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Corona virus disaster has turned out to be an eye-opening situation because of which many powerful nations have suffered and are still suffering. Number of small and big businesses are facing adverse impacts and Pharma industry is not an exception. China is the source of 40% of the global APIs & dominating 68.3% of chemical API market worldwide. In 2018, APIs exported from China accounted for 81% ($30 billion over $37 billion) of total value of exported Chinese pharmaceutical products. Indian pharmaceutical industry despite being a global market leader at generic drug formulations, largely depends on imported APIs from China. APIs which are used to manufacture at least 12 essential drugs such as paracetamol, ranitidine, ciprofloxacin, metformin, acetylsalicylic acid, ofloxacin, metronidazole, ampicillin, amoxicillin, ascorbic acid and some fermentation-based intermediates for which India solely depends on china.

The wise steps taken by Indian government for pharma during this crisis are one of the most important growth propelling factors. The government has now come up with two schemes for pharma; one is the PLI scheme which gives some financial incentives based on sales made by selected manufacturers for 41 products which covers around 53 APIs and the incentive ranges from 5-20% based on the incremental scales. That is going to help companies in terms of bridging the gap between the Chinese prices and India price to some extent. The second scheme which the government has come up with is the bulk drug park and this scheme is primarily to provide easy access to world class common infrastructure which will be located in these parks where companies can come, set up and make use of the common infrastructure. And this is again for a period of five years. As we need to build our strength, the government has come up with these schemes which should help in compensating price gap between China and India to some extent.

India is both competitor and customer of the Chinese API industry:
We are currently the largest producers of generic medicines with a share of 20% of total global production, catering to over 60% of world’s demand. Third-largest medicine market in the Asia Pacific region with Well-established, strong local manufacturing capabilities, with an international export profile are the factors which are really highlighting our identity as ‘Pharmacy of the world’. India is by far the world’s champion of drug master files (DMFs). Drug master files (DMFs) are voluntary submissions to the import country authority, and contain confidential information about human drug products. APIs belongs to the Type II of DMFs, which is concerned with drug substance, material used in their preparation, or drug product. While China holds 12% of DMFs from the U.S., India holds almost half of them. Being the largest holder of DMSs gives India the edge to export higher-value APIs, enlarging the industry’s attractiveness. Indians generally speak better English than Chinese, which facilitates pharmaceutical trade with developed countries. Access to low cost vaccines, affordable generics & HIV treatment from India are some of the greatest success stories in Indian pharmaceutical industry. It is now widely accepted that without the likes of Sun Pharmaceutical, Ranbaxy, Dr Reddy’s Laboratories, Cipla and dozens of smaller Indian companies, many African countries would not have been able to cope with the public health challenges they face. No wonder India is called the “pharmacy to the world”.

Specialty areas to concentrate in future:
HPAPIs:
Nowadays, there is an area of interest in API domain called as HPAPI- High-potency active pharmaceutical ingredient, gaining its identity in Pharmaceutical market worldwide. They are APIs that require special handling due to toxicity and used in extremely small doses in finished drugs. Traditional examples of HPAPIs are cytotoxic compounds and sex hormones such as estrogen. Deeper analysis says that, the generic side of the industry will drive meaningful growth in the HPAPI market. Generics is one of the strongest domains in Indian pharma sector. Having said that, there exist bundles of opportunities in HPAPI sector for India. As per the latest report published by Research Dive, the global HPAPI market is estimated to generate 42,491.7 million and rise at a CAGR of 10.5% during the forecast period from 2020 to 2027. Oncology-focused medicines are one of the leading molecules creating maximum growth due to innovative pipeline candidates and upcoming generic entries. The Asia Pacific region is estimated to witness the fastest growth.
We are now emerging as a 2nd highest supplier base for generics with HPAPIs. Main API producers are headquartered in 24 different countries/territories, though most are based in either India or mainland China. New product introductions are a core growth driver for the generic API industry, and many of the upcoming opportunities are oncology-focused, high-potency compounds. Accordingly, many manufacturers across many territories have been making investments in HPAPI capabilities. Thus, companies should anticipate similarly high levels of competition as product markets develop. Looking at our nation who is blessed with ancient history of medicines and generic portfolio, profitable growth is anticipated in this area in near future. Rather than representing a well-differentiated, more insulated market segment, trends in HPAPIs are still aligned closely with the underlying dynamics of the pharmaceutical industry. Investments in this part should be viewed as essential steps to keep pace with the market.

