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India’s Drug Quality Concerns: Is Light At The End of The Tunnel In Sight Now?

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A brief chronology of some recent events on issues pertaining to patient-health-safety with drugs, as captured below, would possibly generate a mixed feeling for many. This includes a serious concern about, especially generic drug quality safety standards in India, on the one hand, and a ray of hope in the tools available to patients to know more about drugs that they have been prescribed. In this article, I shall dwell on this area. My intent is to bring to the fore the vital point – Is the beginning of the end of a long dark tunnel in sight now?

 A chronology of some recent events:

As reported on July 16, 2023, while talking on the subject, “Pharmaceutical Quality — What are we missing?”, the Drug Controller General of India (DCGI) made a notable comment. He, reportedly, said that the poor quality of drugs exported from India to foreign countries had tarnished the image of the country in the international market. The DCGI further added, pharmaceutical quality has become a subject of discussion on the global platform and the international community has started doubting whether India is capable of making quality pharmaceuticals for the global population.

He underscored, “We boast of our country as the pharmacy of the world, but it seems that it is too difficult to maintain the top position for long. If the position is lost, it will be painful and difficult to restore the faith of the international community. Further, we will lose the opportunity to serve the whole humanity of the world. The responsibility of the loss will not only fall on the manufacturers, but equally on all the stakeholders.”

Alongside, a news report on August 01, 2023, brings some hope in this regard, which I shall elaborate in course of this deliberation.  

A long saga of events: 

Yes, as it appears from the following backdrop:

Over the last several decades, there have been many instances where international drug regulators, including the U.S. FDA, expressed concerns about the quality standards of Indian manufactured drugs. These concerns have generally been related to specific manufacturing facilities – ranging from top domestic manufacturers to smaller ones, raising an uncomfortable apprehension – does India produce ’World-Class’ medicines, for all? 

About a decade ago, one of the most well-known cases was in 2013 when the U.S. FDA issued an import alert on products from the Ranbaxy Laboratories facility in India due to data integrity and manufacturing quality issues. This led to significant scrutiny of other Indian pharmaceutical companies as well. Issues related to data integrity, product quality, and good manufacturing practices lead to inspections, warning letters, import alerts, or other regulatory measures.

It continued. For example, around that time, even Sun Pharmaceutical Industries, one of India’s largest pharmaceutical companies, received a warning letter from the U.S. FDA in 2015 (Source: U.S. FDA). Similarly, Wockhardt, another top Indian pharmaceutical company, faced regulatory scrutiny in 2013 when the U.S. FDA issued an import alert and seized products manufactured at their facility in India. The FDA raised concerns about violations of good manufacturing practices and data integrity issues at the facility. This led to recalls of several products and affected the company’s reputation. (Source: Reuters).

As the juggernaut kept moving, on  December 08, 2016, I wrote in this blog, “Even Smaller Countries Now Question Indian Drug Quality Standard.” On March 04, 2023, the Mint reported, “Death of children in Gambia linked to consumption of India made cough syrups, as the US CDC report states.”  

As I write, the veracity of impact of such incidences remains as serious, if not more, although instances seem to be much fewer. For instance, as reported by Reuters on August 01, 2023: “India has directed Riemann Labs, a manufacturer linked to cough syrup deaths in Cameroon, to stop manufacturing activities, the country’s health ministry said in a statement on Tuesday.”

Thus, On May 27, 2019, I again wrote about: “Drug Quality Imbroglio And ‘Culture of Bending Rules’ in India” in this blog– and that was not the first time I flagged this menace in the country against patient safety.

Even big Indian pharma continued to be struggling with GMP issues:

Big Indian pharma companies are also involved in issues related to lapses in high drug quality standards even recently. Such as, even in 2021, Dr. Reddy’s Laboratories, received a warning letter from the U.S. FDA after an inspection of their manufacturing facility in India. The letter cited violations of good manufacturing practices, data integrity issues, and inadequate investigations of product complaints. Source: The Economic Times). Just a year before, in 2020, the U.S. FDA noted several observations related to good manufacturing practices and quality control. (Source: Moneycontrol).

Drug regulators fight the fire as and when it comes up:

Both the state drug regulators and the Drug Controller General of India (DCGI) fight the fire at the respective manufacturing locations, as and when these come up. No significant actions on the ground for patient safety against such drugs were visible on the ground.  

For example, as reported on August 03, 2023: “Following recent incidents of several countries reporting deaths allegedly linked to “contaminated” India-manufactured drugs, the government has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP) which were revised in 2018, bringing them on par with World Health Organization (WHO) standards.”

The government ponders making technological interventions for patients:

There are early signs of the government trying to embrace technology for patients’ safety. For example on November 17, 2022, the Union Health Ministry released a gazette notification no 823Eimplementing the Drugs (Eighth Amendment) Rules, 2022, making it mandatory for pharmaceutical companies to affix a QR code on the pack of top 300 formulations from August 1, 2023. A QR code, as reported, will contain the unique product identification code, generic name of the drug, brand name, name and address of the manufacturer, batch number, date of manufacture, expiry date and manufacturing license number.

This was part of the Ministry’s ‘track and trace’ mechanism, and of course, an intent at that time. However, a specific timeline for implantation has now been clearly enunciated.

This time it’s a two-pronged action:

For the first time, I think, a two-pronged action has been announced by the government – an enabling action for patients on the one hand against a strong punitive measure for the errant drug manufacturers on the other:

According to the above gazette notification of the Union Ministry of Health, on August 01, 2023, the central government announced stricter regulations for drug authentication and transparency by imposing mandatory QR codes on drugs. This will be effective from the same day. Patients will now be able to check the QR code on their medicines to ensure their authenticity. 

On August 03, 2023, the government set a deadline for adopting WHO-standard good manufacturing practices for drug manufacturers. Companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months, while medium and small-scale enterprises with turnover of less than Rs 250 crore will have to implement it within a year. 

Conclusion:

Besides all important patient safety, there are, at least, three other important factors for manufacturing high quality drugs for all and on an ongoing basis, sans lapses, as below:

  • Patients’ trust in the healthcare system relies on the availability of reliable medication. When patients have confidence in the drugs they are prescribed, they are more likely to comply with treatment regimens, leading to better health outcomes. 
  • A strong pharmaceutical sector that focuses on safe and effective drugs can foster economic growth by generating revenue, creating jobs, and attracting investments. It can also stimulate research and development efforts.
  • A reputation for producing quality drugs can boost India’s position as a global leader in pharmaceuticals, attracting international collaborations and partnerships.

Which is why, from the entire perspective, as above, amid India’s drug quality concerns, I reckon, one may still tend to wonder now – Is a light in sight now at the end of the dark and long tunnel? 

By: Tapan J. Ray      

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Meeting India’s Unmet Biologic Drug Needs Some Global Synergy Evident – But Patients Need More

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Many reports have vindicated the rapidly growing importance of biologic drugs in the treatment of a wide range of complex ailments. These include autoimmune diseases, cancers, hormonal irregularities, anemia, and to prevent various diseases such as vaccines, have drawn healthcare experts’ attention globally.

