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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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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Cephalosporins Today: Current Applications and Impact on Modern Medicine

Introduction:

Welcome to a comprehensive exploration of Cephalosporins, a pivotal group of antibiotics derived from Cephalosporium. In this blog, we’ll delve into their mechanism of action, examine the different generations, explore their diverse applications, and peer into the future with the emergence of the fifth generation. Join us on this journey through time and innovation in the realm of antibiotic therapy.

Cephalosporins- The Future of Antibiotics

Cephalosporins are a group of semisynthetic antibiotics derived from Cephalosporin-C, obtained from the fungus Cephalosporium. These are the largest group of Beta-Lactam antibiotics, i.e., they interfere with bacterial cell wall synthesis. Cephalosporins are broad-spectrum antibiotics effective against both gram-positive and gram-negative bacteria. Therefore, its use is widespread in both medical and dental conditions. 

There are five generations of cephalosporins divided based on chronological sequence of development as well as antibacterial spectrum and potency. 

The generation of cephalosporin determines the indications, contraindications, adverse effects, and route of administration, along with other vital factors. 

Mechanism of Action-

The beta-lactam drugs inhibit cell wall formation by acting against the transpeptidase. This disrupts the cross-linking that maintains the close-knit structure of the cell wall.  The transpeptidase and related proteins constitute the penicillin-binding proteins(PBPs) located in the bacterial cell membrane. Each microorganism has multiple PBPs that have an affinity towards different beta-lactam antibiotics. Therefore, when a bacteria replicates in the presence of a beta-lactam antibiotic, cell wall-deficient organisms are produced. 

Moreover, owing to the hyperosmotic interiors of the bacteria, the cell wall deficient form swells and bursts, thus causing the lysis of the organism. This is how a beta-lactam antibiotic such as cephalosporins exerts bactericidal action. Beta-lactam antibiotics are most lethal during the phase of rapid cell wall synthesis. And because the peptidoglycan cell walls are unique to bacterial species, these antibiotics are practically non-toxic to humans. Also, blood, pus, and tissue fluids do not interfere with the antibacterial action of beta-lactam antibiotics. 

Generations of Cephalosporins-

Based on their activity and potency against the type of bacteria, traditionally there are four generations of cephalosporins-

First Generation- These were developed in the 1960s and have high potency against gram-positive bacteria such as staphylococci and streptococci. However, their action against gram-negative groups is considerably low. Proteus mirabilis, Klebsiella, and E. coli are a few gram-negative species responsive to first-generation cephalosporins.

The first-generation cephalosporins include Cefazolin, Cephalexin, Cephradine, and Cefadroxil.

Second Generation- Developed after the first generation of cephalosporins, this group of drugs works against gram-negative bacteria. Some second-generation compositions are also effective against anaerobes(cephamycin sub-group).

Second-generation cephalosporins include cefuroxime, which is highly active against H. influenza. Other drugs in this group are Cefuroxime axetil, cefaclor, etc.

Third Generation- First introduced in the 1980s, the third generation cephalosporins have high augmented activity against gram-negative Enterobacteriaceae. Some of the formulations also inhibit Pseudomonas activity. All the third-generation cephalosporin drugs are resistant to the beta-lactamase enzyme produced by gram-negative bacteria. However, they are less potent against gram-positive cocci and anaerobes. Cefotaxime is the prototype of this group. Other drugs include Ceftizoxime, Ceftriaxone, Ceftazidime, Cefixime, etc.

Fourth Generation- This generation includes Cefepime, developed in the 1990s. It has a similar activity spectrum as the third-generation drugs. However, its potency is more with high resistance to beta-lactamases. Cefepime is also active against Ps. aeruginosa and Staph. Aureus. Another fourth-generation cephalosporin is Cefpirome. Both of these drugs are highly recommended for hospital-acquired infections and other serious health issues.

Applications of Cephalosporins-

Cephalosporins are extensively used in medical practice. The group of beta-lactam antibiotics have found a wide range of applications.

