Global fight against COVID 19:Medical products and technologies

Presentation to the Heads of Foreign MissionsNovember 6, 2020

Make in India : Make for the World

आत्मनिर्भर र्ारत Aatm Nirbhar Bharat

COVID-19 Pandemic: India

India: Maintaining low case fatality rate @ 1.5%

India: COVID-19 Pandemic Control Strategy

• Testing:• Testing and testing

• Suppressing chains of transmission: • Isolation of cases, contact tracing /

tracking, containment

• Clinical care, treatment and support

• COVID safe behaviours

• Whole of Government approach

• Whole of Nation approach

• Whole of society approach

• Driven by science and evidence

Augmentation in COVID-19 Testing Capacity

Jan 30

10 tests/day

March 15

1,000 tests/day

May 15

95,000 tests/day

October 30

1.2 million tests/day

As on October 30, total tests done: 109 million

2030 Labs

151 Labs

1Lab

Type of BedsACHIEVEMENT

MOHFW 4th Nov 2020

ICU beds 77,131

Non ICU Beds 264,801

Isolation beds 1,274,088

Bed Preparedness reported by states (4th Nov 2020)

Medical Products and Technologies: Themes

1. Ventilators, PPEs and N95 masks

2. Diagnostics

3. Vaccines

4. IT platform

Pre-Covid Now XNo. of

Manufacturers

03 25 X 8

Manufacturing

Capacity per annum

10,000 150,000-200,000

X 15-20

Availability(with public sector facilities)

16,000

(01.04.20)

49,000

(31.10.20)

X 3

Bureau of Indian

Standards

No Yes

Union Government

Orders

58,850

Allied

Jyoti

BEL

AgVa

Ventilators

Pre-Covid Now

No. of

Manufacturers

0 1691

Manufacturing

Capacity

0 1 millionPer day

Bureau of Indian

Standards

No Yes

Union Government

Orders

16.7 Million

PPEs

N 95 Masks

Pre-Covid Now

No. of

Manufacturers

03 3424

Manufacturing

Capacity per day

100,000 500,000

Bureau of Indian

Standards

No Yes

Union Government

Orders 30.8 Million

218 VTM kits evaluated:• 185 approved• 173 indigenous

As on 30th October 2020: 1020 diagnostic commodities

evaluated

191 Kits approved105 Indian kits

285 RT-PCR kits evaluated• 135 approved• 72 indigenous

228 RNA Extraction kits evaluated• 143 approved• 87 indigenous

78 ELISA kits evaluated

• 23 approved• 16 indigenous

172 Rapid Antibody kits evaluated• 21 approved• 12 indigenous

39 Rapid Antigen kits evaluated• 10 approved• 5 indigenous

Self Reliance ‘Atmanirbhar Bharat’Products validated at 24 ICMR Approved Validation Centres

• RTPCR cost from Rs. 1150 to Rs.138• VTM & RNA extraction kit cost from Rs.

320 to Rs. 91 & 94 per test

Quality Assured by ICMR Testing System

Minimum Acceptance Criteria for the COVID-19 Diagnostic products

COVID-19 Diagnostics Overview – India

190+ COVID-19

diagnostic products

are approved by

ICMR; 105 Indian

No. of RT-PCR kits cleared by ICMR 133

No. of Antigen RAPID Kits cleared by ICMR 10

No. of Antibody/Serology Kits cleared by ICMR 27

No. of ELISA Kits cleared by ICMR 20

Country achieved

production capacity

of 40 Million+ RT-

PCR tests/month

Indian Diagnostic Industry – Towards Self Reliance

About 150 quality, affordable products in the market

• Production capacity : 1 Million+ tests per day

• Average testing time ~ 60 minutesRT-PCR based Kits

• Production capacity : 300K+ tests per day

• Average testing time ~ 15 minutes

Rapid Ab Diagnostic Tests

• Production capacity : 150K+ tests per day

• Average testing time ~ 15 minutes

Rapid Ag Diagnostic Tests

• Production capacity : 0.5 Million+ tests per day

• Average testing time ~ 120 minutesELISA Tests

COVID-19 Diagnostic products from Indian manufacturers

200+ Indian Manufacturers registered under the consortium forthe manufacturing of 15 major components/reagents

