Preparing for 2022: Lessons and Strategies

COVID-19 has made serious dents on global economy

India is an exclusive generic exporter. As of FY21, India’s exports of pharmaceuticals to North America and Europe are a little over 51 per cent. These regions being trend setters are all the more important. Hence, developments and thinking of these two regions would be of interest to India’s pharma exporters. India has 18 per cent of the US FDA-registered facilities, the second largest source outside of the US.

COVID-19 has made serious dents on global economy, and has tested each country’s preparedness to handle emergency and resilience to bounce back. India’s pharma industry responded splendidly in managing its clientele. Most importantly, it could also contribute by crystallising its own version of COVID-19 vaccine which has covered many overseas brethren besides lot many countrymen.

Governments all over are exploring various possibilities, inclusive of extending financial concessions, for minimising import dependence of at least off-patented essential medicines. They are considering local production, or reshoring supply chains to regional peers. The Indonesian government is in talks over the possibility of offering the US-controlled pharma firms that wish to move factories out of China, a new production base, according to Coordinating Maritime Affairs and Investment Minister Luhut Pandjaitan (as reported in Fitch solutions). Besides, in high-value markets like the US, pricing controls being discussed is likely to rollover by mid-2022.

The EU parliament recommendations suggest promoting European-made pharmaceuticals by strengthening manufacturing and supply resilience throughout the EU; developing adequate capacity for sustainable production of active substances, raw materials and medicines to reduce dependence on external sources; and setting up a wider political high-level pharma forum.

Africa, yet another important region for India’s pharma industry, is also gearing up for increased local production and some of the Multi-National Companies (MNCs) are loudly thinking of shifting some R&D facilities to these cost-effective locations.

The situation in LAC Region is getting tougher, and instances of companies pulling out of those countries are on the rise.

In this scenario, Indian pharma may have to adapt to the changing scenario of the industry which is moving towards biosimilars and newer dosage forms like drug delivery devices and injectables.

India’s vaccine exports may bring in substantial revenue at least in three quarters of FY23 but it has to face intense competition from Africa besides the existing, where more than six units are in the making.

While India’s pharma exporters made fairly good in roads in device delivery doses of respiratory therapy and more to catch-up in other therapies, biopharma needs to be addressed more intensely.

Off-patent, highly-potent formulations offer major opportunities, especially in the segments of oncology and respiratory. Nearly half of the bio products are slated in this therapy. In the next five years, $26 billion worth of products may go off-patent in some markets. Barrier to entry is high expenses, which requires specialised technologies and dedicated facilities, besides vast experience in regulations. India possesses workforce comparable to the best in the world. To meet the expenses of such infrastructure, working capital, top Indian pharma companies can pool their resources and, probably with adequate government contribution, can zero in on some select bio products to produce biosimilars and a way to share the gains could be modelled.

Pace of vaccine development holds great potential for future of drug development

For the clinical research industry, the pandemic brought to the fore the need for expedited approvals and how a combination of innovative and tech-enabled solutions could fast track the process without compromising on patient safety and confidentiality.

The pace of vaccine development across the globe is testimony to the possibilities of expedited trials and holds great potential for the future of drug development. For emerging biopharma reliant on quick and nimble processes to progress their drug development aspirations, such developments hold much promise. The approach, however, requires the collaborative efforts of multiple stakeholders, amongst whom regulators play a vital role in creating an enabling environment.

India has been on the path of regulatory changes for the last few years. With the introduction of the New Drugs and Clinical Trial Rules in 2019, several regulatory concerns were addressed, resulting in a more balanced and robust regulatory environment. However, despite the progress made to date, there is a need to take stock, review how much we have gained and what more needs to be done to further strengthen the regulatory environment, particularly as we incorporate learnings and the best practices from the pandemic that can become the norm in the future.

The key enablers that will encourage research and innovation from a regulatory perspective are quicker approval and response time (regulatory approvals in some innovator countries like the US, EU and Israel take 20 to 40 per cent less time than India), simplification in the clinical trial submission and review process, inclusion of more technology/subject matter experts in the review and approval committees, and a more collaborative approach with sponsors. A key opportunity, and much needed by the industry is more digital enablement across various touchpoints in the clinical trial lifecycle and creating a robust technology backbone.

While the pandemic saw the introduction of digital approval processes for clinical trial protocol review by ethics committees, more needs to be done and the regulators need to incorporate more tech-enabled options, such as decentralised trials (DCTs), which are becoming more pervasive world over. These remote-based trials with patients participating from the comfort of their homes would be a significant advantage in a country like India which has such a diverse and geographically spread-out population. Tech innovations in DCTs include telemedicine, electronic clinical outcome assessments, e-consent and integrated digital health platforms such as participant reminders and other engagement tools.

