Sri Sharada Institute Of Indian Management -Research

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Project report
On
PHARMACEUTICAL




Submitted To:- Submitted By:-
Prof: Ritesh Bansal Bishwajeet Kishor - 20130112
Manas prtim kakati
Bipin kumar yadav

DECLARATION

We hereby declare that the following report of titled
PHARMACEUTICAL" is an authentic work done by us. This
is to declare that all work indulged in the completion of
this work such as research and honest work of US.







Place: New Delhi Vijay Krishna
PGDM 2013-2015



ACKNOWLEDGEMENT

We would like to express our hearty gratitude to my
faculty guide, MR. RITESH BANSAL for giving us the
opportunity to prepare a project on PHARMACEUTICAL
and for the valuable guidance which helped us in
completing this project.









Contents

1. PARMACEUTICAL INDUSTRY
2. WHAT THE LAW ALLOWS PHARMCEUTICAL
MANUFACTURES TO DO
3. GLOBAL VALUE CHAIN
4. CIPLA
5. RANB












Pharmaceutical Industry

The pharmaceutical industry develops, produces, and
markets drugs or pharmaceuticals HYPERLINK "/wiki/ License
licensed for use as medications. Pharmaceutical companies are
allowed to deal in generic and/or brand medications and medical
devices. They are subject to a variety of laws and regulations
regarding the patenting, testing and ensuring safety and efficacy
and marketing of drugs.

What the law allows pharmaceutical drug
manufacturers to do


Lies, deceit, falsification
The objective of pharmaceutical drug companies is to maximise their profits. They spend at
least two and a half times more on marketing than on research. They have no incentive
whatsoever to provide the cheapest, most effective alternative for any ailment. On the
contrary, they try to hide or discredit all remedies and cures that are alternatives to their
current, most expensive, patented drug, even when these alternatives are demonstrably
superior.
A successful pharmaceutical drug reduces your symptoms, and keeps you dependent for
the rest of your life. A drug that actually cures you is a disaster because a customer is
lost.
The pharmaceutical drug industry is based on patents and legal approvals. The granting of a
patent and approval for sale for a drug or a manufacturing process provides the lifeblood for
drug companies. They will do anything to secure as many patents as possible in order to stifle
their competition, and maximise their profits by selling at the highest possible price.
It currently requires enormous capital for testing and approval before a drug is approved for
sale to the public. In America, it often takes ten years and $1 billion to get a new drug onto
the market. Only the biggest few companies have the resources to do this. This is just one
way that pharmaceutical companies stifle their competition - they simply make it too
expensive to compete - and they continue to lobby (bribe, threaten and lie to) to make testing
as expensive as possible. This also ensures that nearly all testing of pharmaceutical drugs is
financed by themselves, rather than other bodies that do not have this conflict of interest.
The bigger and more profitable the industry, the more it can afford to lobby (bribe, threaten
and lie to) politicians and decision makers to pass laws that benefit the industry.
Usually new drugs approved for patent and sale are me-too drugs, with a slightly
altered molecule to an existing drug. In the USA, the testing required for drugs
does not require that they be compared with their close cousins, with any other
drugs, or with any natural or traditional medicines. It is sufficient to show that they are
effective in curing a particular ailment.
Many drugs are ineffective, with falsified studies, lobbying pressure, and placebo effects
distorting their use. "In more than half of the clinical trials for six leading antidepressants, the
drugs did not outperform the placebo. With pharmaceutical companies funding the research
into and testing of their own products, there is tremendous pressure on the researchers to
come up with the desired results - regardless of whether the drugs really work or not. Huge
bribes, threats, and the making or breaking of careers are all at stake. "It is simply no longer
possible to believe much of the clinical research that is published."
Statin drugs are an example of a pharmaceutical that is promoted using falsified trials and a
massive campaign of misinformation, bribery and corruption.

Global Value Chains: Shifts in the
Configuration of the Industry from 1995
until Present

New Methods of Discovery


The industry has become increasingly focused on understanding the effects of
disease and infection on a molecular and physiological level in order to find
better, more specific targets to concentrate their energies on. When before there
were more hit-and-miss, serendipitous discoveries, new technologies and
understandings can now be used to find targets for innovative drugs.

