India:
Pharmacy of the world
On 6.8.15 I had
the good fortune to give a talk to B Sc students of Christ University,
Bangalore. Christ University, Bangalore, is one
of the best in India, dedicated Fathers, faculty and staff are aiming to make
this university, India’s best and world-class.
Kudos to the sagacious management of Christ University for making a world-class university with a
lively campus, mind-bogglingly splendid infrastructure and a highly motivating
atmosphere for learners and teachers.
Here are some
interesting snaps of my participation (giving the 45 minute lecture with a
powerpoint to strengthen the message).
During the talk,
I elaborated on the following points:
Bright prospects
in Indian Pharmaceutical Industry
‘It
is a proud and successful industry in India today, exporting medicines to 220
countries in the world. Over 60% of
vaccines are produced in India. There
was nothing prior to Independence. In
the next ten years the pharma sector is expected to grow five times from
present Rs. 2.00 lakh crore level’.
-
Dr. Subburaj, Secretary, Pharmaceuticals – Ministry of Chemicals and
Fertilisers (IDMA Bulletin, 22 to 30 March 2015, page no. 36
We
are talking of an industry, which has approximately, Rs. 1.00 lakh crores sales
per annum in domestic market and exports Rs. 1.00 lakh crores worth of
products, making the total to approx. Rs. 2.00 lakh crores/annum.
By
2020, the total worth of business that the Indian pharmaceutical industry is
expected to produce is Rs. 10.00 lakh crores, this future growth
indicates the excellent business and job prospects, for aspirants and people in the
industry.
•
Friends,
we are talking of an industry which provides anti-AIDS drugs at 1 dollar a day…
Cipla has saved 1 crore lives in Africa through their affordable anti -AIDS
medicines: India makes 92% of anti-AIDS medications sold world-wide
•
Today,
according to estimates by the World Health Organisation (WHO), every third
child in the globe — who is vaccinated through its programme — is protected
through a vaccine manufactured in India. No small achievement for a country
where the industry forever seeks to import technology
•
Every
fifth tablet, capsule and injectable generic drug being used in the world is
manufactured in India, according to India’s past Health Minister Ghulam Nabi Azad
•
Médecins
Sans Frontières (MSF), the world body that helps needy countries, dubs India
the ‘global pharmacy of the world’
With
the above sparkling opener points, I was able to attract the wholesome attention of attendees
and then I went onto elaborate points as mentioned below (with several
anecdotes and comments):
The
vibrant pharmaceutical industry in India can be divided into three main
components: APIs (bulk drugs), finished
formulations (branded and unbranded) including vaccines and biosimilars. (The term Biopharma includes biosimilars and
other products such as vaccines, sera etc).
This
numbers of above components:
- As
per AIOCD AWACS June 2015 MAT value: the Indian Pharmaceutical Industry is Rs.
90085 crores (July 2014 to June 2015), growth of 14.3%
- India
exported $15.2 billion or Rs 94,275 crore of pharmaceutical products in
2014-15, with European Union accounting for a fifth or $3 billion, as per Appaji
of Pharmaexcil
- The
Pharmaceutical industry in India is the world's third-largest in terms of volume
and stands 14th in terms of value
- India
is among the top six global pharmaceutical producers in the world
- The
country’s pharmaceutical industry accounts for about 1.4 per cent of the global
pharmaceutical industry in value terms and 10 per cent in volume terms
- India’s
pharma sales are expected to reach US$ 27 billion by 2016
What
are Indian pharmaceutical companies doing?
