Revision. Two pharmacists making medicines revision in a drugstore

The Journey of a Drug: From R&D to Your Pharmacy Shelf

Every drug that reaches your pharmacy shelf undergoes a remarkable journey, traversing through various stages of research, development, manufacturing, and regulation. This journey is a testament to scientific innovation and a demonstration of stringent quality standards and regulatory compliance.

In this article, we delve into the comprehensive process of how a drug evolves from its conception in research and development (R&D) laboratories to its availability on the shelves of pharmacies worldwide. Along with a keen focus on the value chain expertise and the significance of WHO/EU GMP certifications.

Research & Development (R&D)

The research and development phase is at the heart of every drug’s journey. Here, pharmaceutical companies invest significant resources into discovering new molecules or repurposing existing ones to address unmet medical needs. 

This phase involves many scientific disciplines, including medicinal chemistry, pharmacology, and toxicology. Researchers meticulously screen thousands of compounds, seeking those with the desired therapeutic effects and minimal side effects. Consequently, once a promising compound is identified, it undergoes preclinical testing, where its safety and efficacy are evaluated in laboratory settings and animal models. This stage is crucial for determining whether the compound warrants further development.

Clinical Trials

Upon successful completion of preclinical studies, the drug candidate progresses to clinical trials – the cornerstone of drug development. These trials are divided into phases and involve rigorous testing in human subjects to assess safety, efficacy, and optimal dosage. These phases are: 

  1. Phase 1: Primarily focuses on small-scale testing for safety and dosage in healthy volunteers.
  2. Phase 2: Testing in a larger group to determine efficacy and side effects.
  3. Phase 3: Large-scale testing in diverse populations to confirm efficacy and monitor adverse reactions.
  4. Phase 4: Post-marketing surveillance for long-term safety and efficacy.

Regulatory Approval

Adherence to Good Manufacturing Practices (GMP) is central to the pharmaceutical value chain. GMPs are a set of quality assurance guidelines that ensure the consistent production of safe and effective pharmaceutical products. Recognizing the global nature of pharmaceutical manufacturing, organizations such as the World Health Organization (WHO) and the European Union (EU) have established GMP standards to harmonize quality standards worldwide.

Additionally, when a drug developer has gathered evidence demonstrating a drug’s safety and efficacy, they file a New Drug Application (NDA) with the FDA. This comprehensive document includes all relevant data from preclinical and clinical studies, proposed labeling, safety updates, and more. 

Upon receiving the NDA, the FDA review team meticulously examines its contents. If deemed complete, the team has 6 to 10 months to decide on approval. Each team member conducts a thorough review, supplemented by on-site inspections, to ensure data integrity. 

However, if the FDA determines the drug is safe and effective, labeling is refined to reflect its approved uses. Sometimes, additional studies or clarifications are requested before final approval.

Manufacturing

After regulatory approval, pharmaceuticals enter the manufacturing phase. This phase is marked by meticulous attention, stringent quality control, and advanced technology to ensure safe and effective drug production.

Raw Material Sourcing and Quality Assurance

Manufacturing starts with getting raw materials. Manufacturers carefully choose suppliers by checking their facilities to ensure the raw materials are pure and potent, avoiding contamination that could harm the final product. They also check if suppliers follow Good Manufacturing Practices (GMP) to maintain quality standards.

Formulation and Process Development

Pharmaceutical manufacturers optimize drug composition during formulation and process development for efficiency and patient compliance. Scientists assess solubility, stability, and administration routes. And, engineers design manufacturing processes for consistency and quality.

Manufacturing Operations and Quality Control

Pharmaceutical manufacturers move to large-scale production in advanced facilities, ensuring precise control. Each step is monitored for cleanliness and integrity, with quality control labs conducting comprehensive testing. This testing includes HPLC and mass spectrometry, to verify product quality and regulatory compliance.

Packaging and Distribution

After manufacturing, pharmaceutical products are packaged and labeled to safeguard against the environment and tampering while providing essential information. Manufacturers use various packaging formats tailored to dosage forms. These products are then distributed to wholesalers, distributors, and pharmacies, reaching patients.

Post-market Surveillance

Drug safety is a continuous process. Although clinical trials offer critical insights into a drug’s efficacy and safety, complete safety understanding isn’t immediate upon approval. A complete safety profile is only formed over time in the market. The FDA monitors drugs post-approval, updating information and issuing cautions or other measures if needed. 

