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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
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
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
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
India participating in the ACT-Accelerator
(COVAX – Vaccine Pillar of ACT Accelerator)
• Serum Institute committed 200 million doses of vaccine to COVAX
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
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
52
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
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