As the world came to a standstill with COVID-19 Pandemic, technology and human resiliency rose to the occasion and connected people beyond boundaries. One such endeavour of an international specialized agency of the United Nations responsible for international public health, the World Health Organization (WHO) in association with the health and life science-focused Deemed University, JSS Academy of Higher Education & Research (JSSAHER) joined hands to strengthen capacity building in the Pharma Sector.
WHO and JSSAHERhave collaborated for training the Middle and Small-scale Pharma companies to understand the requirements of WHO pre-qualification and mentor them to achieve such standards with experts drawn from all over the world.
This collaboration extended further in conducting training programs in Hemovigilance to the South East Asian region countries and supporting the development of blood safety standards and hemovigilance tools. The key to the success of the collaboration was the technologies and expertise that JSSAHER had and shared with WHO for a global cause.
WHO had undertaken a joint SEARO-WHO India Survey on Pharmaceutical Units in India, with an inter-ministerial effort of Govt of India. It led to several key recommendations for several ministries in India to promote access to medical products for meeting national and global health needs. Strengthening the current GMP with the support of WHO among pharmaceutical units engaged in manufacturing APIs, formulations, and medical devices was one major recommendation of the Survey.
The Good Manufacturing Practices (cGMP) Online Training was conceptualized, to take the recommendations forward and to particularly address the COVID-19 challenges. A series of 6 workshops is being organized and implemented by all three levels of WHO (Country Office, Regional Office, HQ) in collaboration with JSS Academy of Higher Education & Research (JSS AHER), and Indian Pharmaceutical Alliance (IPA).
The pilot cGMP workshop for Pharmaceutical Units was organized from 1st –14th December 2020 for a period of 12 days on a unique and dedicated JSS AHER web portal specifically designed for the workshop. 41 Experts including 11 international Speakers shared their knowledge and expertise on the various topics. External partners, US Agency for International Development (USAID), Medicines, Technologies, and Pharmaceutical Services Program (MTaPS), and Promoting the Quality of Medicines Program (PQM+) of United States Pharmacopoeia (USP) contributed towards developing course content.
The workshop provided an opportunity for them to familiarize themselves with the requirement of strengthening and capacity building of their facilities and systems to meet the WHO Pre-Qualification (PQ) standards.
The WHO in its feedback had mentioned, “It’s the first time anywhere in the world such a Workshop has been attempted by WHO – in person or digital format that we have accomplished. The challenge of COVID-19 was channelled into an opportunity for wider access to industry and all stakeholders came together (industry, academia, government, international organizations including WHO) through a web platform, for which JSSAHER performed a critical role”.
World Health Organization Blood Transfusion Safety program has been established to develop strategies for blood safety and promote them on a global, regional and national basis through advocacy and the provision of technical support to WHO Member States.
Whilst the National Haemovigilance systems are well established in many countries, there is a lack of effective Haemovigilance in many resource-limited settings, and implementation in such settings remains an important and challenging problem. In the COVID 19 scenario, it was not possible for the experts to travel to countries and evaluate and train staff in Haemovigilance.
Mindful of this situation, the WHO and JSS AHER conceptualized a pilot virtual training program that would include prerecorded Audio-Visual educational modules which were developed by 26 domain experts from 8 different countries. 26 pre-recorded audio-visual modules were relayed during the program, with 8-panel discussions for live interactions between the participants and the experts. 240 participants registered and participated from 5 SEAR countries namely, Nepal, Bangladesh, Indonesia, Maldives, and Timor Leste.
The participants from the 5 SEAR countries understood the need for Haemovigilance in blood safety and showed their interest in the development and implementation of Haemovigilance systems in their respective countries.
The feedback collected from the participants on each day of the 5-day program showed that 100% of the participants were interested to attend such programs in the future. 92% of the participants opined that the learning experience of the program was excellent and 8% of them felt it was good.
The representatives from countries where the hemovigilance system is yet to be developed were motivated to initiate and implement concepts learnt during the program for enhancing the safe transfusion practices. The participating countries felt that conduct of such online programs in future should be continued.
JSSAHER is further collaborating with WHO in conducting a “ Regional Desk Review (situational analysis) of regulations overseeing quality and safety of Blood and Blood Products in member states of South East Asia region” and Contributing to the “ WHO-Working group on Haemovigilance Tools”.
As there are different mechanisms of regulation of blood and blood products in various South-East Asian Region (SEAR) countries, harmonization/ standardization of such mechanisms would be the primary approach to bring down such regulatory differences and thus the quality of blood and blood products.
With an aim to conduct a situational analysis of the existing legislation and regulations overseeing blood transfusion systems in member states of South East Asia region and form a regional consortium of regulatory experts of blood and blood products, WHO and JSS AHER has undertaken a Desk review and that can help in the necessary standardization of the systems through effective haemovigilance network.
Further with a strong need to standardise the global haemovigilance systems, the experts from the International Society for Blood transfusion (ISBT), the International Haemovigilance Network (IHN) and WHO experts including Dr. Surinder Singh, the Vice Chancellor of JSSAHER are actively involved in a global working group. The group aims to establish guidelines and tools for haemovigilance that will bring forward comprehensive and safe blood transfusion services.
JSSAHER strongly believes in supporting the global cause in Health Sciences Education, Research and Training that will build resilience in these challenging times.