouples, like testo 176 are
available for ensuring secured work process in labs. These data loggers are also critical for production quality assurance where the temperature has to be frequently checked at various points in production processes. Using thermocouple probes, data loggers can also record data in the kinds of extreme temperature ranges. The probe's fast response also contributes in the validation processes and quality standard optimisation in QA units and clean room applications. These instruments are the most con-
venient and pocket friendly solution for all pharma application areas.
The testo Saveris 2 WiFi data logger system is the simple, flexible and reliable solution to humidity and temperature monitoring in cold storage area like blood banks. This innovative monitoring system is ideal for high product quality and eliminates manual work of reading out or documenting measurement data. With a secure online storage of all readings in Testo Cloud the data can be managed and analysed online by the user
via smartphone, 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 the pharma industry involvesvalidation 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.
Testo offerings are majorly related to the data security along with comprehensive analysis and evaluation of all the recorded measurement data.
Testo data loggers ensure continuous monitoring of temperature and relative humidity of pharma products during production, storage or transit of goods. Real time data monitoring is important for the quality of pharma goods and also enables the supplier to improve the life of the goods. Transportation trucks, warehouses, cold rooms etc. can now be remotely monitored via Testo 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.
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 (InfraRed Thermometer, Thermal Imager). In fact, it is the first and only lab in India to get NABL accreditation forDew Point Temperature as well.
For more details, login to our website www.testo.com or write back to us on info@testo.in
The 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
Gandhi Rolling Shutters are ideal for situations where side room is at a premium and security is required.Their strength,elegance,durability and other salient features are designed for both external and internal applications
Rolling shutters have always been considered as one of the most dependable addition to any building due to its safety, durability, maintenance and ease of operation. Along with safety and other mentioned features to the building, it also provides optimal privacy without compromising the aesthetic appeal of the property.
Modern rolling shutters are outperforming the traditional doors and erstwhile prototype rolling shutter option. This is due to its innovative designs, handiness and material strength which are far better than its earlier roller shutter models. Gandhi Rolling Shutters are ideal for situations where side room is at a premium and security is required. They require very little headroom above the structural opening. Their strength, elegance, durability and other salient features are designed for both external and internal applications.
Gandhi Rolling Shutters are fabricated of interlocking galvanised insulated and non-insulated profile, stainless steel profile, patented aluminum profiles and patented MS rolling grills.
Gandhi Automations, India’s No. 1 Entrance Automation & Loading Bay Equipment Company, is the only manufacturer of Rolling Shutters certified to ISO 9001: 2015, ISO 14001: 2015, ISO 45001: 2018 quality management system. This has resulted in the implementation of continuous improvement in personnel training, production technique, inspection, equipment calibration, machinery maintenance, logistics and customer relations. The product engineering team uses the latest software combined with technologically advanced machinery to offer to the customer a well-engineered product.
Over years of meticulously working on the design, fabrication and installation, Gandhi Automations has developed tech-
nical expertise in manufacturing various kinds of Automated Rolling Shutters. The Research and Development team with its extensive know-how and experience are able to produce specific types of Rolling Shutters unique to certain sites and client requirements. A consistent qual-
ity product has thus become the hallmark of Gandhi Automations' manufacturing process right through installation to after-sales service.
Each of Gandhi Automations’ Rolling Shutters are designed to client's specifications and solidly constructed to pro-
mote trouble-free operation and long life. All Rolling Shutters are automatic using vigorous drive expertise with manual override in case of power failure and are dense, noiseless and dependable.
For further details contact:
Gandhi Automations Pvt Ltd
Chawda Commercial Centre Link Road, Malad (W)
Mumbai – 400064, India
Off: +91 22 66720200/66720300
(200 lines)
Fax : +91 22 66720201
Email: sales@geapl.co.in
Website: www.geapl.co.in
IND256x’s design assures safety while reducing cost of maintenance by up to 60 per cent thus giving a boost to your equipment availability and operational efficiency
IND256x offers an economical and versatile weighing solution for classified areas thanks to its reliable, intrinsically safe design. With a built-in wireless option and integrated power supply or external battery, it reduces installation costs and gives you the freedom to adjust your workflow on demand.
IND256x is globally approved for hazardous areas according to IECEx and ATEX standards for intrinsic safety, providing the same user-friendly look, feel and ease of operation as safe-area terminals. It is designed to operate safely in Zone 1/21 environments where explosive gases or dusts are present.
The built-in power supply and communication interfaces make installation and system integration fast and convenient. Due to this integrated design, floor space is better utilised and maintenance activities are simplified. Compared to alternative protection methods, intrinsically safe design reduces downtime
from maintenance cycles or equipment breakdowns significantly.
IND256x is globally approved for hazardous areas according to IECEx and ATEXstandards for intrinsic safety,providing the same user-friendly look,feel and ease of operation as safe-area terminals
proof solutions is time intensive due to required disassembly and assembly of large and bulky enclosures. All service procedures for Ex or flameproof equipment must be followed meticulously; nevertheless, these are difficult tasks prone to error. IND256x’s design assures safety while reducing cost of maintenance by up to 60% thus giving a boost to your equipment availability and operational efficiency
More mobilityin your ex-area with the IND256x
Terminal
Wireless communication
Maintenance of explosion-
The Wi-Fi module simplifies communication in fixed installations by eliminating cabling that adds cost to installation and maintenance.
In addition, improper cable routing can be a safety risk. IND256x eliminates these issues for increased cost effectiveness and safety.
Battery powered
The Wi-Fi module option and external battery allow for complete mobile applications in hazardous areas giving you the freedom to adjust your workflow on demand. Increased flexibility in configurations allows easier adaptation to local site preferences.
For more information, contact Website: www.mt.com/IND256x
Toll Free: 1800 22 8884 / 1800 10 28460
Email: sales.sales@mt.com
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
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.
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
strict regulations imposed by European Health bodies.
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
a=samplesfromclass100environmentsshouldnormallyyieldno microbiologicalcontaminants
ADVANTAGES
#Eco- friendly- It is totallybiodegradable 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
#Excellentlyrinseable with no remains
PROPERTIES
#Can easilybe dosed
# Does not foam
# Decomposes into water and oxygen
# It is excellentlyrinseable with no remains
# Treats anyother material with consideration
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 is one of the most
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.
Eco-friendly,Non-toxic
Room gets sterilized within 1 hour after fumigation
Requires no de-fumigation
Person can be present during fumigation
Highlytoxic
Requires overnight fumigation
Requires de-fumigation
Causes skin,eye irritation even after next dayof fumigation
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,
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.
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.