Strengthening India’s research and innovation ecosystem requires consistent and strong collaborative efforts of all stakeholder groups from big and emerging biopharma companies, startups and entrepreneurs, academia and clinical researchers. These stakeholder groups’ efforts further need to be supported by growth enablers like infrastructure, financing, and supporting policies and regulations.

All of these developments hold promise for emerging biopharma companies that are flexible and eager to embrace new and innovative processes, be it for DCTs, remote monitoring, patient enrollment and more. There is no doubt that India is a significant market with untapped potential in the biopharma industry. As we come out of the pandemic, we need to take lessons from the last couple of years and work closely with regulators to build an ecosystem that is predictive and precise, and drives better patient outcomes in a country that has the second-highest patient population and the world’s largest disease burden.

Enhance resilience of industrial networks through longer-term emergency planning and strategic collaborations

Following the outbreak of the COVID-19 pandemic, the pharma industry and the global healthcare sector have been significantly affected in an unseen way, prompting pharma companies to shift their focus to prompt, flexible and transparent operations, as well as helping shape the workforce of the future.

In the path of COVID-19 recovery, focussing on key factors is critical for Indian pharma to emerge in the global pharma hierarchy. This involves creating a favourable climate for local production and exports, as well as fostering innovation through a greater focus on research and development.

While pharma sector companies had previously begun to consider methods to improve their value offer, the COVID-19 outbreak has hastened this process due to the challenges it has brought. Massive joint initiatives involving the government, industry and regulatory bodies are becoming increasingly prominent. Various stakeholders have banded together to facilitate the cross-border delivery of critical medications, manage labour safety and deal with increasing regulatory limitations, all while preparing for new vaccines and therapies. Several businesses have established crisis-response command centres to restore calm and effectively control a rather tense situation.

Companies may begin taking stock of what the future holds now that these efforts have been made. Corporations are also shifting their focus to recovery and the route to the new normal. This will very certainly result in significant changes in pharma operations. While several of these changes will be driven by individual enterprises, others will be industry-wide, along with external factors, such as government engagement, that will also influence the post-COVID-19 recovery.

Commonalities between well-studied diseases and the coronavirus are being assessed by researchers, who are sifting through massive databases and previous findings using AI, with the purpose of reusing drugs that have been already marketed or designing ground-breaking new drugs for corona virus or other diseases. An important step to be taken is to enhance the resilience of industrial networks, for which longer-term emergency planning and strategic collaborations are required. Companies must be able to rely on a large number of partners for this purpose. Following the pandemic, industry leaders are incorporating Artificial Intelligence (AI) in their processes and utilising AI’s benefits. AI can also help pharma businesses manage the massive volumes of data and contracts they deal with on a regular basis. One of the key lessons learnt from the pandemic is that countries prioritising their own interests results in ramifications on the global supply chains which include bans or severe restrictions on the export of raw materials, medical products, personal protective equipment, human resources, as well as manufacturing supplies.

The progress gained in treating and preventing COVID-19 was enormous. When the world begins to recover, pharma should consider what remains to be done to better harness the industry’s collective expertise garnered over this period, and to build on what worked while improving on what did not.

Technological trends are sure to transform pharma industry

In India, the pharma market is projected to reach $65 billion by 2024 and grow to $120-130 billion by 2030. Recent initiatives like the National Digital Health Mission (NDHM) and government attempts to unify the pharma sector are providing opportunities for innovation from within the pharma sector in different forms of technology. This includes AI and Machine Learning (ML) capabilities being used more extensively now than ever before.

The use of AI and ML is propelling the drug discovery and development processes. Startups are employing these technologies to address the numerous challenges in the healthcare industry, including automation of manufacturing processes as well as designing effective post-launch strategies. Eligibility criteria identification is an essential step in the drug discovery and development process, which makes it vital for conducting clinical trials. AI simplifies patients’ identification by making it fast and affordable, thus saving time for this key step. 

The large volume of data available throughout the drug discovery and development process requires high-performance systems to properly analyse data and derive value from it. Therefore, pharma companies are looking to open up their data to third parties who can leverage those numbers for applications like modeling, thus making data management a crucial aspect of the innovation ecosystem. Moreover, the analytical techniques are used on almost all types of medical data from patient records, medical imaging, hospital data, etc.

Blockchain technology is being explored to track the sale of counterfeit drugs and substandard medicine that enter into the pharma supply chain and kill thousands of patients every year. The ability to share transactions makes blockchain a promising solution for securing transactions in the pharma supply chain ecosystem.

