Vol -15 / Issue - 1 / April - May 2020
bimonthly update on quality movement ...
A Great Opportunity INDIAN PHARMA 2020-2030
Webinars on Covid-19 Challenges During and after COVID-19 lockdown The New Normal for Pharma Regulatory Tips for Pharma Professionals Exclusive by GURMEET SINGH, Director, Pharma Networks
Vol - 15 Issue - 1
April - May 2020 PUBLISHER & EDITOR
machines & technology
Harjit Singh Dhaul Editorial Office Global Vision 26-B, Rebellow Cottage, Gaon Devi Road, Poinsur (E), Kandivli 400 101 E-mail:email@example.com Advertisement/Circulation/ Subscription enquiries: Tel: 28701520 Fax: 28701848 Mobile: +91 93 24 577012 E-mail:firstname.lastname@example.org Website: www.pharmamachines.com All rights reserved. Reproduction in any manner is prohibited. PHARMA Machines & Technology takes no responsibility for validity of claims in advertisement and articles published. Printed & Published by Harjit Singh Dhaul on behalf of Global Vision and printed at Hariom Printers C/70, Akurli Industrial Estate, Akurli Road, Kandivali East, Mumbai 400 101, and published at 26-B, Rebellow Cottage, Gaon Devi Road, Poinsur (E), Kandivli 400 101. Editor: Harjit Singh Dhaul. DEPUTY EDITOR
Byju Bhaskaran EDITORIAL ASSISTANT
DEAR PHARMA PALS: Covid-19 is a new challenge to the mankind. It's very unfortunate and unexpected. Nobody has ever seen something of this scale at least in our lifetimes. This is easily the worst of all the disasters that have ever happened in the world. Besides affecting almost all humans and their activities across the world, this pandemic has hit almost all industries.
Indian pharmaceutical industry is facing an unprecedented situation. This is a unique challenge, and it calls for unique solutions to manage. This pandemic is going to change everything â&#x20AC;&#x201C; the way we look at things, the marketing, the manufacturing, handling of materials, staff and everything. Since the government has enlisted pharmaceutical manufacturing as an essential service, we need to act swiftly and promptly to ensure continuity of medical supplies to avoid drug shortages. At the same time, we have to ensure the safety of the workforce in the manufacturing facilities. It's absolutely critical! Now this pandemic has clearly shown as to how the entire world is dependent on India and why we are called pharmacy of the world. India has now definitely become a focus country when it comes to the new development and the supply of existing drugs. Another thing which is coming up during this pandemic is that we need to finish our dependency for raw material imports from China. We need to come up, and we need to have our own pharmaceutical API industry. Covid-19 has taught us a lot of things, both on the personal level and as an industry. We now know what working from home really means. The industry has learned that automation and digitalization will be the way of work for the future. There will be lot of changes in the way we are working. This issue of Pharma Machines & Technology is also unique in all respects, starting from a new masthead. It's a complete Covid-19 impact issue, with industry experts extensively discussing the challenges and opportunities. Stay safe, stay updated! Harjit Singh Dhaul
IMPACT Publisher & Editor
During & After COVID-19 The New Normal for Pharma Regulatory 56
A Great Opportunity
Preparedness tips for pharma regulatory 59 professionals
INDIAN PHARMA 2020-2030 Exclusive by Gurmeet Singh, Director, Pharma Networks
Abhishek Sinha, Head Regulatory, Advanz Pharma
Time to Collaborate, Co-operate and Innovate Joining hands to mitigate challenges Indian pharma and technology leaders discuss Covid-19 challenges at webinars organised by Messe Muenchen India and IPMMA.
Dr. Prasanna Bangale, Vice President & Head Global Regulatory Affairs, Alembic
Pharma regulatory experts speak, on invitation from Informa Markets in the run-up to 9th edition of Global Pharma Regulatory Summit.
Regulars DID YOU KNOW? 8
CO IM VID-1 PA 9 CT
Facts & Figures
DID YOU KNOW? In the past month, several Indian companies received FDA approvals for plants after waiting for several months. Lupin and Dr Reddy's got approvals for large manufacturing facilities in Pithampur and Srikakulam last month. Biocon's novel biologic Itolizumab has shown encouraging results for treating some Covid-19 related conditions. Itolizumab, a drug used to treat psoriasis was commercialized in India in 2013. AIIMS Bhopal claims good results in trials of the drug Mycobacterium W (Mw) conducted on COVID-19 patients. Gilead Sciences has signed voluntary patent licensing agreements with four Indian pharma companies, giving rights to manufacture and sell the drug Remdesivir to 127 countries. Remdesivir is presently considered the most promising candidate for the treatment of COVID-19. Treating COVID-19 patients with the malaria drug hydroxychloroquine (HCQ) had no positive effect and caused other health complications, said two new studies in France and China. As part of WHO's Solidarity trial, Indian will evaluate potential anti-viral agents remdesivir, chloroquine/hydroxychloroquine, lopinavir-ritonavir and lopinavir-ritonavir with interferon. Glenmark Pharmaceuticals became the first company in India to initiate Phase 3 clinical trials on antiviral drug Favipiravir to check its efficacy on COVID-19 patients. Favipiravir, which is a generic version of Japan-based Fujifilm Toyama Chemical's Avigan, has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. Goa-based Molbio Diagnostics' device called Truenat is set to become one of the key diagnostic tools for Covid-19. Tocilizumab, a biological drug, is among the most keenly considered repurposed drugs that are likely to help in the fight against Covid-19. Bhagawati Products that produces gadgets under Micromax brand has entered into an agreement with TWorks, a Telangana government initiative, to manufacture the mechanical ventilators. TVS group, Sundaram Medical Foundation and IIT-Madras have jointly developed a lowcost, automated respiratory assist device called The Sundaram Ventago.
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INDIAN PHARMA 2020-2030
A Great Opportunity Indian pharmaceutical industry aspires to become the world's largest supplier of drugs by 2030. India aims to increase its industry revenue to $120 billion-$130 billion by 2030 from current revenue of $38 billion at a CAGR of 11-12%. Of course, the current decade is for the Indian Pharma and related industries and offers a big opportunity which must be grabbed with both the hands and let this opportunity not slip away.
es, all this will require an effective and efficient cooperation between the Indian Pharma and backed with the much-needed support of the government in policy matters and regulations, etc.
Covid 19 and the fallout The world is seeing the not so good behaviour of China in the recent months initially covering the situation on epidemic spread and later in not sharing information. It is well known that sharing the information at the right time could have saved precious lives across the globe and also saved the global economies and other related aspects. Even now, the world is witnessing that the weird mindset of the power few at the top in China as we see that China is selling the Covid related equipment and other essentials at a commercial advantage for the stuff that they received as medical aid a few weeks back (as reported by media)â&#x20AC;Ś This is simply not acceptable morally and ethically and therefore, that may spell 'advantage India'â&#x20AC;Ś
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Exclusive by GURMEET SINGH, Director, Pharma Networks
The current events will certainly see lot of manufacturing going back to the west as the west have realised that they lost out both on manufacturing jobs and concerns on the quality aspects from time to time for the products from China. This I would term as 'reverse swing' where for long the west depended a lot on China and also that they themselves were not in a position to meet the COGS- cost effectiveness of the China offerings and slowly but surely we saw the manufacturing plants in Europe and US closing down as they were rendered cost ineffective.
In the ensuing circumstances India should rise to the situation by capturing the opportunity, and for all this the Indian government should come out all guns blazing and work hand in hand with the pharma industry to effectively and efficiently support the industries which are inter-linked to the pharma sector. The industry players thought that the situation will ease and get back to normal once the Olympics would be over and yes, to some extent it came down but we chose not to see the writing on the wall which was clear as we went for the ostrich approach instead.
tainly does not auger well of a mature and responsible superpower at such a time of global epidemic. In the ensuing circumstances India should rise to the situation by capturing the opportunity and for all this the Indian government should come out all guns blazing and work hand in hand with the pharma industry to effectively and efficiently support the following industries which are interlinked to the pharma sector.
However, we have recently seen that the drug major Sanofi has plans to create a major leading European company dedicated to the production and marketing to third parties of active pharmaceutical ingredients (API).
We have also seen a sharp price rise on some of the Covid19 essential raw materials for the APIs – Bulk Actives which the world depends on China and this cer-
India too made a mistake where the Indian pharma kept on procuring the intermediates across the board including the ones which were polluting in nature from China at quite cost effective prices and did the last step conversion in the plants in India. The first time India got a jolt in this respect was at the time of Beijing Olympics 2008, where a large number of intermediates companies were closed suddenly under the Chinese government dictate and we in India found itself without the key input raw materials and if they got from alternate sources within China, the same came at astronomical prices.
within India Ÿ Scale – The importance of Scale to meet the competition globally Ÿ Green Chemistry and Enzymatic Processes Ÿ High Potency Active Pharmaceutical Ingredient (HPAPI) Ÿ Biotech and Biosimilars Ÿ Complex Generics development Ÿ Basic Chemicals, Building Blocks and Fermentation Capacities Ÿ Enhanced Patenting and IP protection - must for attracting the Big Pharma Ÿ Centralized Services – effluent treatment and Testing Laboratories Ÿ CGMP Compliance, Data Integrity Ÿ Enhance the Medical, Pharmacy and Nursing educational institutes with PPP Ÿ Vaccine development and enhanced investment therein
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Indian Pharma Industry includes the following verticals: Ÿ Contract Manufacturing, CRAMS and Clinical Trials Ÿ API and KSMs – the starting Raw Materials – end to end
April - May 2020
Ÿ Cold storage – warehousing – last mile product integrity and dispensing Ÿ E-pharmacy – quantum growth possible - firm up governing laws Ÿ RFID – track and trace: problem of fake medicines Ÿ Much needed JVs with the best globally – revive IDPL kind?