It includes changes via supplemental applications, new uses via INDs, and routine inspections of manufacturing facilities. The FDA also regulates drug advertising to ensure accuracy and prohibits unapproved uses. Moreover, programs like MedWatch and MedSun facilitate reporting problems and enhance post-market safety monitoring.

Collaboration Across the Value Chain: A Network of Expertise

The journey of a drug from R&D to the pharmacy shelf requires expertise at every stage of the value chain. Pharmaceutical companies collaborate with a diverse network of stakeholders, including scientists, clinicians, regulatory experts, and manufacturing professionals, to navigate the complexities of drug development and commercialization.

Research and development teams leverage their scientific power to identify promising drug candidates and optimize their properties for clinical use. Clinical researchers conduct trials with precision and adherence to ethical standards, generating robust data for regulatory submission. Regulatory affairs specialists liaise with regulatory agencies to ensure compliance with evolving guidelines and expedite the approval process.

In manufacturing facilities, engineers and technicians employ cutting-edge technologies to streamline production processes and maintain the highest standards of quality. 

From Research to Market: A Journey of Expertise

The journey of a drug from conception to pharmacy shelves is a testament to scientific collaboration and regulatory diligence. From meticulous research and clinical trials to stringent manufacturing and post-market surveillance, each stage relies on a network of expertise. 

Interdisciplinary collaboration and strict adherence to WHO/EU GMP standards guarantee safe, effective medications reach global patients. From research laboratories to manufacturing plants, each contributor plays a vital role in advancing the drug along its journey, culminating in its availability to patients in need.

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Understanding APIs, Intermediates, and Finished Dosage Forms: A Guide for Pharma Professionals

Introduction

In the intricate landscape of pharmaceutical development and manufacturing, a fundamental understanding of Active Pharmaceutical Ingredients (APIs), intermediates, and finished dosage forms is paramount for professionals in the field.

Each stage is crucial in ensuring efficacy, safety, and regulatory compliance, from the inception of a drug’s synthesis to its final formulation.

This guide aims to provide pharmaceutical professionals with a comprehensive overview of APIs, intermediates, and finished dosage forms, delving into their intricacies, and regulatory considerations within the pharmaceutical industry.

Active Pharmaceutical Ingredients (APIs)

APIs constitute the central ingredient of any drug formulation, providing pharmacological activity or other direct effects in disease treatment, prevention, or diagnosis. They are manufactured through chemical synthesis, fermentation, recombinant DNA technology, or isolation from natural sources.

Processes of API Manufacture

API Process Development and Production involves several processing stages, such as reaction, crystallisation, separation, purification, filter cake washing, solvent swapping, and solvent exchange.

API Process Development Stage: Following drug discovery and early formulation, scientists determine how to convert the Active Pharmaceutical Ingredient (API) into an appropriate dose form for pilot production. Methods devised during this stage are later scaled up for commercial manufacturing pending successful clinical studies.

Selection of Pharmaceutical Manufacturing Machinery: The choice of machinery for blending, extrusion, drying, milling, and micronization is critical. This selection significantly influences the final drug product’s physical characteristics and quality features.

Powder Processing and Particle Size Distribution (PSD): Powder processing involves milling, which reduces particle size for optimal processability, bioavailability, reactivity, and safety. Achieving the suitable particle size distribution (PSD) ensures drug efficacy and delivery to targeted body sites.

API Manufacturers

API production is a complex process involving chemical synthesis or biochemical methods. According to the FDA, Indian and Chinese companies dominate the API manufacturing sector. Pharmaceutical companies usually adhere to their country’s safety standards when manufacturing the final product.

Regulatory Compliance and Safety

The safety and efficacy of drug products hinge on the quality of their active ingredients, ensured through optimised processes.

Poor API process development and production, along with contaminated active ingredients, are linked to adverse health effects, including fatalities. Thus, regulatory procedures for approving active ingredients are being strengthened globally.

This regulation bolsters the pharmaceutical supply chain, enhancing medication quality and safety. APIs undergo independent pre-qualification processes, ensuring adherence to WHO Good Manufacturing Practices (GMP) and streamlining FPP pre-qualification.

API Intermediates

Pharmaceutical intermediates are chemical compounds synthesised and used to produce active pharmaceutical ingredients (APIs). They are formed at various stages in API synthesis and facilitate API synthesis by serving as building blocks or precursor molecules. They undergo chemical modifications to create the desired API.

Role of Intermediates in API Synthesis

Intermediates play a vital role in API synthesis by enabling controlled modifications for desired chemical properties. They represent various stages in the synthesis pathway toward the API, contributing significantly to the efficiency, scalability, and quality of the synthesis process. Well-designed intermediates can simplify complex routes, enhance yield, and reduce costs.