  • As a substitute for the Penicillin group of antibiotics in allergic patients. The first generation Cephalosporins are the preferred choice.
  • For Respiratory, urinary and soft tissue infections caused by gram-negative organisms, especially Klebsiella, Proteus, Enterobacter, and Serratia.
  • Against Penicillinase-producing staphylococcal infections.
  • In cases of septicemia caused by gram-negative organisms. A combination of aminoglycoside and cephalosporin is a good combination in such cases.
  • Cefazolin is administered for most of the surgical prophylaxis.
  • Ceftriaxone is the first choice of drug(as a single-dose therapy) for gonorrhoea caused by penicillinase-producing organisms. 
  • Cefuroxime and cefotaxime are also preferred for single-dose therapy in cases of chancroid.
  • Ceftriaxone and cefoperazone are the fastest-acting drugs in typhoid.
  • Cefuroxime, cefaclor or any of the third-generation compounds is a choice of drug for mixed aerobic-anaerobic infections in cancer patients.
  • Third-generation cephalosporins are given in colorectal surgery and obstetric complications.
  • Ceftazidime or other third-generation cephalosporins are administered as a prophylactic agent or treatment modality in cases of infections in neutropenic patients.
  • These are a preferred group of drugs given against hospital-acquired infections that are resistant to common antibiotics.
  • Orally active 1st and 2nd generation cephalosporins are primarily prescribed for orodental infections.

Adverse Effects of Cephalosporins

Cephalosporins are a well-tolerated group of drugs. However, they are more toxic than penicillin. Some of the adverse effects related to cephalosporins are-

  • Pain after intramuscular cephalosporin administration is a common occurrence. 
  • Thrombophlebitis on intravenous injections occurs in many cases.
  • Oral administration of cephradine can lead to diarrhea. Parenteral administration of cefoperazone is significantly excreted in bile.
  • Hypersensitivity reactions similar to penicillin. However, the incidence rate is lower. Rashes are a common manifestation. Anaphylaxis, urticaria, and asthma can also occur.
  • Few cephalosporins such as Cephalothin exhibit low-grade nephrotoxicity. Pre-existing renal conditions usually accentuate the condition.
  • Bleeding can occur on administration of cephalosporins like cefoperazone and ceftriaxone.
  • The rare occurrence of neutropenia and thrombocytopenia is also noticed with ceftazidime and some other cephalosporins.
  • Cefoperazone also creates a disulfiram reaction with alcohol.

Contraindications of Cephalosporins-

Although well-tolerated, cephalosporins are contraindicated in the following few conditions-

  • Ceftriaxone is contraindicated in neonates with hyperbilirubinemia.
  • In patients who are allergic to cephalosporins.
  • In individuals who have a history of anaphylaxis to penicillin or other beta-lactam group of drugs.

What is new? The Fifth Generation Cephalosporins

The research work with cephalosporins has seen a dramatic rise in the last decade. Novel cephalosporins such as ceftobiprole, ceftolozane, ceftazidime etc offer excellent in vitro results in terms of microbiological susceptibility. These drugs are considered to be the fifth-generation cephalosporins. These compounds have transport mechanisms to enter multi-drug-resistant bacteria. These drugs work via a sparing approach in different antimicrobial classes such as carbapenems, aminoglycosides etc.

However, more research is required to evaluate their clinical efficacy. Pharma groups like Globela Pharma can contribute to developing and testing the fifth class of cephalosporins which will be a game changer.

Conclusion:

As we conclude this journey through the past, present, and future of Cephalosporins, the potential for groundbreaking advancements in antibiotic therapy becomes evident. With ongoing research and the emergence of the fifth generation, the horizon is broadening for medical professionals and pharmaceutical companies alike. Stay tuned for the latest updates in the dynamic world of antibiotic innovation!

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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.