API & data security:
Now looking into API security, the potential for insider theft exists at every level of the pharmaceutical production and distribution chain. Individuals employed at production sites, distribution centres, and pharmacies are all potential insiders. The API is stored in a secured vault until it is ready for use. It is then moved to the production area, where it is combined with inactive ingredients to make the final dosage form like pills. The pills are then packaged and sent out to distributors, leaving the control of the original facility that made them. In this whole process, there are chances that a small quantity of APIs can be lifted unofficially. Manufacturers can’t afford to overlook such malpractices as most of the APIs are highly expensive. Fortunately, at the pharmaceutical distribution sites, most employees are professionally licensed pharmacists and pharmacy technicians, bound by the ethical standards and keenly aware that a breach would result in the loss of their licenses. Quality assurance (QA) plays a central role in pharmaceutical production, and it is used as an element of theft prevention as well. At production sites, manufactured pills are pulled at random for QA checks. While these checks are primarily intended to ensure accurate formulation, they also provide a check against the diversion of API that would lead to detectable changes in pill formulation.

Way forward in API Manufacturing:
While surfing through one of the Analysis created by PwC, some of the recommendations grabbed my attension. They might not be easy to demonstrate immediately at this point but also are not unrealistic while planning for future strategies.
Some long term recommendations were:
1.Develop large clusters and provide plug-and-play infrastructural support in dedicated zones for manufacturing APIs-
• Construct 2–3 large-sized dedicated zones and lease them to private players for operating manufacturing plants.
• Set up common utilities such as solvent recovery and distillation plants, power and steam units, effluent treatment plants, common logistics centres, regulatory infrastructure and warehousing to make smaller units economically viable in these zones.
• The following support can be looked at to encourage investments in mega parks: – stamp duty waiver – 50% subsidy on water and electricity for 5 years – SGST reimbursement – 75% for 5 years – 50% subsidy on expenses incurred for quality certification/patent registration – waiver on development charges, which are currently at 9% of property cost.
• Evaluate strategic locations for these mega parks, e.g. union territories, where the centre can play a larger role in controlling costs such as like cost of land and utilities.

In the slightly longer term, the government may look at the Chinese model and work on developing clusters for API and also can fuel our HPAPI manufacturing powers. API security and surveillance technologies at industry level is also one of the major factors which has to be taken care of. An emergency is inevitable and it always affects in a very unpleasant manner if we are not fully prepared to deal with it. Self-reliance is must and we have to get habituated to it. India for India and India for global is the strategy that we need to follow. Afterall we have to give justice to ‘Make in India’.

Pharma mergers and acquisitions: – An initiative towards new business opportunities

The Biopharmaceutical industry is probably one of the most active sectors for mergers and acquisitions. These industries do greater number of deals and transactions than any other sector. Both merger and Acquisition are an essential component of the pharmaceutical business model and are crucial for achieving growth and competitive advantage.

How M&A is benefiting the pharmaceutical industry

The single most essential driver for changes in the Pharmaceutical industry is the ever-increasing cost of drug development, which can be controlled with the help of M&A to a greater extent. Most companies can no longer afford to carry out R&D and require high financing or Acquisition for late-stage trials to find innovative compounds and need the capability to navigate complicated regulatory pathways, which are only possible by big pharmaceutical industries. Hence, big pharmaceutical companies who want to enter a new industry or expand their business towards innovation merge with other companies or acquire smaller, creative companies by funding them or buying that company’s stakes. This is how merger and Acquisition can benefit both the big and small pharmaceutical industry.

