WHO PROJECTS / ACTIVITIES

Details of the projects / Activities from July 2020 - December 2020

1. Current Good Manufacturing Practices (cGMP) Online Workshop for

Pharmaceutical Units in active pharmaceutical ingredients (API) and

formulations for access to quality-assured medical products

2. World Health Organization (WHO) Pilot online Training Program for

establishment of National Haemovigilance Systems in SEAR Countries

3. Working Group for The Integration of Medical Devices and In Vitro Diagnostics

Medical Devices Indicators into the Global Benchmarking Tool (GBT)

4. WHO Virtual cGMP Training Marathon Webinar, 07 September to 30 November

2020

5. WHO Live Webinar on Strengthening Blood Systems through Effective Blood

Regulation, 3-6 August 2020

6. Regional Desk Review (situational analysis) of regulations overseeing quality and

safety of Blood and Blood Products in member states of South East Asia region

7. WHO-Working Group on Haemovigilance Tools

1. Current Good Manufacturing Practices (cGMP) Online Workshop for Pharmaceutical Units in active pharmaceutical ingredients (API) and formulations for access to quality-assured medical products Period: August 2020 - August 2021

The workshop is being organized and implemented by;

• All three levels of World Health Organization (WHO)

o WHO Headquarters, Geneva

o WHO Regional Office for South-East Asia (SEARO), New Delhi

o WHO India Country Office, New Delhi

• Ministry of Health and Family Welfare, Government of India

• National collaborators

o JSS Academy of Higher Education & Research (JSS AHER), Mysuru,

o Indian Pharmaceutical Alliance (IPA)

• International Collaborators

o USAID - US Agency for International Development

o MTaPS - Medicines, Technologies, and Pharmaceutical Services

Program, USA

o PQM+ - Promoting the Quality of Medicines Program of United States

Pharmacopoeia (USP).

o USP – United States Pharmacopeial Convention

The aims of the Workshop are;

• Conduct WHO cGMP online trainings for medical products manufacturers

from India in the first instance followed by scale up to the other countries of

the South East Asia Region (Bangladesh/ Indonesia etc.) after August 2021.

• Cover a wide range of medical products for cGMP: Pharmaceutical APIs /

Formulations/ Biologicals including Vaccines and Anti-sera / Medical Devices

in context of COVID19 leading to upgradation of quality management

systems in the manufacturing industries

This capacity building project is being rolled out to target and train the potential

manufacturers and to upgrade their facilities to global standards and training will

comprise of;

i. Concepts and requirements of WHO PQ and similar standards across EU/ US

and other Stringent Regulatory Authorities (SRAs)

ii. Conduct of periodical online training program followed by webinars and

mentoring for APIs/formulations/ Biologicals including Vaccines and Anti-

sera / Medical Devices Manufacturers (in context of COVID19 for period –

August 2020 - August 2021)

The activities of the Workshop includes the following;

• Development of training modules

• Conduct of online training program and self assessment

• Impact assessment of the Training Program

This is the first of its kind collaborative effort from JSS AHER with WHO in the area

of Good manufacturing Practices (cGMP).

Details of the Workshop

● Six subject specific workshops would be conducted, out of which;

- Formulations - Two workshop (Out of which the first workshop will be

a pilot and is currently ongoing)

- APIs - Three workshop

- Medical Devices - One workshop

A. Each training program will have representation from

• 30 pharmaceutical units

• The participants of the training program will be 3 representatives from

each pharmaceutical unit and will include a person each from

Production, Quality and Management domain The total Number of

pharmaceutical units engaged will be 180 for the entire 6 training

programs.

• A total 540 participants are expected to participate, and 165 training

sessions would be conducted.

• In the sixth workshop (API), the pharmaceutical unit representatives

from Bangladesh and Indonesia are expected to participate.

B. Around 35-40 (Including international experts) experts would be involved as

resource persons and provide training and mentorship.

The prominent Experts / Representatives for the workshop are enumerated below;

Sl.No. Organization Representation 1 WHO Headquarters,

Geneva Dr. Deus Mubangizi Coordinator WHO Prequalification Programme

2 Dr. Alireza Khadem Scientist Regulatory System Strengthening Program

3 Ms Lisa Hedman Group Lead Access and Supply Chain

4 Ms Carmen Rodriguez Hernandez Team lead Vaccines assessment and immunization devices (VAX) Prequalification unit (PQ) Regulation and Prequalification (RPQ)

5 WHO Regional Office for South-East Asia (SEARO)

Dr. Manisha Shridhar Regional Advisor Intellectual Property Rights, Trade and Health

6 WHO India Country Office

Dr. Madhur Gupta Technical Officer- Pharmaceuticals

7 Ministry of Health and Family Welfare, Government of India

Dr Mandeep Bhandari, Joint Secretary

8 JSS Academy of Higher Education & Research (JSS AHER), Mysuru

Dr. Surinder Singh Vice Chancellor Former Drugs Controller General of India

9 Indian Pharmaceutical Alliance

Mr. Sudarshan Jain Secretary General

10 USAID – MTaPS (Medicines Technologies and Pharmaceutical Services)

Dr Kate Kikule Principal Technical Advisor, Pharmaceutical Regulatory Systems

11 Dr. Peter Mbwiiri Ikamati Consultant

12 United States Pharmacopeial Convention

Mr Teferi Bedane Technical Advisor

13 Dr Yenny Francisca Technical Advisor for Asia Region - USP Consultant

14 Indegene Mr Tarun Mathur Chief Technology Officer Indegene Los Angeles, USA

The project has a net value of USD 99,210 (Approx. INR 75,40,000).

