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Export and FDI POtential of Indian Pharmaceutical Sector
Export and FDI POtential of Indian Pharmaceutical Sector
INDUSTRY
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India’s pharmaceutical industry is the biggest provider of generic drugs globally. It supplies
more than 50% of global demand for different vaccines, 40% of generic demand in the US, and
25% of all medicine in the UK.It is the third-largest in the world in terms of volume and
fourteenth largest in terms of value.
It enjoys an important position in the global pharmaceuticals sector. The country also has a big
pool of scientists and engineers that have the potential to steer the industry ahead to greater
heights. Currently, over 80% of the antiretroviral drugs used globally to combat AIDS (Acquired
Immune Deficiency Syndrome) are supplied by Indian pharmaceutical firms.
Net Profit
Indian pharmaceutical sector is expected to grow to US$ 100 billion, while the medical device
market is expected to grow US$ 25 billion by 2025. US$ 20.70 billion of pharmaceutical export
was done from India in FY20. The exports include bulk drugs, intermediates, drug formulations,
biologicals, Ayush and herbal products, and surgical.
India’s domestic pharmaceutical market turnover reached Rs 1.4 lakh crore (US$ 20.03 billion)
in 2019, up 9.8%year on year from Rs 129,015 crore (US$ 18.12 billion) in 2018.
10
0
2016 2017 2018 2019
Turnover
Medicine spending in India is projected to grow 9-12% over the next five years, leading India to
become one of the top 10 countries in terms of medical spending.
Covid-19 has exposed India’s overdependence on China for Active Pharmaceutical Ingredients
(API). Over 60% of India’s pharmaceutical imports are API and intermediates, with almost 70%
coming from China. Some of the most important APIs, such as paracetamol, are Chinese
imports.
China has Increased the price of Key starting material (KSMs)by 20%. These materials are the
building blocks for any drug. This will severely affect the indigenous API production in India.
Relaxation of licensing policies and implementation of the 2005 product patent law saw pharma
companies importing APIs rather than producing domestically. Long manufacturing cycles and
strict quality standards that resulted in low margins dealt a further body blow. Now India is
looking at developing itssupply chain network and not be dependent on China.
The imposition of the export ban on 26 drugs by the government led to a substantial 22.8%
fall in pharmaoutbound shipments in March 2020. The list includes paracetamol, Vitamins B1,
B6, B12, female hormone drug Progesterone, antibiotics used to treat vaginal infections like
Tinidazole and Metronidazole, a drug used to treat herpes Acyclovir, and other antibiotics like
Chloramphenicol, Erythromycin Salts Neomycin, Ornidazole, and Clindamycin. Which account
for 10% of Indian pharmaceuticals exports but after a month it lifted the ban from 24 of these
drugs. Paracetamol, a pain reliever, and its formulations were not in the list of drugs freed up
for export.
Credit rating agency ICRA has revised its outlook for the Indian pharmaceutical industry to
‘stable’ from ‘negative’ at the start of the year. Companies like Ipca, Dr. Reddy’s have shown
increased sales and profitability.
Single-Window Clearance
As per NBDS, a proposal has been made to set up the National Biotechnology Regulatory
Authority (NBRA) to provide a single-window clearance mechanism for all bio-safety
products to create efficiencies & streamline the drug approval process.
Pharmaceutical Parks
Government is planning to set up mega bulk drug parks so as to reduce industry’s
dependency on raw material imports.
As of October 2018, the Uttar Pradesh Government would set up 6 pharma parks in the
state and had received investment commitments of more than Rs 5,000-6,000 crore for
the same.
In October 2019, Telangana Government proposed Hyderabad Pharma City for financial
assistance from Central Government of Rs 3,418 crore.
In December 2018, the Government of India approved the National Commission for
Homoeopathy, Bill, 2018 so as to have more transparency in the sector.
The budget allocation to the Ministry of Health and Family Welfare has increased to Rs
65,012 crore.
The National Health Mission Scheme is the largest Government funded healthcare
scheme, which is expected to benefit 7.31 million poor families in the country by
providing a cover of up to Rs 5 lakh per family per year on floater basis in the impaneled
hospitals across India.