For example, a common intermediate in API synthesis is [benzene], which can be modified to produce a wide range of APIs. This versatility is one of the reasons why intermediates are so important in API synthesis.

Examples of Pharmaceutical Intermediates

  • Key Intermediates: Central to API synthesis, these intermediates undergo multiple transformations to form the desired API structure.
  • Protecting Group Intermediates: Involving temporary modifications of functional groups in the API molecule, protecting groups prevents undesired reactions.
  • Salt Formation Intermediates: APIs are sometimes produced as salts to enhance stability and solubility.
  • Chiral Intermediates: Introduce handedness into APIs, enabling the production of specific forms.

Regulatory Consideration:

Pharmaceutical intermediates are subject to GMP guidelines for quality control, compelling manufacturers to establish appropriate systems and processes. To ensure safety and quality, they must identify and control synthesis-related impurities as regulatory authorities require.

Process validation is necessary to maintain consistent quality in manufacturing, with manufacturers obliged to demonstrate process capability to meet specified standards. Additionally, comprehensive documentation is vital for traceability and regulatory assessment, ensuring integrity and compliance throughout the pharmaceutical intermediate manufacturing process.

Finished Dosage Forms (FDFs) 

A finished dosage form (FDF) represents the consumable, finalised drug product. It encompasses tablets, pills, liquid solutions, and other forms of FDFs. All FDFs contain an API along with other inactive components.

Different types of FDF

There are various types of finished dosage forms, each with unique properties and applications:

  1. Tablets: Tablets are solid dosage forms containing API and excipients. They come in multiple shapes, sizes, and colours, and can be designed for immediate release, extended release, or enteric coating.
  2. Capsules: Capsules are solid dosage forms encapsulating API and excipients in gelatin shells. They come in two main varieties: hard capsules (powder, granules, or pellets) and soft capsules (liquid or semi-solid fill).
  3. Liquids: Liquid dosage includes solutions, suspensions, and syrups. These are commonly used for paediatric and geriatric patients and individuals who have difficulty swallowing solid dosage forms.
  4. Ointments: Ointments are semi-solid dosage forms often used for topical application. They are typically a combination of an API and a base and are used for dermatological, respiratory, and ophthalmic purposes.
  5. Inhalants: Inhalants are intended to be inhaled into the lungs. They can be metered-dose inhalers, dry powder inhalers, or nebulized solutions and are often used for respiratory conditions such as asthma and Chronic Obstructive Pulmonary Disease (COPD).

Regulatory Oversight

The FDA mandates manufacturers to demonstrate the efficacy of medications through laboratory settings and clinical trials involving actual patients. Stricter criteria and inspections have been implemented to regulate medications produced outside the home countries of pharmaceutical corporations.

Conclusion

Understanding APIs, intermediates, and finished dosage forms is pivotal for pharmaceutical professionals. The production of APIs encompasses rigorous processes, impacting the efficacy and safety of drug products from development to manufacturing.

Regulatory compliance ensures quality and safety, with intermediates playing a vital role in API synthesis. Diverse finished dosage forms cater to various patient needs. They are regulated to ensure efficacy and safety. Strengthening regulatory oversight is crucial for maintaining medication quality and safety and safeguarding public health globally.

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Innovations in Nephrology Care: Exploring the Latest Treatment Options

Introduction

Nephrology emerged as the leading internal medicine subspecialty post-WWI. Kidneys are vital for bodily function, filter waste, regulate fluids and minerals, control blood pressure, and produce urine and erythropoietin.

Moreover, individuals with kidney disease experience impairment in kidney function, often stemming from conditions such as hypertension and diabetes. 

The National Kidney Foundation reports that kidney disease affects roughly 37 million adults, while an additional 80 million are at risk. Additionally, racial minorities have a higher incidence of kidney disease, with African Americans being approximately four times as susceptible.

In this article, let’s learn more about the kidney, kidney diseases, and worldwide research. 

What is Nephrology

Nephrology is a vital medical branch specializing in the comprehensive study, diagnosis, and treatment of kidney-related diseases. This involves a multifaceted approach, employing clinical, laboratory, imaging, and histopathologic techniques to assess kidney function and structure.

On the other hand, Nephrologists are dedicated to preserving kidney health through tailored interventions, including dietary adjustments, medication, and kidney replacement therapy. They adeptly manage various complications such as hypertension, fluid retention, and electrolyte imbalances, ensuring holistic care for their patients. 

