Cipla
Encyclopedia
Cipla Limited is a prominent India
India
India , officially the Republic of India , is a country in South Asia. It is the seventh-largest country by geographical area, the second-most populous country with over 1.2 billion people, and the most populous democracy in the world...

n pharmaceutical company
Pharmaceutical company
The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices...

, best-known outside its home country for manufacturing low-cost anti-AIDS
AIDS
Acquired immune deficiency syndrome or acquired immunodeficiency syndrome is a disease of the human immune system caused by the human immunodeficiency virus...

 drugs for HIV-positive patients in developing countries. Founded by nationalist Indian scientist Khwaja Abdul Hamied
Khwaja Abdul Hamied
Dr. K. A. Hamied was a vehemently nationalist Indian Scientist who graduated from Allahabad University and held M.A. and Ph.D. degrees from the Humboldt University of Berlin ; he was a disciple of M.K. Gandhi and former founder professor along with Dr. Zakir Husain of the Jamia Milia Islamia in...

 as The Chemical, Industrial & Pharmaceutical Laboratories in 1935, Cipla makes drugs to treat cardiovascular disease, arthritis, diabetes, weight control, depression and many other health conditions, and its products are distributed in more than 180 countries worldwide.

Company Profile

Cipla offers services like consulting, commissioning, engineering, project appraisal, quality control, know-how transfer, support, and plant supply.

Apart from its presence in the Indian market, Cipla also has an export market and regularly exports to more than 185 countries in all corners of the world.

Cipla is also highly regarded for technological innovation and manufacturing processes, and has been approved by numerous international regulatory bodies such as:
  • Food and Drug Administration
    Food and Drug Administration
    The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

     (FDA), USA
  • Medicines and Healthcare Products Regulatory Agency
    Medicines and Healthcare products Regulatory Agency
    The Medicines and Healthcare products Regulatory Agency is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe....

     (MHRA), UK
  • Therapeutic Goods Administration
    Therapeutic Goods Administration
    The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia . It is a Division of the Australian Department of Health and Ageing established under the Therapeutic Goods Act 1989 ...

     (TGA), Australia
  • Medicines Control Council (MCC), South Africa
  • Országos Gyógyszerészeti Intézet = National Institute of Pharmacy (NIP), Hungary
  • Pharmaceutical Inspection Convention (PIC), Germany
  • World Health Organisation (WHO)
  • Health Canada
    Health Canada
    Health Canada is the department of the government of Canada with responsibility for national public health.The current Minister of Health is Leona Aglukkaq, a Conservative Member of Parliament appointed to the position by Prime Minister Stephen Harper.-Branches, regions and agencies:Health Canada...

    , Canada
  • SUKL = State Institute for the Control of Drugs, Slovak Republic
  • Agência Nacional de Vigilância Sanitária = National Health Surveillance Agency Brazil (ANVISA), Brazil

Struggle against HIV/AIDS in the developing world

Cipla is the world's largest manufacturer of antiretroviral drugs (ARVs) to fight HIV/AIDS, as measured by units produced and distributed (multinational brand-name drugs are much more expensive, so in money terms Cipla medicines are probably somewhere down the list). Roughly 40 percent of HIV/AIDS patients undergoing antiretroviral therapy worldwide take Cipla drugs.

In February, 2001, Cipla stunned the HIV/AIDS and public health communities by announcing it would make its triple cocktail of antiretroviral drugs available in developing countries for $350 per patient per year, a tiny fraction of the prices prevailing internationally at the time. Ten years later, looking back on the decade of rapid growth in access which ensued, the Journal of the International AIDS Society
Journal of the International AIDS Society
The Journal of the International AIDS Society is an open-access peer-reviewed medical journal published by BioMed Central. It covers all aspects of research on AIDS and is the official journal of the International AIDS Society....

 (IAS) would write:
Cipla’s dramatic price reduction, which received widespread media attention, hammered the message home that many of the multinational drug companies were abusing their market monopoly in the face of a catastrophic human disaster.


Indian law from 1972 until 2005 allowed no (end-product) patents on drugs, and provided for compulsory licensing, Cipla was able to manufacture medicines which enjoyed patent
Patent
A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....

 monopoly in certain other countries (particularly those where large, multinational pharmaceutical companies are based). By doing so, as well as by making an executive decision not to make profits on AIDS medication, Cipla reduced the cost of providing antiretrovirals to AIDS patients from $12,000 and beyond (monopoly prices charged by international pharma conglomerates) down to under $100 per year. While this sum remains out of reach for many millions of people in Third World
Third World
The term Third World arose during the Cold War to define countries that remained non-aligned with either capitalism and NATO , or communism and the Soviet Union...

 countries, government and charitable sources often are in a position to make up the difference for destitute patients.