Contract Manufacturing, CRAMS and Clinical Trials Several overseas companies have been outsourcing research and clinical trials to Indian companies and some have entered into collaborative R&D arrangements to supplement their R&D productivity. Many foreign companies have also already initiated research on neglected diseases. Even the DNDi – Drugs for Neglected Diseases initiative – a Geneva based R&D Organization has been looking for Indian CDMOs to partner them for taking their R&D projects to commercial levels.
der the current situation where we will see some of the businesses making a shift from other countries in Asia to India as we progress from hereon. This will further gain momentum as the patent regime in India has already strengthened and will become still stronger as we proceed. This will enable the companies in the west to capitalise on the cost savings to be gained from shifting some research activities to India, without jeopardising their most valuable intellectual property.
API and KSMs – the starting Raw Materials – end to end within India
There is a lot of comfort MNCs in the west have while discussing the collaboration with sourcing these activities with Indian companies and all this has been based on performance, cost competitiveness and timely deliverables by the Indian CDMOs and also in the space of clinical trials.
during 1995 – 2005. However, the subsequent period saw There is a lot of comfort MNCs Indian pharma slackening their in the west have while discussing approach for falling prey to low India largely depends on China the collaboration with sourcing cost input raw materials from for its API needs at present, howthese activities with Indian comChina and also the Indian comever, the current crisis has panies and all this has been panies found an easy pathway to opened a window of opportunity based on performance, cost comexit the manufacturing of highly for the Indian drug manufacturpetitiveness and timely deliverpolluting KSMs or Intermediates ers to diversify their supply ables by the Indian CDMOs and thereby making a grave mistake chains and to rely more on doalso in the space of Clinical to increase their dependence on mestic suppliers which is a posiTrials. inputs from China. This needs to tive development in the longer be corrected on immediate basis This was amply observed when I term for the entire sector. to ensure that end to end soluwas associated with a German India has substantial technical cations are available within the based organisation which had country for reasons of selflarge number of pharma projects pability for reverse engineering which saw a mushroom growth dependant and cost competitivethat were being out-sourced of pharma companies in India ness in the long-run. World has from Indian pharma companies. The trend will further increase un- during the window of opportunity seen recently how profiteering
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India largely depends on China for its API needs at present, however, the current crisis has opened a window of opportunity for the Indian drug manufacturers to diversify their supply chains and to rely more on domestic suppliers which is a positive development in the longer term for the entire sector. was resorted to by some countries in the face of pandemic which is the last thing expected of matured nations i.e to make money at the cost of someone's misery.
Scale â&#x20AC;&#x201C; the importance of Scale to meet the competition globally Scale is something which is a must to effectively compete in the world, if we are to be seen as a Pharmacy to the Worldâ&#x20AC;Ś India can never be seen as a formidable pharma player when their capacities are short and look like pilot plants in comparison to the installed capacities in others be it China or the west. The scale of operations will spell the difference and would be the single most important aspect when we compete globally.
Green Chemistry and Enzymatic Processes Commercials are ultimately important and therefore the costs have to be focussed for addressing the COGS and the everdecreasing margins in the generic business across the globe. Though, in the recent times, the supply chain stalwarts upon be-
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ing interviewed as reported by authentic research firms have mentioned that price is not the most important factor but there are others like GMP compliance, batch to batch consistency and non-interference of human element and ensuring data integrity are equally important parameters. In spite of all this, the cost of inputs is important in some of the wafer-thin margin businesses. There is a limit to cost reduction in a chemical process and once that has been exhausted, then, we need to explore the use of green chemistry and also introduction of enzymatic steps in various side-chains in the multi-step manufacturing process to optimize cost of manufacturing.
High Potency Active Pharmaceutical Ingredient The development in the High Potency Active Pharmaceutical Ingredient (HPAPI) and biogeneric drugs is going to boost the growth of the Active Pharmaceutical Ingredient (API) market. There has been a paradigm shift in the use of innovative drugs to that of low-cost API drugs after the last economic reApril - May 2020
cession, thereby causing a positive impact on the overall growth of the API market. In order to keep abreast with this change, API manufacturers are applying various novel technologies to reduce the processing time in order to yield more production. For sure, the High Potency APIs is another window of opportunity to focus for great returns.
Biotech and Biosimilars India has a reasonably good presence in biotechnology industry which is based in Karnataka, West Bengal, Maharashtra, Andhra Pradesh, Telangana, Kerala and Ahmedabad. The leading Indian players include Serum Institute of India, which focuses on immuno-biologicals and vaccines; Biocon, which concentrates on recombinant DNA technologies, bioprocesses, fermentation-based small molecules and enzymes; and Panacea Biotec, which specialises in novel drug delivery techniques and pharmacogenomics. Indian biotech companies are slowly building capabilities in development and manufacturing of biosimilars.
For high speed application.
whole in pharma and other sectors have been actively filing the patents to get the much-needed advantage of 'patenting'. In addition to filing patents by Indian companies there is an equal importance to respect patents and intellectual property of others as that will help get the overseas company to partner with Indian companies.
There has been a paradigm shift in the use of innovative drugs to that of low-cost API drugs after the last economic recession, thereby causing a positive impact on the overall growth of the API market.
Intas Biopharmaceuticals is another company which has done some good work in developing a biosimilar of a protein in the cancer therapy. The challenge for the development of biosimilars arises as the biologics are more complex than small molecules and chemically synthesised drugs. In other words, their replica is 'similar' but not identical to the original drug.
Complex Generics development A complex generic product is a medicine that can be prescribed as a substitute for the originator specialized product because the bioequivalence has been demonstrated; however, it is not as simple as generics to get manufactured. Indian pharma is already have their focus on this attractive area.
Basic Chemicals, Building Blocks and Fermentation Capacities The basic chemicals companies in India have in the recent past had a great run on the bourses for the simple reason that the
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Centralized Services â&#x20AC;&#x201C; effluent treatment and supply chain from China was get- Testing Laboratories
ting impacted in view of the Covid-19 situation and that all these companies like SRF, Atul, Navin Fluorine, Aarti Industries, Deepak Nitrite, GACL, UPL, amongst others have been doing some very good work in the basic chemicals and now is the time for these companies to focus on select chemicals and speciality chemicals and enhance the scale to meet the global demand as once again there is a good possibility for a procurement shift taking place in favour of India. To reiterate the economies of scale would be most critical in order to compete in the global platform.
Enhanced Patenting and IP protection must for attracting the Big Pharma Indian companies have realised in the last decade the importance of filing patents and therefore India as a April - May 2020
In order to get advantages of some of the common services e.g the effluent treatment, common testing laboratories for conducting high end testing of samples at various stages, it is important to have a centralized laboratories which can with the help of Government get the funding at favourable terms and set-up state of the art labs. This will help channelize the companies in the medium and small-scale pharma companies not to spend heavily the lab equipment CAPEX on, and the funds so released can be effectively used in other innovative pharma solutions.
The challenge for the development of biosimilars arises as the biologics are more complex than small molecules and chemically synthesised drugs. In other words, their replica is 'similar' but not identical to the original drug.
changing needs of the pharma industry and comply to those SOPS in letter and spirit.
In addition to filing patents by Indian companies there is an equal importance to respect patents and intellectual property of others as that will help get the overseas company to partner with Indian companies.
CGMP Compliance, Data Integrity The importance of GMP compliance and data integrity cannot but be over-emphasized as we have seen large pharma companies facing the wrath of the USFDA when the companies have erred. Therefore, the workforce needs to be educated and trained on a regular basis to make them understand the
Enhance Medical, Pharmacy, Nursing educational institutes with PPP
The skilled manpower is a resource in shortage today and every step should be taken in this direction to provide the industry with the right quality of skilled manpower at every stage as the strength of the strongest chain lies in its weakest link.
Continuous learning and upgrading of skills, is the need of the dynamic pharma industry today.
Vaccine development and enhanced investment therein Vaccines are another important area of growth. India is one of the largest vaccine producers in the world. India services
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approximately 70% of the world's total vaccine requirement. A large number of new vaccines are set to be launched in the coming 3-5 years. The two companies â&#x20AC;&#x201C; Bharat Biotech and the Serum Institute with their collaborators overseas have been in the news recently for doing some pioneering work in the development of the vaccines to combat Covid-19 situation. Also, Cadila, Panacea Biotech, Biological E, are other known name for the vaccine manufacturing in India who are working on the Covid19 solutions.
