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Upscaling of Production – the Perspective of Pharmaceutical Companies

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(@ashishjoshi)
Posts: 121
Reputable Member Admin
Topic starter
 

Lets share your thoughts on pharmaceuticals companies during COVID-19 and way forward  to meet the increasing need of the people.

 
Posted : July 19, 2021 7:41 pm
(@revathy-j)
Posts: 8
Member
 


Challenges faced by pharma companies during the Covid-19 pandemic

Despite being regarded as the “pharmacy of the world”, during the time when the pandemic struck the sub-continent, the pharma industry failed to supply medicines when they were needed because of the challenges the pharma industry faced due to the pandemic.

Pharmaceutical processing units ran at decreased capacity, and factories became underutilised after millions of workers walked back home. Furthermore, a disrupted supply chain hindered the availability of services such as raw materials and packaging resources in the Indian pharmaceutical industry.

Baddi, Goa, and Sikkim are the major suppliers of medicines across India. During the lockdown, restricted transportation rendered drug movement impossible, affecting both dealers and sellers.

Many experts suspect that new coronavirus strains, such as a more infectious homegrown version detected in 61 percent of samples genome sequenced in Maharashtra, the worst-affected area, are contributing to the rise. Hospital beds, oxygen supplies, medications, and even accommodation in morgues and crematoriums are all in short supply in several cities.

With the second wave possibly being more dangerous than the first, vaccinations are more important than ever. But is the Indian healthcare system successful in vaccinating its citizens? Recent data suggests that in the UK, 48.2% of the population had been vaccinated as of April 17, 2021, compared to 38.2% in the US and 18.9% in Germany, but just 7.7% in India.

 

Pharmaceutical firms can solve the labour crisis by implementing several safety policies and providing bonuses to workers to encourage them to return to work. Pharma firms, like many other industries, may improve their financial performance by avoiding unnecessary costs, revisiting capital expenditures, introducing new items to their pipeline, renegotiating leases, and leveraging the digital platforms to hold meetings and carry out appropriate operations.

If nothing else, the pandemic has shown industries that reducing dependence on a single geographic area, such as China, is critical to survival. As a result, the Indian pharmaceutical industry should consider diversifying the supply chain to prevent a repeat of this scenario.

Reference

//health.economictimes.indiatimes.com/news/pharma/challenges-faced-by-pharma-companies-during-pandemic-nikkhil-k-masurkar/82403218

 
Posted : July 22, 2021 7:07 pm
(@b-shivani)
Posts: 16
Active Member
 

Global emergency of COVID-19 has geared up different industries to meet the urgency. Significant pressure was put on pharmaceutical companies, not only to meet the medical demands but also to reduce the disruption in healthcare delivery system of vaccines and diagnostic tools. Hence, COVID-19 may be seen as an opportunity for the pharmaceutical industry as it has increased its demand.

Set aside the harvest made in the industry, its philanthropic move gave an incentive to meet the urgency in healthcare.

  • Alexion Charitable Foundation has expressed its solidarity by donating funds and lab equipment to non-profitable partner organizations.
  • AstraZeneca has extended its benignancy during the crisis by donating millions of surgical masks to support the healthcare workers globally.
  • Boehringer Ingelheim has donated funds, protective masks, disinfectants, inhalers and medicines to meet the demand. It also allowed its employees, with paid leave, to work as volunteers in approved organizations.
  • Similar altruistic acts were done by Johnson and Johnson for London School of Hygiene and Tropical Medicine.

 

India has contributed 62% to the global demand for vaccine. It has great advantages, which include the availability of a large labor pool and advanced technology, that enable high regulatory standards of markets of the US and European countries to be met.

India has collaborated with partners of different countries in the following ways -

  • Sharing their expertise, knowledge, infrastructure and potential to address the multiple emerging variants. 
  • Signing advance purchase agreements.
  • Combining their plant-derived vaccine candidate with adjuvant technology.

 

The pandemic accelerated the manufacture of drugs like Hydroxychloroquine and Remdesivir. 

According to Pharmexcil, India has exported pharmaceuticals to 202 destinations during FY21. North America is the largest importer of Indian pharmaceuticals, followed by Africa and Europe.