As defined by experts, Biologics are larger, more complex molecules compared to traditional small molecule pharmaceutical drugs. Unlike traditional pharmaceuticals, they require some components from a living organism to be manufactured.

The critical importance of biologic drugs lies in their ability to provide innovative treatment options, address unmet medical needs, and significantly impact patient outcomes in various disease areas. Towards this endeavor, a clear pathway for focused initiatives is warranted, especially in countries like India.

This article will explore this domain to get a sense of how much and how fast the country is progressing in this space, having huge healthcare significance, for all. Let me start with a quick recap on the areas of seminal importance of biologic drugs – to help all to be on the same page – as I start this deliberation.

The critical importance of biologic drugs:

The critical importance of biologic drugs, I reckon, lies in their unique properties and therapeutic potential:

Targeted Therapies: Designed to interact with specific molecules or receptors in the body, allowing for targeted treatment. This specificity can enhance the efficacy of the drug while reducing potential side effects on healthy cells and tissues.

Novel Treatment Options: Offer novel treatment options for diseases that were previously difficult to manage or had limited treatment options. They have revolutionized the management of conditions such as rheumatoid arthritis, psoriasis, multiple sclerosis, and certain types of cancer.

Personalized Medicine: Paving the way for personalized medicine, as it can be tailored to individual patients based on factors like genetic profiles or specific disease characteristics. This approach allows for more precise and effective treatment strategies.

Disease Modification: Unlike some traditional drugs that primarily alleviate symptoms, biologics can often modify the underlying disease process. They can target specific pathways or molecules involved in disease progression, potentially leading to long-term benefits and improved outcomes.

Improved Quality of Life: Has the potential to significantly improve the quality of life for patients living with chronic or debilitating conditions. By effectively managing symptoms and slowing disease progression, they can reduce pain, disability, and the need for other interventions.

It is important to note that biologic drugs are complex to manufacture, often require specialized infrastructure, and can be costly. No wonder why the India specific research paper - published on January 18, 2023 commented: “Although various biologic drugs are already available, they are still not within reach of the common person due to financial constraints.”  This prompts me to explore with examples some of the key issues that Indian patients confront while meeting this health need.

Patient access to original biologic drugs in India faces several key barriers:

Patient access to original biologic drugs in India faces several key barriers, including: 

1. Cost and Affordability:

- Trastuzumab (Herceptin): The cost of a single course of Herceptin, used in the treatment of breast cancer, can range from several lakhs to crores of rupees, making it financially burdensome for many patients in India.

- Eculizumab (Soliris): Eculizumab, used in the treatment of rare blood disorders, can cost several lakhs of rupees per month, making it unaffordable for most patients.

2. Limited Healthcare Coverage:

- Many health insurance policies in India have limitations or restrictions on coverage for expensive biologic drugs, requiring patients to bear a significant portion of the cost out of pocket.

- Some government-funded healthcare schemes, such as the Pradhan Mantri Jan Arogya Yojana (PMJAY), may have restrictions on coverage for expensive biologic therapies, limiting patient access.

3. Regulatory Barriers:

- The approval process for biosimilar versions of original biologic drugs could face delays in India. For example, the biosimilar version of Trastuzumab (Herceptin) faced delays in obtaining regulatory clearance, resulting in delayed patient access to more affordable alternatives.

- The regulatory requirements for original biologic drugs can be complex and time-consuming, leading to delays in drug approvals and subsequent patient access.

4. Limited Local Manufacturing:

- Drugs like Bevacizumab (Avastin) and Adalimumab (Humira) used in India are often imported, leading to supply chain challenges and potential delays in availability.

- Limited local manufacturing of certain original biologic drugs can result in dependence on imported versions, leading to potential pricing issues and supply disruptions.

5. Physician Awareness and Education:

- Some physicians may have limited awareness or familiarity with prescribing guidelines and clinical benefits of certain original biologic drugs. This can result in underutilization or hesitation in prescribing these therapies.

- Lack of specific training and education programs for physicians regarding the latest advancements in original biologic drugs can impact their knowledge and confidence in prescribing them.

6. Patient Education and Understanding:

- Patients may have limited knowledge about the availability and benefits of original biologic drugs. For instance, patients with chronic diseases like rheumatoid arthritis may not be aware of the benefits of newer biologic treatments over traditional therapies.

- Lack of patient education about the appropriate use and potential side effects of original biologic drugs can lead to hesitancy or misconceptions among patients, affecting their willingness to pursue these therapies.

These specific examples illustrate how cost, limited healthcare coverage, regulatory barriers, limited local manufacturing, physician awareness, and patient education can act as barriers to patient access to original biologic drugs in India.

Healthcare impact of inadequate access and availability of biologic drugs in India:

The inadequate access and availability of biologic drugs in India can have several significant healthcare impacts: 

Suboptimal Disease Management: Biologic drugs often provide highly effective and targeted treatments for complex diseases such as cancer, autoimmune disorders, and rare genetic conditions. The lack of access to these therapies can result in suboptimal disease management, leading to poorer patient outcomes, increased disease progression, and reduced quality of life for affected individuals.

Delayed or Incomplete Treatment: Inadequate access to biologic drugs can result in delays or interruptions in treatment. For chronic or progressive diseases, timely initiation and consistent use of these therapies are critical. Delayed or incomplete treatment can compromise the effectiveness of interventions, leading to prolonged disease activity, exacerbation of symptoms, and potential irreversible damage in some cases.

Increased Healthcare Burden: Without access to appropriate biologic therapies, patients may require more frequent hospitalizations, emergency room visits, or other healthcare interventions to manage their conditions. This can place an additional burden on healthcare systems, leading to increased healthcare costs and strain on resources.

Reduced Treatment Options: Biologic drugs often represent the most advanced and effective treatments available for certain diseases. Inadequate access to these therapies limits treatment options for patients, forcing them to rely on less effective or outdated treatments. This restricts the ability of healthcare providers to offer the best available care to patients, potentially leading to compromised treatment outcomes.

Health Inequity: Inadequate access to biologic drugs can exacerbate health inequities in India. Patients from lower socioeconomic backgrounds or those without sufficient insurance coverage may face greater barriers to accessing these expensive therapies. This can result in disparities in healthcare outcomes, with some individuals being unable to afford or access the best available treatments for their conditions.

Impact on Research and Innovation: Inadequate access to biologic drugs can hinder clinical research and innovation in India. Limited availability may reduce opportunities for conducting clinical trials and studying the effectiveness of these therapies in the local population. This, in turn, can hamper the development of new treatments and advancements in healthcare.

Addressing the inadequate access and availability of biologic drugs is crucial to ensure equitable healthcare outcomes, optimize disease management, and reduce the burden of complex diseases in India.  