Rs 34,115 crore has been allocated towards the National Health Mission to benefit the
rural and urban people.
Rs 6,400 crore has been allocated to health insurance scheme Ayushman Bharat –
Pradhan Mantri Jan Arogya Yojana (AB-PMJAY)
Government launched The Industry – Academia mission in June 2017 to boost the
development of biopharmaceuticals in India.
To make all essential drugs accessible to common people through affordable prices.
To provide the Indian pharmaceutical sectora long-term stable policy environment.
To make India self-sufficient in end to end domestic drug manufacturing.
To maintain world class quality for domestic drug consumption and exports.
To create a conducive environment for research and development in the pharma sector.
As per the new policy, the Department of Pharmaceuticals will have control over the National
List of Essential Medicines (NLEM), which decides the drugs for which the Government of India
can control the prices.
In November 2019, Cabinet approved the extension of the Pharmaceuticals Purchase Policy
(PPP) with the same terms and conditions while adding an additional product called Alcoholic
Hand Disinfectant (AHD) to the existing list of 103 medicines till the final strategic disinvestment
of the Pharma CPSUs.
GROWTH DRIVERS
Growing
Patent Rapid Health
Expiry Urbanization Insurance
• Pharma Vision 2020 was launched to position India as world leader in end-to-end drug
manufacturing
• To control the affordability and availability issue of drugs, the govt launched:
• In it’s Pharma Vision 2020 initiative, govt also reduced the approval time for new
facilities to attract investments
• To fasten the quality assessment process and regulate the quality of imported and
exported drugs, the GOI has begun setting up mini drug testing laboratories around
Growing
major ports and airports
Health
• Insurance
A venture capital fun of Rs. 1000 crores has been set up by the Dept of Pharmaceutical
to support start-ups in the sector
• A Rs. 10,000 crore incentive has been announced by the govt to boost API
manufacturing in India and reduce dependency on China
• This investment is set to garner expertise from around the world
2. FDI Policies
• Such synergies, bring with them technology, expertise, knowledge, access to newer
markets amongst many other benefits.
3. Medical Infrastructure
• Medical infrastructure will be driven by 2 major players
— Govt expenditure
Govt expenditure stood at 3.24 lakh crore in FY20 with a CAGR of 18%
— Foreign investment
Indian pharma witnessed an FDI of $16.39 billion in the past 20 years
• India is most cost efficient when it comes to manufacturing pharma products
• Manufacturing in India is 60% cheaper than that in the US and UK
• Due to low cost of treatment, India is the number 1 choice for affordable medical
tourism
• Increased number of medical infrastructures would drive the demand for pharma inputs
• Foreign investment will also benefit from developed medical infrastructure
• With growing infrastructure and adoption of medical facilities, India becomes a lucrative
option for foreign investment
4. Compliance
• Increase in compliance measures develops a quality culture in the pharma ecosystem
• For this, Indian companies would benefit from foreign expertise
• US forms a significant market for Indian generic medicines and hence India has the 2 nd
highest US FDA approved pharma manufacturing plants after USA itself
6. Health Insurance
• Non-life insurance including health insurance has been growing at a CAGR of 16%
• This would help expand medical facilities in India and encourage their adoption
• The gross direct health insurance premium in India reached Rs. 516 billion in India which forms
close to 27% of all non-life insurance premium in the nation
• National Health Protection scheme would cover close to 10 crore Indians from the under
privileged section. This further increases the scope of health insurance coverage in India which is
a key driver of growth to the Pharma industry
• Apart from exports, this gives foreign companies an opportunity within India with healthcare
becoming more affordable for the masses
• Urban markets for pharma industry have grown at a rate of 14-15% in the past 5 years
• To add to this growth rate, around 250 million people are estimated to migrate to metro
and tier-1 cities from the lesser privileged areas in search of a better life.
• With more medical facilities and higher income levels in urban areas, expenditure on
medical facilities is bound to rise
• Increased footfall at OTC and access to drugs
1. India is the largest exporter of generic medicines, accounting for around 20% of global
generic drug exports in terms of volumes.