Manufacturing Capacity/month (Supply)

Taqman Probe 18 2,43,85,600 Units, 20,010 micromole, 135

grams, & 10,000 ml

SyBr Green based

Master Mix22 1,00,80,002 Units, 22.4506 L & 100 gm

dNTPs 16 17,56,000 Units, 8.8251.1 L & 41.66 gms

Taq DNA Polymerase 25 7,73,18,000 Units & 12.5251 L

Bst 2 Enzyme 11 1,17,48,000 Units, 0.5 L & 10,000 gm

Buffers 19 13273548 L & 1500000 tests

Positive & Negative

Controls

11 2,40,52,33,000 Units & 10000.005 grams

Consumables No. of

Manufacturers

Promoting domestic manufacturing of

COVID-19 Diagnostic Components/Reagents

Domestic manufacturing of Components for RT-PCR - Nucleic Acid detection‘A Make in India’ initiative

for Biomedical research and innovative products, towards promoting import substitution and exports

MOBILE LABInfectious Disease

Diagnostic Lab (iLAB)

More than 10000 tests performed

E- BROCHURE

E- BROCHURE

FELUDA: the Game-changerCRISPR Based Rapid Test

• Paper strip based

• CRISPR technology (FnCas9)

• Sensitivity and specificity equals qRT-PCR

• Results within 75 minutes

• Cost half of RTPCR

• Rolling out next week, 1 Mn test capacity by Dec

India:SARS Cov 2 Vaccines

23

“As the largest vaccine producing country of the world, I want to give one more

assurance to the global community today.

India’s vaccine production and delivery capacity will be used to help all

humanity in fighting this crisis.”

The Hon’ble Prime Minister at the UN General Assembly on September 26, 2020

Indian Vaccine Market

UIP Sales

Private Market

Export

Indian Vaccine Market is ~1.95 B USD

(US$ 545.00 million)

(US$ 470.00 million)

(US$ 935.00

million)

India accounts for ~ 5.5% of global vaccines market ($ 35.3 B USD)

India accounts for ~ 1/4th of manufacturing capacity globally and accounts for 60% of supplies made to UNICEF.

Indian manufacturers strong in conventional vaccines manufacturing > 30 vaccines ; Indian Vaccine Impact - > 140 countries with > 1.45 billion doses

New vaccines developed for Rotavirus, Japanese Encephalitis, Typhoid and Malaria

Innovative vaccines at early stage - Dengue, Zika and Chikungunya, SARS-CoV2

~US$800M by UNICEF

Source: Indian Vaccines Industry Addressing Human Health Challenges 2019 (Case study by FISD); India’s Role in Global Health R&D Report (Study by R4D), Dutch report; Center For Global Health R&d Policy Assessment

25

India’s Vaccine Industry Serving the world

“Without India, there won’t be enough vaccines to save the world”- Peter Piot, Director of the London School of Hygiene and Tropical Medicine

Indian drug companies are major manufacturers of vaccines distributed worldwide, particularly those for

low-income countries

> 60% of vaccines supplied to the

developing world

7 WHO Prequalified manufacturers

Indian Vaccine Industry Strengths

3

1Strong manufacturing technical expertise to produce several vaccines at an affordable price

2 A large number of WHO certified Indian vaccines manufacturing premises

Availability of low cost highly skilled manpower

4 Availability of alternate affordable raw materials, packaging material and pre-filled syringes

5 Huge manufacturing capacity - > 2 Billion Liters volume capacity annually

India has established a reputation as an important global supplier of high-quality, low-cost vaccines, and

the technological sophistication of its vaccine industry is growing

India has 19 vaccine producing companies with 24 vaccine manufacturing establishments