Increasing need for biosimilar drugs in India and issues involved:

From the above perspective, increasing the availability of biosimilar drugs in India is crucial. Fostering competition may improve affordability. Thereby, it would increase access to essential therapies – bridging treatment gaps, disease management, healthcare system sustainability and foster market competition and innovation.

However, it can ensure that patients receive appropriate and effective treatments while addressing the healthcare challenges faced by a diverse population, only when some key barriers created for biosimilar drug entry, besides patent thickets, are also adequately addressed. One such way is creating a global synergy in this space by collaborating with MNC pharma – having deep pockets and other requisite wherewithal.

Some global synergy is evident in this critical healthcare space:

The good news in this space has started flowing. There have been several collaborations between multinational pharmaceutical companies (MNCs) and domestic Indian drug companies to develop even high potential interchangeable biosimilar drugs in India. Here are a few examples:

- Biocon and Mylan: Biocon has collaborated with Mylan, a global pharmaceutical company, to develop and market biosimilar products. This collaboration has resulted in the development and approval of biosimilar drugs such as Trastuzumab (Herceptin) and Adalimumab (Humira) in India. 

- Dr. Reddy’s Laboratories and Merck: Dr. Reddy’s Laboratories, an Indian multinational pharmaceutical company, entered into a collaboration with Merck & Co., a global pharmaceutical company, to develop biosimilar versions of biologic drugs. This collaboration has resulted in the development and launch of biosimilars such as Pegfilgrastim (Neulasta) and Rituximab (Rituxan) in India.

- Cadila Healthcare and Novartis: Cadila Healthcare, an Indian pharmaceutical company, collaborated with Novartis, a multinational pharmaceutical company, to develop and manufacture biosimilars. This collaboration has resulted in the development of biosimilar drugs such as Rituximab (Ritucad) and Bevacizumab (Bevatas) in India.

These are just a few examples of collaborations between MNCs and Indian drug companies in the field of interchangeable biologic drugs. The landscape of collaborations and partnerships in this area is dynamic, and there may be more ongoing collaborations between companies to develop and commercialize biosimilars in India.

Conclusion:

Overall, patient access to biosimilar drugs in India is crucial for ensuring affordable and comprehensive healthcare, improving patient outcomes, and promoting a competitive pharmaceutical market. It helps address the challenges of access and affordability of biologic drugs, ultimately benefiting the well-being of patients across the country – promoting healthcare equity, and the sustainability of the healthcare system in the country. But patients need more…much more.

By: Tapan J. Ray      

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

‘Indian Pharma’s Apathy Towards Digital Marketing’ – A Misgiving Or Real?

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As I gather from different sources, an increasing number of Indian pharma companies are increasingly embracing digitalization in their marketing operations, especially after the crippling experience during the Covid lockdown period. They realize the use of digital platforms would be a great enabler for them to reach a wider audience, promote their products, and engage with healthcare professionals more effectively, in any given situation. The depth, span, and speed of adaptation of this initiative is fast gathering momentum in the capable hands of astute marketers.

In this article, I shall explore this area to ferret out the fact, whether ‘The Indian pharma industry’s apathy towards Digital Marketing’ is a misgiving or still a reality. However, I would start with an important note about getting caught in some possible controversies due to occasional overenthusiasm in this space. 

Some possible reasons for a brouhaha or controversy:

There may be several reasons why a brouhaha or controversy could continue surrounding the use of digitalization in Indian pharma companies’ marketing operations. Some possible factors include:

  • Compliance and Regulatory Issues: Digital marketing practices must ensure full compliance with regulations set by regulatory bodies, such as the Drug Controller General of India (DCGI) and the Medical Council of India (MCI). Any violation of these regulations can lead to legal consequences and damage the reputation of the companies involved.
  • Misinformation, data Integrity and Misleading Claims: The widespread use of digital platforms can make it easier for misleading, breach of data integrity and false claims to be disseminated. Regulators and critics may raise concerns about the accuracy of information being shared and the potential impact on patient health. 
  • Privacy, cyberthreats and Data Security: The use of digital platforms involves the collection and storage of user data. Privacy concerns, including cyberthreats, can arise if pharmaceutical companies do not handle personal information responsibly or if patient data is compromised due to inadequate security measures. 
  • Unethical Practices: There have been instances where pharmaceutical companies have been accused of engaging in unethical practices in their marketing efforts. These may include off-label promotion (promoting a drug for an unapproved use), undue influence on healthcare professionals, or aggressive marketing tactics that prioritize sales over patient welfare. 

It is important to recognize that the specific reasons for the ongoing brouhaha on this topic may have further evolved. From this perspective, let me now focus on a few Indian examples where using digital tools and analytics could offer several advantages for domestic pharmaceutical companies, as available from different sources.  

Examples of some areas where Indian players are using digital tools:

Here are some recent examples of how Indian pharmaceutical companies have utilized digital tools and analytics in their marketing operations, as available in the public domain:

  • Enhanced Targeting: Aurobindo Pharma Limited has implemented data analytics to identify key customer segments for targeted marketing. By analyzing prescribing patterns and patient demographics, they tailor their marketing efforts to reach specific healthcare professionals and patient groups more effectively. 
  • Personalized Marketing: Biocon Limited has embraced digital tools to deliver personalized marketing content. Through their digital platforms, such as websites and mobile applications, they provide customized information about their products, disease education materials, and patient support resources.
  • Improved Marketing ROI: Lupin Limited has utilized digital analytics to measure the performance of their marketing campaigns. By tracking key metrics, such as website engagement, social media interactions, and email response rates, they can optimize their marketing spend and allocate resources to channels that yield higher returns. 
  • Efficient Resource Allocation: Sun Pharmaceutical Industries Ltd has leveraged digital tools and analytics to optimize resource allocation. They analyze market data and customer behavior to identify regions and healthcare facilities with the highest growth potential, enabling them to allocate their sales resources strategically.
  • Real-time Market Insights: Dr. Reddy’s Laboratories Ltd utilizes digital tools and analytics to monitor real-time market insights. By leveraging social listening tools and data analytics platforms, they stay updated on market trends, competitor activities, and customer feedback, enabling them to adapt their marketing strategies accordingly.
  • Improved Customer Engagement: Cipla Ltd has focused on improving customer engagement through digital channels. They utilize social media platforms, online forums, and chatbots to interact with healthcare professionals and patients, providing information, answering queries, and offering support. 
  • Streamlined Communication: Torrent Pharmaceuticals Ltd has implemented digital communication tools to streamline interactions with healthcare professionals. They utilize virtual meeting platforms, webinars, and online training sessions to engage with physicians, pharmacists, and other stakeholders more efficiently, eliminating geographical barriers.
  • Data-driven Decision Making: Glenmark Pharmaceuticals Limited leverages data analytics for data-driven decision making. By analyzing sales data, market trends, and customer feedback, they gain insights that inform their strategic decisions regarding product launches, marketing campaigns, and market expansion. 

These examples demonstrate how Indian pharmaceutical companies have harnessed digital tools and analytics while recomposing notes in a pharma marketing playbook to enhance their business operations. However, please note that specific initiatives and strategies are still evolving, and the extent of adoption may vary among different companies. 