Cipla also pioneered a three-in-one tablet called Triomune containing a fixed-dose combination (FDC) of three ARVs (Lamivudine, stavudine and Nevirapine), something difficult elsewhere because the three patents were held by different companies. Another popular fixed-dose combination is produced under the name Duovir-N. This contains Lamivudine, Zidovudine and Nevirapine. Cipla manufactures generic versions of many of the most commonly prescribed anti-retroviral medication in the market, and is a highly capable manufacturer in its own right. This innovation made ARVs far more accessible and easy-to-take for patients everywhere, but particularly in poor- and middle-income countries, where the vast majority of people on anti-retroviral therapy (ART) now take such combination pills.

Cipla was among the first companies to register AIDS drugs under the US relief program PEPFAR
President's Emergency Plan For AIDS Relief
The President's Emergency Plan For AIDS Relief was a commitment of $15 billion over five years from United States President George W. Bush to fight the global HIV/AIDS pandemic...

. It has also been a major supplier of ARVs to the Clinton Foundation
Clinton Foundation
The William J. Clinton Foundation is a foundation established by former President of the United States Bill Clinton with the stated mission to "strengthen the capacity of people throughout the world to meet the challenges of global interdependence." The Foundation focuses on four critical areas:...

's HIV/AIDS Initiative, which has negotiated low-cost drug supplies for numerous developing countries.

Through its breakthrough price offers to developing country governments and leading NGOs such as Doctors Without Borders (MSF) and Oxfam
Oxfam
Oxfam is an international confederation of 15 organizations working in 98 countries worldwide to find lasting solutions to poverty and related injustice around the world. In all Oxfam’s actions, the ultimate goal is to enable people to exercise their rights and manage their own lives...

, along with its keen participation in PEPFAR, the Global Fund, the Clinton Foundation
Clinton Foundation
The William J. Clinton Foundation is a foundation established by former President of the United States Bill Clinton with the stated mission to "strengthen the capacity of people throughout the world to meet the challenges of global interdependence." The Foundation focuses on four critical areas:...

's HIV/AIDS Initiative and other major donor programs fighting HIV/AIDS in Africa and elsewhere in the resource-poor world, Cipla has played an unparalleled leadership role in ensuring access to antiretroviral treatment (ART) rose from under 10,000 on the entire African continent at the time of its $350 per patient per year offer in 2001, to well over 5 million in the developing world by the end of 2009.

AHF 'smear campaign'

In August 2007 a US-based group known as AIDS Healthcare Foundation
AIDS Healthcare Foundation
AIDS Healthcare Foundation , the largest global AIDS organization, currently provides medical care and/or services to more than 152,000 individuals in 26 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia-Pacific Region and Eastern Europe...

 (AHF) took out full-page ads in Indian newspapers suggesting Cipla was pricing its AIDS drugs higher in India than in Africa.

It turned out that AHF was closely associated with American pharma conglomerate Gilead Sciences
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics. For many years since the company was founded, the company concentrated primarily on antiviral drugs to treat patients infected with HIV, hepatitis B or influenza. In 2006, Gilead acquired two...

, which made competing products. The Economic Times
The Economic Times
The Economic Times is an English-language Indian daily newspaper published by the Bennett, Coleman & Co. Ltd.. The Economic Times was started in 1961. It is the most popular and widely read financial daily in India, read by more than 8 lakh people...

 of Delhi wrote that:
It has now emerged that Aids Healthcare Foundation (AHF), the US-based NGO that accused Cipla of over pricing anti-AIDS drug, Viraday, in India is part funded by American anti-AIDS drug maker Gilead and the NGO's treasurer is a senior Gilead executive.
This is largely the reason why foreign and Indian NGOs such as Medicins Sans Frontieres (MSF), Delhi Network of Positive People (DNP+), Indian Network of Positive People (INP+), Sahara and others refused to be part of AHF's anti-Cipla campaign.”