2. 4 Indian Pharma companies are among the top 10 generic companies of the world in
terms of exports.
3. The Indian Pharma exports stood at US$20.58 billion in FY20. The exports primarily
include bulk drugs, intermediates, drug formulations, biologicals, Ayush& herbal
products and surgical from India.
4. Drug formulations and biologicals, contribute almost 72 per cent of exports, they
showed 9.5 per cent growth in FY 2020.However, bulk drugs and drug intermediates
registered a dip of 0.73%, bringing down the overall performance.
5. India exports drugs to more than 200 countries in the world with US being the biggest
destination.
20.58
20 19.1
16.9 16.8 17.3
15
10
0
FY 16 FY 17 FY 18 FY 19 FY20
15%
6% 32%
7%
7%
16% 18%
China has been one of the leading countries to produce and sell APIs to the rest of the
world. However, with the outbreak of COVID-19 and its origin traced to China, the
production of APIs took a toll.
With the decrease in exports of APIs by China, India’s dependence has been affected as
it uses Chinese ingredients to produce one-fifth of the world’s supply of medicines.
Indian antibiotic manufacturers depend heavily, closeto around 90%, on Chinese
imports of raw materials. A number of Indian pharmaceutical companies are dependent
on Chinese APIs for manufacturing medicines. Granules India and Aurobindo Pharma has
the highest exposure to imports of APIs from China.
Already, inventory levels of APIs in India are decreasing. This along with reduced
production of APIs in China will mean that prices of medicines in India could drastically
increase.
India’s medical diplomacy has, so far, entailed giving quick clearances for export of
Hydroxychloroquine to countries that requested it, and sending Indian military doctors
to neighbouring countries such as Bhutan and Nepal to help local administrations there
to tackle the spread of COVID-19.
India would want to continue supply of generic medicines to the world using its
inventory of APIs. If India is unable to fulfil the global demand for generic medicines due
to the APIs shortage, its influence and power as one of the leading suppliers of generic
medicines could be affected.
Also, countries that depend on India may refuse to co-operate with it. These countries
will look to secure their supply chain elsewhere or even invest in the production of
generic medicines in their home ground if possible .
The pharmaceutical industry is experiencing stringent control over the prices of drugs by
the Government of India which is becoming a hurdle in the innovation capabilities of
Pharma companies as they hesitate to invest significantly in the R&D department of drug
discovery due to the fear of lower return on investment.
There is a significant gap in the ratio of pharma graduates’ number, their acumen and
the actual skill requirements in the industry. There has been an initiative to start
industry relevant programmes for the required labor, however they too seem to be too
minuscule with respect to the overall training requirements of the Pharma Industry.
Insurance Coverage
Only 30% of the Indian population is covered under the insurance schemes due to which
out of the pocket expenditure on medicines is too high. Most of the insurance
companies do not cover OPD charges in the insurance schemes which constitutes a
major healthcare expenditure. This leads to the low affordability of the drugs and low
utilization of manufactured drugs, thereby impacting the overall sale of drugs.
Stringent government policies hinder the potential of common man to establish small
scale, raw material manufacturing units across the country to improve availability of raw
materials to manufacture generic drugs at affordable rates. Further raw material production
from small scale units needs to be properly validated in the testing laboratory of the state to
meet the quality specifications for which there is a need to establish functional testing
laboratory in every state to fasten this process.
Spurious/Fake drugs
According to ASSOCHAM, fake drugs constitute around 25% of the domestic medicines market
in India.
This issue is creating a severe impact on the overall healthcare resulting in the negative image
of the high value/volume brands affecting their overall business and also posing a threat to the
health of the end consumer.
Only up to 74% of FDI is allowed in pharmaceuticals through automatic route and big-ticket
acquisitions are required to get additional clearance. Also, India’s FDI inflows are experiencing a
continuous dip registering a downfall of 1.44% in the 3 rd quarter of FY20. The impact of Covid-
19 coupled with unfavourable policies including tight price control, injected a high degree of
uncertainty among investors interested in both the drugs and medical devices segments . We
need to retain the foreign investors for long-term by including consistent and remunerative
policies.
