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JSSAHER HELPING HEALTH CARE & PHARMA SECTOR THROUGH

WHO TRAINING PROGRAM.

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Details of the WHO- JSSAHER projects / Activities in 2020-2021

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

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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 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

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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 include 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 Good manufacturing Practices (cGMP).

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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.

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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,

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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).

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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).

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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 encompass the six regions of WHO worldwide. Participation in the Vitrual cGMP webinar 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

Two members from JSS AHER are :

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

• Dr Vikas Jain, Assistant Professor, JSS College of Pharmacy, JSS AHER, Mysuru, India.

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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

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The aim of the program is to conduct online training program through pre-recorded 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.

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The activities of the Training program include 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 the area of 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 in 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 feed back of the participants was encouraging to conduct further training

program in future.

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

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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

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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).

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

August 2020

JSS AHER, partnered in “Haemovigilance and Blood Regulation in India”, WHO Webinar on Strengthening Blood Systems through Effective Blood

Regulation in 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 a talk on 6th August 2020 and was

appreciated by WHO. He was the only speaker representing India in “Haemovigilance and Blood Regulation in India”, WHO Webinar.

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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

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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 in 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 participating in the

deliberations from 8th December 2020 onwards.