Nanotechnology-based anti-viral drugs have enabled to combat COVID-19.

With persistent efforts, any global crisis can be kept at bay.

 
Posted : July 22, 2021 11:08 pm
(@pooja-k-b)
Posts: 6
Active Member
 
Posted by: @ashishjoshi

Lets share your thoughts on pharmaceuticals companies during COVID-19 and way forward  to meet the increasing need of the people.

Pharmaceutical companies have deep scientific knowledge gained from decades of experience with similar viruses. Companies are researching vaccine candidates and undertaking inventories of research portfolio libraries to identify additional potential treatments for R&D.Some have donated compounds with the potential to treat coronavirus for emergency use and clinical trials, including compounds formerly tested on other viral pathogens such as Ebola and HIV. Other are exploring ways to use existing technologies that provide the ability to rapidly upscale production once a potential vaccine candidate is identified.

companies are working in four areas:

Treatment development

Vaccine development amd manufacture

Diagnostics

Helping the NHS on the ground

REFERENCE:

//www.abpi.org.uk/medicine-discovery/covid-19/what-are-pharmaceutical-companies-doing-to-tackle-the-disease/

 
Posted : July 23, 2021 12:53 pm
(@shrutis)
Posts: 6
Active Member
 

Pharmaceutical companies played an important role in managing pandemics related to Influenza(H1N1), MERS, SARS in the past. For a unified global effort, there must be a response from organizations like pharmaceutical companies, government, and private bodies, NGOs, etc. Globally many initiatives to tackle problems related to COVID 19 like vaccine shortage, gaps in the supply chain, and research and development.

Many companies like AstraZeneca, Johnson & Johnson, Pfizer, etc are in the race to develop treatment options for COVID 19. 

13 vaccines are available to the general public with approval from WHO for emergency use and over 320 in various stages of clinical trials.

However, discovering the vaccine was only half the battle. Administering the population and meeting the demand and supply chain requirements are crucial for preventing the future spread of disease. Vaccine manufacture and development efforts are upscaled through collaborative efforts of pharmaceutical companies in association with government bodies and private healthcare organizations. For example, AstraZeneca is collaborating with 20 partners globally via the COVAX initiative to increase the supply of its vaccine.

COVID 19 testing is crucial in treating and preventing future outbreaks by identifying hotspots of the disease. Many pharmaceutical companies like Roche, GSK AstraZeneca, and Takeda are taking initiatives like creating test kits that can be immediately used and accessible to everybody.

Along with these strategies, targeting the fight against COVID 19 requires a unified community effort. Pharmaceutical companies supporting the NHS are one such example. Funds and healthcare supplies are needed to organize efforts on the ground level. Takeda UK donated to organizations providing emergency services like AGE UK, AstraZeneca donated masks to health care providers, and Johnson and Johnson donated to the London School of Hygiene & Tropical Medicine for research and other charitable causes.

Meeting the current vaccine demands and carrying out research for innovative methods to treat and prevent COVID 19 will be key in ensuring a holistic recovery from this pandemic. The pharmaceutical industry can play a vital role to carry out these efforts.

References:

//www.abpi.org.uk/medicine-discovery/covid-19/what-are-pharmaceutical-companies-doing-to-tackle-the-disease/

//www.who.int/news-room/q-a-detail/coronavirus-disease-(covid-19)-vaccines?adgroupsurvey={adgroupsurvey}&gclid=Cj0KCQjw0emHBhC1ARIsAL1QGNeKL531RopByBMxKXfxsByQ9vPun9GDVVHdl-xpJ8Gm3oyS957ewaYaAsu1EALw_wcB

 
Posted : July 23, 2021 3:55 pm
(@kaviya_or)
Posts: 3
New Member
 

Although hospitals battled to cope with the influx of patients at the height of the crisis, the pharmaceutical industry struggled to meet raw-material production demands. Then there were shortages of critical treatment medications.the pharma industry failed to supply medicines when they were needed because of the challenges the pharma industry faced due to the pandemic.

What strategies should the pharmaceutical industry and other stakeholders adopt ?