2. Working Group for The Integration of Medical Devices and In Vitro Diagnostics

Medical Devices Indicators into the Global Benchmarking Tool (GBT)

WHO has also established a “Working Group for The Integration of Medical Devices

and In Vitro Diagnostics Medical Devices Indicators into the Global Benchmarking

Tool (GBT)”

The Global Benchmarking Tool (GBT) represents the primary means by which the

WHO objectively evaluates regulatory systems, as mandated by WHA Resolution

67.20 on Regulatory System Strengthening for medical products. The tool and

benchmarking methodology enables the WHO and regulatory authorities to:

• identify strengths and areas for improvement;

• facilitate the formulation of an institutional development plan (IDP) to build

upon strengths and address the identified gaps;

• prioritize IDP interventions; and

• monitor progress and achievements.

The working group has six major representations from the six regions of WHO and

Dr Surinder Singh, Vice Chancellor, Former Drugs Controller general of India is the

only nominated representative from South East Asia (SEA) region of WHO.

JSS AHER would be supporting in formulation of guidelines and activities of the

Working Group for The Integration of Medical Devices and In Vitro Diagnostics

Medical Devices Indicators into the Global Benchmarking Tool (GBT).

3. WHO Virtual cGMP Training Marathon Webinar, 07 September to 30

November 2020

JSS AHER, Mysuru was invited by WHO to nominate two individuals from JSS AHER

to attend the “Virtual cGMP Training Marathon” Webinar organized by the World

Health Organization (WHO), HQ, Geneva - Local Production & Assistance Unit

(LPA), Regulation and Prequalification Department (RPQ), Access to Medicines and

Health Products Division (MHP), starting from 07 September ending on 30

November 2020.

The participants for the webinar would encompass the six regions of WHO

worldwide. Participation in the Vitrual cGMP webinar would further imprint the

efforts of JSS AHER for collaboration with WHO providing global outreach.

General objective

To support and strengthen local medical product manufacturers to improve

sustainable access of quality assured essential medical products in LMICs thereby

contribute in the achievement of WHO triple billions goals embodied in the WHO

GPW13.

Specific objectives

Decrease the risk of producing poor quality Medical products by local medical

product manufacturer that could be produced by lack of technical knowledge

cGMP

Support LMICs NMRA staff reducing the risk of poor quality medical product

production in the market locally by increasing their technical knowledge cGMP

Design and implement an innovative Virtual GMP training marathon that benefit

larger number of LMICs countries in a cost effective manner

Design an innovative Virtual GMP training marathon to combat COVID -19

pandemic and to get prepared for future pandemic

Presently two faculty members from JSS AHER, Mysuru are participating in the

program. They are;

1. Dr Vishal Kumar Gupta, Deputy Director (academics), JSS AHER, Mysuru

2. Dr Vikas Jain, Assistant Professor, JSS College of Pharmacy, Mysuru

4. World Health Organization (WHO) Pilot online Training Program for

establishment of National Haemovigilance Systems in SEAR Countries

The training program is being organized and implemented at;

• WHO Headquarters, Geneva

• WHO Regional Office for South-East Asia (SEARO), New Delhi

• JSS Academy of Higher Education & Research (JSS AHER), Mysuru, India

• Participation from 5 countries

▪ Nepal

▪ Bangladesh

▪ Indonesia

▪ Maldives

▪ Timor Leste

The aim of the program is to conduct online training program through prerecorded

videos on the concept and implementation of Haemovigilance for the healthcare

providers engaged in blood transfusion services in the countries of the SEAR for

establishing / upgradation of National systems for Haemovigilance throughout the

transfusion chain to promote blood safety. The training program utilized the

expertise of experts from India, USA, Nepal Bangladesh, Indonesia and Sri Lanka.

The activities of the Training program includes the following;

• Development of Recorded training modules

• Conduct of online training program and self assessment

• Impact assessment of the Training Program

Action Plan

Selected Experts in Haemovigilance will assist in setting up and implementation of

National Haemovigilance system in SEAR countries through pre-recorded sessions

that will:

• Facilitate Capacity Building of Safe blood transfusion practices and

Haemovigilance in the Blood Banks and Hospitals of the country

• Promote Safe Blood Transfusion Practices, Rational Use of Blood and Blood

Components

• Encourage Voluntary Blood Donations

The pilot Training program was conducted from 23-27 November 2020 and had

240 participants from five of the 11 SEAR Countries. The five countries are Nepal,

Bangladesh, Indonesia Maldives, and Timor Leste.

