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BROOKINGS INDIA
REPORT
MARCH 2020
The Brookings Institution, is an American research
group founded in 1916.
It conducts research and education in the social
sciences, governance, foreign policy, global economy,
and economic development
Brookings has five research programs at its Washington,
D.C. campus and three international centers:-
•Doha (Brookings Doha Center)
•Beijing (Brookings-Tsinghua Center for Public Policy)
•New Delhi (Brookings India)
Introduction
“The Right to Health, including access to
essential medicines, is a human Right. To
ensure access to essential medicines,
affordable prices are a major element,
together with a rational selection & use of
medicines, sustainable financing and
reliable health & supply systems”.
- WHO (2004)
Section 21
“No person shall be deprived of
his life or personal liberty except
according to procedure
established by law.”
Right To Health
In State of Punjab v. M.S. Chawla
Right To Medical Care
In Parmananda Katara v. Union
of India
Healthcare in
India
Infrastructure
Mercury
Is the closest planet to the Sun
and the smallest one in the
Solar System
Venus
Has a beautiful name and is
the second planet from the
Sun. It’s terribly hot
 In light of the Sustainable Development Goal of
achieving universal health coverage for all by
2030, access to safe, effective, quality, and
affordable essential medicines needs to be
addressed.
Sustainable Development Goals - 2030
Has a nice name
and is the second
planet from the Sun
Venus Mars
Govt Mandate – Universal Health
Coverage
PMJAY
Aayushmaan
Bharat Yojna,
2018
HDI
131 Off 189
countries.
2020
PMBJP
New Health
Policy
2017 (Draft in
2015)
NHP
Prashanmantri
Bhartiya Jan
Aushadhi
Pariyojna, 2015
This report focuses
on three important
aspects of medicines
in India –
• Accessibility
• Affordability
• Quality
• High Out of Pocket
Expenditure
• Jan Aushadhi &
e-Pharmacy
CREDITS: This presentation template was created
by Slidesgo, including icons by Flaticon, and
infographics & images by Freepik
In 2004, the World
Health Organization
estimated that 649
million Indians lacked
regular access to
essential medicines.
“Affordability of
medication & Accessibility
of medication are two
major problems faced by
the Rural Indian
Healthcare”
CREDITS: This presentation template was created
by Slidesgo, including icons by Flaticon, and
infographics & images by Freepik
 80% in Bihar
 75% in UP
WHO data on
global health
expenditures,
2016
 65% for India versus
world average of around
20% in 2016
CREDITS: This presentation template was created
by Slidesgo, including icons by Flaticon, and
infographics & images by Freepik
 The share of medicines
in OOPE was around 51%
in 2013-14 while 43% in
2015-16
WHO data on
global health
expenditures,
2016
 65% for India versus
world average of around
20% in 2016
CREDITS: This presentation template was created
by Slidesgo, including icons by Flaticon, and
infographics & images by Freepik
 India has been
placed in Lower
Middle income
group
WHO Report on
Health
Expenditure by
countries, 2020
CREDITS: This presentation template was created
by Slidesgo, including icons by Flaticon, and
infographics & images by Freepik
 India has been
placed in Lower
Middle income group
 High OOPE
though a declining
trend for India
WHO Report on
Health
Expenditure by
countries, 2020
Jan Aushadhi scheme was launched
in 2008 to increase access to
affordable and quality medicines
Overlap with other schemes like
AMRIT
Currently, all medicines are
cheaper by at least 50%. More than
900 medicines and 154 surgical
items are available
No. of stores and purchasing from
these stores has significantly
increased after 2016
80%
Success Rate
Govt Intervention
Young and
healthy people
20 - 80
Participants
6 wks
Experimentation
Secondary Effects
Mercury is the closest planet to the Sun and
the smallest one in the Solar System—it’s
only a bit larger than our Moon
Results
Venus has a beautiful name and is the
second planet from the Sun. It’s terribly hot—