Cold storage â&#x20AC;&#x201C; warehousing â&#x20AC;&#x201C; last mile product integrity and dispensing Storage of temperature sensitive medicines and vaccines is most important to be maintained for the entire length of the supply chain. This is important for maintaining the product efficacy and product integrity for the entire length of the shelf life of the product and to ensure that the product is as per label claim till the point of administration of the drug product to the patient. In order to serve the remote corners within India and also overseas markets the importance of warehousing and dispensing assumes great importance and therefore the increased need for cold chains and warehousing in the desired storage conditions to ensure product integrity and safety. A huge opportunity is envisaged in this part of the supply chain.
coding etc to ensure that the right product is delivered to the patient.
Much needed JVs with the best globally – revive IDPL kind?
E-pharmacy – quantum growth possible - firm up governing laws The rise of digital India and with it there has been a phenomenal rise to the e-pharmacies and thereby aiding the much-needed process to make the medicines reach the remote corners of India and also a much desired connect globally. However, the functioning of epharmacies requires the framing of rules and regulations that will govern the running of these platforms to ensure the medico-legal compliances etc. While rules
have been in place to some extent but these need to be revisited to ensure plugging any holes to ensure that the patient gets the right product at the correct terms and conditions.
RFID – track and trace: problem of fake medicines It is a matter of grave concern that the domestic India market and elsewhere, the problem that the industry faces in terms of fake medicines. For sure the technology has to come to the rescue to address this problem be it track and trace, holograms, bar
The current epidemic has once again made a case to review our policy to look at the possibility of having governments role in the industry like what we had in the past in terms of IDPL – Indian Drugs and Pharmaceuticals Limited which had some state-ofthe-art manufacturing plants and high tech products like Pen G, vitamins etc., and it also had some tie-ups with global companies in terms of technology. We all very well know that the closure of IDPL Hyderabad gave a rise to the mushroom growth of pharma industry in the then undivided state of Andhra Pradesh which the country is still proud of. Well the government role might not be the ideal one to contemplate in the current times, but certain products Vitamins, Pen-G, Tetracyclines
Huge Opportunity in Supply Chain In order to serve the remote corners within India and also overseas markets the importance of warehousing and dispensing assumes great importance and therefore the increased need for cold chains and warehousing in the desired storage conditions to ensure product integrity and safety.
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Medicines for Millions The current epidemic has once again made a case to review our policy to look at the possibility of having governments role in the industry like what we had in the past in terms of IDPL â&#x20AC;&#x201C; Indian Drugs and Pharmaceuticals Limited, which had some state-of-the-art manufacturing plants and high tech products like Pen G, vitamins etc., and it also had some tie-ups with global companies in terms of technology. might call for a different approach or government backed incentive scheme or additional support in terms of energy intensive fermentation-based product.
Medical Devices - The situation of ventilators is a case in point The medical devices industry in
India consists of large multinationals, with extensive service networks, as well as small and medium enterprises (SMEs). The medical devices include - diagnostic imaging, IV diagnostics, consumables, patient aids, orthopaedic prosthetics, dental products and other medical devices. The awareness around the need to have a robust medical devices ecosystem in the country is gaining importance resulting in higher growth rates for India as compared to the global industry. For sure the Indian medical devices industry
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has an opportunity to leapfrog innovation combining physical devices and integrating with the digital framework. It is an opportune time for the Indian pharma companies to consider adding a new vertical of medical devices and getting into JVs with some of the MNCs for making the devices in India and with innovation bring down the costs and service the growing needs of a large populace. The recent pandemic has seen a large number of small and large corporate houses getting into the act of making low costeffective ventilators which is a tremendous case in point to demonstrate this aspect of opportunity and serving the large numbers in India and will also help boost the Make in India plans.
Chemicals Industry - a big opportunity here Chemicals industry in India is highly diversified and it covers bulk chemicals, specialty chemicals, agrochemicals, petrochemicals, polymers and fertilizers. India is a strong global dye supplier and accounts a little over 15% of the world production of dyestuff and dye intermediates. The current situation has given the chemicals industry in India to assess its strengths and weaknesses and in the process of selfassessment look at areas where it can measure up to the end user industries effectively and efficiently.
Hospitals â&#x20AC;&#x201C; infrastructure push and medical tourism as a result thereof It is a well-known fact that the hospital beds and the patient ratio in the country is abysmally low. While we have seen a large private investment that has taken place in India in the last two decades with the result, we find that the condition of the government hospitals have been going down over the years or it is also that the corporates realised that the standards were going down in the government managed hospitals and they saw an opportunity to get in and make big bucks... ironically the same what we have seen in the education sector. Of course, we have few pockets of excellence like the AIIMS, PGI etc., but there is an urgent need for the government to get into
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the act of creating large number of hospitals and at the same time encourage the private sector to invest further by extending attractive sops. For sure there is a need for increasing the medical colleges which will help in increasing the number of doctors
and the nursing and other support staff. Mind you, the government should see that the private hospitals conduct themselves in the right manner by that it is meant that the medical ethics must be followed in letter and spirit.
To summarise, Indian pharma companies had been an underperformer over the last decade or so and finally the tide has turned in its favour though in unfortunate circumstances. The global pandemic has thrown open a lot of opportunities to Indian pharma companies and related sectors like medical devices, hospitals and medical tourism etc. We also noticed how fast the Indian pharma geared up to service the HCQ and Chloroquine salts-based drug product to countries across the globe while ensuring sufficient SKUs for the Indian population. The Indian pharma units also witnessed several approvals from US FDA in the recent weeks augurs good for the Industry. For sure, India has won a lot of goodwill which, in turn has helped the perception of Indian generic drug manufacturers. It is opportune time for the India pharma to leverage this opportunity to the maximum. About the Author Gurmeet Singh is Director Pharma Networks - a veteran for over 30 years in the Indian pharmaceutical sector. He has served some of the best pharma companies at the decision-making levels in companies like Ranbaxy, Wockhardt â&#x20AC;&#x201C; Swiss and Ireland, Orchid Pharma and Midas GmbH. He was retained as Pharma Development Consultant with DNDi â&#x20AC;&#x201C; Drugs for Neglected Diseases initiative, a Geneva based R&D organization. Mr. Singh is a Bachelor at Law (LL.B), a Post Graduate in Management Studies and Post Graduate Diploma in Intellectual Property Rights Law. He can be contacted on email@example.com om and +919703599123
April - May 2020
Time to Collaborate, Co-operate and Innovate During Covid-19 lockdown, Messe Muenchen India, the organiser of leading trade fairs like analytica Anacon India, India Lab Expo and Pharma Pro & Pack Expo in association with Indian Pharma Machinery Manufacturers Association (IPMMA) has organised a serious of webinars focused on the challenges faced by the pharmaceutical industry. The webinar held on 16th April 2020 deliberated on the topic “Time to collaborate, co-operate and innovate to face challenges in pharma industry”, and was well attended by over 400+ participants from not only India but also countries like Germany, Italy, UAE and Nepal. The webinar was also supported by IAIA (Indian Analytical Instruments Association). The panel included names such as Dr. Viranchi Shah, Senior Vice President pan India & Chairman for Gujarat State board of Indian Drug Manufacturers Association, and Director of Saga Labs; Mr. Paresh Chawla, Chairman for MP State Board of Indian Drug Manufacturers Association, and MD of Alpa Laboratories Ltd; and Mr. Shirish Belapure, Senior Technical Advisor at IPA; and was moderated by Mr. Kaushik Desai (Advisor at IPMMA). The webinar shed light on the current challenges faced by the
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pharmaceutical industry in the light of the pandemic and gave expert insights on what to expect in the future and viable ways for the industry to brave these challenges. The pharmaceutical industry has been evolving continuously to ensure that there is minimum disruption and uninterrupted supply chain. This pandemic has given rise to many innovative means of communication, policies for ease
of doing business, newer approaches in managing manufacturing operations, supply chain management and patient centric regulatory pathways. It is said that necessity is the mother of invention, and the pharmaceutical industry is not behind. In the webinar, the experts shared their insights, thoughtprovoking ideas, and discussed the industry preparedness to fight this challenge.
'Unique challenge calls for unique solutions'
Dr. Viranchi Shah April - May 2020
Let me set one thing right, this is a unique challenge and it comes with a unique set of situations that nobody in the world has ever seen. So I think the first thing that every industry needs to do is take things day by day, because that is not too much that you can plan. However, if you see this challenge, this is a pandemic that has affected almost all the
industries across the globe, and all sizes, whether it is small, medium or large, or whether you are in a healthcare space or in an automobile space. In whichever space you are, this pandemic has a very direct effect on you. This is a unique challenge, and it calls for unique solutions to manage. There are disruptions in manufacturing and supply chain. But, I believe, when we say we are the global pharmacy we will bounce back in a short time, because there is definitely a need for our pharmaceuticals everywhere across the globe. On the manufacturing side, most of our members have reported presence of almost 30 to 35 percent of their workforce, even when we are working during the lockdown. This translates into an efficiency of around 30 percent for most of the manufacturing units. This is something that needs to be rectified, because if you do not rectify this we will probably see more disruptions in essential medicines or in the supply chain in the coming years. Let me reiterate that this particular epidemic is unique; nobody has ever seen something of this scale at least in our lifetimes. It comes with unique challenges, very, very big challenges. But the pharmaceutical industry is quite robust, we have whatever it takes to surpass this challenge, and when we are through this phase, when we pass this phase, we will prevail and the Indian pharma industry will prevail.