•
Focus
is on me-too products
•
Branded
generics
•
Me-too
biopharma (including biosimilar) products (using rDNA technology) (Eg., MAB or Monoclonal Antibody business)
•
Bulk
drugs
•
Herbal
extracts and herbal formulations (including Ayurvedic)
•
Vaccines
•
Importing
and marketing (contract marketing)
•
CRAMS:
Contract Research and Manufacturing Services; NDDS (Novel Drug Delivery System) research and new product research to some extent
•
Exports
worldwide
•
Veterinary products
•
Food supplements/nutrition products/nutraceuticals
Top 20 pharma companies
•
Indian
pharmaceutical industry is estimated to grow at 20 per cent compound annual
growth rate (CAGR) over the next five years, as per India Ratings, a Fitch
Group company
•
The
Indian pharma market size is expected to grow to US$ 85 billion by 2020
• Presently
there are 10,500 manufacturing units and over 3,000 pharma companies in India,
growing at an exceptional rate
•
India
has about 1,400 WHO GMP approved manufacturing units
•
India
has been accredited with approximately 1,105 CEPs, more than 950 TGA approvals
and 584 sites approved by the USFDA
• Globally
more than 90 per cent of formulations approvals for Anti-retroviral (ARVs),
Anti-tubercular & Anti-malarial (WHO pre-qualified) have been granted to
India
• Manufacturing
costs in India are approximately 35-40 per cent of those in the US due to low
installation and manufacturing costs
•
India
accounts for 36.9 per cent (3,411) of the 9,296 Drug Master Files (DMFs) filed
with the USA, which is the highest outside of the USA (as on December 31, 2013)
•
Higher
spending on R&D, owing to products patents have made India a major
destination for generic drug manufacturing
• Cipla
has saved 1 crore lives in Africa through their affordable anti -AIDS
medicines: India makes 92% of anti-AIDS medications sold world-wide
•
Lupin
is the 5th largest generic pharma company in US prescription market;
fastest growing in Japan and S Africa; global leader in anti TB bulk drugs and
formulations
•
Today,
according to the estimates by the World Health Organisation (WHO), every third
child in the globe — who is vaccinated through its programme — is protected
through a vaccine manufactured in India. No small achievement for a country
where the industry forever seeks to import technology
•
Every
fifth tablet, capsule and injectable generic drug being used in the world is
manufactured in India, according to India’s Health Minister Ghulam Nabi Azad
•
Médecins
Sans Frontières (MSF), the world body that helps needy countries, dubs India
the ‘global pharmacy of the world’
•
The
global pharmaceuticals market is worth US$300 billion a year, a figure expected
to rise to US$400 billion within three years
• The
10 largest drugs companies control over one-third of this market, several with
sales of more than US$10 billion a year and profit margins of about 30%
•
The
cost of AIDS treatment — a whopping $10,000 a year — dropped by more than 30
times to just $300 per year simply because ‘affordable excellence’ was part of
the DNA of Indian researchers
•
Cipla
of Mumbai says it has developed its own methods for producing the three drugs —
stavudine, lamivudine and nevirapine — thereby avoiding the process patents
owned by the major manufacturers in India
•
The
company says it will supply a combination of the drugs to the French charity
Médecins sans Frontières (Doctors without Borders) for $350 a year per patient,
on condition that the organization provides the treatment free to patients
• Approximately
70 per cent of the patients in developing countries, receive Indian medicines
through NGOs like The Clinton Foundation, Bill & Melinda Gates Foundation,
Doctors Without Borders, the UNCTAD etc
• Biologics
are drugs whose active ingredients are sourced from living organisms so these
products are based on proteins, genes, etc, unlike normal small-molecule drugs
where the active ingredient is a chemical
• Biosimilar
sales grew 20% annually to Rs 2,000 crore or approximately 2.5% of overall
market sales at the end of November 2014. Sales margins on biosimilar drugs
range from 20% to 80%
•
In
April 2013, Cipla started selling a biosimilar of the rheumatoid arthritis drug
Enbrel with a launch price of $100. The price of the drug from the innovator,
Amgen, was $133.