even hotter than Mercury
Goals
Study the safety of medication
 In 2015, the government rebranded the Jan Aushadhi
scheme & waived the application fee
 Increased trade margins for retailers from 16% to 20%, and
from 8% to 10% for distributors
 The financial incentive was raised to Rs. 2.50 Lakhs, from
the original Rs. 1.50 Lakhs
 Improved supply chain
80%
Success Rate
Comments
Young and
healthy people
20 - 80
Participants
6 wks
Experimentation
Secondary Effects
Mercury is the closest planet to the Sun and
the smallest one in the Solar System—it’s
only a bit larger than our Moon
Results
Venus has a beautiful name and is the
second planet from the Sun. It’s terribly hot—
even hotter than Mercury
Goals
Study the safety of medication
 Many JA stores already face shortage problems due to Supply
Chain
 Jan Aushadhi may have to compete with state governments’
own programmes that provide essentially the same services
 While PMBJP is run under the Department of
Pharmaceuticals, similar program exists under MoHFW-
Affordable Medicines and Reliable Implants for Treatment
(AMRIT) Retail Pharmacy Stores
• More financing by the
government implies less
financial burden on
households
• Drug Price regulation
Affordablitiy
Preclinical Phase 1 Phase 2 Phase 3
Lab Studies Human Safety Expanded Safety
Price control has been chosen as
the policy instrument to keep costs
of medicines low in the country
National List of Essential Medicines
(NLEM). 347 formulations
2013, The latest and current
DPCO switches to the
essentiality-based
Formulations—what the patient
actually consumes—as opposed to
the active ingredient
NPPA- National
Pharmaceutical Pricing
Authority (1995)
DPCO- Drug Price Control
Order (2013)
NLEM- National List of
Essential Medicines
 Drugs and Cosmetics Act, 1940
 The Essential Commodities Act,
1955
 The Patents Act, 1970
 The Medical Devices Rules, 2017
Govt Regulations
Anti-infectives for Systemic
Use” make up the largest
proportion of each DPCO
DPCOs select drugs that are
deemed essential to the
population
Corresponding to the disease
burden
DPCO- Drug Price Control
Order
Trend of disease burden
Preclinical Phase 1 Phase 2
Lab Studies Human Safety Expanded Safety
India’s disease
burden has shifted
towards non-
communicable
diseases, and
towards lifestyle
diseases.
80%
Success Rate
Comments
Young and
healthy people
20 - 80
Participants
6 wks
Experimentation
Secondary Effects
Mercury is the closest planet to the Sun and
the smallest one in the Solar System—it’s
only a bit larger than our Moon
Results
Venus has a beautiful name and is the
second planet from the Sun. It’s terribly hot—
even hotter than Mercury
Goals
Study the safety of medication
 Consumer welfare
 Balance between affordability and innovation is crucial for
adequate compensation to companies
 The Patents Act, 1970 (later omitted in 2005) abolished drug
patents
 In the period between 1980 to 1985, manufacturers shifted
production away from drugs under price control, which created
shortages of essential medications
 In response, the DPCO 1987 covered only 141 bulk drugs
In 2015, 27 different drug
companies operating 39 drug
manufacturing facilities lost
their clearances to make
medicines for U.S. consumers
India was a top-ten exporter
of pharmaceuticals based on
sales in 2015
Roger Bate, Ginger Zhe Jin, Aparna Mathur, and Amir Attaran (2016), “Poor Quality Drugs and Global Trade: A
Pilot Study.” American Journal of Health Economics 2, no. 3 (Summer 2016): 373-98. doi:10.3386/w20469.
80%
Success Rate
Important Definitions
Young and
healthy people
20 - 80
Participants
6 wks
Experimentation
Secondary Effects
Mercury is the closest planet to the Sun and
the smallest one in the Solar System—it’s
only a bit larger than our Moon
Results
Venus has a beautiful name and is the
second planet from the Sun. It’s terribly hot—
even hotter than Mercury
Goals
Study the safety of medication
 Spurious drugs - Counterfeits of existing brands or drugs whose active
pharmaceutical ingredients are substituted by another substance.