Mixed reality, virtual reality and augmented reality are making the visualisation of data a more meaningful reality than ever before, in several ways related to the biomedical sector. With tools like HoloLens, enterprises can cost-effectively design holographic augmented-reality applications that facilitate better interactivity with live-data samples and construction blueprints for example. Because of this, there has been more exploration for potential human augmentation of pharma products in the manufacturing spheres.

The concept of precision medicine relies on the idea that each patient is an individual. Precision medicine is coming from new technology that has allowed researchers to better understand and apply the differences in the way people respond to drugs. With advanced manufacturing methods like 3D printing and other innovations, precision medical manufacturing is helping shape how we, as a society, approach healthcare by focussing on making drugs more effective and less dangerous for individual patients.

Pharma technology has advanced to the point where we can now predict patients’ behaviour and outcomes. Predictive models like this certainly help match patients with the most effective treatment plans. The more we know about how each patient will respond to specific treatment plans, the better we are able to prevent adverse events and develop individualised plans for those who show signs of illness earlier in their healthcare experience. However, since their high costs prevent most businesses from adopting them, these technological trends are sure to transform the pharma industry.

In the drug development process, the role of patients is fundamental

The pandemic has shown that an all-around patient-centric approach is the future of the pharma and healthcare industry. Pharma companies must be prepared to participate in an emerging health ecosystem where patient advocacy groups, disease foundations, healthcare systems and doctors, health plans, competitors, regulators, wellness and technology companies work in tandem, keeping the patient at the centre. With digitisation and technology pervading the healthcare industry at a rapid pace, this shift is expected to be much more immediate than imagined.

In the drug development process, the role of patients is fundamental. However, the focus is now more on engaging patients as ‘individuals’ in clinical trials and not simply as ‘patients.’ To achieve the same, pharma companies are providing Plain Language Summaries, written keeping in mind the patient in mind, not the clinician. When patients are able to understand the results of the study, they feel better about the entire experience and are more willing to take active participation. This can improve the overall outcome of clinical trials.

A better understanding of the target population needs is also helpful in designing mechanisms that may affect the use of certain drugs. For example, paediatric and geriatric patients often face difficulties in swallowing capsules or tablets. Another example is people with arthritis may not be able to use medication packages with child lock. Making oral dosages easier to swallow and better tasting can aid compliance, as would packaging that is easier to open.

The development of a drug starts with the discovery of an Active Pharma Ingredient (API) for potential use against an unmet or underserved medical need. At every stage of the development process, it is recommended to complete a detailed product profile questionnaire before the initiation of any formulation work, and this should be reviewed continually. This forms a crucial part of the risk assessment process at every stage of the project and makes sure that the programme is always aimed at improving the quality of life of patients. For instance, in the case of orphan drug products, it can be useful to engage with patient support groups to make sure that their particular needs are kept in consideration throughout the programme and achieved upon conclusion.

The shift in focus to patient-centric care has given rise to the pharma Internet of Things (IoT). It mainly revolves around smart applications and connected devices, cloud services in creating patient medical record databases, drug development, clinical trials and patient care. Pharma companies are eager to understand how patients respond to therapies and identify sub-populations to ultimately improve health outcomes. AI platforms can help understand and predict the behaviour of the patients. This can help to understand the gaps in the lifecycle of the products and the findings can be used further for research and development.

Through the use of advanced technologies, pharma companies are now working on collecting multiple data points such as a patient’s genomic, molecular, phenotypic and clinical data. The multiple variables that are collected could be used to simulate clinical trials that can improve clinical trial outcomes and reduce the time taken to complete trials.

Moreover, with the increasing use of wearables, patients are now able to monitor their health and connect with their doctor, while the devices also act as alarms alerting doctors about an impending health outcome. This information can not only be used to help the patient concerned, but can also be used to develop better treatments that could help many more.

To jab or not to jab

In the wake of considerable success of vaccination drive in India, certain local administrators (e.g. district-level authorities at Bengaluru, Kerala, Pune and Chennai) imposed liability on the private employers to ensure that the employees attending offices physically are duly vaccinated and are compliant with COVID-appropriate behaviour. Some of these administrators have also gone ahead to state that the employers should bear the cost of vaccination and appoint an officer to ensure compliance. It may be pertinent to note that the orders issued by the local administrators are issued under the provisions of Disaster Management Act, 2005, Epidemic Diseases Act, 1897 or other similar state-level statutes. None of these orders are issued from the perspective of labour law-compliance and hence are silent on the vaccination being linked to terms of employment or actions to be taken against the employees for non-vaccination.