•
Biocon’s
CANMab, a breast cancer therapy that is a generic of Roche’s Herceptin, was
launched in February 2014 with a 25% discount to the innovator price
•
Bulk Drug Industry is the backbone of the
self-reliant Pharmaceutical industry in India
•
The
capital investment in the pharma industry is about Rs.35,000 crores
•
Today
90% of the domestic bulk drugs requirement is met by the Indian industry,
itself
•
The
Bulk Drug industry contributed about Rs. 48,000 Crores worth of exports, during
the year 2010-2011 which is growing by over 15%-20% every year
•
Over
45% of the world's bulk drug requirement is met by India
• The Rs 11,086-crore Lupin
Ltd, the largest producer of Lisinopril in the world, used in the treatment of
high blood pressure and sold to around 30 pharma companies, both in India and
overseas
•
It
makes Lisinopril in both bulk drug and finished drug form as well as Lisinopril
formulations. Last year, Lupin produced 105 tonnes per annum of Lisinopril API,
and this year is ramping it up to 120 tonnes
•
Indian
bulk drug industry to grow to US$ 17 billion by 2014
The Indian Bulk Drug industry is expected to grow at a CAGR of 21% to reach
US$16.91 billion by 2013-14 as per this study
•
Cygnus estimates the size of the Indian bulk
drug industry for 2009-10 at US$ 11.54 billion, out of which exports contribute
about US$ 7.5 billion, constituting 65% of the industry
•
The Indian Contract Manufacturing market stood
at US$986m in 2009 and is expected to grow at a CAGR of 41.7% to reach US$5.63
billion by 2014.
•
“About
1/3rd of global vaccines are manufactured in Hyderabad
•
Hyderabad is already an established bulk drug
hub of the country and about 40 per cent of country’s pharmaceutical products
are manufactured in Hyderabad”
•
Biopharma
is the largest sector contributing about 62 per cent of the total revenue, with
revenue generation to the tune of over Rs 12,600 crore (US$ 2.03 billion)
•
The
bio-pharma sector comprises vaccines, therapeutics and diagnostics
•
India
produces 40-70 per cent of the WHO demand for DPT & BCG and 90 per cent of
measles vaccine
•
A
recent report estimates that the vaccine production sector will shoot to an
estimated $871 million by 2016, a sizable jump from the 2011 value of the
sector, which sat at $350 million
•
Of
course, India will need to contend with another growing vaccines powerhouse in
the coming years: China
•
The
country is home to 12 major vaccine manufacturing facilities and exports to 150
countries
•
Much
of India's vaccines market depends on exports; they made up 65% of the market
last year (2012 statistics)
•
Serum
Institute of India Ltd., India's No. 1 Biotech Company and the World's
Largest Vaccine Manufacturer (by volume, more than 1.3 billion doses) which
includes Polio vaccine
•
Serum
Inst. is one of the largest suppliers of vaccines to over a 140 countries
and it is estimated that about 65% of the children in the world
receive at least one vaccine manufactured by Serum Institute of India Ltd
•
It
is estimated the current Indian vaccine market is around $900 million, with a
potential to touch $4.6 billion by 2017
•
As
per 'Pharma Vision 2020', the Government of India aims to make India a global
leader in end-to-end drug manufacturing
•
Manufacturing
costs in India are approximately 35-40 per cent of those in the US due to low
installation and manufacturing costs
•
Pharmaceutical
exports from India have grown at a CAGR of 21 per cent over the last decade
•
Indian
vaccines are exported to 150 countries
•
The
projected human resource requirement in the Indian pharma sector is estimated
to be about 21,50,000 by 2020
TAKE
HOME MESSAGE
•
Pharmaceutical
industry is presently approx. Rs. 2.00 lakh crores per annum and will reach Rs. 10 lakh crores by
2020
•
Good
scope in HRD, Accounts/Finance, Manufacturing (QA, QC, Production, R & D…),
Regulatory and Marketing
•
Futuristic…
scope for entrepreneurial work (eg., PCD business)
•
Knowledge
based profession
•
Global
Thanks to Dr. Ganesh Gaekwadji, Prof. of Zoology, Christ University, Bangalore for organizing
above speaking opportunity, due thanks to Dr. Anthony, Prof.... at Christ University, Bangalore
- please do scroll down and read all other posts!