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'New challenge to the mankind'
Mr. Shirish Belapure Senior Technical Advisor, IPA
I think it's a new challenge to the mankind. I have never seen such a thing happening to the whole country or to the whole world in the last 67 years of my life. Thousands of health professionals are battling this virus, putting their own lives at the risk. Governments
and industries are working together to understand and address this challenge. Currently, we don't know what will be the outcome of this situation. We need to support the victims and their families and communities, and search for treatments and vaccines. In that regard, I think, India is also in the forefront. I know at least two Indian companies which are looking for vaccine manufacturing. There are multinational companies as well. Now the Government of India has enlisted pharmaceutical manufacturing as an essential service. We need to act swiftly and promptly to ensure continuity of medical supplies to avoid drug shortages. At the same time, we have to ensure the safety of the workforce in the manufacturing facilities. It's absolutely critical.
'Trend is negative, but positive signs too'
The Indian pharma industry has been the world leader in generics both in global as well as in domestic market. You all know that our industry is significantly contributing to the global demand for generics. Now this pandemic has clearly shown as to how the entire world is dependent on India and why we are called pharmacy of the world. Even the President Mr. Paresh Chawla, Chairman for MP State Board of Indian Drug Manufacturers Association, and MD of Alpa Laboratories Ltd April - May 2020
of the US, the most powerful nation of the world, had to request India to lift the ban on hydroxychloroquine. I feel this is a very big feather in our cap that the world has started looking towards India with a lot of expectations. India has now definitely become a focus country when it comes to the new development or the supply of existing drugs. So I see a very positive side of this pandemic. Of course, everybody has their own set of problems in the industry in dealing with situation. Although the trend is negative, all these things are coming as positive signs to the industry. Although pharmaceutical manufacturing is exempted from the lockdown, the supply chain disruptions are becoming evident. The non-availability of labour, lack of clarity over transportation of ingredients like packing materials, physical distancing, all these have bottlenecked the production volumes. Also there is a production slowdown due to raw materials and ancillaries not reaching the factories. I would like to express my gratitude to the entrepreneurs of pharma companies who are operating their companies amidst all these, and taking a big risk. Nobody at this time would like to go to the company and would like to work. So, definitely, we should be grateful to all our fellow members, our staff and everybody else. Another biggest challenge in front of the industry is how to
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manage the supply chain, how to keep the staff motivated, how the risk can be mitigated, and how you can keep your labour safe. This will be a very big thing in times to come, because I don't see this pandemic to end very soon. So it's very important that we keep our staff and people working in the industry safe. Another thing which is coming up during this pandemic is that we need to finish our dependency for raw material imports from China. We need to come up, and we need to have our own pharmaceutical API industry. The packages announced by the government are definitely going to help. On the innovation and collaboration, which is the topic of this discussion, we need to innovate
and we need to collaborate for the times to come, because this pandemic is going to change everything â&#x20AC;&#x201C; the way we look at things, the marketing, the manufacturing, the handling of materials, staff and everything. So, definitely, each and every company needs to find out the ways to collaborate and innovate.
Another thing which is coming up during this pandemic is that we need to finish our dependency for raw material imports from China. We need to come up, and we need to have our own pharmaceutical API industry. - Mr. Paresh Chawla
What are the operating challenges and how are we managing with limited resources?
Dr. Viranchi Shah: Once the lockdown was announced in March, the first challenge that everybody had was that nobody knew how the pharma industry was expected to work. We were knowing that we were an essential industry, and in the interest of the society and the nation we had to work and make sure that all the medicines were April - May 2020
available, not only to the population of India, but across the globe who have been depending on us for medicines for decades all together. So the first challenge was understanding the dynamics, and how things work. As an association and industry, we did a lot of efforts talking to the government and trying to open up the channels where the people can travel, and materials and products can be transported. In my opinion, currently the biggest operating challenge
that we as an industry have is the availability of the manpower. We have been collecting data from across India from various manufacturers, and the summery that I have is that almost the entire India is working, on an average, with around 30-35 percent of their manpower. There could be exceptions, but this is the major figure that I have. When you are working with limited manpower, obviously there are limited number of activities that you can do. So you need to prioritize your activities in such a way that you continue to manufacture at least the essential portion of your drugs. On the other hand, since you are a part of GMP there are certain things you don't want to deviate. So certain basic things, for example, your maintenance has to go on, and there are certain other activities. Prioritizing them on the manufacturing front is actually a very big challenge. When we started talking to the employees, there are several reasons why employees could not turn up. One of the things that came up was that many had travelled back to their hometowns and there was no way they could come back. There's a challenge bringing them back. Many of the people who are in the close proximity have reported to work, while others are not reporting either due to family issues or in many cases the chairmen or secretaries of their housing societies do not want them to go out every day and comeback, proba-
34 PHARMA machines & technology
bly, with some infection. So there are these kinds of challenges to overcome. Most of the industry entrepreneurs or people who run the industry have been talking to their employees, their key team leaders, and trying to explain that as an essential industry our role is to make sure that there is no shortage of drugs, and the supply chain remains intact. In my experience, if you put the right safety mechanisms in your plant like temperature mapping and ensuring that everybody has proper masks, gloves, and sanitizers are available, and if you try to explain the situation, handle the team with compassion and patience, then probably you will have the number of people coming to the plants increas-
ing. And probably in the coming time, we would be able to see this challenge going down and would have people to undertake our operations in a much better way.
In my experience, if you put the right safety mechanisms in your plant, like temperature mapping and ensuring that everybody has proper masks, gloves, and sanitizers, and if you try to explain the situation, handle the team with compassion and patience, then probably you will have the number of people coming to the plants increasing. - Dr. Viranchi Shah
What are the risk assessments and the mitigation strategies that can be adopted or are adopted?
Mr. Shirish Belapure: For risk mitigation, first we need to identify the risks and then adopt the mitigation strategies. The two risks mentioned here are: the supply is being hit, and the absenteeism of the employees. These two risks have to be mitigated. I am sure that most of you must have April - May 2020
seen â&#x20AC;&#x153;Creation of Emergency Planâ&#x20AC;?, the FDA guidance which had come out in 2011. It talks about the guidance for the industry, planning for the effects of high absenteeism to ensure availability of the medically necessary drug products. If you look at this document, it actually talks about the things that we need to do to mitigate the risk of not supplying the medicines, and it is taking about creating an emergency plan where the things that can be avoided during the period
when absenteeism is high, and particularly when the absenteeism in the quality control is hurting in a big way, compared to even the manufacturing. Some of the non-critical activities can be reduced like production equipment routine maintenance; utility system performance checks and maintenance (e.g., air temperature, lighting, compressed air); environmental monitoring of facilities such as cell culture, harvesting, and purification rooms during production; stability testing for certain drug products and
components; and periodic examinations of data and of reserve samples. You can actually extend this list to avoid the problems and the stoppage of your activities.
uct. Every regulatory authority today, be it European or American or our own, understand the current situation and they are ready to help us in this regard.
We can even reduce testing of packaging materials, testing of raw materials, etc. So this is one way of mitigating the risk. We need to have this emergency plan. Write down the things which are required to be done during this period, and how you are going to handle without impacting the quality of the prod-
We need to have the emergency plan in place. Write down the things which are required to be done during this period, and how you are going to handle without impacting the quality of the product.
- Mr. Shirish Belapure
ancillary industries like the printing industry, the bottle making industry, the shippers, etc. Many things were needed to take portation could open up, espethings forward and the governcially the interstate transport, as ment on our request did immedithe API industry is concentrated ately react and gave permission around Hyderabad, and the forto open up these industries. Now mulation industry is concentrated most of the ancillary industries in Gujarat and North India. So are working, the transportation is we had to make sure that the materials would come, and the gov- working, and the industry is workernment was very active in listen- ing. But yet, I still repeat, the major challenge is the people who ing to us, and they promptly reare not coming in. That's why sponded and we made sure that probably we are not able to exethe channels were opened up. There were issues of opening the cute it the way we want it.
What are your experiences on managing the supply chain issues?
Dr. Viranchi Shah: The supply chain of the incoming materials was the first challenge that we faced when the industry started working. When the lockdown was announced IDMA and all other industry associations were talking to the state and central governments almost on a day to day basis. The first thing we took was to address the supply chain issue, because we realized that unless the materials could come in, unless our finished products could go out seamlessly, the entire exercise of keeping your plants open would be futile. Ultimately there would be shortage of medicines in the market.
What are the collaborative and innovative practices that can be adopted? Mr. Paresh Chawla: As I said in my opening remarks, this is the real time to innovate
So the first task all the associations took was talking to the government to make sure that our employees could come, materials could move, and the trans-
36 PHARMA machines & technology
April - May 2020
and collaborate. First of all, we need to work upon the user expectations. We need to shift our focus from product-centric to user-centric, and discover the ways to innovate. We need to define our goals and prepare a
Raising compaction standards with Enhanced throughput in The Largest*
Roll Compactor - 300/125
prototype as to what should be innovated and how to be innovated. There's a very good concept which has come up now. It's called design thinking. I think all the pharma entrepreneurs should now have some sort of learning on design thinking. This will help us in planning, and we can predict and it is a personalized sort of plan. Another big thing which needs innovation is in the segment of marketing. During the lockdown the marketing is dead. Everything needs to be online now. So we all need to go digital. We need to find out ways of, may be, a medical representative giving presentation to the doctor online. Another thing which is very important now is to do internal collaboration in our organisation, by getting all the functional heads together. We need to talk to them and interact with them to bring about innovation. We need to get them in the boardroom now. The people who were earlier focussing on their particular job now need to do internal cross-collaboration, which will bring out very good results. We need to work on reducing the process time of our batches. How fast you can put the raw materials into processing and how fast the product can be moved out of your company. Earlier if you were processing a batch in 15 days or 20 days, you now have to innovate ways, within all
38 PHARMA machines & technology
the regulatory purview, on how the period can be shortened. This will definitely help the industry as well as the end users in this pandemic period. Innovation should happen in a lot of areas, not just in manufacturing or marketing. We need to innovate on how we can handle our materials, and more importantly, how
we can handle our people, because the primary concern at this time is the safety of the people. If they don't have this feeling that the organization they are working in is managing for their adequate safety, they will not be ready to come to work. So we need to innovate on each and every front.