Unlike the first wave, we witnessed a steep rise in cases in the second wave due to virus mutants’ high transmission rate. The pharma industry prioritised building production capacity and working with stakeholders to contain the adverse effects of the second wave.

As the world anticipates a possible third wave, the Indian pharma industry is preparing and taking a proactive approach to tackle it. Along with strategies for ramping production of essential covid-19 drugs, collaborating with all relevant stake holders across supply chain of pharma industry from central, state to district level coordination. We are the second-most populous country in the world, hence inventorising of essential Covid-19 drugs and vaccines is necessary to meet the high demand.

Additionally, collaboration within the industry should continue to fast track the Covid-19 drugs and vaccine production. We have to focus on agility on the production and supply chain operations as the demand situation is unpredictable in the Civid environment.

Reference:
//health.economictimes.indiatimes.com/news/pharma/covid-19-has-highlighted-the-indian-pharma-industrys-potential-in-transforming-into-an-innovation-hub-sudarshan-jain/83608836

//health.economictimes.indiatimes.com/news/pharma/challenges-faced-by-pharma-companies-during-pandemic-nikkhil-k-masurkar/82403218

 
Posted : July 23, 2021 8:33 pm
(@isha09)
Posts: 30
Eminent Member
 

During the COVID-19 pandemic, the pharma industry has been highly responsive. The shift in focus of pharmaceutical companies leaders has increased their focus on agile solutions, transparent operations, and network risk management. The pharma operations leaders have enabled the swift supply of vital medical products, medicines and rolling out diagnostics across states and countries, ensuring proper licensing, workforce safety, and handling government restrictions while preparing for new vaccines and therapeutics. Companies have upscale the production and started taking stock of the possible future crisis alongside building the path to recovery. Cost implications, location related issues and risks, supply chain management, risk mitigation has lead to evolution in their networking strategy.

Moreover, newer technologies are emerging besides increased adoption of digital tools, telehealth, and app-based ecosystems. Companies are becoming more focused on operational resilience and accelerating initiatives that ensure agile workforce, distribution and deployment of analytical automated tools. Although there are considerations for governments and regulators for which, companies are reassessing and complying with the standards of production with special attention paid to delivery mechanism to the containment zones or higher-risk areas.

Not only this but the turbulence caused by COVID-19 has made pharma companies to rethink their launching strategy including diversifying the partner portfolios, adopting local-for-local strategies, medical education, engagement channels, and platforms. There is a need for reshuffling product launching approaches without disrupting the entire business model but taking into account all the innovations developed for new drugs and diagnostics etc.

 

Sources:

//www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/pharma-operations-the-path-to-recovery-and-the-next-normal

//www.mckinsey.com/business-functions/risk/our-insights/covid-19-implications-for-business

//www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/ready-for-launch-reshaping-pharmas-strategy-in-the-next-normal

//www.abpi.org.uk/medicine-discovery/covid-19/what-are-pharmaceutical-companies-doing-to-tackle-the-disease/

 
Posted : July 24, 2021 2:13 am
(@diveshkrishnaa_or)
Posts: 3
New Member
 

Introduction:

  Pharmaceutical companies are working globally to combat COVID-19.Pharmaceutical companies have deep scientific knowledge gained from decades of experience with similar viruses.The role of the Indian pharmaceutical sector has been fortified during the pandemic when global and Indian companies stepped forward and enhanced their efforts in service of the country. India is often referred to as the ‘pharmacy of the world’, this has been proved completely true during the ongoing Covid-19 pandemic when India continued to produce and export critical life saving medicines to the rest of the world.

     Some have donated compounds with the potential to treat coronavirus for emergency use and clinical trials, including compounds formerly tested on other viral pathogens such as Ebola and HIV. Other are exploring ways to use existing technologies that provide the ability to rapidly upscale production once a potential vaccine candidate is identified.