 Adulterated drugs - Those contaminated by outside substances that
compromise the safety and effectiveness of the drug.
 Misbranded drugs - Products which have misleading or false labeling,
or do not follow prescribed conventions.
Quality of drugs in India
Substandard drugs can prolong
treatment, adding additional costs
and can lead to accelerated
antibacterial resistance.
Amendments to the Drugs and
Cosmetics Act, 1940, were
introduced in 2008 to deter the
sale and manufacture of spurious
and adulterated drugs.
CDSCO : Central Drugs Standard Control Organisation
80%
Success Rate
Comments
Young and
healthy people
20 - 80
Participants
6 wks
Experimentation
Secondary Effects
Mercury is the closest planet to the Sun and
the smallest one in the Solar System—it’s
only a bit larger than our Moon
Results
Venus has a beautiful name and is the
second planet from the Sun. It’s terribly hot—
even hotter than Mercury
Goals
Study the safety of medication
 Nationwide shortage of inspectors
 Not enough Labs
 Seven central drug-testing laboratories under CDSCO
 Only Karnataka has three Govt-run labs
 Irregularities exist between states/union territories and their quality
tests.
 Most of the sub-standard drugs found from Uttarakhand & Himachal
Pradesh
80%
Success Rate
Recommendations
Young and
healthy people
20 - 80
Participants
6 wks
Experimentation
Secondary Effects
Mercury is the closest planet to the Sun and
the smallest one in the Solar System—it’s
only a bit larger than our Moon
Results
Venus has a beautiful name and is the
second planet from the Sun. It’s terribly hot—
even hotter than Mercury
Goals
Study the safety of medication
 Centralise manufacturing licensing system
 Standardise hiring and training process of inspectors
 Quality checks should be boosted at the manufacturing site
 Central database of spurious drugs and their manufactureres
Summing
up
80%
Success Rate
Executive Summary
Young and
healthy people
20 - 80
Participants
6 wks
Experimentation
Secondary Effects
Mercury is the closest planet to the Sun and
the smallest one in the Solar System—it’s
only a bit larger than our Moon
Results
Venus has a beautiful name and is the
second planet from the Sun. It’s terribly hot—
even hotter than Mercury
Goals
Study the safety of medication
 Pharmaceuticals contribute 43.16% to the total out-of-pocket
expenditure (OOPE) on health
The JA scheme saw maximum expansion in urban districts,
areas of high literacy and high level of development
E-pharmacies form 0.5% of the Indian pharmaceutical market
Price control has been chosen as the policy instrument to keep
costs of drugs low in the country
Between 3-4% of drugs are found to be substandard, or fake or
spurious (FS) in India
Questions?
