Published on: September 28, 2024

This article series by Dr. Preeti Chauhan continues to draw upon the foundational knowledge presented during the five-day training on “Access to Medicines, TRIPS, and Patents in the Developing World.” Day Two of the training offered valuable insights into the pharmaceutical industry, with presentations by Dr. Aashna Mehta, Reji K. Joseph, and Dr. Gargeya Telakapalli.
In this second instalment, we will delve into the journey of medicines from lab to shelf to community, a topic expertly presented by Dr. Gargeya Telakapalli. This exploration builds upon the core concepts introduced by Dr. Gargeya and Dr. Arathi PM during Day One, where we examined the complex interplay between health rights, intellectual property, and access to medicines in developing countries.
By understanding the intricate processes involved in the pharmaceutical industry, we can gain a deeper appreciation for the challenges and opportunities that exist in ensuring equitable access to essential medicines.

Read the previous article on Health Systems and Access to Medicines in India

The Journey of a Medicine: From Lab to Shelf to Community

A Global Perspective with a Focus on India

This part of the article delves into the intricate journey of medicines, from their discovery in laboratories to their availability on shelves and ultimately reaching communities worldwide. We will explore the key stages involved, the role of research and development, clinical trials, and the factors influencing access to medicines. With a particular focus on India, we will examine the country’s significant contribution to the global pharmaceutical industry and its impact on the Indian diaspora.

The Penicillin Story: A Testament to Collaboration

The year is 1928. Alexander Fleming, working at St. Mary’s Hospital in London, stumbles upon a revolutionary discovery – penicillin. This groundbreaking antibiotic promised to significantly reduce deaths from infections. However, Fleming’s initial struggles to communicate his findings and convince chemists to assist in extracting and stabilizing the compound highlight the importance of collaboration in scientific progress.

Research and Development: Picking Up the Mantle

Fast forward to 1939. Enter Ernst Chain and Howard Florey, who join forces to investigate natural antibacterial agents. Their work leads them to revisit Fleming’s research on penicillin, abandoned years earlier due to perceived difficulty. It is Chain and Florey who persevere, isolating and concentrating penicillin’s germ-killing properties, paving the way for its use in clinical trials.

The Challenge of Mass Production

The early success of penicillin in treating patients presented a new hurdle: mass production. In 1941, the first patient received penicillin, but limited supplies tragically led to his death. Collaboration once again played a crucial role as scientists and manufacturers like Merck & Co. tackled the complex task of large-scale production. By 1943, the War Production Board stepped in, ensuring penicillin distribution to Allied troops in Europe.

Understanding the Building Blocks of Medicine

The article sheds light on the key components of a medicine:

• Active Pharmaceutical Ingredients (APIs): The active ingredient responsible for a medicine’s therapeutic effect.
• Formulations: The form in which a medicine is delivered (e.g., tablets, capsules, syrups), ensuring the API reaches the right part of the body at the correct dosage and rate.
• Biologicals: Medicines derived from living organisms, such as vaccines and insulin.

Clinical Trials: Ensuring Safety and Efficacy

The article introduces the concept of clinical trials, a crucial stage in a medicine’s journey. These rigorous studies, involving multiple phases, assess the safety and effectiveness of a potential drug in humans.

Beyond Penicillin: The Intricate World of Pharmaceutical Manufacturing

The complexity of drug development is further emphasized by the distinction between small molecules (conventional drugs) and large molecules (biological products). The article briefly explains the various phases of manufacturing for small molecules, including API production and formulation.

Who Pays for Innovation?

The article raises a vital question – who funds the high costs associated with research and development (R&D)? Interestingly, public funding contributes significantly to R&D, with much pharmaceutical innovation building upon publicly funded scientific work.

Ensuring Access: A Global Challenge

The concluding section highlights the crucial issue of access to medicines. The COVID-19 pandemic starkly exposed the inequities in access to critical medical products.

The article concludes by mentioning the TRIPS waiver proposal championed by South Africa and India, aiming to increase access to affordable medicines during public health emergencies.

Important Insights

• Indian Government’s Role: The Indian government has played a crucial role in supporting the pharmaceutical industry through various initiatives, including research funding, tax incentives, and regulatory reforms.
• Public-Private Partnerships: Collaboration between public research institutions and private pharmaceutical companies has been instrumental in driving innovation and accelerating drug development in India.
• Challenges and Opportunities: While India faces challenges such as intellectual property rights and infrastructure limitations, it also presents significant opportunities for growth and expansion in the global pharmaceutical market.
• Ethical Considerations: The ethical implications of drug development and access, including issues of affordability, accessibility, and patient safety, are increasingly important considerations in the pharmaceutical industry.

Additional Story:

• Kerala’s Quest for Vaccine Self-Sufficiency: Kerala’s proactive stance in seeking domestic sources for Active Pharmaceutical Ingredients (APIs) for vaccine production in 2021 was seen as a strategic move that aligns with the state’s broader healthcare goals. By reducing reliance on foreign suppliers, Kerala aims to enhance vaccine security, ensure timely access to essential medications, and stimulate economic growth within the pharmaceutical sector.
• The Pasteur Institute Vaccine Supply Story: The Pasteur Institute, a renowned global health organization, has played a pivotal role in vaccine development and distribution. However, recent challenges in the global vaccine supply chain, including disruptions caused by the COVID-19 pandemic, have highlighted the importance of regional self-sufficiency. Kerala’s initiative to establish domestic API production can be seen as a response to these global trends and a proactive measure to safeguard public health.
• Impact of Domestic API Production on Kerala:
• Enhanced Vaccine Security: By producing APIs locally, Kerala can reduce its vulnerability to global supply chain disruptions, ensuring a consistent and reliable supply of vaccines for its population.
• Reduced Dependence on Imports: Domestic API production can help Kerala reduce its reliance on foreign imports, saving valuable foreign exchange and strengthening the local economy.
• Job Creation and Economic Growth: The development of domestic API manufacturing facilities can create new jobs and stimulate economic growth in Kerala’s pharmaceutical sector.
• Technological Advancement: Investing in API production can drive technological advancements and foster innovation within the state’s pharmaceutical industry.
• Public Health Benefits: Access to locally produced vaccines can improve immunization rates and public health outcomes in Kerala.

Conclusion

The journey of a medicine from lab to shelf to community requires collaboration, innovation, and access. As the pharmaceutical landscape evolves, addressing ethical considerations, affordability, and accessibility is crucial.