Case Study: –

The biggest M&A (mergers and acquisitions) of 2020 are as follows: –

AstraZeneca & Alexion: –

By far, one of the biggest pharma deals of the year 2020 was between AstraZeneca and Alexion, where AstraZeneca offered a deal worth $39 billion to Alexion. Alexion has predominantly featured among the top list of biopharma takeover prospects in the last few years. With the purchase, AstraZeneca will strengthen its immunology franchise with a blockbuster of $4 billion, plus a pipeline of 11 drugs for autoimmune and rare diseases. The boards of directors of both industries have unanimously sanctioned the acquisitions. With both the sectors’ shareholders’ consent, the purchase is poised to close in Q3 2021. Upon completion, Alexion shareholders will also get a 15% stake of AstraZeneca.

Way Forward with Mergers and Acquisitions in the fiscal year 2021:

Mergers and Acquisitions, an aspect of the business world that has been rapidly growing in recent years, are poised to bloom in the year 2021 and beyond as it is one of the easy ways for pharma companies to gain horizontal or vertical integration in an industry without having to break into a new part of it from scratch. Due to the pandemic, as the market was at a complete standstill in deal activity, smaller innovative pharmaceutical companies are looking for funds and, bigger pharmaceutical industries are looking for innovations, which means that there is even more significant potential for more M&A deals to take place in the coming years as pharma businesses are recovering and are determining the best and easy way to navigate and grow the market.

REFERENCES: –

• https://www.mckinsey.com/business-functions/strategy-and-corporate-finance/our-insights/whats-behind-the-pharmaceutical-sectors-m-and-a-push
• https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-to-acquire-alexion.html

Revolutionizing pharmaceutical R & D sector

India has thrown a right smack on International co-operation by sending vital medicines to many countries during the pandemic, which has led India’s pharmaceutical sector to boom as a source of employment and innovation and become a global healthcare leader provider in need. With a well- equipped and low-cost skilled workforce, India is playing a significant role as a global manufacturing hub. This makes the country be on a growth trajectory. From the past few years, world-class competence, advantageous market conditions, robust framework, pecuniary and non-pecuniary incentives, and a growing R & D ecosystem have made India one of the most remunerative pharmaceutical sectors globally. India has allured tremendous praise and acknowledgment across various countries to globally recognize its on-going and practical steps to export this vital drug. 

India’s significant advantage is:

• Funding in big-scale manufacturing pharma product units and expanding the business.
• Improving India’s ‘soft skills’ through technical knowledge and competence building and help to other developing and developed countries.
• strengthening the research & development ecosystem and Fuelling pharmaceutical exports
• Enhancing access to efficacy and good secondary/tertiary health services.

According to the IPA McKinsey Report, Indian Pharmaceutical industry is poised to increase its revenue from $38-40 Bn to $120-130 Bn by 2030, with a CAGR of 11-12%.

Therefore, India is increasingly known as the ‘pharmacy of the world,’ or ‘pharma hub,’ exporting its pharmaceutical products globally.

Advanced technologies used in Pharma R&D: 

Nanotechnology and Microarray are the new emerging technologies in the pharmaceutical R & D sector. Along with this pharmaceutical R & D sector make use of FAIR (Findability, Accessibility, Interoperability, and Reuse), AI-enabled digital platforms, research partnerships with academia and digital tech companies, AI for drug discovery, data principle, and blockchain technology, which is becoming a new level of sharing information and transparency to reduce many challenges faced by pharmaceutical industries. These advanced technologies have developed success rates and have minimized the time and cost of drug discovery.

 Path Ahead: 

Healthcare is taking centre stage due to pandemic onset, which is likely to remain at the public’s utmost priority even in the aftermath of COVID-19 worldwide. This is a tremendous opportunity for the domestic pharmaceutical players to play a leading role in global drug management by emerging as the global ‘medical superpower’ by providing medical expertise, essential drug treatment framework, and competency building to other nations with limited prospects. 