Moreover, Nephrologists play a crucial role in addressing chronic conditions like diabetes and hypertension, which significantly impact kidney function, alongside managing acute renal failure cases. Collaborating seamlessly with transplant teams, they extend their expertise to oversee the care of kidney transplant recipients, ultimately striving to enhance patient quality of life and prevent complications.

Areas of Focus in Nephrology

Nephrologists may focus on diagnosing and treating various kidney disorders, catering to specific patient groups, or conducting specialised procedures. Specialised areas within nephrology encompass:

  1. Critical care nephrology
  2. Diabetic kidney disease management
  3. Dialysis oversight
  4. Geriatric nephrology (for age 65+)
  5. Interventional nephrology (including dialysis access and arteriovenous fistula surgery)
  6. Renal oncology (kidney cancer)
  7. Kidney stones treatment
  8. Kidney transplant care
  9. Paediatric nephrology (infants to adolescents)

Latest Treatment Options in Nephrology Care

Research and innovative developments shape treatment paradigms for kidney-related conditions in nephrology care. Some of these innovations are:

Kidney Fibrosis Treatment:

Researchers found increased histone lysine crotonylation (Kcr) in fibrotic kidneys, driven by the ACSS2 enzyme. Histone lysine crotonylation (Kcr) is a new acylation modification discovered in 2011 having important biological significance for gene expression, cell development, and disease treatment. 

TGF-β for Improved CKD Treatment:

In Chronic Kidney Disease (CKD), TGF-β, a transforming growth factor affects kidney cell mitochondria, worsening the disease. However, in diseased conditions, TGF-β loses its anti-proliferative response and becomes an oncogenic factor. 

Moreover, recent research shows blocking TGF-β in mice’s proximal tubules increases mitochondrial damage and inflammation. Similar issues were found in CKD patients’ kidney samples. Hence, this new insight may lead to new CKD treatment approaches targeting TGF-β pathways.

Denosumab in Osteoporosis Patients with Kidney Disease

In a recent innovation, Denosumab, commonly used for osteoporosis in advanced kidney disease patients, raises concerns about severe hypocalcemia. A study of 2804 older females on dialysis reveals a higher risk compared to oral bisphosphonates. Prolia now carries a boxed warning, emphasising intensified monitoring during treatment.

Genetic Solution to Mitigate CKD

New research reveals that certain APOL1 gene variations increase chronic kidney disease (CKD) risk in people of West African descent. However, another mutation, p.N264k, counters this risk. In vitro studies show that p.N264k reduces the harmful effects of high-risk APOL1 variations. This suggests potential drug targets for CKD prevention.

Enhanced Advance Care Planning for Dialysis Patients

A study in 42 dialysis clinics with 430 patients and their decision-makers showed improved patient-surrogate communication through 45-60 minute discussions led by clinic healthcare workers. This approach reduces end-of-life decisional conflicts and increases adherence to care goals among dialysis patients, enhancing their overall care experience.

Medicinal Options in Nephrology Care

Medicinal Options in Nephrology Care delves into the diverse pharmacological interventions available for managing kidney-related conditions.

Renaglob

Renagold Tablet is frequently prescribed as a nutritional supplement for individuals suffering from chronic kidney failure and uremia. Its primary function is to inhibit the elevation of urea levels in the bloodstream from consuming non-essential amino acids among kidney failure patients.

Uriglob/Uriglob D

Uriglob Tablet effectively relaxes muscles in the bladder and prostate to alleviate symptoms associated with an enlarged prostate. This relaxation enables easier urination, providing rapid relief from urinary difficulties.

Trientine HCL Capsules

Trientine Hydrochloride is prescribed for Wilson’s disease, functioning as a copper-chelating agent. Its mechanism involves binding surplus copper in the body’s tissues and facilitating its elimination through the kidneys in the urine.

Selaglob

Trientine Hydrochloride reduces high blood phosphorus levels in dialysis patients. Selaglob Tablets stop phosphate absorption in the intestine, reducing blood phosphate levels.

Kalara

Calcium Polystyrene Sulfonate reduces high blood potassium levels, particularly in kidney conditions such as anuria, severe oliguria, and chronic kidney disease. It’s also utilised to lower potassium levels in patients undergoing regular dialysis.

Febuglob

Febuglob Tablet treats gout by lowering uric acid levels. It’s for patients unresponsive to allopurinol. Also used for hyperuricemia in adults with hematologic malignancies at medium to high TLS risk during chemotherapy.