Companies are working in four areas:

  1. Treatment development
  2. Vaccine development and manufacture
  3. Diagnostics
  4. Helping the NHS on the ground

Current challenges:

  1. Complex supply chain and counterfeit
  2. Stakeholder expectations
  3. Low availability of medicines in public health care facilities
  4. High out of pocket expenses

Potential solutions:

  1. Use of technology and partnerships to resolve supply chain and access related issues
  2. Government regulations and strong governance can help in addressing data privacy and drug quality concerns
  3. E-pharmacy has the potential to improve access of medicines

Future consideration:

  1. Improving access to medicines
  2. Accelerating research and innovation
  3. Strengthening manufacturing and supply base in domestic and global markets
  4. Achieving equitable and sustainable healthcare
  5. Achieve drug affordability sustainably
  6. Improve drug accessibility in tier 2/3 cities and remote areas

The way forward:

  1. Strengthening primary care
  2. Continued focus on formulations
  3. Enhancing manufacturing attractiveness
  4. Improve plant operations
  5. Upgradation of manufacturing technology
  6. Focus on quality and compliance
  7. Focus on talent
  8. Additional support from the government and regulators
  9. Standards specific to the pharmaceutical industry

Reference:

//assets.ey.com/content/dam/ey-sites/ey-com/en_in/topics/health/2021/ey-ficci-indian-pharma-report-2021.pdf?download

//www.abpi.org.uk/medicine-discovery/covid-19/what-are-pharmaceutical-companies-doing-to-tackle-the-disease/

//www3.weforum.org/docs/WEF_Challenges_and_Opportunities_Post_COVID_19.pdf

 

 
Posted : July 24, 2021 5:27 pm
(@arthana-j)
Posts: 10
Active Member
 

The emergence of the new type of coronavirus put significant pressure on the pharmaceutical industry. As health professionals were figuring out how to treat the virus, pharmaceutical companies set out to investigate what existing drugs might help treat patients with COVID-19, potential new medicines to help mitigate the symptoms and long-term effects, and the production of a vaccine. At the same time, they also needed to ensure that the regular production of medicines for various other diseases was not impacted.

Aside from responding to the immediate threat, organizations have had to adapt quickly to ensure that they can be resilient to disruption and work in more agile ways, both in a post-COVID environment and in preparation for a possible second wave of the virus.

Several projects have been undertaken by pharmaceutical industries in developing a reliable coronavirus vaccine.

  • One particular study at the University of Oxford has recently had positive results in producing a strong immune response. This study is being conducted in partnership with the biopharmaceutical company AstraZeneca in order to manufacture and distribute the vaccine when it’s ready.
  • Pharmaceutical company Gilead has also produced a drug called Remdesivir which can help patients recover quicker from COVID-19. It was found to have positive results on two older forms of coronavirus, MERS, and SARS, which have a similar structure to COVID-19.
  • The RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial was set up in March 2020 to test a range of existing treatments to find ways to treat patients with COVID-19. The trial found that dexamethasone helped reduce deaths by one-third in hospitalized patients with respiratory complications. 

One of the most integral steps that all major pharmaceutical companies have taken to combat COVID-19 is to increase their production capacity.

  • For instance, the formulation plant of Alembic is functioning at more than 80% capacity, while its API (Active Pharmaceutical Ingredients) unit is working at 60-70% capacity on average. They are also majorly focusing on the production of drugs that are critical and in high demand during COVID-19, such as azithromycin.
  • Another leading pharma company – Zydus, a top manufacturer of hydroxychloroquine (HCQ), has increased its capacity manifold to facilitate the formulation and API process.

Domestic pharma companies in India like Zydus Cadila, Serum Institute, Bharat Biotech, Panacea Biotec, Biological E, Mynvax, and Indian Immunologists have been working aggressively to manufacture sufficient coronavirus vaccines in India.                                                                Other international companies such as Pfizer, GSK, Inovio pharmaceuticals, Johnson & Johnson, Novovax, Sanofi, Moderna therapeutics, have also been assiduous in developing a reliable vaccine.

Due to lockdowns and value chain disruptions, the supply of essential medicines has been significantly affected. However, the pharmaceutical companies are working in collaboration to minimize the disruptions and ensure the medicines reach the public in a fast and efficient manner.

At the same time, the government is playing an integral role to ensure export of pharma goods is done in a restricted way and that there is an abundant stock of medicines in the country.