Conclusion:

From the above perspective, I reckon, Indian drug companies are increasingly embracing digital toolsand analytics to enhance their marketing efforts. With the advancement of technology and the growing importance of digital channels, pharmaceutical players in India are recognizing the need to adapt and leverage digital tools to stay competitive and effectively reach their target audience. Hence, any feeling about the ‘Indian pharma industry’s apathy towards Digital Marketing’ seems to be a misgiving to me.

By: Tapan J. Ray      

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Collaboration For Sustainable Excellence – The Name of The Game in The New Normal

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The union minister of health and family welfare of India recently invited Japanese companies to collaborate with Indian companies on research and innovation in emerging therapies, like precision medicine, cell and gene therapy, biological products, and on the utilization of digital tools and technologies. This was reported on May 16, 2023.

Underscoring this objective, the minister articulated, “such collaboration on research and innovation would help enhance the domestic availability and affordability of these innovative therapeutic options.”

The area of research and drug innovation in emerging therapies and on the utilization of digital tools and technologies has emerged as one of the top focus areas of the country in the new normal. Currently, the Indian pharmaceutical industry is primarily focused on manufacturing generic medicines, exporting bulk drugs, and supplying active pharmaceutical ingredients.

Thus, this goal can be quickly achieved through global collaborations – at a time when India plays a pivotal role in improving health outcomes worldwide by serving as a dependable supplier of affordable and high-quality generic drugs. The country is currently providing approximately 60 per cent of the global vaccine supply, and 20-22 per cent of generic exports. Importantly, ‘In the battle against the Covid-19 pandemic, India has supplied essential drugs to around 185 countries,” he underscored.

Interestingly, after the Covid-19 pandemic, there has been a significant shift in the approach of both Indian and multinational drug companies towards business collaboration. This article will focus on this area with recent Indian examples, culled from available reports. However, before delving into this space, let me also point out that drug MNCs operating in India are also changing focus on their India operations, as reported in recent times.

Drug MNCs operating in India are also changing business focus: 

This was brought to the fore by several recent reports. For example, in February 2022, The Economic Times reported: 

  • In February, Novartis India passed on the sales and distribution rights of three of its established brands to Dr Reddy’s Labs and terminated the employment of 400 staffers.  
  • In October, US drugmaker Eli Lilly sold the marketing rights of its anti-diabetes drugs to Cipla and laid off 120 employees in India. 
  • Around the same time, Danish pharma company Lundbeck decided to exit India as part of its global strategy. 

However, their key goal remains - delivering new patient-perceived value – not just incremental, but in quantum measure for business growth.

The need for increased collaboration and shared resources:

Against the above backdrop, it appears to me that the pandemic has highlighted the need for accelerated cooperation and sharing resources to address global healthcare challenges, effectively. As a result of which, both Indian and MNC drug companies are recognizing the benefits of working together, and are actively seeking collaboration opportunities in the following areas. 
  • Access to Emerging Markets: Indian pharma companies have a strong presence in emerging markets due to their cost-effective generic drug manufacturing capabilities. Multinational companies recognize the potential of these markets and are looking to collaborate with Indian firms to gain access to these regions. By partnering with Indian companies, MNCs can tap into local expertise, distribution networks, and regulatory knowledge. 

- Example: In 2022, Cadila Healthcare entered into a collaboration with Novartis to develop and commercialize multiple oral solids and injectable generics for global markets, including emerging markets.

  • Research and Development: Collaboration in research and development (R&D) activities has become crucial for drug companies. MNCs bring advanced research capabilities, cutting-edge technologies, and substantial financial resources, while Indian companies offer a skilled workforce and a cost-effective environment for R&D. By joining forces, they can pool their strengths and accelerate the discovery and development of new drugs and therapies.

- Example: In 2021, Bharat Biotech collaborated with the Washington University School of Medicine in St. Louis and the International AIDS Vaccine Initiative (IAVI) to develop a novel vaccine candidate for HIV. This collaboration aims to combine the strengths of all three organizations to advance HIV vaccine research.

  • Manufacturing and Supply Chain: The pandemic exposed vulnerabilities in global supply chains, particularly in the pharmaceutical sector. Collaborations between Indian and MNC drug companies can help diversify manufacturing locations and strengthen supply chain resilience. Indian companies’ expertise in large-scale generic drug production can complement the specialized manufacturing capabilities of multinational firms.

- Example: In 2021, Hetero entered into a partnership with the Russian Direct Investment Fund (RDIF) to manufacture the Sputnik V Covid-19 vaccine in India. This collaboration aimed to increase the production capacity of the vaccine to meet global demand.

  • Regulatory Compliance: Regulatory compliance is a critical aspect of the pharmaceutical industry. Indian companies have been working closely with regulatory authorities to meet global standards and gain approvals for their products. Collaborating with Indian companies enables MNCs to leverage their understanding of regulatory processes, navigate local regulations efficiently, and ensure compliance with diverse international requirements.

- Example, in 2022, Biocon Biologics partnered with Adagio Therapeutics, a US-based biotechnology company, to develop and commercialize an antibody treatment for COVID-19. This collaboration involves regulatory support from both companies to navigate global regulatory processes.

  • Market Expansion: Collaborations provide an opportunity for both Indian and multinational companies to expand their market presence. Indian companies can benefit from the MNCs’ established marketing networks, while MNCs can leverage the Indian companies’ extensive distribution channels and market knowledge. Joint ventures and partnerships facilitate market entry, improve market penetration, and help companies capture a larger share of the global pharmaceutical market. 

- Example: In 2022, Torrent Pharmaceuticals collaborated with Swedish multinational company Handicare Group AB to distribute and market Handicare’s range of mobility solutions in India. This collaboration enables Torrent Pharmaceuticals to diversify its product portfolio and expand into the healthcare mobility market. 

  • Technology and Innovation Sharing: Collaborations foster knowledge exchange between Indian and multinational drug companies. MNCs can share their technological advancements and research findings, while Indian companies can contribute their insights and expertise in managing large-scale production. Such knowledge-sharing initiatives can drive innovation, improve manufacturing processes, and enhance overall operational efficiency. 

- Example: In 2022, Glenmark Pharmaceuticals entered into a collaboration with the Canadian multinational company SaNOtize Research and Development Corp. to develop a nitric oxide nasal spray for the treatment of COVID-19. This collaboration combines Glenmark’s expertise in drug development with SaNOtize’s innovative nitric oxide platform.

  • Intellectual Property and Licensing: Collaboration often involves the exchange of intellectual property (IP) rights and licensing agreements. Indian companies possess a vast pool of generic drug formulations and manufacturing capabilities. MNCs can license their patented drugs or technology to Indian partners for production and distribution in specific markets. These licensing arrangements benefit both parties by expanding the product portfolio and maximizing revenue potential. 