The prominent National / International Experts who were part of the training

program are;

Sl No

Organization Representation

1 WHO HQ

Dr Yuyun MARYUNINGSIH Team lead Blood, Blood Products and Products of Human Origin WHO-HQ- Geneva

2 WHO SEARO Mr. Manoj Jhalani Director-HSD SEARO-WHO

3 WHO SEARO

Dr Aparna Singh Shah Regional Advisor Blood , Blood Products and Products of Human Origin SEARO-WHO

4 US Food and Drug Administration Dr Jay Epstein US Food and Drug Administration (Informal consultant to WHO)

5 JSS Academy of Higher Education & Research

Dr Surinder Singh Vice Chancellor JSS Academy of Higher Education & Research, Mysuru, Karnataka, India Former Drugs Controller General of India

6 Srilanka Dr. Ananda Gunasekera Secretary General, AATM, SRILANKA

7 Bangladesh

Dr. Md Ashadul Isalm Professor in Department of Transfusion Medicine, Bangabandhu Sheikh Mujib Medical University, Dhaka, BANGLADESH

8 Bangladesh

Dr. Sheikh Daud Adnan Associate Professor, Transfusion Medicine Head of the Department,Blood Bank ,NICVD Additional Charge, Program Manager Hospital Service Management, DGHS,Mohakhali,Dhaka, Bangladesh

9 Nepal Dr. Manita Rajkarnikar Director, Central Blood Transfusion Service,NEPAL

10 Nepal

Dr. Rekha Manandhar Co-ordinator of National Bureau for Blood Transfusion Services at National Public Health Laboratory, Kathmandu, NEPAL

11 Indonesia

Dr. Teguh Triyono Chairman of the National Committee for Blood INDONESIA

The project has a net value of USD 19,981 (Approx. INR 15,11,000).

5. WHO Live Webinar on Strengthening Blood Systems through Effective Blood

Regulation, 3-6 August 2020

JSS AHER, Mysuru was invited by WHO to present a talk on “Haemovigilance and

Blood Regulation in India” in the WHO Live Webinar on Strengthening Blood

Systems through Effective Blood Regulation which was conducted by online mode

from 3-6 August 2020.

The talk and the complete webinar were translated in the six languages – Arabic,

Chinese, English, French, Russian and Spanish – and was broadcasted and had

participants from across the world.

Dr Surinder Singh, Vice Chancellor, JSS AHER, Mysuru and Former Drugs Controller

General of India presented the talk on 6th August 2020 and was appreciated by

WHO. He was the only speaker representing India.

6. Regional Desk Review (situational analysis) of regulations overseeing quality

and safety of Blood and Blood Products in member states of South East Asia

region

Provision of safe blood is a fundamental need for the health system of every

country for which efficient blood transfusion services are important. With the

impact being so immense and diverse, the regulatory network that governs and

strengthens the procedures concerning the blood and blood products applications

in health systems need to be robust, frequently monitored and updated.

Elaborate guidelines have been developed hitherto; however, the universal

regulatory framework remains a possibility yet to be achieved across the different

economies globally and in the South-east Asian economies. Apart from this

diversity, the intrinsic systems of functioning of every country presents a challenge

in creating a unified effective national regulatory system and network. Though all

eleven member states have national blood policies. It is important to draft/ enforce

legislations and regulations for NBTS. As there are different mechanisms of

regulation of blood and blood products in various SEAR countries, harmonization/

standardization of such mechanisms would be the primary approach to bring down

such regulatory differences and thus quality of blood and blood products. In order

to accomplish this, it is important to understand the existing situation of

regulations overseeing blood and blood products. This need was also highlighted

during VC of HQ with regional offices. Enforcement of regulations overseeing NBTS

is one of component of WHO action framework to advance universal access to safe

blood and products. This activity proposes to conduct a desk review (situational

analysis) of the current situation of existing legislations and regulations overseeing

BTS in member states.

The proposed strategic approach to conduct the activity is as follows:

Understanding different blood regulatory systems Preparing a questionnaire to capture the standards (scientific and Technical) that are currently adopted in each of the countries

Analysis of the captured data Identification of the barriers for safe regulation of blood and blood products in each member state.

Determination of the gaps

Identify the areas of the gaps and the recommendation of solutions (in country’s context) to create a sustainable regulatory system (Administrative, Regulatory, Scientific and Applied Technical). Recommendations in line with situational analysis and line list training needs

Forming a regional consortium- network of regulatory experts of blood and blood products To ensure continued handholding, support and streamlining of the framework and effective troubling shooting through a common consortium.

For this Project, WHO-SEARO has signed Agreement of Performance of Work

(APW) with Dr Surinder Singh, Vice Chancellor, Mysuru, Former Drugs controller

General of India to submit the report by February 2021.

7. WHO-Working Group on Haemovigilance Tools

WHO has constituted a Working group on Haemovigilance Tools for developing

standardized haemovigilance tools for safe blood transfusion practices. Dr Surinder

Singh, Vice Chancellor, JSS AHER, Mysuru is a nominated member of the working

group and would be participating in the deliberations from 8th December 2020

onwards.