Deferglob

Deferglob Tablet is prescribed for managing chronic iron overload resulting from recurrent blood transfusions. Its function involves eliminating surplus iron from the body and lowering the likelihood of organ damage induced by iron accumulation.

Conclusion

Innovations in nephrology care are revolutionising treatment approaches for kidney-related conditions, addressing diverse challenges with promising solutions.

The landscape of nephrology is evolving, from groundbreaking genetic insights offering potential preventive strategies for chronic kidney disease to enhanced communication practices improving end-of-life care for dialysis patients. Furthermore, advancements in medicinal options provide tailored interventions, such as Renagold for nutritional support and Trientine HCL for Wilson’s disease.

These developments underscore nephrology’s commitment to optimising patient outcomes and enhancing the quality of life, ushering in a new era of personalised and effective kidney care.

 Globela Pharma offers high quality and affordable nephrology solutions across 50+ countries. 

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Beyond the Virus- The Connection Between CVD and COVID-19 Complications

Introduction-

The world witnessed a catastrophe in the form of the COVID-19 pandemic. As per statistical data, more than 702 million active Covid positive cases are present worldwide. Moreover, the world lost around 7 million to the deadly virus. The COVID-19 is characterised by severe respiratory distress syndrome caused by novel SARS-CoV-2. 

At the beginning of COVID-19, evidence of the acute symptoms of the pandemic was pretty straightforward. However, several studies are being carried out to analyse the long-term sequelae of COVID-19. Reports of the trials suggest a strong link between COVID-19 and Cardiovascular Diseases.

According to the World Health Organization, Cardiovascular Diseases are the leading cause of mortality worldwide. Heart attack and stroke are significant CVDs that have high mortality prevalence. The data put forward by a report, COVID-19 and Cardiovascular Diseases, published in 2020, stated a high occurrence of CVDs in COVID-19-positive patients, with more than 7% of patients experiencing myocardial injury due to the virus. 

Therefore, the identification of risk factors and prevention of cardiovascular diseases in patients with a COVID-19 history is a challenge for the medical fraternity. Risk factors associated with cardiovascular diseases are well known, such as lifestyle and genetics. However, the role of these two factors in precipitating CVDs in patients affected by SARS-CoV-2 is still unknown.

COVID-19 and CVDs

One of the long-term consequences of the pandemic manifested in the form of an increased global cardiovascular burden. Recent statistical data presents a rise in mortality and morbidity related to Cardiovascular diseases owing to the direct and indirect effects of COVID-19.

Moreover, research has found an interlink between genetic factors and poor lifestyle with cardiovascular disorders in COVID-19 patients. 

The genetic association is determined using the Polygenic Risk Score. High values show a high risk of developing coronary artery disease, atrial fibrillation and venous thromboembolism in people with SARS-CoV-2 infection. Similarly, poor living habits such as smoking habit, increased alcohol consumption, and sedentary living put individuals at a higher risk for developing cardiac complications. 

Although the exact pathophysiology behind the risk of CVD in COVID-19 patients is not yet understood, researchers have attempted to explain a couple of mechanisms. Some of them are:

Direct cardiotoxicity- The SARS-CoV-2 virus directly infects the cardiac cells leading to myocarditis. 

Post-disease hyper-inflammation- Post-COVID-19 cases have shown uncontrolled release of cytokines leading to plaque formation and vascular inflammation. It ultimately precipitates Myocardial Infarction, cardiomyopathy and Heart Failure.

Systemic manifestations- COVID-19 also causes systemic complications such as Disseminated Intravascular Coagulation(DIC), sepsis etc which result in cardiovascular diseases.

Genetics and Lifestyle- Potent Risk Factors for CVD

Genetics and lifestyle influence the occurrence of cardiovascular diseases. A family history of CVD raises the chances of acquiring the disease. The proportion of risk will also be influenced by the age of the affected relative. CVDs such as congenital diseases, high cholesterol levels, and high blood pressure can be inherited. Alteration even in the single gene code can lead to heritable cardiac disorders.

Similarly, lifestyle also influences the prevalence of CVD in an individual. Poor diet, high alcohol consumption, a history of smoking, and less physical activity are culprits of cardiac diseases.

But, how do these two potential risk factors augment the chances of CVDs in people who have a history of COVID-19?

What does Research Show?

A study was conducted between March 2020 and September 2021 on 25,335 COVID-19-positive patients to evaluate the role of genes and lifestyle. The study aimed to correlate the link between PRS(Polygenic Risk Score), lifestyle factors and cardiovascular disorders in selected patients within 90 days after diagnosis of COVID-19. 