- Example: In 2021, Glenmark Pharmaceuticals signed a licensing agreement with Canadian biopharmaceutical company Xenon Pharmaceuticals to develop and commercialize a potential treatment for epilepsy. This collaboration involves the licensing of Xenon Pharmaceuticals’ proprietary technology for the development of a novel therapeutic product.

Conclusion:

Overall, as the recent trends indicate, the post-pandemic era has accelerated initiatives of strategic collaboration between Indian and multinational drug companies. By leveraging each other’s strengths and with shared value and resources, these collaborations aim to drive innovation, address global healthcare challenges, and deliver affordable and accessible healthcare solutions to patients worldwide. And thereby, will help deliver a unique patient experience.

Additionally, the examples, as available from published sources, highlight an increasing number of such recent collaborations, besides operational re-focusing by several MNC drug majors in India.  

These strategic steps clearly emphasize their joint efforts to drive innovation, expand their market presence, and address critical healthcare needs. From this angle, I believe, for sustainable business excellence and for staying relevant to customers in the new digital world, one of the top focus areas for Indian pharma players deserves to be strategic collaboration initiatives.

By: Tapan J. Ray        

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Exploiting India’s Weakness For Monopolistic Commercial Gain?

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Public access to healthcare in India is a complex issue with several challenges. While India has been making progress over the years in improving healthcare access and reducing the burden of disease, there are still significant disparities in healthcare access and outcomes across the country. The three primary barriers continue to remain:

  • Affordable access to quality healthcare: This arises out of the shortage of healthcare infrastructure and resources, more in rural areas. The shortage includes an inadequate number of doctors, nurses, and other healthcare professionals, as well as inadequate facilities and equipment.
  • Cost of healthcare: While India has a largely publicly funded healthcare system, the quality of care in public hospitals is often poor, and many people are forced to opt for private healthcare, which can be expensive.
  • Access to affordable drugs: Despite India being a major producer of generic drugs, many people in India still lack access to essential medicines. This is due in part to the high cost of branded medicines, which are often out of reach for many people, as well as a lack of availability of certain medicines in some areas.

Undoubtedly, this remains a weak area for the country, till date. Successive Indian governments have taken steps to address these challenges. However, public funding on healthcare as a percentage of GDP and implementation of policies to increase access to medicine, continue to remain below par. Much work needs to be done to ensure that all people have access to quality healthcare and essential medicines.

Amid this situation, especially on the international political front, drug MNCs are continuously blaming India for the fact that the Indian Patents Act is not robust enough to protect their drug patents on NMEs and technologies. For example, in its 2022 Special 301 Report, the USTR designated seven countries on the Priority Watch List. These are Argentina, Chile, China, India, Indonesia, Russia, and Venezuela. To give some more examples from the available reports:

  • In February 2021, PhRMA, a trade group representing multinational pharmaceutical companies, raised concerns about India’s policies related to IP rights and access to medicines. PhRMA argued that India’s policies were undermining innovation and investment in the pharmaceutical industry, and that multinational pharmaceutical companies were facing difficulties in doing business in India. 
  • In March 2021, Pfizer’s CEO also expressed concerns about India’s policies related to IP rights and access to medicines. He said that Pfizer was facing challenges in obtaining patents for its products in India, and that the lack of adequate patent protection was discouraging investment in research and development.
  • In May 2021, Novartis’s CEO criticized India’s policies related to IP rights and access to medicines. HE stated that the lack of adequate patent protection in India was discouraging innovation and investment in the pharmaceutical industry, and that multinational pharmaceutical companies were facing difficulties in doing business in India. 

Against this backdrop, in today’s article I shall deliberate on this vexing issue – starting from some key grievances of drug MNCs in this regard. Thereafter we will look at the Indian industry response to drug MNCs’ concern about the robustness of the Indian Patents Acts. This could possibly help us to understand the key question – Is it then an attempt to exploit India’s weakness regarding inadequate overall access to medicines for monopolistic gain by the vested interest?

Key grievances of drug MNCs for poor access to medicines in India: 

One can recall that the Patent Act in India was amended in 2005 to comply with the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. The amendment made it more difficult for multinational pharmaceutical companies to obtain patents for their products in India for the ‘me too’ type of innovation, which has led to lower prices for medicines and increased access to affordable drugs for the Indian population.

However, drug MNCs generally argue that:

  • The lack of adequate patent protection in India discourages innovation and investment in research and development, which ultimately limits the availability of new drugs for patients in India.
  • They have also criticized the Indian government’s use of compulsory licensing, which allows the government to authorize a third party to produce a patented drug without the consent of the patent holder. They argue that this undermines their intellectual property rights and discourages investment in research and development, which ultimately limits access to new and innovative drugs for patients in India.

Counter argument by Indian companies:

Indian companies, on the contrary, defend their position and policies related to access to medicines and healthcare in India, and have responded to the accusations made by drug MNCs in the following ways:

  • Provides adequate patent protection: The Indian Patents Act provides adequate IP protection, in accordance with the TRIPS agreement. They have also pointed out that the patent laws in India allow for the grant of patents for genuine inventions, while preventing the grant of frivolous or secondary patents (the me-too types), which can result in excessive monopolies and high prices for medicine. 
  • Encourage innovation: Indian policies have not discouraged innovation in the pharmaceutical industry. They have pointed out that Indian companies invest heavily in research and development and have developed several innovative drugs that have been approved by regulatory authorities in India and around the world. 
  • Rare occurrence of Compulsory licensing: The use of compulsory licensing is a legitimate tool under international law and is aimed at promoting public health and ensuring that life-saving drugs are accessible and affordable to patients in India. They have also pointed out that the use of compulsory licensing is a rare occurrence in India and is only used in exceptional circumstances.

Overall, Indian drug companies have emphasized their commitment to improving access to medicines and healthcare in India, while ensuring that their policies are in line with international laws and regulations. They have also emphasized the need for collaboration and dialogue with multinational pharmaceutical companies to find mutually acceptable solutions that benefit patients in India and around the world.

Examples of innovative drugs developed by Indian drug companies:

It’s interesting to note that in the same IP scenario, Indian companies with limited resources, are developing innovative drugs that have been approved by regulatory authorities around the world. Here are a few examples, as reported at different times:

  • Lipaglyn: Developed by Zydus Cadila, Lipaglyn is the first-ever drug approved for the treatment of diabetic dyslipidemia. It has been approved in India and several other countries, including the European Union. 
  • Tafinlar: Developed by Dr. Reddy’s Laboratories, Tafinlar is a kinase inhibitor that has been approved by the US FDA for the treatment of advanced melanoma. 
  • Mycapssa: Developed by Sun Pharma, Mycapssa is a novel oral formulation of octreotide, a hormone therapy used to treat acromegaly. It has been approved by the US FDA. 
  • Saroglitazar: Developed by Zydus Cadila, Saroglitazar is a dual PPAR agonist that has been approved in India for the treatment of diabetic dyslipidemia and non-alcoholic fatty liver disease (NAFLD). 
  • Nexavar: This much discussed drug, originally developed by Bayer and by Natco Pharma, is a kinase inhibitor that has been approved by the US FDA for the treatment of liver and kidney cancers.