Marketing and New Consumerism

In 1990s, the marketing that could be performed by the pharmaceutical industry
expanded. Due to the rise of the Internet, consumers could purchase non-
prescription drugs directly from the producers. Also, in 1997 the FDA loosened
its requirements for the presentation of risks, so companies have been able to
market direct-to-consumer through TV, radio, and print media advertisements.
The industry has also seen a shift in the drugs that are going through the pipeline.
New blockbusters, as of the 1990s, are antidepressants such as Prozac. Also
increasingly popular are nutritional supplements and alternative medicines, which
have presented new competition into the industry.


Outsourcing

Pharmaceutical companies need to be constantly innovating and developing new
products in order to remain competitive. However, the industry is very high-risk,
high-reward, and the risk is derived from the time-intensive and costly process of
research and development for producing a new drug.
Therefore, even big, vertically integrated pharmaceutical companies have become
more horizontal in an effort to reduce costs, especially since they have been rising
consistently over the past few year

Source: IBM Business Consulting Services
From 1999-2004, the pharmaceutical industry dramatically increased the amount
of outsourced R&D. This is due to the high costs of required, expensive clinical
trials. Also, again, the risk involved with R&D can be costly if the high-reward
results are not produced. This is very likely with a drug pipeline that has an
extremely high attrition rate, like in the pharmaceutical industry. According to the
Pharmaceutical Research and Manufacturers of America (Parma), a
pharmaceutical research and biotechnology trade group, out of 250 drugs that are
tested, only five will enter clinical trails, and only one will receive the right to be
produced and marketed to the public.
The cost of discovering, developing, marketing, and launching a new drug
(factoring in the cost of all those that fail to make it to market) has risen to a high
of $1.7 billion according to a study by Bain & Company.


CIPLA
Cipla Limited is a pharmaceutical company based in Mumbai, India. Cipla
makes drugs to treat cardiovascular disease, arthritis, diabetes, weight control,
depression and many other health conditions
.

On 31 March 2013, its market capitalisation was INR 305 billion (US$ 5.6
billion), making it India's 41st largest publicly traded company by market value.
History
It was founded by Dr. Khwaja Abdul Hamied as 'The Chemical, Industrial &
Pharmaceutical Laboratories' in 1935 in Mumbai
[.

The name of the Company was changed to 'Cipla Limited' with effect from 20
July 1984, wherein the word Cipla came from the first letters of each word in the
old name 'The Chemical, Industrial &Pharmaceutical Laboratories'
In the year 1985, US FDA approved the company's bulk drug manufacturing
facilities.
In 1994, Cipla launched Deferiprone, the worlds first oral iron cheater.
In 2001, Cipla offered medicines (antiretroviral) for HIV treatment at a fractional
cost (less than $350 per year per patient).
In 2012, the company slashed prices of three life-saving cancer drugs by 50-64%.
In 2013, it increased its stake in its South African joint venture CIPLA Metro
from 50% to 100% stake for INR 27 billion to strengthen its position in the
African continent. Cipla Medpro is the third largest South African pharmaceutical
company and it was founded in 1993.



Operations
Cipla has 34 manufacturing units in 8 locations across India and has presence in
170 countries. Exports accounted for 52% of its revenue for FY 2012-13.Cipla
cooperates with other enterprises in areas such as consulting, commissioning,
engineering, project appraisal, quality control, know-how transfer, support, and
plant supply.

Products and services
Cipla manufactures a range of pharmaceutical and personal care products. The
company offers active pharmaceutical ingredients (APIs); and formulations in
therapeutic areas, such as allergy, analgesic, anti-malarial, anti-invectives,
cardiology, dermatology and cosmeceuticals, diabetology, gastroenterology, HIV-
AIDS, hormones and steroids, iron chelators, musculoskeletal, neuropsychiatry,
nutritional and ophthalmic products, oncology, respiratory, urology, and womens
health in various dosage forms. It also provides veterinary products for various
animals, including companion, equine, general care, livestock, and poultry. In
addition, the company offers inhaled medication and devices, such as dry powder
inhalers, single-dose capsule and multi-dose dry powder inhalers, breath-actuated
metered dose inhalers, non-static spacers, baby and infant masks, and nasal
sprays. Further, it provides consulting, commissioning, plant engineering, and
technical know-how transfer and support services.
Cipla has over 2000 products in 65 therapeutic categories available in over 40
dosage forms
.
Its key products include the following drugs - Citalopram (anti-
depressant), Lamivudine, Fluticasone propionate.


