Health, Human Capital, Human Development And GDP Growth – A Discord in India

Is sustainable growth rate of Gross Domestic Product (GDP) intertwined with public health, human capital and human development, or each one of these deserves to be seen and analyzed in isolation? Or, is there a discord between India’s GDP growth rate, and various published indices of its public health, human capital and human development?

This important issue, which has various facets and dimensions, such as, social, economic, education and health, needs to be debated widely.  However, in this article, I shall try to address this question only from the public health perspective. 

It is a generally accepted fact that GDP growth rate, at any given point of time, is just one of the primary indicators, and not the sole indicator, to gauge the real health of any country’s economic ground realities. Nevertheless, considering its time-tested importance, one can well understand why India’s key focus is now primarily on boosting the rate of GDP growth of the nation. 

To translate this core objective into reality, the Government in power, almost single-mindedly and quite commendably, is actively engaged in various well publicized campaigns, such as, ‘Make in India’, several basic infrastructure developments, and attracting more Foreign Direst Investments (FDI) into the country.

High GDP growth and the general well-being of a nation:

The above initiatives are indeed praiseworthy. However, according to experts’ reports, though GDP growth presents a good first approximation of economic well being of a country for international comparisons, it ignores many basic and critical factors of the general well-being of a nation.

For that reason, there is a need to deliberate whether the pursuit of achieving a sustainable high GDP growth of India is in sync with a commensurate improvement in the indices of human development and human capital, where health stands out as one of the most critical common factors.

Some key parameters to assess the ground reality:

To properly assess the ground reality of the general well being of a country, such as India, at least, the following important parameters should be looked at together, and not in isolation: 

  • GDP growth: It’s a rate at which a nation’s Gross Domestic product (GDP) changes/grows from one year to another.  
  • Human Development Index (HDI): It is a tool developed by the United Nations to measure and rank countries’ levels of social and economic development based on the health of people, their level of education attainment and standard of living.
  • Human Capital Index (HCI): It measures countries’ ability to nurture, develop and deploy talent for economic growth. One of the most significant parameters, that is effective in human capital performance, is the role of individual health, and its related indices in enhancing the economic level of a country, besides the investment in individuals’ education. Among health features of a society, high life expectancy, low death rate in children, healthy nutrition, degree of medical advancements, the costs that the government or the family incur for the health sector and low-cost services before birth, are considered most important. 

It is worth noting, both in HDI and HCI, public health stands out as one of the most critical common factors.

A discord in India:

Keeping this in perspective, in my view, a huge discord does exist in India between HDI, HCI and the GDP growth.

High GDP growth:

All Government initiatives backed by favorable international prices of, especially, crude oil and commodities have enabled India to record the highest GDP growth of around 7.5% in 2015, as against estimated 0.5% of Brazil, -3.8% of Russia, 6.8% of China and around 1% of South Africa among the BRICS countries, in the same period.

However, according to the World Economic Forum (WEF), India has the lowest per capita GDP of US$ 5,238 among the other members of the bloc and is also lagging behind the other BRICS economies in terms of quality of life.

It is a different matter though, many experts, including a prominent member of the ruling party, are not quite convinced with India’s high GDP growth numbers.

Low Human Development Index (HDI):

According to the 2015 Human Development Index (HDI) report, recently released by the United Nations Development Program (UNDP), India occupies 130th position among 188 countries.

Among BRICS nations, Russia ranks 50, Brazil 75, China 90, South Africa 116. While among India’s neighboring countries, Sri Lanka occupies rank 73, China 90, Bhutan 132, Bangladesh 142, Nepal 145, Pakistan 147 and Afghanistan 171.

Low Human Capital Index (HCI):

According to the 2015 HCI report released by Geneva based World Economic Forum (WEF) earlier this month, India occupies105th rank out of the total 130 countries included in the index.

Among the BRICS countries, India ranks at the bottom, as against Russia’s 28th, China’s 71st, Brazil’s 83rd and South Africa’s 88th. Among the neighboring countries, even Bangladesh, Bhutan and Sri Lanka are also placed higher on the index, besides China.

Public health is the common denominator:

As I said before, for all the three – GDP growth, HDI and HCI, the health of the population is the common denominator, which no nation can possibly afford to ignore for a sustainable and high rate of GDP growth.

An article titled, “Health and the economy: A vital relationship”, published in the ‘OECD Observer’ also underscored that health care performance is strongly dependent on the economy, but also on the health systems themselves. This link should not be underestimated.

Such expert recommendations, by all means, create a high priority situation, which needs to be addressed with commensurate well thought-out policy measures, backed by adequate budgetary support.