A polygenic Risk Score is an accumulation of genetic risk factors for a particular trait. It is an authentic tool to predict precision medicine and cardiovascular disease occurrence rates. In the study, the PRS was determined for cardiac diseases such as venous thromboembolism, coronary artery disease, atrial fibrillation and ischemic strokes. Moreover, the prospective cohort research also used a lifestyle index comprising 9 variables to determine its role in the precipitation of cardiovascular diseases.

The study used the Cox proportional hazard model to calculate the hazard ratio and confidence interval for studying the link between genes and CVD. In contrast, the multivariable Cox regression model was applied to determine the lifestyle factors.

The result of the study confirmed a linear association between gene mutations and a higher incidence of cardiovascular disorders post-COVID-19 infection. The participants with the top 20 per cent Polygenic Risk Score have a high risk of developing atrial fibrillation(3-fold increase), coronary artery disease(3.5-fold increase) and venous thromboembolism (2-fold rise). However, no apparent association is observed between ischemic strokes and genetic factors. Another interesting finding is the positive existence of risk factors even in fully vaccinated individuals.

A positive correlation exists between a healthy lifestyle and a lower incidence of CVDs in COVID-19 patients. It is also noteworthy that COVID-positive cases with unhealthy lifestyles, when switched to healthy living diminished their risk of developing CVDs. Cardiac complications such as CAD and AF also demonstrate an additive rise in patients with high scores of PRS and an unhealthy lifestyle.

The Conclusion

Although the fatal wave of the pandemic is over. The world lost more than a million lives. But, the threat persists. The long-term consequences of COVID-19 in patients with a positive history are still a medical mystery. Several research groups and pharmaceutical companies like Globela Pharma are trying to do evidence-based studies to deal with chronic complications.

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Collaboration-A need of hour to Speed up Access to New Vaccines

Introduction:

The fatal wave of COVID-19 made everyone aware of the importance of vaccines to prevent and control tremendously dangerous and infectious diseases. The whole world during the COVID-19 pandemic needed an efficient vaccine to kill the virus and save them from a lethal contagious disease. Scientists and researchers globally were focused on creating an efficient and reliable vaccine to protect the world from such a dangerous virus. 

During the pandemic crisis, this situation not only demonstrated the importance of vaccines and medicines in our lives but also proved how important it is to have a well-organized and synchronised process for vaccine manufacturing.  To combat all the challenges that the world faced during the time of pandemic a new tool of “regulatory collaboration” came to light. 

In this article, we will learn the importance of global regulatory collaboration and how this global regulatory collaboration helps in achieving a single goal i.e., speed up the access to vaccines.

What does Global Regulatory Collaboration mean?

A global regulatory collaboration simply means the collaboration or working together by regulatory bodies from various countries. It works in different ways to discuss, develop, manage and achieve the same goal. 

The Global Regulatory Collaboration came out as an emerging tool to have more access to vaccines and medications. Also, it helps to manage its proper manufacturing as well as distribution across the globe. 

What is the importance of Global Regulatory Collaboration?

The traditional regulatory process for the validation and approval of vaccines involves a series of rigorous trials and preclinical examinations along with an assessment of manufacturing processes. 

Global regulatory collaboration also plays a vital role in ensuring the rapid development, approval and distribution of vaccines worldwide. 

The era of COVID-19 demanded the healthcare system’s urgency of efficient and useful vaccines along with acceleratory regulatory pathways without compromising on scientific rigour. 

Thus, the Global Regulatory collaboration helps in acknowledging the need for expeditious decision-making along with ensuring excellent standards and quality in vaccine development and efficient distribution. 

How does the Global Regulatory Collaboration aim to speed access to new vaccines?

There are various benefits of Global Regulatory Collaboration as it aims to speed the access to new vaccines.

Global Regulatory collaborations work while promoting the sharing of information, harmonizing standards and promoting mutual recognition of regulatory decisions it enables the availability of access to safe and efficient vaccines. 

So let’s understand it’s working as follows:

Enhancing Information Sharing and Cooperation:

A very crucial aspect of global regulatory collaboration is the exchange of information and cooperation among regulatory authorities. Collaboration enables regulatory agencies to share their data from every event. 

It starts from clinical trials to post-marketing surveillance along with no confidentiality, but total transparency. By enabling access to the expertise and resources of various collaborated regulatory bodies the companies can minimize the approval timelines and other efforts too. 

It also can help companies to facilitate the global availability of safe and quality vaccines throughout the globe. 