Cancer medications
In May 2012, Cipla made headlines by slashing prices on several cancerdrugs.
The quoted Cipla chairperson Yusuf Hamied as saying: "We had taken the lead to
provide affordable medicine for AIDS and I think the time has now come -- 10
years later -- when we do a similar thing for cancer. The revised prices averaged
roughly 75% less than the previous ones and Hamied announced plans to
similarly reduce prices on the full range of cancer drugs made by Cipla. The
move was expected to prompt significant price drops from other producers,
providing access to medicine and saving many millions of cancer patients
unnecessary suffering and/or death.

Other drugs


Sakhalin - a CFC-free inhaler
Cipla also has a product range comprising antibiotics, anti-bacterial, anti-
asthmatics, anthelmintic, anti-ulcer ants, oncology, corticosteroids, nutritional
supplements and cardiovascular drugs. The company has at least nine different
prescription drugs registered with the US FDA.Active in the anti-bacterial and
anti-asthmatic segments, Cipla was the first in Asia to launch a non-CFC metered
dose inhaler.
In a September 2011 article, The New York Times discussed Copals efforts to
radically lower costs of biotech drugs for cancer, diabetes and other no
communicable HYPERLINK
"http://en.wikipedia.org/wiki/Noncommunicable_diseases" diseases, referencing
the leading role the company had played in getting low-cost AIDS drugs to the
developing world:
In retrospect, the battle 10 years ago over AIDS medicines was a small skirmish
compared with the one likely to erupt over cancer, diabetes and heart medicines.
The AIDS drug market was never a major moneymaker for global drug giants,
while cancer and diabetes drugs are central to the companies very survival.




Awards and recognitions
In April 2013, former US President Bill Clinton praised Cipla and other
Indian generic drug companies for their contribution in the fight against
HIV/AIDS and noted that their cheap drugs saved millions of lives.
In 2012, Cipla received the Thomson Reuters India Innovation Award.
Cipla won Dun & Bradstreet American Express Corporate Awards for 2006.
In 2005, Forbes included Cipla in the 200 'Best under a billion' list of best
small Asian companies.
In 1980, Cipla won Chemical Award for Excellence for exports.

Ranbaxy Laboratories
Ranbaxy Laboratories Limited (BSE: 500359) is an Indian multinational
pharmaceutical company that was incorporated in India in 1961. The company
went public in 1973 and Japanese pharmaceutical company Daiichi Sankyo
acquired a controlling share in 2008.Ranbaxy exports its products to 125
countries with ground operations in 43 and manufacturing facilities in eight
countries. In 2011, Ranbaxy Global Consumer Health Care received the OTC
Company of the year award.

History
Formation
Ranbaxy was started by Rangier Singh and Gurbax Singh in 1937 as a distributor
for a Japanese company Shionogi. The name Ranbaxy is a portmanteau of the
names of its first owners Ranbir and Gurbax. Bhai Mohan Singh bought the
company in 1952 from his cousins Ranbir and Gurbax. After Bhai Mohan Singh's
son Parvinder Singh joined the company in 1967, the company saw an increase in
scale.