India is still a laggard in public health standards:

Leave aside the developing nation or BRICS countries, even some much smaller neighboring nations continue performing far better on some critical health indicators than India.

In fact, the World Bank health indicators’ data show that even Bangladesh, Nepal and Vietnam, with much lesser per capita GDP are ahead of India in several key health indicators, as shown in the following table:

Some Key Indicators India Bangladesh Nepal Vietnam
GDP Per capita(PPP) (Constant at 2011 US$) 2014 5445 2981 2261 5370
Life Expectancy At Birth (Female) 2013 68 71 70 80
Survival to Age 65 (% of Cohort) 2013 63 72 69 72
Public Health Expenditure (% of GDP) 2013 1.3 1.3 2.6 2.5
Infant Female Mortality Rate/1000 of Live Birth 2015 38 28 27 15
Mortality Rate (Under 5 year of Live Births) 2015 48 38 36 22
Maternal Mortality Ratio (per 1000 Live Births) 2013 190 170 190 49
Rural Population With Improved Access to Sanitation Facilities (%) 2015 29 62 44 70
Vitamin A Supplementation Coverage Rate (% of Children 6-59 months) 2013 53 97 99 98
Immunization DPT (% of Children 12-23 month) 2014 83 95 92 95
(Source: Live Mint, October 28,2015) 

Similarly, another 2011 study published in the ‘The Lancet’ reported that Out of Pocket expenditure on health in India is the highest, as compared to its much smaller neighbors, as follows:

Country Out of Pocket expenditure on health (%)
Maldives 14
Bhutan 29
Sri Lanka 53
India 78

Intriguingly, this overall dismal public health situation continues to remain unchanged even today, despite well hyped high GDP growth rate of India.

Conclusion:

For a sustainable and high economic growth, if public health also becomes one of the top priority areas of the country, it would get reflected in India’s commensurate higher ranking in both HDI and HCI, as well, highlighting the general well-being of the nation.

Thus, just a single minded valiant chase in pursuit of registering high GDP growth, in isolation, may not necessarily mean significantly more job creation, and attaining world-class public health standards in India.

To ensure all-round well being of the general population of India, a well integrated and comprehensive strategic roadmap, with public health included in it, I reckon, would prove to be more meaningful. 

This approach would also help resolve the prevailing discord between high GDP growth, low Human Development Index (HDI) and low Human Capital Index (HCI), where public health clearly emerges as the common denominator.

By: Tapan J. Ray 

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

 

Takes ‘Two to Tango’: Encashing Opportunities with Biologic drugs in India

Despite current ‘Patent Cliff’ ongoing research on biologics is now at the forefront of the Global Pharmaceutical Industry.  The bottom-line impact of a successful new biologic molecule to treat intractable ailments like, cancer, blood disorders, Parkinson’s, Myasthenia Gravis, Multiple Sclerosis, Alzheimer’s diseases, will be huge.

Currently, faster growth of this segment as compared to conventional small molecules is primarily driven by novel technologies and highly targeted approaches, the final outcome of which is being more widely accepted by both physicians and patients.

Lesser generic competition makes it more attractive:

After patent expiry, innovators’ small molecule brands become extremely vulnerable to cut throat generic competition with as much as 90% price erosion.This is mainly because  these small molecules are relatively easy to replicate by many generic manufacturers and the process of getting their regulatory approval is also not as stringent as biosimilar drugs in most of the markets of the world.

On the other hand biologic drugs involve difficult, complex and expensive processes for development. Such resource intensive scientific expertise together with stringent regulatory requirements for obtaining marketing approval, especially in the developed markets of the world like, EU and USA, help creating a significant market entry barrier for many players. That is why even after patent expiry, biologics enjoy significant brand protection from generic competition for quite some time, in many cases.

It is for this reason brands like the following ones are expected to go relatively strong even for some more time, without any significant competition from biosimilar drugs in many of the major markets of the world:

Brand Company Launch date
Rituxan Roche/Biogen idec 1997
Herceptin Roche 1998
Remicade Centocor/J&J 1998
Enbrel Amgen/Pfizer 1998

Global Market:

In 2011 the turnover of Biologic drugs increased to over US$ 175 billion in the total market of US$ 847 billion. The sale of Biosimilar drugs outside USA exceeded US$ 1 billion.

Six biologic drugs featured in the top 10 best selling global brands in 2012 with Humira of AbbVie emerging as the highest-selling biologics during the year.  Roche remained the top company by sales for biologics with anticancer and monoclonal antibodies.

According to IMS Health, by 2015, sales of biosimilars are expected to reach between US$ 1.9 – 2.6 billion, an increase from US$ 378 million for the year to the first half of 2011.