Harmonization of Standards:

Various countries have various wide range of rules. Yes, different countries have different and unique regulatory requirements and approval processes which eventually make the consumers suffer for their needs.

Additionally, these processes are time-consuming and require various recognitions. Thus, it takes very long for these vaccines to reach across borders. 

In this, Global regulatory collaboration attempts to harmonize standards and requirements among different agencies to hasten the approval process. 

By ensuring proper synchronisation and utilising recognition companies can prevent the duplication of efforts. Also, it aids the regulatory bodies to speed up access to vaccines without compromising their safety and efficacy.

Mutual Recognition of Regulatory Decisions:

Mutual recognition agreements (MRAs) are the key tools that play a major role in global regulatory collaboration. It allows regulatory bodies to accept the decision and verdict established by another authentic regulatory body. 

This process not only saves time by avoiding fake evaluations but also helps in enhancing trust and confidence in the safety and functioning of approved vaccines.

MRAs’ functioning is so effective and incredible that they make countries rely on the expertise of authentic regulatory agencies and also enable quick authorisation of vaccines within their jurisdictions.

International Consortia and Collaborative Platforms:

International consortia and collaborative platforms have established themselves as the leaders of global regulatory collaboration. Huge and reputed agencies like the World Health Organization (WHO), The International Coalition of Medicines Regulatory Authorities, and the Coalition for Epidemic Preparedness Innovations have also played a major part in cherishing cooperation among regulatory bodies. 

These platforms focus on sharing scientific information, harmonization standards and other relevant information required to help maintain a coordinated global development and distribution of vaccines throughout the globe. The international consortia and collaborative platforms also help by optimising resources and coordinating efforts to make vaccines. 

Impact on Access and Equity:

Global regulatory collaboration has profound implications for access and equity in vaccine distribution. Accelerating the regulatory process ensures the access of vaccines to developing countries as well, as that to the advanced ones. 

For instance, WHO’s very well-known COVAX and other Emergency Use Listing (EUL) had an equal distribution of the vaccines by regulatory collaborating bodies. They also encouraged the sharing of the doses with other countries in need. 

By developing and distributing vaccines across the world the regulatory collaboration not only bridged the gap in accessing vaccines to individuals but also saved thousands of lives reducing health disparities.

Conclusion:

In a nutshell, global regulatory collaborations have proved themselves to be a pillar in saving lives by speeding up access to vaccines during times of crisis. The COVID-19 pandemic has reinforced the need for a synchronised and coordinated regulatory body to ensure the timely availability of safe and effective vaccines. 

As the world continues to battle with an ongoing pandemic and prepares itself for future global health crises, it is now a mandatory part to promote and accept global regulatory collaboration as a smart strategy to accelerate access to life-saving vaccines.

This same goes for the medicines as well. Collaboration is also a need in the manufacturing of medicine as well. In this, Globela Pharma with collaboration services provides rigid cooperation while maintaining the transparency in manufacturing of medicines.

Empowering Access

Empowering Access: The Crucial Role of Pharmaceutical Companies in Affordable Healthcare

Introduction:

Over the last 20 years, Indian pharmaceutical companies have played a crucial role in improving health care in India and around the world. Even during the COVID-19 period, the companies were standing in front to mobilise their resources to fulfil the supply chain despite the lockdown and restrictions in the country. Indian pharmaceutical companies generate 60% of global vaccine production. They contribute to around 40-70% of DPT (Diptheria, Pertussis and Tetanus) and BCG (Bacillus Calmette – Guerin) vaccines produced by WHO (World Health Organisation).

Affordable healthcare is a fundamental right that everyone should have access to. In a country like India, with a population of over 1.3 billion, ensuring affordable healthcare for all is a monumental challenge. However, Indian pharmaceutical companies have played a significant role in making healthcare more accessible and affordable for millions of people. This blog explores the crucial role of Indian pharmaceutical companies in providing affordable healthcare solutions.

What do these pharmaceutical companies do?

Pharmaceutical companies provide affordable healthcare as an essential aspect of individuals’ and communities’ well-being. These companies play a crucial role in researching, developing, manufacturing, and distributing life-saving medications and treatments. Their contributions are vital to making healthcare accessible and affordable for people across the globe. By investing in research and development, collaborating with healthcare providers, and advocating for policy changes, pharmaceutical companies can significantly impact healthcare affordability. 