Aurobindo pharma

Panacea biotech

Serum Institute of India

Zydus Cadila

Bharat Biotech

Biological E

Biomed

Cadila healthcareChiron Behering

Dano Vaccine & Biological

Green Signal BioPharm

Ranbaxy

Shantha Biotechnics (Sun Pharma)

BIBCOL

Haffkine

Pasteur Institute of India

HLL Biotech

CRI

Source: Indian Vaccines Industry Addressing Human Health Challenges 2019 (Case study by FISD); India’s Role in Global Health R&D Report (Study by R4D

Indian Immunological

Global Landscape : COVID Vaccine Candidates in Clinical Trials

As on 3rd November, 2020

*47 candidates in CTs

10: Phase 302: Phase 213: Phase 1/222: Phase 1

inactivated

VLP

Sub unit

replicating viralvector

non replicating viralvector

DNA

mRNA

2

9

4

5

6

14

7

*3 Indian Vaccines in Clinical trialsClinical trials of 2 more accorded DCGI approval; to be initiated

155 candidates in pre-CTs

Vaccines in clinical trials in India: 1

•Bharat Biotech

• Indian / ICMR

• Inactivated virus

• Phase II completed, results expected soon

• Phase III being started this week

• Clinical trials also proposed in neighboring countries

Vaccines in clinical trials in India: 2

•Zydus Cadila

• Indian

•DNA Vaccine• ICMR and DBT

partnering

• Phase II nearly complete

• Results end November

Vaccines in clinical trials in India: 3

•Serum Institute

•UK / USA origin•Non-replicating

viral vector (ChAdOx1)

•Oxford -

•AstraZeneca

• Phase III progressing well in India and other countries.

• AstraZeneca proposes to seek emergency use authorization in UK this month

• 200 million doses pledged toCOVX Facility (WHO-ACT A)

Sputnik V: The Russian VaccineNon-replicating viral vector

The Gamaleya Center National Research Center of Epidemiology and Microbiology

Russian Direct Investment Fund (RDIF) Sovereign Wealth Fund of Russia established in 2011

• Received DCGI approval for Phase II/III trial by Dr Reddy’s Lab

• In collaboration with DBT/BIRAC• Trials starting soon.

Vaccines in clinical trials in India: 4

• Permission given for phase I/II trials.

Vaccines in clinical trials in India: 5

•Biological E

•USA origin• Protein subunit

(recombinant) Receptor

Binding Protein

• Jenssen

•DBT partnering

S. No. Industry Status Platform

1. Zydus Cadila Pre-clinical (advanced) Replicating viral vector

2. Serum Institute Pre-clinical (advanced) Replicating viral vector

3. Serum Institute

Codagenix

Pre-clinical (advanced)

Phase I to start; further clinical

development in India

Live attenuated

4. Indian Immunologicals

Griffith University, Australia

Pre-clinical (advanced) Live attenuated (codon

deoptimization technology)

5. Reliance industries Pre-clinical (advanced) Subunit

6. Premas Biotech

Akers Biosciences

Pre-Clinical (advanced) r-DNA using D-Crypt

Technology

Other vaccines in Pre-Clinical stage

S. No. Industry Status Platform

7. Bharat Biotech

Thomas Jefferson Univ, USA

Pre-clinical (Advanced)

Phase I to start

Inactivated rabies

vector platform

8. Bharat Biotech

Washington Univ, USA

Pre-clinical

Phase I to start

By nasal drops

9. Gennova

HDT, USA

Pre-clinical (Advanced)

Phase I to start

Self Amplifying

mRNA vaccine

10. Serum Institute

Novavax

Phase III under consideration in India Sub-unit

11. Aurobindo Pharma

Aurovaccine, USA

Pre-clinical (Advanced) Vesiculo Vax

Platform

Other vaccines

➢ 3-4 scientists from national research laboratories also working on vaccine candidates