Attractiveness:

The answer to the key question of why do so many companies want to enter into the biotech space of the business, in summary, could lie in the following:

  • Truly innovative small molecule discovery is becoming more and more challenging and expensive with the low hanging fruits already being plucked.
  • More predictable therapeutic activity of biologics with better safety profile.
  • Higher percentage of biologics have turned into blockbuster drugs in the recent past.
  • Market entry barrier for biosimilar drugs, after patent expiry of the original molecule, is much tougher than small molecule generics.
  • A diverse portfolio of both small and large molecules will reduce future business risks.

A 2012 report by PwC titled ‘From Vision to Decision: Pharma 2020’ states that “the next few years may look bleak for pharma, but we’re convinced that the following decade will bring a golden era of renewed productivity and prosperity.”

The document also points out that the global pharmaceutical industry is now focusing its R&D initiatives on biologics for the treatment of cancer and rare diseases. Nearly 30 percent of the 7,891 molecules currently in clinical testing cover cancer and autoimmune conditions.

Another emerging opportunity:

As stated above, unlike commonly used ‘small molecule’ drugs, ‘large molecule’ biologics are developed from living cells using very complex processes.

It is virtually impossible to replicate these protein substances, unlike the ‘small molecule’ drugs. One can at best develop a biologically similar molecule with the application of high degree of biotechnological expertise. These drugs are known as ‘Biosimilar Drugs’ and usually cost much less than the original ones.

Biosimilar drugs market is currently fast evolving across the world with varying degree of pace and stages of developments. The U.S currently holds the leadership status in the production of biologics, with around 45 percent of the total share. India’s share, now being at 7 percent is continuously increasing.

Biosimilar Monoclonal Antibodies (mAbs) in the Pipeline:

Company

Location

Biosimilar mAbs

Development Status

BioXpress

Switzerland

16

Preclinical

Gene Techno Science

Japan

6

Preclinical

Zydus Cadilla

India

5

Preclinical

PlantForm

Canada

3

Preclinical

BioCad

Russia

3

Preclinical

Celltrion

South Korea

2

Phase 3

LG Life Sciences

South Korea

2

Preclinical

Gedeon Richter

Hungary

2

Preclinical

Cerbios-Pharma

Switzerland

1

Preclinical

Hanwha Chemical

South Korea

1

Preclinical

PharmaPraxis

Brazil

1

Preclinical

Probiomed

Mexico

1

Phase 3

Samsung BioLogics

South Korea

1

Preclinical

Novartis

Switzerland

1

Phase 2

Teva

Israel

1

Phase 2

Zenotech

India

1

Phase 3

Spectrum

US

1

Preclinical

Biocon/Mylan

India/US

1

Preclinical

(Source: PharmaShare; as of September 10, 2011 from Citeline’s Pipeline database)

Future business potential with cost arbitrage of India:

In 2013, products like, Avonex of Biogen Idec, Humalog of Eli Lilly, Rebif of Merck KgaA, Nupugen of Amgen will go off-patent, paving the way of entry for lower priced biosimilar drugs. The sum total of revenue from all such drugs comes to over U.S$ 15 billion.

The report from the ‘Business Wire’ highlights that, ‘the manufacture and development of a biosimilar molecule requires an investment of about US$ 10 to 20 million in India, as compared to US$ 50 to 100 million in developed countries’, vindicates the emergence of another lucrative business opportunity for India for such drugs with significant cost arbitrage.

Government support in India:

In India, the government seems to have recognized that research on biotechnology has a vast commercial potential for products in human health, including biosimilars, diagnostics and immunobiologicals, among many others.

To give a fillip to the Biotech Industry in India the National Biotechnology Board was set up by the Government under the Ministry of Science and Technology way back in 1982. The Department of Biotechnology (DBT) came into existence in 1986. The DBT currently spends around US$ 300 million annually to develop biotech resources in the country and has been reportedly making reasonably good progress.

The DBT together with the Drug Controller General of India (DCGI) has now prepared ‘Regulatory Guidelines for Biosimilar Drugs’ in conformance to international quality and patient safety standards.

Currently, a number of both financial and non-financial incentives have been announced by the Central and the State Governments to encourage growth of the biotech industry in India, which include tax incentives, exemption from VAT and other fees, grants for biotech start-ups, financial assistance with patents, subsidies on investment from land to utilities and infrastructural support with the development of ten biotech parks through ‘Biotechnology Parks Society of India’.

A commendable DBT initiative:

Towards this direction, the Department of Biotechnology (DBT) of the Government of India has taken a commendable step to encourage the small and medium scale business outfits by setting-up ‘The Small Business Innovation Research Initiative (SBIRI)’. This scheme has been launched to boost ‘Public-Private-Partnership (PPP)’ projects in the country.