Thank You

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Brookings India Report 2020

  • 2. The Brookings Institution, is an American research group founded in 1916. It conducts research and education in the social sciences, governance, foreign policy, global economy, and economic development
  • 3. Brookings has five research programs at its Washington, D.C. campus and three international centers:- •Doha (Brookings Doha Center) •Beijing (Brookings-Tsinghua Center for Public Policy) •New Delhi (Brookings India)
  • 5. “The Right to Health, including access to essential medicines, is a human Right. To ensure access to essential medicines, affordable prices are a major element, together with a rational selection & use of medicines, sustainable financing and reliable health & supply systems”. - WHO (2004)
  • 6. Section 21 “No person shall be deprived of his life or personal liberty except according to procedure established by law.” Right To Health In State of Punjab v. M.S. Chawla Right To Medical Care In Parmananda Katara v. Union of India
  • 8. Infrastructure Mercury Is the closest planet to the Sun and the smallest one in the Solar System Venus Has a beautiful name and is the second planet from the Sun. It’s terribly hot
  • 9.  In light of the Sustainable Development Goal of achieving universal health coverage for all by 2030, access to safe, effective, quality, and affordable essential medicines needs to be addressed. Sustainable Development Goals - 2030 Has a nice name and is the second planet from the Sun Venus Mars
  • 10. Govt Mandate – Universal Health Coverage PMJAY Aayushmaan Bharat Yojna, 2018 HDI 131 Off 189 countries. 2020 PMBJP New Health Policy 2017 (Draft in 2015) NHP Prashanmantri Bhartiya Jan Aushadhi Pariyojna, 2015
  • 11. This report focuses on three important aspects of medicines in India – • Accessibility • Affordability • Quality
  • 12. • High Out of Pocket Expenditure • Jan Aushadhi & e-Pharmacy
  • 13. CREDITS: This presentation template was created by Slidesgo, including icons by Flaticon, and infographics & images by Freepik In 2004, the World Health Organization estimated that 649 million Indians lacked regular access to essential medicines. “Affordability of medication & Accessibility of medication are two major problems faced by the Rural Indian Healthcare”
  • 14. CREDITS: This presentation template was created by Slidesgo, including icons by Flaticon, and infographics & images by Freepik  80% in Bihar  75% in UP WHO data on global health expenditures, 2016  65% for India versus world average of around 20% in 2016
  • 15. CREDITS: This presentation template was created by Slidesgo, including icons by Flaticon, and infographics & images by Freepik  The share of medicines in OOPE was around 51% in 2013-14 while 43% in 2015-16 WHO data on global health expenditures, 2016  65% for India versus world average of around 20% in 2016
  • 16. CREDITS: This presentation template was created by Slidesgo, including icons by Flaticon, and infographics & images by Freepik  India has been placed in Lower Middle income group WHO Report on Health Expenditure by countries, 2020
  • 17. CREDITS: This presentation template was created by Slidesgo, including icons by Flaticon, and infographics & images by Freepik  India has been placed in Lower Middle income group  High OOPE though a declining trend for India WHO Report on Health Expenditure by countries, 2020
  • 18. Jan Aushadhi scheme was launched in 2008 to increase access to affordable and quality medicines Overlap with other schemes like AMRIT Currently, all medicines are cheaper by at least 50%. More than 900 medicines and 154 surgical items are available No. of stores and purchasing from these stores has significantly increased after 2016
  • 19. 80% Success Rate Govt Intervention Young and healthy people 20 - 80 Participants 6 wks Experimentation Secondary Effects Mercury is the closest planet to the Sun and the smallest one in the Solar System—it’s only a bit larger than our Moon Results Venus has a beautiful name and is the second planet from the Sun. It’s terribly hot— even hotter than Mercury Goals Study the safety of medication  In 2015, the government rebranded the Jan Aushadhi scheme & waived the application fee  Increased trade margins for retailers from 16% to 20%, and from 8% to 10% for distributors  The financial incentive was raised to Rs. 2.50 Lakhs, from the original Rs. 1.50 Lakhs  Improved supply chain
  • 20. 80% Success Rate Comments Young and healthy people 20 - 80 Participants 6 wks Experimentation Secondary Effects Mercury is the closest planet to the Sun and the smallest one in the Solar System—it’s only a bit larger than our Moon Results Venus has a beautiful name and is the second planet from the Sun. It’s terribly hot— even hotter than Mercury Goals Study the safety of medication  Many JA stores already face shortage problems due to Supply Chain  Jan Aushadhi may have to compete with state governments’ own programmes that provide essentially the same services  While PMBJP is run under the Department of Pharmaceuticals, similar program exists under MoHFW- Affordable Medicines and Reliable Implants for Treatment (AMRIT) Retail Pharmacy Stores
  • 21. • More financing by the government implies less financial burden on households • Drug Price regulation
  • 22. Affordablitiy Preclinical Phase 1 Phase 2 Phase 3 Lab Studies Human Safety Expanded Safety
  • 23. Price control has been chosen as the policy instrument to keep costs of medicines low in the country National List of Essential Medicines (NLEM). 347 formulations 2013, The latest and current DPCO switches to the essentiality-based Formulations—what the patient actually consumes—as opposed to the active ingredient
  • 24. NPPA- National Pharmaceutical Pricing Authority (1995) DPCO- Drug Price Control Order (2013) NLEM- National List of Essential Medicines  Drugs and Cosmetics Act, 1940  The Essential Commodities Act, 1955  The Patents Act, 1970  The Medical Devices Rules, 2017 Govt Regulations
  • 25. Anti-infectives for Systemic Use” make up the largest proportion of each DPCO DPCOs select drugs that are deemed essential to the population Corresponding to the disease burden DPCO- Drug Price Control Order
  • 26. Trend of disease burden Preclinical Phase 1 Phase 2 Lab Studies Human Safety Expanded Safety India’s disease burden has shifted towards non- communicable diseases, and towards lifestyle diseases.