Conclusion:

The IP issues keep haunting India and are being captured in different Special 301 Reports of the USTR, even after The Indian Patents Act 2005 came into force – till 2022. Any change to this Act seems very unlikely now as this is an important piece of legislation that helps balance the interests of protecting intellectual property, promoting innovation and access to affordable medicines. Any dilution of this Act could have negative consequences for India and its citizens.

From this perspective, I reckon, any further pressure in this area may be construed as an attempt to exploit India’s weakness of inadequate access to medicines for monopolistic gain by vested interests. 

By: Tapan J. Ray        

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Indian Pharma Leadership: A Glimpse of Changing Mindset Post Pandemic

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A recent survey of physicians, published by the CMI Media Group, provides fresh evidence that Medical Representatives meetings with the physicians that have become trickier to arrange since COVID-19, still continue. This was also reported in the March 29, 2023, edition of Fierce Pharma.  

The survey objective was to capture what are physicians’ preferences, when asked whether they want to meet with pharmaceutical reps in person more often, less often or in equal frequency as pre-pandemic. Some of the key findings of this recent study include the following: 

  • 25% of the doctors, reportedly said they are reducing face-to-face interactions.
  • With 10% of doctors responding never seeing reps, it could be challenging for many pharma players to call on these doctors via the traditional in-person route. 
  • However, another 51% of physicians replied that the frequency of their in-person interactions is unchanged from pre-pandemic and 14% seeing reps more frequently than before. 
  • It also found that digital channels have potential to compensate for the pullback from in-person meetings.  
  • Most of such doctors prefer receiving resources for talking to reps via video or phone. 
  • Interestingly, 70% and 78% of physicians said digital resources are more convenient, educational and valuable than remote rep visits. 

Let me hasten to add that the above study was carried out mostly in the European countries. Thus, in today’s deliberation, I would focus mainly on two areas:

1. How is this situation evolving in India and the way some of the Indian majors are gearing up to convert this challenge into opportunities to gain a competitive edge, and 

2. What, in my view, needs to be a pharma marketing leadership mindset change, alongside its traits for effective change management, to excel in the changing market dynamics. More importantly, whether or not this trend is also visible within some of the Indian pharma majors.

The comparable situation in India:

I find some interesting data on the Indian pharma industry in this regard, from several public domain. These indicate that while some physicians may be open to virtual interactions with medical representatives during and after the COVID pandemic, there are also examples of physicians who were not too keen to meet with pharma reps. These seem to be for several reasons. Some reported examples are as follows:

  • Delhi Medical Association (DMA), which represents more than 15,000 doctors in the Indian capital, has banned pharma med reps from entering hospitals or meeting with doctors in person. The DMA has cited concerns about the influence of pharma reps on prescribing practices, besides potential conflict of interest.
  • With over 3.5 lakh memberships, the Indian Medical Association (IMA) appears to have discouraged physicians from meeting with MRs. Instead, the association has urged them to rely on evidence-based information and guidelines while prescribing drugs to patients.
  • Some private hospital chains in India have also restricted or banned pharmaceutical sales representatives from interacting with physicians. This includes Fortis Healthcare, which has banned pharma reps from its hospitals in Delhi and Mumbai, and Max Healthcare, which has restricted interactions to virtual meetings only. 
  • The Indian Psychiatric Society (IPS) has issued guidelines for its members recommending that they avoid interactions with pharma med reps. The IPS has stated that interactions with pharma reps can create conflicts of interest and bias in prescribing practices and may not always provide accurate and reliable information.
  • Some physicians in India are increasingly turning to online platforms to access unbiased information about medications and treatments, rather than relying on information provided by reps. Online platforms such as Medscape and Docplexus provide physicians with access to up-to-date medical information and peer-reviewed research studies.

With a changing mindset, some Indian players are facing this challenge:

Evidence suggests that there is a growing awareness among several physicians in India about the potential biases and conflicts of interest that can arise from interactions with pharma representatives. While virtual interactions and non-promotional information may still be acceptable to some physicians, others may prefer to rely on more objective sources of information or avoid interactions with pharma reps altogether. 

There are several examples in this area highlighting how some Indian pharma majors are trying to stay ahead of the technology curve. As reported, some specific responses of Indian pharmaceutical companies to the restrictions on interactions with physicians

include, Cipla’s launch of a digital platform called CiplaMed to provide healthcare professionals with access to non-promotional medical information and education.

Post-pandemic changes in the mindset and outlook of marketing leadership:

As I see, the COVID pandemic experience has brought significant changes in the mindset and outlook, especially, in the marketing leadership of several Indian drug companies. One key reason could be the success requirements in contemporary pandemic market dynamics are going through a metamorphosis. Which is why the emerging situation demands new approaches and strategies for success.  

Many pharma marketing leaders are now trying for early identification of even the nuanced change requirements relevant to their respective organizations for sustainable business success in the current paradigm. Some of these requirements were identified as:

Agility and Adaptability: The pandemic has highlighted the importance of being agile and adaptable. Pharma marketing leaders must now be able to quickly pivot their strategies and tactics based on changing market conditions and consumer needs.

For example, Cipla adapted quickly to the changing market conditions during the pandemic by ramping up the production of essential medicines and medical supplies. The company also developed innovative product solutions, such as a portable mechanical ventilator, to address the critical shortage of medical equipment during the pandemic. 

Similarly, Lupin demonstrated agility by diversifying its product portfolio to include COVID-19 testing kits, PPE, and other pandemic-related products, besides helping to develop innovative solutions to address the pandemic, such as a telemedicine platform that enables patients to consult with doctors remotely. 

Digitalization: The pandemic has accelerated the shift towards digitalization in the pharma industry. Marketing leaders must be able to effectively leverage digital channels such as social media, online advertising, and telemedicine to reach and engage with consumers.

For instance, Dr. Reddy’s Laboratories leveraged digital technologies to enhance its customer engagement efforts. The company developed a mobile app called - ‘Medznat.’ It is touted as a one-stop solution for physicians, medical students and other healthcare professionals to stay abreast with the latest medical knowledge. It offers an umbrella of offerings, such as news, scientific articles, case studies, regulatory updates, medical events, drug flashcards, and many more. The app offers some key features, such as: personalized quality content, any time, anywhere and patient education materials.

Customer-centricity: The pandemic has increased the need for customer-centricity in the pharma industry. Marketing leaders must now prioritize customer needs and preferences and tailor their marketing strategies accordingly.

Sun Pharma appears to be another leading example that, reportedly, demonstrated customer-centricity by developing patient assistance programs that provide financial support to patients who cannot afford their medications. The company also partnered with healthcare providers to develop disease management programs that improve patient outcomes and reduce healthcare costs.

Data Analytics: The pandemic has highlighted the importance of leveraging data science and data analytics in the pharma industry. Marketing leaders must be able to effectively analyze data to understand customer behavior and preferences and to measure the effectiveness of their marketing campaigns. 

