blog image 2 (1)

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.