SBIRI supports ‘the high-risk pre-proof-of-concept research’ and ‘late stage development’ in small and medium size companies to get them involved in the development of biologics.

Some examples:

Examples of some among many of the PPP initiatives in the healthcare space under SBIRI are as follows:

No.

Company Name with Collaborator

Title of the Project Supported

1. IcubedG Ideas Private Limited, New Delhi Risk based Process Design for large scale Manufacturing of male injectable contraceptive
(Phase I)
2. Incozen Therapeutics Pvt. Ltd., Hyderabad Discovery and Development of Novel, Selective and Potent Dihydroorotate Dehydrogenase Inhibitors in Inflammatory Bowel diseases.
(Phase I)
3. Mediclone Biotech Private Limited, Chennai Commercial Production of Monoclonal Antibodies as an import substitute with special reference to Red Blood Cell Phenotyping (Phase II)
4. Orchid Chemicals & Pharmaceuticals Ltd., Chennai in collaboration with AU-KBC Research Center, Chennai Development and validation of a cell-tissue co-culture model for aiding liver specific studies and drug discovery applications. (Phase I)
5. Reliance Life Sciences Pvt. Ltd., Navi Mumbai An open label, multicenter, prospective clinical study to evaluate the safety and efficacy of tissue engineered R-STE-001 in patients with symptomatic cartilage defect of femoral condyle (Phase II)
6. USV Limited, Mumbai Development of a Vaccine capable for eliciting immunological memory for the prevention of Typhoid (Phase II)
7. Virchow Biotech Private Limited, Hyderabad Development of commercialization of a recombinant uricase for the prevention and treatment of tumor lysis syndrome associated with leukemia, lymphoma & solid tumor malignancies (Phase II)
8. Virchow Biotech Private Limited, Hyderabad Indigenous development of a recombinant Fuzeon for the treatment of AIDS (Phase II)
9. Zenotech Laboratories Limited., Hyderabad Development of humanized monoclonal antibodies against human epidermal growth factor receptor (Phase I)
10. Advanced Neuro-Science Allies Pvt. Ltd, Bangalore in collaboration with Vittal Mallya Scientific Research Foundation, Bangalore Pre-clinical studies of Human mesenchymal stem cells (MSCs) isolated and characterized from different sources in autoimmune disease, namely rheumatoid arthritis (RA) and type 1 diabetes (TIDM)(Phase I)
11. Avesthagen Ltd., Bangalore Hepatocyte-like cells generated from human embryonic stem cells (hESC) for hepatotoxicity screening of xenobiotics in the drug discovery process(Phase I)
12. Avesthagen Limited, Bangalore Scale-up and evaluation of high-value biosimilar product (Etanercept) aimed at providing cost-effective healthcare solutions to the emerging markets(Phase II)
13. Bharat Serum and Vaccines Limited, Mumbai Expression of recombinant proteins for development of synthetic pulmonary surfactant for Respiratory Distress Syndrome(Phase I)
14. Cadila Pharmaceuticals Ltd., Ahmedabad Development of Mycobacterium was an adjuvant for anti – rabies vaccine(Phase I)

Besides, Indian pharmaceutical majors like Dr. Reddy’s Laboratories (DRL), Reliance Life Science, Shantha Biotech, Ranbaxy, Biocon, Wockhardt and Glenmark have made good investments in biotech drugs manufacturing facilities keeping an eye on the emerging opportunities with Biosimilar drugs in the developed markets of the world.

Funding remains a critical issue:

That said, many industry experts do feel that R&D funding for the Biotech sector in the country is grossly inadequate. Currently, there are not many ‘Venture Capital’ funds for this sector and ‘Angel Investments’ almost being non-existent, Indian biotech companies are, by and large, dependent on Government funding.

Making India a global hub for biosimilar manufacturing:

However, with around 40 percent cost arbitrage, adequate government support and without compromising on the required stringent international regulatory standards, the domestic ‘biologic’ players should be able to establish India as one of the most preferred manufacturing destinations to meet the global requirements for particularly ‘biosimilar drugs’.

Experience in conforming to stringent US FDA manufacturing standards, having largest number of US FDA approved plants outside USA, India has already acquired a clear advantage in manufacturing high technology chemical based pharmaceutical products in India. Significant improvement in conformance to Good Clinical Practices (GCP) standards will offer additional advantages.

Conclusion:

With increasing support from the government and fueled by creative, scientific and technological inputs from various experts and entrepreneurs in the country, India has the potential to emerge as one of Asia’s best powerhouses in the field of biosimilars drugs by the end of this decade. It will take ‘two to tango’.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.