Innovations in CRAMS How Indian Pharma Companies are Revolutionizing the Industry

Innovations in CRAMS: How Indian Pharma Companies are Revolutionizing the Industry

An era of COVID has indeed changed the whole scenario in the pharmaceutical industry. With the wide range of disruptions and challenges fought due to the coronavirus, various technologies like AI (Artificial Intelligence), quantum computing etc., have got acceptance by different pharmaceutical companies to help conduct R&D efforts, create personalized products and much more. 

In this, the Contract Research and Manufacturing Services or CRAMS, a rapidly growing industry has revolutionized the pharmaceutical industry. They provide cost-effective solutions to pharmaceutical companies, allowing them to focus on their core competencies. 

In all this, innovation is a must and is at the heart of the CRAMS industry. India is one of the leading players in the CRAMS industry, with its pharma companies at the forefront of innovation. Moreover, the global CRO (Contract Research Organisation) as per market value has mainly, reached $39 billion in 2018 and around $44 billion in 2021. 

In this article, we will explain the innovations in CRAMS and how Indian pharma companies are revolutionizing the industry.

What is CRAMS?

CRAMS stands for Contract Research and Manufacturing Services. It involves outsourcing drug development, manufacturing, and research services to third-party providers. It is a procedure where the product’s parent doesn’t produce the item themselves but gets it done by other organizations known as Contract Research Organisations (CRO). 

While understanding CRAMS, there are some important aspects including:

  • Cost-effective solutions
  • Quality assurance
  • Regulatory compliance
  • Intellectual property
  • Process improvement.

Cost-Effective Solutions:

One of the primary advantages of CRAMS is the cost-effective solutions it offers. By outsourcing drug development, manufacturing, and research services, pharmaceutical companies can focus on their core competencies and reduce costs. The involvement of CRAMS in research and manufacturing services offers cost-effective solutions to pharmaceutical companies, allowing them to develop and manufacture drugs and make them available at a lower cost.

Quality Assurance:

Quality assurance is critical in the CRAMS industry, and Indian pharma companies like Globela Pharma ensure that they meet regulatory requirements and maintain high-quality standards. Without proper quality assurance, the drugs manufactured by drug manufacturing companies may cause harm to the patient. 

The various pharma companies rely upon the contract service provider to accelerate research and manufacturing services. Indian pharma companies are investing in quality assurance processes, including quality control and quality assurance systems, to ensure that drugs meet regulatory requirements and are safe for patients.

Regulatory Compliance:

Regulatory compliance is another salient feature of the CRAMS industry. Indian pharma companies like Globela Pharma are ensuring that they comply with all regulatory requirements to be fulfilled. They are investing in regulatory compliance processes to ensure that drugs meet all regulatory requirements and are safe for patients. 

This process is necessary for the safety of individuals consuming drugs and other medicated products. Any inferior or ignorant quality procedure at any stage can compromise the health of the patients. Hence, it is vital to regulate proper regulatory compliance to keep the health of individuals uncompromised.

Intellectual Property:

Intellectual property is an asset that pertains to original and novel creations from the human brain or intellect. It may include copyrights, patents and regulatory licences. The Indian pharma companies are ensuring that they protect their intellectual property. Indian pharma companies are investing in intellectual property processes, including patent protection and trademark registration, to protect their innovations and ensure they are not infringed upon.

Process Improvement:

Improvement is something that any working era always has a space for. So is in the CRAMS industry as well. The Indian pharma companies are continuously improving their processes to increase availability, efficiency and reduce costs. 

They are investing in process improvement processes, including lean manufacturing, availability, and affordability of manufacturing services at a very minimal and justified amount.

Innovations in the field of CRAMs

One of the innovations in the CRAMS industry is the use of technology to improve drug development and manufacturing processes. Indian pharma companies are leveraging technology to develop new drugs, improve manufacturing processes, and ensure regulatory compliance. These all require constant efforts and various authentic technologies and collaboration with other companies to maintain quality assurance and the best results.

Technologies aiding in revolutionizing the industry:

One of the innovations in the CRAMS industry is the use of technology to improve drug development and manufacturing processes.