This raises the question of whether mandatory vaccination policy can be imposed by an employer upon its employees, and, if yes, whether any action can be taken against the employees refusing to take vaccination.

In this regard, the Central government in its FAQs has clearly stated that vaccination for COVID-19 is voluntary. Further, while the courts have emphasised on the importance of vaccination, several high courts have taken the view that mandatory or forceful vaccination does not find any force in law, and continuity of employment linked to vaccination would unreasonably discriminate only against unvaccinated persons and deprive them of their livelihood. 

A few matters relating to legality of mandatory vaccination remain subjudice under different high courts. Currently, there is a lack of clarity as to the actions which can be taken by employers if the employees refuse to get vaccinated. Basis the views taken by courts thus far and the clarity provided in FAQs, it can be inferred that termination of employment cannot be made a consequence of an employee’s refusal or inability to get vaccinated.

For implementing a mandatory vaccination policy, the employers may consider including requirement of vaccination as part of employee handbook, employment contract or pre-condition for appointment of a non-workman (white-collar employees). However, in case of workmen (blue-collar employees), vaccination cannot be made a ground for dismissal or retrenchment under the applicable statutes. As an alternative, employers can conduct vaccination camps, offer reimbursement of cost of vaccination or offer other positive incentives to employees who are vaccinated and can require attendance of such employees in the workplace.

Further, for implementation of vaccination policy, the employers must also ensure that they comply with all the guidelines of COVID-appropriate behaviours, applicable for their relevant jurisdictions, and obtain express consent of the employees before requesting proof of vaccination, as the medical records are considered as ‘sensitive personal information’ under Information Technology (reasonable security practices and procedures and sensitive personal data or information) Rules, 2011.

Innovations should be consumer-friendly

COVID-19 has been one of the strongest drivers leading to an increase in the concern of the patients towards their health. Moreover, the buying patterns of the consumers have also shown a tremendous change, wherein the consumption of products such as immunity boosters and vitamin supplements has shown a rapid increment. This change in attitude strongly indicates a dire need for the evolution from the traditional, disease-oriented methodology to a patient-centric outlook in the Indian pharma scenario.

Many changes and rising trends can be observed in the pharma domain owing to a lot of factors such as the pandemic and rapidly evolving technologies. Moreover, in order to achieve the ideal patient-centric pharma domain, improved drug delivery systems are available. For instance, formulations such as rapid Mouth Dissolving Tablets (MDTs) are developed that are geriatric- and pediatric-friendly and show better bioavailability than the conventional tablet dosage form.

Additionally, with the rise in several genetic diseases, a one-solution-for-all model stands obsolete. Personalised healthcare can be the only solution and precision medicine is the key to it. Precision medicine is an emerging trend that is interdisciplinary in nature. Currently, what the pharma industry needs is appropriate technology and data analytics tools to manage patient data and provide necessary insights.

Engagement with the patients increases the quality of the treatment exponentially and also impacts the cost of the treatment favourably. One such avenue is the patient engagement apps. These beyond the pill apps are essential as they regularly monitor the progress of a patient as well as supervise patient adherence towards the regimen. Various prominent pharma companies such as Abbott, Pfizer and Merck are adopting apps that help in monitoring their patient’s health and providing doctor’s assistance is evidence of the usefulness in going beyond the pill.

Furthermore, the Indian e-pharmacy sector is gaining rapid momentum as well. The market is estimated to reach $2.7 billion by 2030 and this figure was estimated even before the pandemic came into existence. The waves of COVID-19 resulted in a rise in demand for oximeters, PPE kits, sanitisers and other health equipment. Chronic diseases, the rise of the internet and the ease in ordering medications are some of the other growth drivers of the market. With various key market players such as NetMeds and PharmEasy aiming for patient satisfaction into the play, the growth looks promising. Telemedicine and teleconsultation are two such avenues because of which distance is no longer a barrier for the patients to avail medical assistance.

As seen in the above examples, patient-centricity is the new norm and digitisation is inevitable. In order for companies to sustain themselves with the changing times, they have to adapt themselves keeping the patients or consumers in mind. Firstly, the organisation needs to adapt its goals and objectives in line with patients. Moreover, they also need to adopt various digital and data analytics opportunities to understand their strengths and weaknesses as well as engage and collect patient data.

The Indian pharma industry is highly driven by innovative technology. In such a situation, it is essential to note that the innovations should be consumer-friendly as well. The drug discovery, manufacturing and regulatory process are tedious and this would create a gap between the industry and the patients. It is of paramount importance that in order to create an ideal patient-centric model, such a ‘patient-technology’ gap must be met.