India being the strategic industry and with the advantage of both reach and scale, it is essential to make a collaborative effort with regulatory agencies and government to help build an excellent ecosystem that will help the industry to grow by 11-12%, which will make India continue to be the ‘World Pharmacy’ and soon be the larger producer worldwide.

References: 

1. https://www.investindia.gov.in/siru/india-pharmacy-world
2. https://joinhubpharma.com/why-india-is-a-hub-for-pharma-manufacturing-worldwide/

 

Digitalisation & Pharmaceutical World

The pharmaceutical manufacturing industry is growing drastically due to the increasing demand for its service. Digitalization can embrace almost all spheres of pharma industry, especially manufacturing. Let us see how!

Five Paradigm Shifts in Pharmaceutical industry: 

A comprehensive approach is necessary because of five fundamental shifts in how the pharmaceutical industry will be shaped in the coming years. These five paradigm shifts are as follows: 

1. Minimizing Variations: Pharmaceutical companies can run historical data on Chemistry, Manufacturing, and Control (CMC) by building an advanced analytical model to determine the impact of individual changes. Pharmaceutical companies can use modern and new technologies to understand better how input parameters such as operator training levels, raw materials options, and machine settings will affect the quality of products and outcomes. To eliminate testing and cut throughput times in half, companies can control over input parameters to regulators. This automatically boosts efficiencies, as most of the quality control and quality assurance tasks disappear. Also, by mapping outputs to inputs, companies can proactively optimize all inputs and thus reduce variations.
2. Real-time data to map market trends: Internal and external indicators, big data, and machine learning algorithms can be leveraged by the industry stakeholders to forecast trends and automatically identify and mitigate risks such as quality issues, deviations, and machine failures, etc.
3. Digital optimization: The real-time digital twin stimulation allows companies to steer the process presciently by assuming the effect of adding a new machine, changing the team allocation, or changing schedules. This can help the company optimize production parameters for a highly complex system, proactively and accurately, without risk. Companies can also build digital stimulation of production processes on individual machines, factories, labs, or the entire manufacturing network. This is a significant advancement in efficiency compared to the traditional approach of going through historical data manually to spot trends.
   
   

   Fig 1.1 Five Data Driven Paradigm Shifts in Pharmaceutical industry

4. Automation through robotics: Digital robots can autonomously handle supply scheduling and planning measures, using self-learning algorithms to support decisions such as corrective and preventive actions (CAPA) or portfolio margin optimization. Such tools are emerging to improve knowledge work, automation, and administrative processes. Suppose there is any deviation in a product. In that case, natural language processing can be used, which can help to show where and what went wrong and compile it into a Pareto diagram or some other type of visualization. All these solutions can reduce the company’s time by 10% but by 90-100%.
5. Reducing human errors: Human error is the biggest weakness in pharma production. Tasks done by humans are almost 92% accurate statistically. This does not comply with pharma expectations. Therefore, new digital systems that support operators in daily tasks highly repetitive have a massive increase in the pharma industry. These tools can let managers know if something is going wrong or is likely to go wrong.

Future prospect: Digital manufacturing in pharma is the industry’s new reality. Leading companies can develop a roadmap to implement and capture substantial gain in production capacity by 40% and reducing unit costs by 15%. The companies can embrace innovation and position themselves to compete in a future that will look very different from today.

References:

1. https://www.epicflow.com/blog/2020-challenges-and-trends-in-pharmaceutical-industry/
2. https://www.mckinsey.com/business-functions/operations/our-insights/how-data-is-changing-the-pharma-operations-world#

 

How AI Can Play a Role in Tackling the COVID-19 Pandemic?

The global healthcare industry faced the most significant health challenge in 2020. To protect ourselves against the novel COVID-19 virus and lower the overall disruption many AI companies started to develop new tools to overcome this difficulty. Here are some keyways that prove how AI is essential in tackling COVID-19.