A few innovations that promote revolutionary change and progress in the industry are:

  • AI or Artificial Intelligence – AI is helping industries accelerate the discovery and manufacturing process of drugs. 
  • Huge data and analytics – The cost of production of medicines become the biggest hurdle in launching a new medicine. However, by using data and analytics, Indian Pharmaceutical companies can reduce the exploration cycles and make the new drug or vaccines available sooner for use. 
  • Bioprinting – One of the biggest challenges that are faced by Pharmaceutical companies is clinical trials. Bioprinting technology enables the exact imitation of human organs using the 3D technique. Pharmaceutical companies check the efficacy and effects of a drug on live subjects to observe all the vital changes. Hopefully, bioprinting now can save time as well as effort and also has reduced the dependency on live subjects to initiate clinical trials. 

Role of Collaboration to Uplift the Indian Pharma Companies

Another innovation in the CRAMS industry is collaboration. Indian pharma companies are collaborating with other companies and research organizations to promote drug development, cost-effective solutions, improve manufacturing processes, and share knowledge and expertise. 

This collaboration allows companies to pool resources and knowledge, leading to faster drug development and improved manufacturing processes. Moreover, the companies like globelapharma are working on great R&D efforts, quality manufacturing, and a sturdy distribution system with collaboration. 

Conclusion:

The Indian pharma companies are revolutionizing the CRAMS industry and paving the way for the development of new and innovative drugs. Through new technologies, collaboration, etc., pharmaceutical companies are getting the support they need to achieve growth, find flaws, initiate new conversions, and ultimately provide better health care. 

Moreover, India has already presented itself to be a cost-efficient and quality manufacturer for many Pharma companies. Therefore, with technological advancements and innovations continuing to progress, the pharmaceutical industry is expected to grow and evolve quickly. Thus, its demand will increase in the future throughout the world.

Solving healthcare challenges in underserved regions across the world

Solving healthcare challenges in underserved regions across the world

Introduction:

Healthcare is a primary necessity for every human being, whether you are living in a developed country, a developing country, or any underserved region. Globally, there are numerous healthcare challenges and in underserved regions, healthcare has always been in worse condition than in other parts of the world. 

Countries like Africa, the Middle East, South and South East Asia and Latin America with Africa being one of the most affected, witness more challenges to ensure proper health due to numerous reasons. These regions often lack the vital resources, infrastructure, and healthcare professionals to provide adequate medical care to their populations. 

However, healthcare innovation, research, and development can help address these challenges and improve healthcare outcomes in underserved regions. In this article, we will explore concerning innovative solutions that can help solve healthcare challenges in these underserved regions.

What are the challenges faced by underserved regions to reach out to healthcare? 

Countries like Africa, the Middle East, and South and South East Asia witness more challenges in the healthcare system.

The key disputes that come to underserved regions to achieve good health include are:

  • Low access to healthcare services
  • Shortage of good quality medicines at affordable prices
  • Lack of awareness
  • Unavailability of knowledge 
  • Limited access to various facilities

Solutions to improve healthcare challenges in underserved regions across the world

There are a lot of changes needed for a strong healthcare system. While, it can be achieved through investments in healthcare infrastructure, training of healthcare professionals, provision of medical equipment and supplies and many more. 

Some of the major solutions to strengthen the healthcare system in underserved regions are: 

  • Availability of Telemedicine
  • Educating people about health and its importance 
  • Making healthcare professionals and medicine easily accessible
  • Providing quality medicines
  • Boost medical research
  • Promote more pharmaceutical manufacturing

Availability of Telemedicine– It can enable people in underserved areas to have consultations with specialists even at a long distance. It can be particularly effective in rural areas where only a few healthcare facilities and specialist healthcare professionals are available. 

Educating individuals – Increasing education about healthcare can help improve access to healthcare. This empowers them to take control of their health and seek medical care when needed. Also, educating individuals about the importance of personal hygiene, sanitation, hand washing, and seeking medical help at the right time helps them to avoid any worse conditions. 