Moreover, the Indian pharmaceutical industry has established itself as a global leader in generic drug production. Their expertise and adherence to international quality standards earn them the trust and confidence of healthcare professionals and regulatory bodies worldwide. This leads to increased collaborations and partnerships with multinational pharmaceutical companies. Moreover, this facilitates the transfer of technology and knowledge ultimately accelerating the availability of affordable healthcare solutions globally.

How can Indian pharmaceutical companies help provide affordable healthcare?

Pharmaceutical companies contribute to affordable healthcare in various ways. Explore the potential benefits and challenges associated with their role:

  • Generic Medicines: 

Indian pharmaceutical companies have been at the forefront of producing high-quality generic medicines at affordable prices. Generic medicines are bioequivalent to their branded counterparts but available at a fraction of the cost. Indian companies’ production and distribution of generic medicines have significantly reduced patients’ financial burden, especially in developing countries like India.

  • Research and Development:

Indian pharmaceutical companies like Globela Pharma invest heavily in research and development (R&D) to develop innovative and cost-effective healthcare solutions. By focusing on R&D, these companies have developed generic versions of expensive drugs, enabling patients to access life-saving treatments at affordable prices. Additionally, Indian pharmaceutical companies have made significant contributions to the development of vaccines and medicines for diseases such as HIV/AIDS, malaria, and tuberculosis, further enhancing affordable healthcare options.

  • Manufacturing Capabilities:

India is known for its robust pharmaceutical manufacturing capabilities. The country has a vast network of pharmaceutical manufacturing units that produce a wide range of medicines, including essential drugs. The economies of scale achieved by Indian pharmaceutical companies have led to lower production costs, making medicines more affordable for patients. This manufacturing process has also allowed India to become a major exporter of pharmaceutical products to other countries, further expanding access to affordable healthcare globally.

  • Government Initiatives and Partnerships:

Indian pharmaceutical companies have collaborated with the government and non-governmental organizations to implement various initiatives aimed at providing affordable healthcare. For instance, public-private partnerships have been instrumental in setting up healthcare facilities in rural areas, ensuring access to medicines, and promoting preventive healthcare measures. These collaborations have not only made healthcare more affordable but also improved the overall healthcare infrastructure in the country.

  • Global Health Aid and Philanthropy Initiatives:

Indian pharmaceutical companies have an admirable track record of aiding global health crises through humanitarian initiatives and philanthropic activities. During emergencies such as humanitarian crises, natural disasters and disease outbreaks. Companies have stepped forward by providing essential medicines, vaccines and medical supplies at a subsidized or no-cost basis. Their commitment to social responsibility extends beyond borders contributing to global efforts aimed at improving healthcare access for the most vulnerable populations.

  • Patent Challenges:

Indian pharmaceutical companies have challenged patents on expensive drugs, allowing affordable generic versions. By challenging patents, these companies have played a crucial role in breaking monopolies and promoting competition, resulting in lower drug prices. This has had a significant impact on making healthcare more affordable, not only in India but also in other countries.

Although, Indian pharmaceutical companies have not been easy. Before 1970, most of the pharmaceutical industry was owned by foreign owners. However, thanks to the Indian Patents Act in 1970 and the Drug Policy in 1978. It allowed the next generation of scientists and entrepreneurs to take advantage of the opportunities provided by these resources to build a tremendous pharmaceutical industry.

  • Health Awareness and Education:

Indian pharmaceutical companies have also been involved in creating awareness and educating the public about various health issues. Through campaigns and initiatives, these companies have helped spread awareness about diseases, preventative measures, and the importance of early diagnosis and treatment. By promoting health education, Indian pharmaceutical companies reduce healthcare costs by preventing diseases and promoting overall well-being.

Conclusion:

Indian pharmaceutical companies have emerged as key players in making healthcare more cost-effective and accessible. Their contributions in the form of generic medicines, research and development, manufacturing capabilities, government partnerships, patent challenges, and health awareness initiatives have significantly impacted affordable healthcare in India and beyond. 

Globela Pharma helps attain affordable healthcare by making significant strides in ensuring access to quality medications for all individuals. Through our commitment to innovation collaboration and affordability, Globela is changing the landscape of healthcare by putting patient well-being at the forefront.

At Globela, we are bridging the gap between healthcare and individuals ensuring that quality medicines are accessible to all. By working together with stakeholders investing in research and development and engaging in corporate social responsibility initiatives Globela is reshaping the pharmaceutical industry and transforming lives for the better.

However, there is still work to be done to ensure universal access to affordable healthcare. Continued efforts and collaborations between the government, pharmaceutical companies, and other stakeholders are essential to address the existing challenges. This will make affordable healthcare a reality for all.