Could you elaborate on IPAâ&#x20AC;&#x2122;s guidance document on best practices for employees safety?
Mr. Shirish Belapure: When Covid-19 struck us, we were not aware what safety precautions needed to be taken for the safety of employees. They are actually taking risk by coming to the factory, so they should not get infected. That was our prime concerns and prime responsibilities as factory managers or owners. So we collated information from different companies and also from the US and WHO, and created a document on the best practices for protecting staff in pharmaceutical manufacturing facilities in relation to Covid-19. The need for communication is one of the important things it talks about. We can't bring lots of people together and talk to them in current situation. So the communication has to be virtual, and at the same time you have to ensure that it reaches everybody. Employees should also communicate to the employer about their condition and of their family members and neighApril - May 2020
bours, so that other people are not affected. So both ways of communication are important. Employee segregation is another very important thing. You have to divide the workforce into essential and non-essential categories. Non-essential staff like those in planning, purchase, regulatory, etc. can work from home. Those who are required to be on the job are production and quality control people, and may be the supporting staff for housekeeping, running canteen, etc. We also have to look at which medically necessary products are to be manufactured, and employees should work in small groups, so that one doesn't impact the other. The staff buses should run in fifty percent capacity, keeping sufficient distance between the seats. These are essential things to be done in addition to sanitation, hygiene, masks, etc. to ensure the safety of the employees.
What more is expected from the government for the smooth running of the plant and uninterrupted supply chain?
Mr. Paresh Chawla: The government is definitely trying to extend all its support. We expect government to come out with special incentives for the pharma as it is an essential industry. Measures to promote bulk drugs manufacturing in India is a step in the right direction. Not just the bulk drugs, but even the formulation industry needs incentives. The government should give special focus on R&D. If we have a very strong base of R&D, we will be able to innovate more products and become number one in terms of value as well, not just in volumes. Dr. Viranchi Shah: When we
talk of the government, I had a very good experience with the government. Whatever interactions the associations had with the government, either it is central, state or local, the government has been earful of whatever we had to say, and have supported us in whatever requests we had come up with. But there are certain basic fundamental things that need to be done as a nation. The most fundamental thing is addressing the API deficit. The good thing is that the government has recently come out with a package of almost Rs. 10,000 crore to strengthen our API industry, especially those based on fermenta-
tion and those kind of industries that we do not have in India. We have some strength in synthetic APIs, but in things like fermentation we are very badly dependent on China and some other countries. So this is one area where the government have initiated a very good package. The industry and government will continue to work forward and make sure that our dependence on other nations, especially China could be reduced. So that our industry become self-sufficient and we are in a better position to serve the world. I think this is one of the most important messages that has come out of this pandemic.
What are the learnings from this pandemic?
Mr. Shirish Belapure: I think we have learned a lot of things, both on the personal level and as an industry. We now know what working from home really means. The industry has learned that automation and digitalization will be the way of work for the future. There will be lot of changes in the way we are working. I think majority of the work which are currently being done from the home will continue to be done from home. Woking from home will be a normal thing in future. We have also learned the skill of prioritization; prioritizing the
40 PHARMA machines & technology
product, prioritizing the employees who are important, etc. I think these are the main areas where the learning has taken place. Dr. Viranchi Shah: I think one of the important learnings that we have is that every industry has to have a very robust business continuity plan. Unless you have a very robust business continuity plan in pandemic situations like this, when the whole axis on which we have been working for several years or decades suddenly changes, it is very difficult to comprehend the path forward. So the need to have a very roApril - May 2020
bust and very strong business continuity plan is something that everybody has learned. People had business continuity plan, but I don't think very rarely there could be a company who has been able to continue the work based on the plan they already had. Because what happened now is something massive. Therefore, it is important to learn that in order to continue our businesses in such emergencies we need to have a very elaborate and a very robust business continuity plan, where we could obviously include automation, digitalization, prioritization,
working in limited resources, etc. If you suddenly find yourself left alone in a jungle, how do you survive? We all need to develop such survival tactics. Another important learning I can share is that until now the global research was mostly focused on the chronic segment, especially diabetes, cancer and cardiovascular. The nations who invested in research never felt the need to invest into infections and infectious diseases or bacterial or viral infections. Suddenly this perspective has now changed. So I believe one of the lessons that the world has to learn is that we also need to invest in acute diseases, because this kind of situa-
tions wouldn't go so easily. There are chances of recurrence, it may come out next year in a new form, and we don't know how it is going to play out. So we, as a nation or world, need to invest in infectious diseases. And the last thing I feel is that this particular pandemic will bring a lot of strengthening of healthcare systems across the world. All the countries will have to heavily invest in their healthcare spending in developing the infrastructure and maintaining a large pool of medications and essential medicines. This will actually result in a lot of investment and a lot of focus on the pharma industry as well.
Therefore, I believe that this industry has a lot to do and there are tremendous growth opportunities in the coming years. Mr. Paresh Chawla: Definitely, this pandemic has taught us that we shouldn't be a single source dependent company, be it raw materials or packing materials. In contract manufacturing there are companies who ask your risk mitigation plan as to how you plan to mitigate these type of risks. It is a part of their agreement. Now each and every company needs to have a disaster management plan or team or a committee who constantly evolve new ideas so that the business can stay as robust as it can be.
What are the critical factors you feel most important for collaboration and cooperation to overcome this challenge?
Mr. Shirish Belapure: I have become a safety man after spending forty years in manufacturing. So for me safety of the employees is most critical. For that collaboration between the industry, employees, health officials, associations and the government is very important. Secondly, we have found that we are fighting this pandemic together. There is a lot of cooperation between each section of the society, that is one of the critical things which I feel very important in emergencies like this. I am sure we will come out of it, and let us have patience until then. Mr. Paresh Chawla: I com-
42 PHARMA machines & technology
pletely agree that we need to collaborate internally for the safety of our people. It's most important, and especially in situations like this. Your employees are the ones who are actually driving the company. So the employee safety needs a big collaboration amongst our internal team. And definitely collaboration is required on the marketing side as well, to put our products across the market. Dr. Viranchi Shah: I think collaboration and innovation are very important outcomes of this particular pandemic management. We have seen car companies making ventilators and April - May 2020
sugar companies making hand sanitizers. So collaboration has come from between the industries. We have the state governments, the central government, the industry associations, the NGOs, the police and everybody collaborating to deliver the good to the people. In our own organization, I have seen people from different departments collaborating each other. I have seen collaboration between the teams within the organization, between the organizations, between nations, and between industries. I think this innovative way of collaboration is going to take us forward.
Joining hands to mitigate challenges As part of its webinar series during the pandemic, Pharma Pro&Pack Expo, analytica Anacon India and India Lab Expo hosted a comprehensive seminar on 30th April 2020, titled “Covid-19: Pharma and machinery sector join hands to mitigate the challenges”. The extensive webinar, organised by Messe Muenchen India in association with Indian Pharma Machinery Manufacturers Association (IPMMA), was led by an esteemed set of panelist from the pharma and pharma machinery sector. The panel included names such as Mr. Narasima Raju, Site Head (Quality), Dr. Reddy's Laboratories; Mr. Ashis Banerjee, CMD, Gansons Limited; Mr. Shankar Gupta, COO - ACG Engineering; Mr. Vishesh Parekh, Managing Director, INCOME; Mr. Shaunak Dave, CEO (Asia), Optel Group; Mr. R. Ramanathan, COO and Director, Parle Global Technologies Pvt. Ltd; and was moderated by Mr. Kaushik Desai, Advisor at IPMMA.
44 PHARMA machines & technology
Mr. Narasima Raju Site Head (Quality) Dr. Reddy's
Mr. Ashis Banerjee CMD Gansons Limited
Mr. Shankar Gupta COO ACG Engineering
Mr. Vishesh Parekh Managing Director INCOME
MODETRATOR Mr. Shaunak Dave CEO (Asia) Optel Group
Mr. R. Ramanathan COO and Director Parle Global Technologies Pvt. Ltd
The renowned speakers on the panel shared their perspective on how the pharma industry and machine manufacturers can work together to lessen the impact of Covid-19. The webinar was attended by over 500 attendees from different countries. Messe Muenchen India organises a series of webinars that focus on various industries, giving a platform for industry experts to discuss and analyse current market situation and future possibilities for their respective sectors. April - May 2020
Mr. Kaushik Desai Advisor IPMMA.