• Containing the Spread:

AI can be harnessed in forecasting the spread of the virus by developing an early warning system. The one thing that AI excels in is analysing and uncovering patterns in vast data swathes. This is precisely what makes AI the perfect tool for modelling and tracking the distribution of the virus. Facebook gives an example of how this ability was utilized in practice; the AI works by sharing anonymized data about people’s movement through mapping software, which enabled Facebook to generate accurate population density estimates that offer a clear picture of when and where people were congregating. Hence, such tools are useful for tracking the virus’s spread and allocating medical resources more efficiently.

• Diagnosing the Virus: 

First, to control the virus effectively, we need to know who has already overcome the infection, who has it, and who has never been infected. Hence, many companies tackled this challenge by launching the Coronavirus AI solution, which helps clinicians detect and monitor the virus. It even lowers the medical practitioners’ burden by allowing them to locate the virus on images of the patient’s lung, based on the data derived from the vital statistics. AI provides essential information for resource allocation by prioritizing the need for ventilators and respiratory supports in the Intensive care unit.

• Drug Development: 

Never has mankind witnessed such a race for developing a vaccine against a pathogen or virus. Vaccine development can be a laborious and lengthy process, mainly due to the human immune system’s complexity and its variability among different groups and people. The pace of the discovery can be enhanced manifold by witnessing the power of AI. Entities have leveraged AI platforms, genomics, computing, system biology, and bioinformatics, as these technologies can anticipate where the disease will go next and identify drugs that will be effective against COVID-19.

Way Forward: 

Soon, AI will play a significant role in the pharma industry to explore the healthcare sector’s unmet medical needs. In collaboration with AI companies, many pharma companies can develop cloud-based AI platforms to accelerate their drug discovery programs. These platforms will look for patterns in data and use algorithms to make accurate predictions about the potential drug molecules based on computational structure analysis, drug target, and data from in-vivo cell line studies. Hence, it shows that AI has a massive Pharmaceutical industry application in the coming years.

 

References: 

• https://www.researchgate.net/publication/345045154_The_role_of_Artificial_Intelligence_in_tackling_COVID-19

• http://www.pmlive.com/pharma_intelligence/Has_AI_been_the_key_to_tackling_the_COVID-19_pandemic_1346052

• https://www.expresspharma.in/it-at-pharma/artificial-intelligence-the-future-of-pharma-industry/

 

 

Importance of Sustainability in the Corporate

COVID-19 has disrupted many business processes and few have been changed in last ten months. Now, it is time to stabilise and ensure that new systems and SOPs work for improving business. 

Stability is one of the fulcrums and essential elements for sustainability.

To sustain in this environment, 4 pronged approach is essential:

Sustainability is important tool for the corporates for managing reputation & brands. It is extremely important to incorporate sustainability in wide range of a corporate like managing the internal operations, developing regulatory strategy, marketing of products & services as well as attracting & retaining talent. The reason companies incorporates sustainability strategies is basically to maintain and improve company’s reputation, strengthening positive competitiveness, leadership’s personal interest, meeting the expectations of distributors, retailers & others & helps in aligning with the business goals.

These engaged companies do more than others to communicate the programs that involve sustainability through various engagement activities like embedding sustainability data in communication with the investors. The companies should participate in sustainability rankings and/or indexes produced by financial-index companies information provides on socially responsible investing or media or PR firms. The companies should inculcate sustainability through its CSR activities. They can also publish a sustainability section in their corporate website for their external audiences.

Therefore, companies that proactively handle sustainability are far more likely to explore and uncover opportunities for value development. Communicating better with customers and other stakeholders may be a first step in achieving awareness and enhancing the effectiveness of sustainability activities. Companies where sustainability is a top item on the agenda of their CEOs are twice as likely as those to introduce sustainability into the management strategies of their firms. This indicates that senior management who wish to enjoy the advantages of implementing sustainability into the overall policies of their businesses must play an active role in the initiative.