Making healthcare easily accessible – Accessibility is the key to a better healthcare system. In underserved regions building primary healthcare centres with high-quality pharmaceutical medicines, medical equipment, and facilities is critical to building a sound healthcare system. 

Providing quality medicines- When it comes to build-up a strong healthcare system the vital factors are availability, quality and affordability of medicines. In terms of quality of medicines, Globela Pharma is providing good value medicines through their continuous efforts and innovations. As part of the solution to the healthcare crisis in underserved regions, it is necessary to innovate affordable pharmaceutical solutions without compromising on quality. It is essential to reach out to every corner of the globe so that everyone has access to quality medicine regardless of their financial capacity. 

Boosting medical research- Medical research is essential to addressing healthcare challenges in underserved regions. It will help identify the most persistent healthcare challenges and develop solutions. One example of successful medical research is the development of vaccines and immunizations. Vaccines are critical in preventing the spread of infectious diseases such as HIV/AIDS, Malaria, Tuberculosis, Cholera, and Neglected tropical diseases. In addition, vaccines can help prevent seasonal infections and allergies.

Pharmaceutical manufacturing – It can help address healthcare challenges by ensuring that essential medicines are available to these people at a very affordable price. Where there is no comprise on the quality of the medicine, despite their financial status it will help in strengthening the healthcare system. Although, this can be achieved through partnerships between pharmaceutical companies and governments in underserved regions.

What innovative steps can be taken to resolve some common issues in underserved areas?

In underserved regions, some diseases are more prevalent than others like malnourishment, diabetes, infectious disease, etc. In order to combat these diseases definite innovative measures are necessary. Such as: 

  • Non-communicable diseases: A group of diseases like diabetes, cardiovascular disease and cancer are becoming increasingly prevalent in underserved regions. A multifaceted approach is needed to address these diseases, which includes healthcare innovation, strengthening of the healthcare system, and educational efforts in the healthcare field. 

For instance, promoting innovation in forming mobile health applications will help individuals monitor their health. This type of innovation will help address the problem as early as possible. Additionally, healthcare education is also critical in managing these diseases. It can include education on healthy lifestyles, such as healthy eating and exercise. 

In addition, making people aware of the importance of regular medical checkups will help reduce the complications associated with these diseases.

  • Neglected Tropical Diseases: A group of diseases that affect more than one billion people globally, relatively more in underserved regions. These diseases include dengue, chikungunya, Guinea-worm disease, leprosy, lymphatic filariasis, onchocerciasis, sleeping sickness, etc. The aim of solving the healthcare challenges in the underserved region requires scaling up through improving public health. 

For that, it is vital to establish a public health centre with adequate medical professionals, good quality pharmaceuticals, and medical equipment. Moreover, in managing NTDs, it is essential to regulate water sanitation and hygiene properly. 

  • Malnutrition and Poverty: Malnutrition and poverty are significant healthcare challenges in underserved regions. A wide approach can be addressed to improve the status of malnutrition and poverty in these underserved areas. 

Poverty reduction is also critical in addressing malnutrition and poverty. This can be achieved through investments in education, job creation, and social safety nets. 

In addition, increasing healthcare awareness and education can help individuals take control of their health and seek medical care when needed.

Conclusion:

In a nutshell, we all know that in various parts of the globe, people are not fortunate enough to access all the health facilities and take advantage of them. Hence, the healthcare challenges in underserved regions are complex and multifaceted. However, healthcare innovation, research, and development can help address these challenges and improve healthcare outcomes in these regions. 

By working together and leveraging technology, we can help ensure that everyone has access to the medical care they need to live healthy and productive lives. There is a very well-known saying that “HEALTH IS WEALTH”. By drawing a good amount of attention towards the healthcare sector we can not only save a good amount of wealth but can also provide a great amount of happiness in their life, to cherish it happily with family, friends and loved ones.