Field Sites for Clinical Trials

36

INCLEN Trust International Palwal, Haryana

Society for Health Allied Research Education (SHARE) Hyderabad

ICMR-National Institute of Epidemiology, Tirunelveli,

Tamil Nadu

Christian Medical College, Vellore, Tamil Nadu

KEM, Vadu, Pune*

urban/rural

tribal ∙

Maulana Azad Medical College, Delhi

Society for Applied Studies, Delhi

INCLEN Trust InternationalShillong, Meghalaya

ICMR-Regional Medical Research Centre, Bhuwaneshwar, Orissa

Pondicherry Institute of Medical Sciences, Pondicherry, Tamil Nadu

Andhra Medical College, Vishakhapatnam, Andhra

Pradesh *

Additional field SitesEpidemiology Initiated

DBT’s Resource of Indian Vaccine Epidemiology Network (DRIVEN)

* Involved in clinical trials for Covshield

There are also > 66 sites with experience in Vaccine clinical Trials

Public Institute

Private Institute

Delhi

Animal facilities• NII• THSTI• ICGEB

Hyderabad

• NIAB• CCMB

Thiruvananthapuram

• SCTIMST• RGCB

Bhubaneshwar

• ILS

Pune

• IISER-Pune• NCCS

• Vivo biotech• NIV

• Vimta Labs

Bangalore

• Instem-NCBS

• Syngene

Mumbai

• ACTREC

• Eurofins

Preferred Go-to Facilities/Opportunities to Ramp-Up for Harmonized COVID Vaccine Development

Animal facilities

Animal facilities

Animal facilities

Animal facilities

Animal facilities

Animal facilities

Faridabad

Pune

Interactive Research School for Health Affairs (IRSHA)

National Institute of Virology (NIV)

National AIDS Research Institute (NARI)

Vellore

Christian Medical College (CMC)

Immunogenicity assay labs for COVID-19 Vaccine Development

Translational Health Science And Technology Institute (THSTI)

Bangalore

Syngene International

DBT – THSTI Lab reconigzed by CEPI as one of the six Regional Labs for Immuno assay testing of COVID Vaccine

Vaccine Portal of India

Weblink: https://vaccine.icmr.org.in

India participating in the ACT-Accelerator

(COVAX – Vaccine Pillar of ACT Accelerator)

• Serum Institute committed 200 million doses of vaccine to COVAX

•India reaching to other countries to conduct Phase III trials of indigenous vaccines

Phase III Clinical Trials of Indian COVID vaccines in Neighbouring and Other Countries

3

1For Indian companies and researchers, conducting Clinical trials of vaccines developed by them in neighbouring and friendly countries

2For LMICs, access to advisory support for planning and executing Phase III trials

For partnering countries, access to the Indian Vaccine development Ecosystem e.g. immunogenicity assay testing of potential vaccine candidates

Building science diplomacy for technological advancement and acceleration of indigenous vaccine development efforts

43

Training Program to Strengthen the Clinical Trial Research Capacity in Neighboring Countries

Organised by DBT India and BIRAC, through their Ind-CEPI Mission alongwith MEA and Missions abroad: GCP, Ethics in Clinical Research, GCLP and Vaccine trials in population

‘Training Program to Strengthen the Clinical Trial Research Capacity in Neighboring Countries’ initiated on 22nd

Sept and various modules are planned for next 02 months

1. Afghanistan2. Bhutan3. Bangladesh4. Maldives5. Mauritius6. Nepal7. Sri Lanka

22nd September 09th October

SOPReady

Disinfectants and Sterilizers

Ventilator and Other Medical Equipment

Informatics

CoVINCOVID Vaccine Intelligence Network

A Global Tool to Manage Vaccine Delivery

World’s Largest Immunization Program monitored through eVIN

47

>650 million doses procured every year

>9 million immunization sessions held every year

*according to NFHS- IV for year 2015-16

~100 million <5 years of age children every year

for immunization

~27 million newborns every year for immunization

to be contacted 5 times in a year

~30 million pregnancies every year for

immunization

~27,000 vaccine storage points

(95% sub-district)