References:

//www.ideagen.com

//lindstromgroup.com  

 

 

This post was modified 3 years ago 2 times by Arthana J
 
Posted : July 25, 2021 12:48 am
(@shambhavi-shree)
Posts: 4
New Member
 

The pandemic has brought about a revolutionary changing experience to the healthcare industry, right from the population freaking on health & wellness related understandings, Life science organizations involving end-consumers in trials & drug designs, companies.
In  2019, patients globally received an estimated 1.8 trillion days of therapy; an average of 234 per person. Global medicine spending is projected to increase at 2–5% annually and exceed $1.1 trillion in 2024.
The pandemic hit all equally but not all could sustain the effect in the same manner. The Pharma Industry although wounded, managed the crisis astoundingly well with great crisis responses. Digital Marketing was a weak spot for the Pharma fraternity, but with the robust online presence in these crucial times, partnering with the right providers helped the crisis management processes run smoother dealing with rapidly evolving practices. Companies around the world are suffering from event cancellations preventing pharma companies to introduce new products and services. Digitalization in the Pharma world incorporated learning into future crisis plans and processes.

Indian domestic pharma market turnover in India has reached Rs. 1.4 lakh crores in 2019.
The coronavirus pandemic  badly affected all major sectors of the economy, but it has come as a boon in disguise to the Indian pharmaceutical sector. Though some part of pharmaceutical business was affected such as supply chain and import of active pharmaceutical ingredients from China, Covid-19 has provided some opportunities in the pharmaceutical sector, especially India.
On the positive side, demand for both high quality and high volume CGMP(current good manufacturing practices ) drug substance and drug product manufacturing services has soared, and able to support a wide range of COVID vaccine technologies and, to a lesser extent, therapeutic monoclonal antibody products.The pandemic has, however, had some negative side which effects as budgets and resources are diverted to COVID products at the expense of other biologics projects in development for other therapeutic areas. The  disposable components for single use systems are being allocated to support major COVID programs leaving unacceptably high lead times for delivery of consumables required to support other critical programs. Vendors are working hard to increase capacity, but the impact is undoubtedly starting to be recognised.

Way forward -  Government of India has taken important steps by proposing an incentive package of Rs. 13.76 billion for the promotion of domestic manufacturing of critical key starting materials, drug intermediates, APIs and medical devices.

As the frequency of people visiting India for medical treatment has increased at about 55 per cent since 2014 , the Government has relaxed the rules for promoting India as a better medical tourist destination by issuing fast-track medical visas, rapid airport clearances for those visiting as medical tourists. 

Union Cabinet to boost pharma industry, which include the amendment of existing Foreign Direct Investment policy to allow FDI to invest up to 100 per cent under the automatic route for manufacturing medical device subject to certain conditions.

 The generic drug makers signed MoUs with Hidalgo (Mexico) to establish a large pharma cluster for the production and logistics in Mexico. 

GOI has planned to set up Rs. 1lakh crore fund for boosting the pharma sector to manufacture pharmaceutical ingredients domestically by 2023.

National Health Protection Scheme, a Government funded healthcare programme, which benefit 100 million poor families in the country, provides an insurance cover of up to Rs. 5 lakh per family per year for secondary and tertiary care hospitalization.

References - https:/www.abpi.org.uk/medicine-discovery/covid-19/what-are-pharmaceutical-companies-doing-to-tackle-the-disease/

//www.google.com/amp/s/www.financialexpress.com/lifestyle/health/covid-19-impact-pharma-industry-trends-for-2021/2277793/lite/
//link.springer.com/article/10.1007/s40199-020-00358-5
//www.contractpharma.com/issues/2021-01-01/view_features/covid-19-impact-report/
//www.pharmabiz.com/ArticleDetails.aspx?aid=135427&sid=9#:~:text=The%20domestic%20pharma%20market%20turnover,as%20per%20the%20government%20data.&text=The%20Indian%20pharmaceutical%20industry%20supply,global%20demand%20for%20various%20vaccines.