The name of Glenmark Pharmaceuticals comes to the top of mind in this area. The Company is now using data analytics to analyze sales data and identify trends in the market. The company is also using analytics to track physician interactions and ensure compliance with government regulations.

Continuous Innovation: The pandemic has created new opportunities for innovation in the marketing domain. Thus, marketing leaders must be willing to experiment with new approaches and technologies to stay ahead of the competition and meet changing customer needs.

As is known to many, Zydus Cadila has developed a COVID-19 vaccine and has also been working on the development of a COVID-19 drug. The company has also been involved in the development of new drugs to treat various other diseases.

Collaboration: The pandemic has underscored the need for collaboration across the healthcare ecosystem. Pharma marketing leaders need to work closely with other stakeholders, including healthcare providers, payers, patient advocacy groups, and government agencies, to develop solutions that meet the needs of all stakeholders.

In this area, Biocon, for instance, collaborated with government agencies and NGOs to distribute COVID-19 vaccines and treatments to underserved communities. The company also worked with healthcare providers and patient advocacy groups to develop education and awareness campaigns that promote better health outcomes.

Similarly, Dr Reddy’s Laboratories partnered with IQVIA to rollout IQVIA’s OCE application to its entire field force and marketing users in India to drive more meaningful and impactful customer engagement.

 Conclusion: 

These are a few areas with examples from a few Indian pharma majors that would give a sense of how the mindset and outlook of their marketing leadership teams are changing. This is happening, as is widely believed, after having experienced the last two years’ unprecedented disruptions in business and customer behavior.

It’s equally interesting to note that our domestic drug industry, which was not traditionally well known for effecting significant proactive changes – is transforming itself while stepping into the post-pandemic world – in pursuit of excellence. 

By: Tapan J. Ray        

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

 

Accelerating Footfalls In Less Charted Pharma Marketing Frontiers

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Having experienced unprecedented disruptions, especially in the pharmaceutical and biopharmaceutical business, many global and local drug majors, are rethinking their marketing strategies. These have, no doubt, been prompted by the challenges of change, which are sometimes stark, but more often than not - nuanced.

Many of them are now, therefore, charting into less charted or even uncharted frontiers of pharma marketing warfare. Most companies had no choice, though, but to embrace new approaches, at least as a stopgap, to reach their target audience – hoping to revert to pre-pandemic practices, ultimately.

Interestingly, some pharma majors could envisage that long-term focus on many of these new and innovative areas – more effectively than even the pandemic lockdown time, could be a game-changer in the business. Accordingly, they tried to adapt, several of these approaches, quickly and effectively – for sustained excellence in the post-COVID paradigm.

In this article, I shall focus with several global and local, publicly available examples, of innovative pharma marketing approaches that are now being tried by several top drug companies in the post-COVID period.

I. Continuation of pandemic induced innovative approaches – global examples: 

  • Virtual Conferences and Events: Experiencing success with virtual events and conferences during the COVID-19 pandemic, many pharma companies are leveraging this digital space to reach out to healthcare professionals and patients. These events now include webinars, selected virtual conferences, and online workshops.

Pfizer, reportedly, held its first virtual investor day in September 2020, which was attended by thousands of participants from around the world. The company also organized several virtual events to educate healthcare professionals about its vaccine.

  • Social Media Marketing: The use of social media marketing is also increasing in the pharmaceutical industry. Companies are using platforms such as Facebook, Twitter, and LinkedIn to reach out to their customers and engage with them on a regular basis to build long-term relationships.

For example, Novartis, among a few others, is using social media to promote core values of its products and engage with customers. The company has built a strong presence on social media platforms where it shares news and updates about its products and research, as well.

  • Influencer Marketing: Many companies are partnering with influencers in the healthcare industry to promote their products. These influencers can be doctors, nurses, patient advocates, or even celebrities who are passionate about health and wellness. Influencer marketing can help companies reach a wider audience and build trust with their customers.

The French pharma major – Sanofi, has partnered with celebrity chef and diabetes advocate Charles Mattocks who was diagnosed with type 2 diabetes in 2011. The objective is to raise awareness about diabetes and promote the company’s diabetes products through social media and other channels.

  • Patient Education Programs: Companies are investing more on patient education programs to educate patients about their health conditions and treatment options. These programs can include online resources, mobile apps, and support groups. By providing patients with accurate and reliable information, companies can improve patient outcomes and build brand loyalty.

Merck, another global player, developed an online resource called MerckEngage to educate patients about their health conditions and treatment options. The platform provides patients with information about various health topics, including diabetes, cancer, and heart disease.

II. Continuation of pandemic induced innovative approaches – Indian examples: 

Some Indian pharma players are also not far behind in several innovative areas for business excellence in the post pandemic paradigm. Following are some of those examples from Indian pharma companies, as available in the public domains. These seem to have attracted greater focus in the pandemic period, and are continuing even today, with undiluted focus:

Virtual Conferences and Events: Illustratively, Lupin has been using virtual events to promote its products in the post-COVID period. The company is organizing virtual conferences and webinars to reach out to healthcare professionals and other customers. Similarly, Sun Pharma launched a virtual conference for healthcare professionals to discuss the latest developments in the field of dermatology.

Digital and Social Media Marketing:  Several Indian pharma companies are increasingly adopting digital marketing “strategies to reach out to their customers. Companies are using social media, online ads, email marketing, and other digital channels to promote their products and services.

For example, Dr. Reddy’s Laboratories continue using social media platforms like LinkedIn, Twitter, and Facebook to engage with healthcare professionals and consumers. Even, Cadila Healthcare, reportedly, has been using search engine optimization (SEO), pay-per-click (PPC) advertising, and social media marketing to reach out to its customers.

Telemedicine: With the rise of telemedicine during the pandemic, pharma companies are partnering with Telehealth/Telemedicine platforms to reach out to patients. Companies like Cipla have partnered with telemedicine platforms to offer online consultations and delivery of medicines to patients’ doorsteps. Sun Pharma has also been using telemedicine to reach out to its customers and has partnered with telemedicine providers to offer its products to patients who cannot visit a doctor in person.

  • Direct-to-Consumer (DTC) advertising: DTC advertising is gaining popularity among Indian pharma companies. With the rise of online pharmacies, companies like Abbott and Pfizer are launching DTC campaigns to increase disease and treatment awareness programs directly to consumers.
  • Collaborations and partnerships: Indian pharma companies are increasingly collaborating with other players in the healthcare ecosystem to provide integrated solutions. For example, as mentioned above, Lupin has partnered with a health-tech firm to offer a platform for online consultations and home delivery of medicines.
  • Greater patient-centric approaches: Some Indian pharma companies are adopting more patient-centric approaches for more effective omnichannel patient engagement initiatives. For example, Dr. Reddy’s Laboratories have launched an initiative to educate patients on the proper use of medicines and the importance of adherence to treatment.