62%full immunization coverage

• Union Ministry of Health and Family

Welfare has an integrated Vaccine

Logistics Management Platform, eVIN

(Electronic Vaccine Intelligence Network)

• Real time tracking of vaccines including

monitoring of cold chain

• Currently operational in 33 States/UTs

• Covers more than 28,000 Health Facilities

(more than 99.9% coverage)48

• The platform is further upgraded as

CoVIN (COVID Vaccine Intelligence

Network) for monitoring COVID vaccine

delivery to the prioritized categories of

population

• CoVIN is being designed & developed in

coordination with IIT, Delhi (Computer

Science & Management Department) as a

global good as per the directions of

Hon’ble Prime Minister

eVIN (Electronic Vaccine Intelligence Network) CoVIN (COVID Vaccine Intelligence Network)

eVIN to CoVIN

Four critical questions to work towards vaccine delivery system

Are they stored in

adequate quantities?Are they stored at

recommended temperatures?

What is the Beneficiary Coverage?

Where are my vaccines?

01

03

04

02

CoVIN: Electronic Vaccine Intelligence Network – an ongoing initiative

50

CoVIN AppCoVIN Dashboard

Web interface for real-time visibility

Health Worker/ Manager is able to visualize:

Temperature loggers for accurate remote temperature monitoring in real time

Cloud ServerTemperature Logger

eVIN Mobile App

Health Worker updates:• Issues• Receipts• Stock Counts

Easy-to-use mobile app for recording vaccine data

• Real-time stock views• Alerts on low stock/expiry• Optimal order

recommendations• Temperature alarms

• SOP reminders• Beneficiary

Vaccination Status• Monitoring Coverage

Co-VIN Beneficiary Management Platform

Beneficiary

• Beneficiaries tracking• Vaccination Session

Management

• Discards• Orders

CoVIN Beneficiary Management Platform

51

Management of Session Sites

• Block Admin and District

Admin to create

sessions based on

micro-plan

• As and when session is

created, respective

Vaccinator & managers

will be notified

Registration of Beneficiary

Primary Data Collection

• In pre-defined template

by Surveyor, Vaccinator &

Mobilizer

Self Registration

• Through beneficiary

registration form

Accessing other existing

data base

• Use of existing database

for bulk upload into

CoVIN

Registration of Vaccinator

• Vaccinator will login

& opt for conducting

session

• Verify Beneficiary

details

• Update Vaccination

Status

Beneficiary acknowledgement & status updation

Beneficiary to get a SMS alert on phone with link for vaccination with details such as:

• Name

• Age

• Mobile Number

• Vaccination Status

• Date, time & place of

Vaccination

• Session Site

• Health Facility, District, State

• Name of Vaccinator

CoVIN as a Global Good: Soon to be available for India and the World

• CoVIN is developed with high end technology in Open source

environment with exposed APIs

• Can be integrated with existing MIS of any other country

• Contains flexible plug-ins to accommodate any number of

Health Facilities, Materials & Push-Pull related SOPs

• Has dedicated training & communication team

• Supported by Call Centre to facilitate implementation

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Health protection with Ayurveda products in COVID-19 times

https://www.ayush.gov.in/

Key points: Indian medical products and technologies for the World

1. India has developed a comprehensive range of quality, affordable COVID 19 diagnosticswith a large manufacturing capacity

2. India is at the forefront of COVID 19 vaccine R&D and manufacturing• Working with ACT A and global

partners and looks forward to bilateral collaborations

Key points: Indian medical products and technologies for the World

1. India has developed a comprehensive range of quality, affordable COVID 19 diagnosticswith a large manufacturing capacity

2. India is at the forefront of COVID 19 vaccine R&D and manufacturing• Working with ACT A and global

partners and looks forward to bilateral collaborations

3. India is fast developing an adaptable end-to-end IT solution (COVIN) for COVID 19 vaccine logistics and delivery solution as a global public good

4. Our Ayurveda products, ventilators, N95 masks and PPEs are also available for greater global use

Thank you