'World is looking at Indian pharma industry'
When the lockdown was announced and we were told to work from home, it was something unbelievable, because I've never worked from home. These are very difficult times. True, change is the only constant, but this is a change we need to look at differently. There are challenges everywhere. Working from home is a challenge, managing your family essentials is a challenge, managing children who are not used to
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12-14 December 2018 Expo Mart, Greater Noida, Delhi NCR
Hall-16. Stand No. C02.
staying at home is a challenge, contacting your sales team, getting people in plants, making them work, organizing supply chain and logistics, the list of challenges goes on... But we have to look at different ways, because we are in an industry which is serving people, which is serving humanity. It is essential that we stand up to this challenge and deliver not only for our people and our country, but also to the mankind, because world is looking at the Indian pharma industry." - Mr. Shankar Gupta, COO ACG Engineering
taught to us is that we really cannot plan much. I guess that humankind is used to live in an age of certainty, and you would always like to make sure that there is something which is reasonably certain in the future. I do believe that this will go away. It's a question of time, whether it is going to be three months, six months or a year, but we will come back to what we were. And I think what is more important for planning is that what do we do when this occurs again? We will see how we, the pharma industry, will handle this. - Mr. Vishesh Parekh, Managing Director, INCOME
'What do we do when this occurs again?'
I am reminded of an old English saying: “How do you make the almighty laugh? And you make him laugh by telling him your future plans”. Probably what this pandemic has actually taught us or is teaching us, as we go along, is no matter how big plans you make, one needs to be adaptable, to be able to change very fast, because the tiniest of things can change your mega plans in such a way one cannot think of. There is an interesting calculation about this virus. The total weight of the corona virus in the whole world comes to just around one gram. See how one gram could change the whole world. Actually I find it a little ironic because, we here are trying to plan for the future, but what is being
46 PHARMA machines & technology
''The way pharma runs has changed'
You are all aware how the pharma industry runs. It's completely regulatory driven, and there are lot of procedures and GMP practices to be followed, with product safety being the main concern. But now in the Covid-19 situation, a lot of things have changed. Apart from ensuring the product safety, now we need to look upon the safety of the employees as well. Many things have changed in the way pharma facilities run in terms of human safety perspective. At the same time we have to ensure that the medicine is always available within the reach of the patient. For that we have to ensure that all our operations run seamlessly with no intervenApril - May 2020
tion at all. We did face some challenges in the form of equipment issues. But somehow with the support of all the OEMs and equipment manufacturers we could correct them online, and some of the issues were resolved through video calls. In my view, pharma equipments must be designed like missiles. They should work without any intervention. And whoever is operating the equipment, they should behave as if they are the owners of the equipment. It should be like: I run, I maintain and I comply, so I take care of everything. Rather than following reactive approach, we should follow predictive and proactive approach. We need to work absolutely with zero intervention. Only then the medicines would reach the patients and fulfil their needs. So, we all have to play a very big role to achieve this. - Mr. Narasima Raju, Site Head (Quality), Dr. Reddy's Laboratories
'Come together, work together and address this issue'
Thank you for this opportunity to be part of this forum. One of the things I noticed was the exponential increase of participants as the time drew near for the webinar. And what's interesting is that 'exponential' has become a very scary word in this current corona scenario. So the only time it is really
interesting and exciting is when exponential interest is shown in a joint collaborative effort to address this issue. As my colleagues mentioned earlier, this has become the age of irrationality, which means that to a large extent all our conventional modes of even attempting to predict the future are being recalibrated now. Having said that what I mean in terms of what lies ahead for us is a very disciplined and cautious approach towards addressing this serious challenge. We have huge responsibility because we are the second largest populous country in the world, and we have huge masses of people who have a sense of helplessness beyond anything we can imagine. Going forward, I think we have a significantly higher responsibility in our own respective roles to be able to come together, work together and address this issue." - Mr. Ashis Banerjee, CMD, Gansons Limited
'We have to relook, reassess and reorganize'
It's proud to see that pharma industry have turned to be the saluteworthy brave warriors like our dear doctors and many of those great humans who are out in the pandemic giving their best to the society. Today we are in something that we have never experienced. There's no news other than this pandemic all over the
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world. This is the worst of all the disasters that have ever happened in the world. But one thing I am pleased about to some extent is that we are not in those very difficult time industries like tourism, banking, real estate, retail, auto, etc., where the impact is much more worst. Sad to say this, but we are blessed to be in an industry which is the very essential one. Even if there is an impact, I am pretty confident we are bound to revive and strive for better. Overall, the industry has to relook, reassess, reorganize, and the business outlook has to be totally changed." - Mr. R. Ramanathan, COO and Director, Parle Global Technologies Pvt. Ltd
'Leveraging digitization is not luxury, it is a necessity'
Have you ever seen a tornado is transformed into a rainbow? Dr APJ Abdul Kalam has said that adversities always present opportunity of introspection. And when we do the introspection, the opportunities and potentials pop up. The pandemic of Covid-19 has brought immense potential. Yes, there are severe repercussions, we all know about it. But the Indian pharma machinery manufacturers and the pharmaceutical industry can do a lot. Globally there is a need for transparent communication and collaboration. If the communication had been transparent in the beginning things could have been different. And with collaboApril - May 2020
ration, the world will see the new vaccine researched and launched in record time.Then there is a thought process shift to global interdependency. Previous to Covid-19, everybody was talking about country specific barriers to business and various other restrictions, but now there is global interdependency, and for India being the global pharma manufacturing hub, it is a huge opportunity. As industry we need to connect with the entire ecosystem. There is a lot of fragility in our supply chain and I would see that digitisation with Industry 4.0 and end-to-end supply chain, we can create a visible, secure and integrated supply chain. Integrated supply chain ecosystem and automation and Industry 4.0 are the two learnings for pharmaceutical industry. Leveraging digitization is not luxury, it is a necessity. Now the question is how we can, as pharma machinery manufacturers, support the pharmaceutical industry? Now the coin is flipped. Previously the pharmaceutical industry could run with local support provided by the equipment manufacturers. Now the industry will ask us digital technology to give them remote support in this kind of pandemic. As people, in this pandemic and lockdown our goal has shifted from success and money to health and happiness, and our living from materialistic to sustainable living." - Mr. Shaunak Dave, CEO (Asia), Optel Group
What are the challenges in running a manufacturing facility with minimum workforce, minimum support from machine manufacturers, and by maintaining safety of the employees?
Mr. Narasima Raju: As explained before, since pharma is an essential service we all have to continue producing our medicines. During this pandemic period we are operating with the minimum workforce by dividing into two shifts instead of three shifts. Most of our equipments have online connectivity, so the OEMs could take the system online to support us. So the digitization aspects of the equipment, and the predictive and proactive approaches we follow, rather than reactive approach, helped us a lot.
For maintaining safety of the employees, we have ensured that the fumigation for the buses is taken place and sanitizing agents are placed at all entry and exit points, which are touchfree. And we have divided the entire operation into multiple zones. If people need to cross their zone and go to the other zone, they have to follow certain procedures. Apart from that we are creating awareness among the employees on the need to keep social distancing whether they are in the workplace or outside.
We also have a contingency plan in place. Zoning is one of the action plans as part of this. This limits the movement of the people as they work in their respected zones only. So if one person is affected in a particular zone, the entire operation is not stopped. We are also doing some mockups in our regular operation as to what should be done if any person gets affected, how he needs to be treated, etc. So the mock-up plan is in place, isolation rooms are in place, and the PPEs are at hand.
What are the challenges and issues you faced for reaching the critical equipments and spares to your customers?
Mr. R. Ramanathan: We have a lot of consignments of spares and equipments that come from Japan, US and other countries. We did face a lot of challenges. There was problem for the clearing and forwarding agent to reach even the nearby port. No operations were there at the container freight station, because there was no labour or rather less labour. Mechanical devices like forklifts and cranes were not there, and the containers were piled up in a haphazard way. Detention periods were getting over, and charges were being levied by the shipping line. The
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transportation costs increased as there was no driver or no vehicle available, and so on. We faced lots of challenges, but our exim team and logistics team did excellent works in a very short span of time. Prior tracking of the shipments and containers were done well in advance, prior filing of documents to customs to avoid late filings and to avail any waivers, documentation verified and completed in all respects, prior liaisoning with the container freight station for labour and mechanical instructions, and prior liaisoning with transporters to get proper e-pass for vehicles April - May 2020
with RTO for smooth commuting. We did a lot of things like that. But in all, pre-emptive actions in terms of documentation, filing with customs, information on loaders, etc. were all done in proper manner that could help us to reach the consignments to the customers. There were also problems with the countries where our principals were located, because they could not have many of their consignments moved on time because of the challenges they had. But still we could manage all of those challenges across with some preemptive planning.
Can you throw some light on services or the troubleshooting support? And what do you recommend on spares and equipments in such crying times?