As the industry continues to evolve, we can expect to see more companies adopting newer and more innovative marketing strategies to engage with their customers.

Summary:

Many of the above examples are pandemic triggered innovative approaches to keep the neck above water during unprecedented business disruptions in the pharma industry. Interestingly, some companies are not just continuing but further sharpening these initiatives in the post pandemic days. Moreover, it’s good to note that these are now being implemented by the concerned sales and marketing teams with greater gusto and zeal.

The point to ponder, therefore, is pharma industry ready now to excel amid start and more often nuanced – the challenge of change? To respond to these challenges effectively, more companies now need to seriously evaluate and consider adapting such strategic footsteps, first as pilot studies and then gradually scale up, for business excellence in the contemporary period.

Let me hasten to add, in this ball game pharma leadership mindset change to act decisively, after accurately studying – based on data-science, to ascertain where and how to change could well be a win-lose situation. However, the good news is, recent data vindicate the accelerating footfalls in many these less or even un- charted pharma marketing frontiers, both globally and locally.

By: Tapan J. Ray        

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Effective Change Management – The Magic Wand For Business Success And Sustainability

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Change – just as it’s an integral part of our life, so is for any business, including pharmaceutical or healthcare. Interestingly, the phase of transition of such changes isn’t always slow and gradual. In many cases, especially for business, or for a lifestyle too, these transitions could also be faster and disruptive.

The speed of many such changes is now driven by rapidly evolving technology. Or these could often be triggered by some unanticipated event, like the Covid-19 pandemic that we all experienced, very recently. Such changes may impact people working in different functions, in different ways. Which is why, organizations need to be all-time ready, with a robust process in place – known as Change Management.

In this article, I shall focus on the relevance of putting in place a well-validated system driven Change Management process within, especially, the Indian pharmaceutical organizations. Let me start with my understanding on what is the Change Management, so that all of us be on the same page in this regard. 

To be on the same page on what is Change Management:

There are several definitions of the change management process expressed differently, but it’s core concept remains unchanged. One such illustration comes from The TechTarget network. It says:“Change management is a systematic approach to dealing with the transition or transformation of an organization’s goals, processes, or technologies. The purpose of change management is to implement strategies for effecting change, controlling change, and helping people to adapt to change.”

Why many pharma majors are considering it now, more than ever before:

Being amid a technological revolution, encompassing almost all aspects of life and then in the post-pandemic area, change is being expected as a way of life and business, more than ever in the past. Although pharma industry a late learner - and is also traditionally late to change – these can’t be now pushed to the back burner, any longer, as was happening in the pre-pandemic era.

‘Change Management’ can’t be pushed to the back burner, any longer:

This process has now attracted a sense of urgency for many pharma players, as we read and look around. Several big companies have already started addressing the leadership challenges to manage and leverage the evolving changes, as I wrote in my article of October 3, 2022, in this blog.

To be in sync with both customers and employee expectations on an ongoing basis, the change management process in an organization has assumed a priority. User friendly state of the art technology is facilitating to effectively address the growing intricacies of today’s field staff role by infusing leadership mindset change in the organizational culture. Emphasizing this point in my article on July 19, 2021, I underscored that such change should necessarily reflect the company’s vision for the future, unambiguously.

Most companies have changed over a period of time in varying degree:

Most companies have changed over a period of time. Nonetheless, today’s need, pace and the process of change demand a data science based customized approach. The good news is several pharma majors have also started feeling that they require not just to change with time, but also need to put more data science based cerebral input to fathom why and how it changed to be more effective in the future.

An insightful understanding is essential to put in place and kick start a right change management process. To give a sense of it, let me cite a contemporary example of one of the successful global pharma majors – GSK. This case study was prepared by the Project Management Institute.

Achievement of a key milestone could make all the difference:

When GSK initiated this process in 2009, the organization realized that an important milestone in the implementation of the company’s change initiative must be to gain the trust and belief of leadership—many of whom were neutral or cynical about it.

To achieve this goal a custom made ‘Accelerating Delivery and Performance (ADP) program; was found to be quite effective for the company. It delivered both hard business benefits as well as softer organizational development benefits. This approach allowed the team to gain the attention of those leaders who wanted both.

Five principles formed the bedrock of the ADP approach:

The following ADP principles are time-tested, contemporary, and several of these were practiced by GSK in their change management process when it started in 2009.

  • Changes should begin with the initiator of change and focusing on greater customer satisfaction.
  • Active support of all stakeholders in the process of change is critical.
  • Include all staff who will be impacted by the change – while defining, explaining, and ensuring accountability and continuously measuring the time bound shared goals, especially the business and financial ones.
  • Make sure they all share ownership for the outcome of change, through seamless teamwork.
  • Make a pilot study before pan organization implementation.

The change management process continues:

That the change management process needs to be ongoing even for successful drug majors – such as GSK, is particularly evident from their Press Release on June 23, 2021.

The communique giving details of the organization’s strategic and other transformation pathways, also highlighted, “New GSK to deliver step-change in growth and performance over the next ten years driven by high-quality Vaccines and Specialty Medicines portfolio and late-stage pipeline.” 

Specific areas of change, as the pandemic wanes:

There are several studies in this area, such as the one published in the Growth Faculty Learn, published on February 07, 2023. Let me paraphrase its summary as follows:

  • Although the pace of change in different businesses may vary but will certainly keep changing. The leaders should, therefore, act proactively to lead their teams through a well validated change management process to gain a competitive edge.
  • Full preparedness for the change and garnering change management skills before the process begins are critical.
  • Advance planning for employee wellbeing, well structured individual and collective communication strategy, deciding on specifics of a hybrid work culture – all based on data-science, are of great importance.
  • To ensure the effectiveness of the change management process a positive workplace environment is a must, which will stand on five pillars - Trustworthiness, Empathy, Genuineness, Self-awareness, and a Learning mindset.

Thus, it’s high time for all to realize that the pharma business ball game is now changing fast for all, creating an urgent need to focus on the critical areas of change.

Conclusion:

It now boils down to an important point, which was also echoed in an article on this area published in the Pharma IQ on November 23, 2022. It underscored just as any living being keeps moving on the pathway of change, pharma and healthcare industry should proactively follow a similar path.

External environmental factors would play a catalytic role to accelerate the speed of change. These include fast evolving consumer friendly digital applications and health apps - newer, better, and more targeted drugs and treatment processes, or even unprecedented disruptions of lives and livelihoods, just what we all have recently experienced.

A study published in the Pharma Marketing Network on October 27, 2021, also reiterated that the main goal of any change management approach is to foster support of all concerned that leads to good outcomes within an organization. It found that an effective way to implement a change is by engaging and inspiring employees to adopt new (and improved) ways of working.

Against the above backdrop, putting a structured change management process in place by Indian pharma players, I reckon, is now essential. This approach seems to be a Magic Wand, as it were, for ongoing business success and sustainability in today’s rapidly evolving paradigm.

By: Tapan J. Ray       

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.