  • 27.
  • 28.
  • 29.
  • 30. 80% Success Rate Comments Young and healthy people 20 - 80 Participants 6 wks Experimentation Secondary Effects Mercury is the closest planet to the Sun and the smallest one in the Solar System—it’s only a bit larger than our Moon Results Venus has a beautiful name and is the second planet from the Sun. It’s terribly hot— even hotter than Mercury Goals Study the safety of medication  Consumer welfare  Balance between affordability and innovation is crucial for adequate compensation to companies  The Patents Act, 1970 (later omitted in 2005) abolished drug patents  In the period between 1980 to 1985, manufacturers shifted production away from drugs under price control, which created shortages of essential medications  In response, the DPCO 1987 covered only 141 bulk drugs
  • 31. In 2015, 27 different drug companies operating 39 drug manufacturing facilities lost their clearances to make medicines for U.S. consumers India was a top-ten exporter of pharmaceuticals based on sales in 2015 Roger Bate, Ginger Zhe Jin, Aparna Mathur, and Amir Attaran (2016), “Poor Quality Drugs and Global Trade: A Pilot Study.” American Journal of Health Economics 2, no. 3 (Summer 2016): 373-98. doi:10.3386/w20469.
  • 32. 80% Success Rate Important Definitions Young and healthy people 20 - 80 Participants 6 wks Experimentation Secondary Effects Mercury is the closest planet to the Sun and the smallest one in the Solar System—it’s only a bit larger than our Moon Results Venus has a beautiful name and is the second planet from the Sun. It’s terribly hot— even hotter than Mercury Goals Study the safety of medication  Spurious drugs - Counterfeits of existing brands or drugs whose active pharmaceutical ingredients are substituted by another substance.  Adulterated drugs - Those contaminated by outside substances that compromise the safety and effectiveness of the drug.  Misbranded drugs - Products which have misleading or false labeling, or do not follow prescribed conventions.