 
Posted : July 25, 2021 3:25 pm
(@iram_ali-605)
Posts: 6
Active Member
 

The COVID-19 pandemic has forced many pharmaceutical companies to dramatically increase production of essential drugs needed to manage respiratory critical care patients who are ventilated as an important part of their treatment. In turn, this has placed an unprecedented demand on those manufacturing active pharmaceutical ingredients (APIs), highlighting the importance of adaptability in order to maintain supply. Not only must API manufacturers have robust processes in place to enable rapid scale up, but they must also implement measures that address the global interdependency of pharmaceutical supply chains to avoid unnecessary production delays.

Common challenges of scale up
Scaling up drug production is a notoriously challenging exercise. A multitude of factors can affect product quality and yield, meaning that transitioning from lab-scale production to a scale suitable for commercial supply necessitates an in-depth knowledge of process design.

Successfully scaling up production also requires having the right equipment to do the job. Where additional instrumentation must be purchased, this not only involves identifying equipment that is fit for purpose, but also installing it and subsequently qualifying and validating its performance. “The COVID-19 pandemic has led many companies to bring in additional technologies to increase capacity,”“However, purchasing equipment can be a lengthy process involving decision-making at multiple levels. Staying ahead of the game means maintaining a current working knowledge of both new and existing technologies to streamline selection and integration of equipment when the time comes.”

Another major challenge of scale up relates to the supply chain since it is widely recognized that using multiple API suppliers does not necessarily guarantee uninterrupted drug production.

With many API manufacturers sourcing raw materials from a shared provider, continuous drug manufacturing can be jeopardized should that provider suddenly become subject to restrictions or experience unforeseen delays in acquiring raw materials. “Communicating frequently with providers and understanding the measures they are taking to secure their own supply chains and assure consistent quality of product is vital to understand rolling forecasts as well as retaining sufficient stock levels of starting material for API production,” “Having that transparency prevents any unwanted surprises that can ultimately impact on manufacturing the final drug.”

 

REFERENCES

//www.contractpharma.com/content-microsite/covid-19/2020-09-09/production-scale-up-to-meet-covid-19-demand

 
Posted : July 29, 2021 4:04 pm
(@animeshl)
Posts: 9
Active Member
 

Some might argue that leaders of operations in the pharmaceutical industry have been historically slow to respond to changing times. During the COVID-19 pandemic, however, many across the industry have been highly responsive. Industry operations leaders have rallied to enable the supply of key medicines across borders, manage workforce safety, and handle evolving government restrictions all while beginning to prepare for new vaccines and therapeutics. And most companies have put crisis-response command centers in place to appropriately manage and bring stability to an otherwise unstable time.

With these initiatives established, companies can begin taking stock of what lies ahead. Given the shifts that have taken place seemingly overnight in response to the immediate crisis, companies are also turning their attention to recovery and the path to the next normal. This will likely bring about fundamental changes in pharma operations. While individual companies will drive many of these changes, some will be driven industry-wide, and external factors, including government’s involvement, will also have impact on shaping the post-COVID-19 recovery 

At the industry level, for example, network strategy has evolved. Landed costs are no longer the key metric as the focus shifts to the cost implications of location risk. As the pandemic has reinforced, supply chains can be at significant risk when there is over-reliance on a location that may be vulnerable to disruption. Shifting production locations so that production is closer to end markets or in lower-risk countries that are less subject to disruption are now routine considerations in risk mitigation.

Supply chains are also becoming more patient-centric due to the increased adoption of digital tools, tele health, and app-based ecosystems. New technologies are expected to also emerge, such as mRNA-based vaccines, that may alter the market dynamics for capacity.

At the individual company level, companies are now more focused on operational resilience and accelerating initiatives that enable more agility—including workforce agility as workforces become more remote and distributed—and transparency through greater deployment of digital and analytics tools and automation.

As the recovery begins to shape, there are considerations for governments and regulators as well. This is likely to evolve as the industry itself evolves in its recovery from the crisis.

Each of these shifts—at the industry, company, and government level—will have fundamental implications for pharma operations and its path to recovery.

Source : //www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/pharma-operations-the-path-to-recovery-and-the-next-normal#

 
Posted : August 2, 2021 8:45 pm
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