Mr. Ashis Banerjee: We have essentially worked with systems and designs for a long time. The duty cycles of the components were already designed for a virtually continuous operation. But there is an obvious wear and tear on components and parts. So what we did is we have actually analysed and been able to predict the wearing of a part and mandated to clients that they actually store or keep these parts in stock. We have also engineered systems in a way that they are easily replaceable. Now from the records we have from the period of the lockdown, we have had minimal or no issues per se on the supply or repair of parts. One of the things we are exhorting our clients to do is buy OEM spare-parts only, because unfortunately for reasons of contingency we find that some of our clients are buying parts on an ad-hoc basis for breakdown maintenance. Mr. Narasima Raju: If we can have some virtual imaging techniques as part of the equipment, we can make use of them, mainly for rectifying the problems related to parts. The problems are not the same every time. Sometimes we get a different problem. If we can have
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some virtual techniques available as part of the equipment, we can make use of them and it will be very helpful. If any problem comes up with the equipment, we get the alarm, but to do the maintenance these kinds of virtual models will be really of use. Mr. R. Ramanathan: Most of our machines do have that, and there is also a conscious effort being put in to invest in this area. We also had some demonstrations done in the last P-MEC as well. Overall, the suppliers also have understood the value and need for the same. The online support also needs certain conditions at the site as well, like uninterrupted power supply, good net connectivity, better skill set of individuals who should assist the subject, and so on. This is the demand in the machinery world today. Many of you must be knowing that the cost of services globally is very expensive. Many of the global equipments have these virtual models in place. But bringing this value across the Indian pharma industry against some cost and commercial considerations is always a challenge. However, as the discussion that is on today, to bring in the best
April - May 2020
to the industry forward at this situation, these things have to be put into practice. I would say building video manuals with the systems, that too in multi languages, be it hard or soft manuals, also should be the need of the time. The guidance and demonstrations will go a long way in avoiding any physical support, which should be the goal. The extent of training and support provided during the initial phase of the machine is also very important. The refreshers that you give from time to time should help you controlling the situation by using telecon methods. We have also provided time-zone based telecon support when we were at different time intervals. Sill the service engineers were able to support because the individuals working on the machine had right skill sets. The overall remote assistance goal supports, but the journey is really endless. There must also be some amount of planning done at the customers end, wherein the equipments that they are likely to be procured must comply to these requirements. This would force any supplier to bring about the same in the equipments rather than expecting it later.
Head Off: EL , TTC Industrial Area, Mahape, Navi Mumbai , India. Tel: + E: infobox briopharmatech.com. W: www.briopharmatech.com
How much would digitization impact the technical support in the current scenario and in the future?
Mr Shaunak Dave: We have been providing digitization support for the last 10 years. Initially it was on the Skype tool or taking control of the controllers and setting the recipes and all. But later, being a global company, we realized that it's not going to happen when it comes to maintenance. Setting of the recipes or parameters and taking the control of controllers and changing it is all fine, but what about maintenance? So in the last five years we have come up with remote tech support with augmented vision. We call it Optel smart glasses. As part of its SLA offer, Optel provides virtual tech support â&#x20AC;&#x201C; a cutting-edge way to solve any issue you may experience, with a unique â&#x20AC;&#x153;see-what-I-seeâ&#x20AC;? augmented reality technology. This mobile, hands-free remote assistance solution allows Optel field technicians and technical experts to collaborate in real time, anywhere in the world. Apart from that we have implemented the digital service process digitization, where there is a global service toll-free number. Anybody, who is working in India, US, Canada, Brazil or in Europe, can call the toll-free number. Somebody would pick up and assist you. All data is available on our platform. So, even if you have installed something in India, and there is a re-
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mote FAT support in Ireland, you can see what exactly the problem. It's a very active technology and it is getting more and more adaptable day by day. Digitization has changed the face of technical support. Industry 4.0 with predictive maintenance support and integrated digital platform is going to be the new normal. Mr. Shankar Gupta: Except our granulation lines, most of our machines are manufactured in India. ACG generally competes with all the best in the world. When you say that a machine is designed in India, whatever you say that you have the design facility of the best engineers, customers perception is always that European machines are better. Where India can have an edge apart from pharma, the one industry where India is a global leader is IT. So we thought that we will leverage the Indian IT to have a leadership position for ourselves and the country.
inventory. First we are doing the proof of the concept in our capsules plant, because that's a process plant and we can directly replicate it to our customers. We have identified a few customers. Incidentally, Dr. Reddy is also one of the partners in our digitization process. There's a huge focus across the organization. There's a completely different team to work on the IIoT, a complete setup which will work on the predictive. Right now we are doing on preventive, the next step will be going to predictive, and finally we will go to prescriptive. A huge investment is going on. Any of you who had visited P-MEC, we had a separate room there for our IIoT . Yes, that's a journey, and we are moving very fast.
Mr. Vishesh Parekh: I have a different take on this. No matter what we talk of digitization, automation, online support, there is nothing like a human hand on a machine and this will remain. In the whole age of industrialization Today all our customers are workwe have gone through that. ing on Industry 4.0, which is leveraging the big data, which is Today I have got the most somatrix based data to dashboard phisticated latest laptop in my setup for getting real-time KPI. hand, but when it breaks down, I What it does is it streamlines the need somebody to sit on this and manufacturing process, enhancwork on it. So, anybody who ing efficiency, reducing waste, thinks that everything is going to avoiding breakdowns, keeping happen in a virtual cloud, I think less spare parts and avoiding the he is in a virtual cloud.
April - May 2020
What are the critical takeaway points you would suggest for the industry in the days to come?
Mr. R. Ramanathan: The current time is very unfortunate and unexpected. But friends, I think we need to believe that these are bound to come in the way of our process of building and contributing to our nation's economy, strengthening our businesses, and also our homes. So this is not going to stop only here. Such situations have to be accounted in for our businesses. Post Covid, I feel it will not be the survival of fittest, it will be that of quickest. Adaptability and agility will be quite important. We should have not just annual targets and half-yearly targets to meet our business needs, but should also have a micro plan in place to stay with such new normals. But I hope we will have three good quarters to come up. Mr. Shankar Gupta: We need to take this as a huge disruption to our lives and our businesses. I have just one request to everybody: use this opportunity to build efficiency of your business. Pharma industry, as compared to FMCG and a few other industries has not been efficient. So build efficiency through digitization, automation and improving productivity. If that happens, then even in the lean period, and even if there are challenges you can run your business very efficiently and smoothly.
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ways think that everything has a positive side, and we we'll get better sooner or later.
Mr. Ashis Banerjee: We would all have in our life thought that if I had the time to really think and ponder to do things I would have done things much better. So, God willing, this lockdown period should end earlier than the most pessimistic estimates. But we should use this time first to spend quality time with our families, which we have always hankered after. Two, use this time in our own creative ways to think of what we're going to do once we come out of this pandemic. And three, for God's sake, please cooperate with the government and the authorities. It's easy with the gift of hindsight to say that they should have done this or that. But stay safe and stay healthy. Mr. Narasima Raju: I would say that we keep getting challenges in our life. This is one of the challenges which we are facing right now. Whenever we get challenges, we have to act upon them, and as long as you act upon them and continue moving in our journey, we will absolutely find a different solution. Let us alApril - May 2020
Mr. Vishesh Parekh: Be lean and cut your flap, and be ready for the change, because change is going to come. We will overcome this phase. There is no question about it as I said earlier. We will work on this Covid pandemic and life will get back to normal. The only question is that how well are we going to be prepared for the next one? Just one more thing to everybody, please don't just look at your balance sheet and your bottomline. Think of the guys who are working with you. For you it is probably a number on your balance sheet, but for the poor peon probably working in your office, it is the food on the table for his family. So bear this in mind always. Mr. Shaunak Dave: My concluding remarks would be: it's not about the artificial intelligence replacing human intelligence. It's not about the digital world is replacing the human world. But how the digital technologies can augment the human world to innovate and improve efficiency for the next generation of our manufacturing businesses. I would say that leverage digitization, connect, communicate and collaborate. The technology is there. Why don't we use it?
During & After Covid-19
The New Normal for Pharma Regulatory Dr. Prasanna Bangale, Vice President & Head â&#x20AC;&#x201C; Global Regulatory Affairs, Global Specialities, Alembic Pharmaceuticals Limited, on invitation from Informa Markets, the organizers of 9th edition of Global Pharma Regulatory Summit, shares pointers on The New Normal for Pharma Regulatory; how this is the best time to generate ideas and develop the best in class, highly productive regulatory team, along with relevant tips on work from home for pharma regulatory professionals.
At the outset, let me thank Informa Markets for inviting me to express my opinion on current Covid-19 situation with respect to global regulatory affairs. I am delighted to express my personal comments over here. Before I start, I hope all of your families and friends are safe in this tragic unforeseen situation. Please do follow all the necessary guidelines and instructions issued by respective authorities, and contribute in stopping the spread of Covid-19. Covid-19 will have an impact on many industries and pharma is certainly not an exception. In fact, if you ask me pharma and healthcare will be at the core of it. All other Industries are hoping pharma guys to take lead to fight back this situation. We are likely to see both positive and negative. Let's talk about something positive which is happening currently, the new synergies between the companies. As an example, Sanofi and GSK are coming together to work on Covid-19 vaccine. Is it not amazing? This is just one example among several
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others. When most of the companies and even the regulatory authorities are having Covid-19 vaccine and treatment as their priority, which is correct in all the aspects, we regulatory professionals have our own routine agenda to deal with. Such priorities and resource constraints arising due to lockdown situations are certainly likely to delay some normal routine regulatory procedures and processes like submissions and approvals. Which we need to understand and schedule our priorities and timelines accordingly. As an impact of this situation, I will not be surprised if current regulatory norms and patterns
undergo some modification in near future. Hence we need to anticipate such likely changes and be ready with our strategic plans, by taking management into confidence. Let's wait and watch to see how things shape up in near future. We have to remember that a smooth sea has never made a skilled sailor. And hence, we must master the skill of converting challenges into opportunities. No doubt Covid-19 is a great learning for all of us and I am confident that we will have better outcomes from this, benefitting our future generations. So stay positive.