API’s are used to manufacture at least 12 essential drugs namely Paracetamol, Ranitidine,
Ciprofloxacin, Metformin, Acetylsalicylic Acid, Ampicillin, Ofloxacin, Ascorbic Acid, Amoxicillin,
Metronidazole
• high concentration
• In the early 90’s India was self-sufficient in finished medicines as well as APIs
• Post LPG India made use of the comparative advantage with China
• Indian facilities operate at 30% of its capacity as against 70% of that of China’s
Current Scenario:
• To boost manufacturer confidence, the Niti Aayog has suggested to gradually ban 38
drug raw materials
Strategies to Adopt:
• The need to do this is to keep and unprecedented flow in the times of epidemics
India's exports represent 6.5% of world exports for this product, its ranking in world
exports is 6
The Herfindahl index for India over the years has reduced from 0.804 to 0.691 which shows that India
has diversified with respect to its exports due to expertise in the pharma sector.
From the graph, it is clear that the export intensity index has shown upwards and downwards trend in
the last 3 years which indicates that the trade flow between the countries is larger than expected.
The relationship between public health and economy is under rated and unrecognized. Labor and capital
are two important factors of productivity and labor is directly influenced by health. If the public health is
not in good shape, productivity of a nation is affected.
A few relations that have been established through researchers like Dreze and Sen (2002) mentioned
that post liberalization, opening of economy, rise in GDP has been accompanied by a slowdown in infant
mortality rate.
But when we look at the flipside of things, when healthcare improves, fertility rate improves and thus
the per capita income falls. But in the long run this population would go on to increase productivity with
high amount of labour and working class age group.
Hence, inviting FDI does not just directly contribute to India’s trade balance, but will also have an impact
on the productivity and a flourishing economy.
• India has made a name for itself in the field of generics by constituting 20% of
the world’s pie
• Hence India needs to draw a parallel field and promote innovation too to attract
companies that flourish by investing in R&D
• Higher investment by companies and the government in R&D can increase the
scope for Indian Pharma industry
• Since India’s major exports are generics, establishing leadership in terms of value
before India becomes an innovation hub, is an uphill task
• The strategy India can adopt for this is establishing home markets outside the
subcontinent
• Just like it has captured a huge chunk in a developed economy like the US, India
should look at other options like the UK and Japan
• India is taking steps in the right direction with initiatives like pharmaceutical
parks, single-window clearance, and drug testing laboratories around major ports
• Indian pharma companies partnering with foreign players to share resources can
make for ideal launchpad for global dominance
• This would help increase India’s DALY and bring it at levels of developed nations
like the US and Japan
SOURCES
1. https://www.statista.com/statistics/1038337/india-leading-pharma-companies-by-net-
profit/
2. https://www.ibef.org/industry/pharmaceutical-india.aspx
3. https://www.relocatemagazine.com/articles/enterprise-coronavirus-exposes-indian-
pharmas-overdependence-on-china-au20
4. https://www.newindianexpress.com/business/2020/aug/29/indian-pharma-sector-
sales-to-rise-after-cost-cuts-support-margins-in-pandemic-hit-q1-2020-2189947.html
5. https://www.thehindubusinessline.com/economy/policy/govt-puts-export-curbs-on-26-
pharma-ingredients-medicines/article30971571.ece
6. https://www.indiatoday.in/india/story/coronavirus-india-lifts-restrictions-on-24-drug-
exports-as-global-crisis-deepens-1664132-2020-04-07
7. https://www.forbesindia.com/article/healthcare-special/indias-pharma-firms-see-
strong-growth/62255/1
8. https://www.timesnownews.com/business-economy/companies/article/china-
increases-prices-of-key-drug-ingredients-by-up-to-20-likely-to-put-pressure-on-indian-
pharma-companies/656068
9. https://www.orfonline.org/expert-speak/understanding-the-coming-challenges-to-
indias-pharma-sector-66556/
10. https://pharmastate.blog/challenges-being-faced-by-indian-pharma-industry/
11. https://www.thehindubusinessline.com/news/dwindling-fdi-in-pharma-medical-
devices-worries-industry/article27526068.ece