Trading
In 1998, Ranbaxy entered the United States, the world's largest pharmaceuticals
market and now the biggest market for Ranbaxy, accounting for 28% of
Ranbaxy's sales in 2005.
For the twelve months ending on 31 December 2005, the company's global sales
were at US$1,178 million with overseas markets accounting for 75% of global
sales (USA: 28%, Europe: 17%, Brazil, Russia, and China: 29%). For the twelve
months ending on 31 December 2006, the company's global sales were at
US$1,300 million.
Most of Ranbaxy's products are manufactured under licence from foreign
pharmaceutical developers, though a significant percentage of their products are
off-patent drugs that are manufactured and distributed without licensing from the
original manufacturer because the patents on such drugs have expired.
In December 2005, Ranbaxy's shares were hit hard by a patent ruling disallowing
production of its own version of Pfizer's cholesterol-cutting drug Lipitor, which
has annual sales of more than $10 billion.In June 2008, Ranbaxy settled the
patent dispute with Pfizer allowing them to sell Atorvastatin Calcium, the generic
version of Lipitor and Atorvastatin Calcium-AmlodipineBaseplate, the generic
version of Pfizer's CA duet in the US starting on 30 November 2011. The
settlement also resolved several other disputes in other countries.
On 23 June 2006, Ranbaxy received from the United States Food HYPERLINK
"http://en.wikipedia.org/wiki/Food_%26_Drug_Administration"& HYPERLINK
"http://en.wikipedia.org/wiki/Food_%26_Drug_Administration" Drug
Administration a 180-day exclusivity period to sell simvastatin (Zocor) in the US
as a generic drug at 80 mg strength. Ranbaxy competes with the maker of brand-
name Zocor, Merck HYPERLINK
"http://en.wikipedia.org/wiki/Merck_%26_Co."& HYPERLINK
"http://en.wikipedia.org/wiki/Merck_%26_Co." Co.; IVAX Corporation (which
was acquired by and merged into Tea Pharmaceutical Industries Ltd.), which has
180-day exclusivity at strengths other than 80 mg; and Dr. Reddy's Laboratories,
also from India, whose authorised generic version (licensed by Merck) is exempt
from exclusivity.
In June 2008, Japan's Daiichi Sankyo Company took a majority (50.1%) stake in
Ranbaxy, with a deal valued at about US$4.6 billion. Ranbaxy's Malvinder Singh
remained as CEO after the transaction.
On 1 December 2011, Ranbaxy got the much-awaited approval from the US Food
and Drug Administration to launch the generic version of drug lipitor in the
United States of America after its patent expired.

Issues
During 20042005, Dinesh Thakur and Rajinder Kumar, two Indian employees of
Ranbaxy, blew the whistle on Ranbaxy's fabrication of drug test reports. Thakur's
office computer was soon found tampered with. Ranbaxy then accused Thakur of
visiting graphic websites using his office computer, forcing him to resign in 2005.
Thakur escaped from India to the USA and contacted the Food and Drug
Administration which started investigating his claims. As a result, on 16
September 2008, the Food and Drug Administration issued two warning letters to
Ranbaxy Laboratories Ltd. and an Import Alert for generic drugs produced by
two manufacturing plants in India.By 25 February 2009 the US Food and Drug
Administration said it halted reviews of all drug applications including data
developed at Ranbaxy's Paonta Sahib plant in India because of a practice of
falsified data and test results in approved and pending drug applications.
On 8 February 2012, three batches of the proton-pump inhibitor HYPERLINK
"http://en.wikipedia.org/wiki/Pantoprazole"Pantoprazole were recalled in the
Netherlands due to the presence of impurities. On 9 November 2012, Ranbaxy
halted production and recalled forty-one lots of atorvastatin due to glass particles
being found in some bottles.
In May 2013 the US fined the company US$500 million after it was found guilty
of misrepresenting clinical generic drug data and selling adulterated drugs to the
United States. In September 2013, further problems were reported, including
apparent human hair in a tablet, oil spots on other tablets, toilet facilities without
running water, and a failure to instruct employees to wash their hands after using
the toilet. Ranbaxy is prohibited from manufacturing FDA-regulated drugs at the
Mohali facility until the company complies with U.S. drug manufacturing
requirements
.


Acquisition
In June 2008, Daiichi-Sankyo acquired a 34.8% stake in Ranbaxy,for a value $2.4
billion. In November 2008, Daiichi-Sankyo completed the takeover of the
company from the founding Singh family in a deal worth $4.6 billion by
acquiring a 63.92% stake in Ranbaxy.
The addition of Ranbaxy Laboratories extends Daiichi-Sankyo's operations
already comprising businesses in 22 countries.The combined company is worth
about US$30 billion In 2009 it was reported that former Novartis Senior Vice-
President Yugal Sikri would lead the India operations of Ranbaxy Laboratories.