  • 33. Quality of drugs in India Substandard drugs can prolong treatment, adding additional costs and can lead to accelerated antibacterial resistance. Amendments to the Drugs and Cosmetics Act, 1940, were introduced in 2008 to deter the sale and manufacture of spurious and adulterated drugs. CDSCO : Central Drugs Standard Control Organisation
  • 34. 80% Success Rate Comments Young and healthy people 20 - 80 Participants 6 wks Experimentation Secondary Effects Mercury is the closest planet to the Sun and the smallest one in the Solar System—it’s only a bit larger than our Moon Results Venus has a beautiful name and is the second planet from the Sun. It’s terribly hot— even hotter than Mercury Goals Study the safety of medication  Nationwide shortage of inspectors  Not enough Labs  Seven central drug-testing laboratories under CDSCO  Only Karnataka has three Govt-run labs  Irregularities exist between states/union territories and their quality tests.  Most of the sub-standard drugs found from Uttarakhand & Himachal Pradesh
  • 35. 80% Success Rate Recommendations Young and healthy people 20 - 80 Participants 6 wks Experimentation Secondary Effects Mercury is the closest planet to the Sun and the smallest one in the Solar System—it’s only a bit larger than our Moon Results Venus has a beautiful name and is the second planet from the Sun. It’s terribly hot— even hotter than Mercury Goals Study the safety of medication  Centralise manufacturing licensing system  Standardise hiring and training process of inspectors  Quality checks should be boosted at the manufacturing site  Central database of spurious drugs and their manufactureres
  • 37. 80% Success Rate Executive Summary Young and healthy people 20 - 80 Participants 6 wks Experimentation Secondary Effects Mercury is the closest planet to the Sun and the smallest one in the Solar System—it’s only a bit larger than our Moon Results Venus has a beautiful name and is the second planet from the Sun. It’s terribly hot— even hotter than Mercury Goals Study the safety of medication  Pharmaceuticals contribute 43.16% to the total out-of-pocket expenditure (OOPE) on health The JA scheme saw maximum expansion in urban districts, areas of high literacy and high level of development E-pharmacies form 0.5% of the Indian pharmaceutical market Price control has been chosen as the policy instrument to keep costs of drugs low in the country Between 3-4% of drugs are found to be substandard, or fake or spurious (FS) in India

Editor's Notes

  1. Drugs have been declared as essential and accordingly put under Section 3 of Essential Commodities Act, 1955 and passage of Drugs (Price Control) Order DPCO in 2013. DPCO -  This order includes the various prices of drugs decided to be fixed and revision of prices, procedures are incorporated of implementation, procedure for recovery of dues, how penalties will be imposed and punishments involved, and various other guidelines and directions. Currently Government is regulating 24 devices which are regulated as drugs under Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945. Off these, ceiling prices had been fixed for the fwg: Cardiac Stents Drug Eluting Stents Condoms and Intra Uterine Device (Cu-T),
  2. 542 as on 21 may 2020.
  3. Drugs have been declared as essential and accordingly put under Section 3 of Essential Commodities Act, 1955 and passage of Drugs (Price Control) Order DPCO in 2013. DPCO -  This order includes the various prices of drugs decided to be fixed and revision of prices, procedures are incorporated of implementation, procedure for recovery of dues, how penalties will be imposed and punishments involved, and various other guidelines and directions. Currently Government is regulating 24 devices which are regulated as drugs under Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945. Off these, ceiling prices had been fixed for the fwg: Cardiac Stents Drug Eluting Stents Condoms and Intra Uterine Device (Cu-T),
  4. Drugs have been declared as essential and accordingly put under Section 3 of Essential Commodities Act, 1955 and passage of Drugs (Price Control) Order DPCO in 2013. DPCO -  This order includes the various prices of drugs decided to be fixed and revision of prices, procedures are incorporated of implementation, procedure for recovery of dues, how penalties will be imposed and punishments involved, and various other guidelines and directions. Currently Government is regulating 24 devices which are regulated as drugs under Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945. Off these, ceiling prices had been fixed for the fwg: Cardiac Stents Drug Eluting Stents Condoms and Intra Uterine Device (Cu-T),
  5. Drugs have been declared as essential and accordingly put under Section 3 of Essential Commodities Act, 1955 and passage of Drugs (Price Control) Order DPCO in 2013. DPCO -  This order includes the various prices of drugs decided to be fixed and revision of prices, procedures are incorporated of implementation, procedure for recovery of dues, how penalties will be imposed and punishments involved, and various other guidelines and directions. Currently Government is regulating 24 devices which are regulated as drugs under Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945. Off these, ceiling prices had been fixed for the fwg: Cardiac Stents Drug Eluting Stents Condoms and Intra Uterine Device (Cu-T),