How regulatory professionals should manage their day while working from home and how they can make the best use of this situation?
This lockdown and elongated work from home have changed our routine to a great extent teaching us new ways of working. Facing this unimaginable situation is not an easy task. The April - May 2020
best way to cope up with this situation, which I am following currently, is to keep the routine same like office, mainly from work timings perspective. I am currently managing most of my
During & After Covid-19
what best way you can contribute in shaping the regulatory environment. I am sure this move of yours will be highly appreciated.
things for global regulatory at different time zones by using manmachine interface at its best. One has to be a dreamer, and incurable optimist and strongly believe in such situations that every cloud has a silver lining. Because of work from home, we are likely to save some amount of travelling time which is a great add-on. It is a considerable time for people who stay in crowded cities like Mumbai where traffic can be explained as bumper to bumper. And the energy you save due to no travel is of course plus, plus. Don't you think this is a great opportunity to do something which we are planning for long, but could not do due to our busy routine? Certainly yes! So let's talk about what we can do additional as regulated professions while continuing focusing on our business and uninterrupted medicine supplies to our patients, and other routine works. I suggest, just have a glance at countries which are not priority countries for you. Study their regulations, explore if they are quick wins from regulatory perspective having good business potential. I am sure you will find amazing similarities and differences between their regulations and an opportunity to learn some good practices too. Keep momentum on by learning new things with the help of online trainings. Is it a good idea to even opt for trainings from other relevant areas such as pro-
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Talk to your industry colleagues and discuss interpretations of existing and new regulations. Trust me, you will gain a lot of knowledge even without losing confidentiality.
duction, quality assurance, quality control, supply chain? I will even include sales and marketing. This will surely help you to understand your internal customers and their needs better for providing elevated support. Initiate deliberate dialogues to develop superb rapport with your internal stakeholders. This will help you to identify better ways to work together from organizational point of view, mainly how to deal effectively with post Covid-19 business situation without losing focus on patients and consumers. Interact and collaborate with federal and state regulators, policy makers, industry associations, and even scientific bodies. Take a chance to get some additional clarifications on matters, which previously you categorize as â&#x20AC;&#x153;important, but not urgentâ&#x20AC;?.
Brainstorm and speculate what challenges you are likely to face in the future due to this Covid-19 situation. And be ready with action plan and other necessary requirements as well. For example, you may need to provide different type of nonroutine expedited regulatory support to your business to achieve organizational targets. Question is, are you ready for it? Think and be prepared. Rather I would suggest, talk to your leadership team about this proactively and take their suggestions and concurrence. Human resource is most valuable resource. Trust the principle of unity in diversity, take advantage of the situation and schedule one-on-one dialogues with each of your teammates. Generate ideas and ask for their submissions, which will help you to build the best in class, highly productivity team.
Perform check on the robustness of your systems and processes and also your database maintenance. This you can Explore future knowledge ex- do it along with your team memchange opportunity with the bers. This will also help boosting stakeholders. Also think about the innovation. April - May 2020
During & After Covid-19
Speak with your external suppliers, service providers to define your wants and the best way to collaborate with each other in the future post Covid-19 situation. However, while doing all this, do not become aggressive and push others unnecessarily. You never know the situation at others end. There is a lot you can do with currently available technologies, irrespective of your organization level. So much so that ultimately you will start feeling that, this current lockdown, slow down or restrictive situation is not that long. In fact, you may land up in including many of these activities in your normal routine day to day functioning by making spe-
Keep yourself motivated for the good days, which are goRemember, your dream ing to come soon. I believe it might be closer than you strongly. So, take good care of think and hence you need to be yourself and see you soon in the prepared from your side always. next conference, seminar or Just a caution, please do take adworkshop. Thank you! equate precautions to maintain confidentiality while using various technological platforms Dr. Prasanna Bangale will be speaking at the 9th Annual which are available. Global Pharma Regulatory On personal front, this is a Summit about Changing face rare opportunity to venture of legislation/policy â&#x20AC;&#x201C; globalizainto areas which you were plantion. ning for long. Develop hobbies, keep chatting with school and college friends. Watch movies and dramas at home. Spend quality time with your family and friends. cial provisions in your calendar.
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April - May 2020
During & After Covid-19
Preparedness tips for regulatory professionals Abhishek Sinha, Head Regulatory, Advanz Pharma, shares his views on the best practices to improve functional expertise and how one can be business ready during and after the Covid-19 lockdown period.
These are of course unprecedented times, so it's very vital we follow government and healthcare service guidelines to protect ourselves, our families and the wider community. I recognize this is difficult time for all of us, but I would encourage everyone to remain optimistic, stay indoors, stay connected, using the amazing technology that's available nowadays and most importantly, be there for each other. I am a firm believer that with every adversity comes opportunity and very optimistic that using this opportunity you can use this period to invest in yourselves and think about how you can shape up your future. Here are some tips I would like to suggest to all of you: Maintain a healthy approach: Stick to your normal timetable, watch your diet, and try to get some exercise done indoors given the current lockdown situation. Upskill yourself: This is a good time to be either learning new skill sets, or refresh or upgrade the existing ones. With most of us currently working from home, use the time you would have spent commuting.
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Try to flexibly manage your time. There are plenty of online resources and platforms available on the internet both for technical and soft skills. For example in my organization, Advanz Pharma, we have access to learning platforms which I can share with my team and encourage my team to make most of it during this period. Grow your contact base: You
can use this time to try to make new contacts either by sharing experiences on discussion groups or looking for opportunities to collaborate across the industry and peer forums. Informa is a very good example which allows you to reach out to a broader, wider community and share your experience with everyone. Work on your leadership qualities: You may or may not be in a leadership role, but it is never too early to start honing leadership qualities which will go a long way in defining you as an individual and hope you will be able to use some of these qualities in your future endeavors.
What are the best practices to improve functional expertise?
With Covid-19 situation, most regulatory authorities have started issuing advisories about ways of working, taking flexible approaches wherever necessary. Being in regulatory affairs we have to watch this space very carefully. One of our important responsibilities will be to ensure that our internal stakeholders are made aware of all such changes. The changes that impact them.
April - May 2020
It's also critical that we work very closely with our commercial supply chain colleagues, with our external partners, and with regulatory authorities to ensure that the continuity of essential medicines is maintained all the time. We continue to anticipate challenges and also fulfill all our regulatory obligations. So I think crossfunctional team working is going to be a very important in these days.
During & After Covid-19
How can you be business ready during the lockdown period?
The best way would be to protect yourself and your family by following all the guidelines issued by your local authorities. Any business is run by people, and hence it is paramount that everyone is very mindful of the precautions that the local authorities have lain down and take it very seriously. This is our philosophy at Advanz Pharma where we have moved to home working almost a month ago. I think in these unprecedented times we should make extra effort to reach out to our teams, our stakeholders and try to be supportive as much as possible. As always, one of our important priorities at Advanz Pharma has always been patient access to critical medicines. So it's all about taking necessary steps to make sure we continue to ensure supply essential medicines particularly for those which we are the sole suppliers.
Prioritization is another important thing in these pressing times, which will be very important. You need to prioritize your work properly, what's more important for you. You have to work very closely with your manufacturing facility, your supply chain teams to look at the potential impact owing to the limited supply capabilities of maybe some of your API suppliers or some of your manufacturers because of their locations where they are based out of. Many regulatory authorities are coming out with regulatory flexibilities. They know they are expediting regulatory assessments in many cases if things are patient critical. They are bringing in reduced additional testing criteria just to facilitate importation, etc. I think regulatory can play a key role in the decision-making process by making sure that the stakeholders are aware of these options which are available.
9th Annual Global Pharma Regulatory Summit Scheduled on 19-21 August, 2020, the 9th edition of Global Pharma Regulatory Summit, organized by CPhI Conferences and Informa Markets, will witness a gathering of senior leaders and experts of regulatory affairs, compliances, quality assurance and policy makers to discuss and share their perspectives on current trends and challenges in the global regulatory landscape. The themes are designed to inspire and enable the brilliant minds from across the pharma ecosystem to come together to examine, discuss and debate how to improve the regulatory system and lower the challenges associated. To know more about the summit's detailed agenda and speaker line-up visit:www.pharmaregulationsin dia.com
What must a regulatory professional expect once lockdown opens up?
I think we are all looking forward to coming back to our offices and start working from our offices, getting reunited with our colleagues. I believe we will see a greater degree of bonding across all the teams as we come
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across the other side of the situation. I am very optimistic about the fact that we are going to be a more stronger, a more collaborative and more grittier team in the long run, courtesy this situation.
April - May 2020
Abhishek Sinha, Head Regulatory, Advanz Pharma, will be speaking at the 9th Annual Global Pharma Regulatory Summit about Changing face of legislation/policy â&#x20AC;&#x201C; globalization.
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