Pioneering American AIDS
AIDS
Acquired immune deficiency syndrome or acquired immunodeficiency syndrome is a disease of the human immune system caused by the human immunodeficiency virus...

 activist Gregg Gonsalves
Gregg Gonsalves
Gregg Gonsalves is an HIV/AIDS activist and advocate. He found out he was HIV+ in 1995. He has authored three reports of HIV and written many publications including the 1992 critical review AIDS research at the NIH and a report from the International Treatment Preparedness Coalition in 2006...

 added the following about AHF:
Let's be clear here: AIDS Healthcare Foundation has had a long history of self-serving, grand-standing efforts that have alienated much of civil society in the USA. They wrap themselves up in an AIDS activist mantle, but their goals are to drive financial resources to AHF and consolidate power for themselves. [...] They give civil society a bad name.

Antiflu and Virenza

In December 2008, Cipla won a court case in India allowing it to manufacture a cheaper generic version of oseltamivir
Oseltamivir
Oseltamivir INN , an antiviral drug, slows the spread of influenza virus between cells in the body by stopping the virus from chemically cutting ties with its host cell; median time to symptom alleviation is reduced by 0.5–1 day. The drug is sold under the trade name Tamiflu, and is taken orally...

, marketed by Hoffmann-La Roche
Hoffmann-La Roche
F. Hoffmann-La Roche Ltd. is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX Swiss Exchange....

 (Roche) under the trade name
Trade name
A trade name, also known as a trading name or a business name, is the name which a business trades under for commercial purposes, although its registered, legal name, used for contracts and other formal situations, may be another....

 Tamiflu, under the Cipla tradename Antiflu. In May 2009, Cipla won approval from the World Health Organization
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...

 certifying that its drug Antiflu was as effective as Tamiflu, and Antiflu is included in the World Health Organization
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...

 list of prequalified medicinal products.

Cipla announced that Oseltamivir 75 mg capsules marketed as `Antiflu` by the company has been included in the World Health Organization (WHO) list of prequalified medicinal products (PMP).

Oseltamivir is indicated for use in the treatment of influenza A (H1N1) infection commonly known as swine flu.

Cipla also produces a generic version of zanamivir, marketed by Glaxo under the trade name Relenza, under the Cipla tradename Virenza.

The New York Times
The New York Times
The New York Times is an American daily newspaper founded and continuously published in New York City since 1851. The New York Times has won 106 Pulitzer Prizes, the most of any news organization...

 reported that the government of Saudi Arabia
Saudi Arabia
The Kingdom of Saudi Arabia , commonly known in British English as Saudi Arabia and in Arabic as as-Sa‘ūdiyyah , is the largest state in Western Asia by land area, constituting the bulk of the Arabian Peninsula, and the second-largest in the Arab World...

 purchased stockpiles of Antiflu in preparation for Hajj
Hajj
The Hajj is the pilgrimage to Mecca, Saudi Arabia. It is one of the largest pilgrimages in the world, and is the fifth pillar of Islam, a religious duty that must be carried out at least once in their lifetime by every able-bodied Muslim who can afford to do so...

 in late 2009, fearing an outbreak of flu among Hajji
Hajji
Hajji or El-Hajj, is an honorific title given to a Muslim person who has successfully completed the Hajj to Mecca, and is often used to refer to an elder, since it can take time to accumulate the wealth to fund the travel. The title is placed before a person's name...

s arriving from all parts of the world.

The firm announced the launch of the drug under the name "Antiflu" on November 11, 2009 to be sold as a category X drug, strictly under prescription.

Other drugs

Cipla also has a product range comprising antibiotics, anti-bacterials, anti-asthmatics, anthelmintics, anti-ulcerants, 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
The New York Times
The New York Times is an American daily newspaper founded and continuously published in New York City since 1851. The New York Times has won 106 Pulitzer Prizes, the most of any news organization...

 discussed Cipla's efforts to radically lower costs of biotech drugs for cancer
Cancer
Cancer , known medically as a malignant neoplasm, is a large group of different diseases, all involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. The cancer may also spread to more distant parts of the...

, diabetes and other noncommunicable diseases, and, referencing the leading role the company had played in getting low-cost AIDS
AIDS
Acquired immune deficiency syndrome or acquired immunodeficiency syndrome is a disease of the human immune system caused by the human immunodeficiency virus...

drugs to developing world, the Times opined:
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.

Milestones

  • 1935
Dr K A Hamied sets up "The Chemical, Industrial and Pharmaceutical Laboratories Ltd." in a rented bungalow at Bombay Central.

  • 1941
As the Second World War cuts off drug supplies, the company starts producing fine chemicals, dedicating all its facilities to the war effort.

  • 1952
Sets up first research division for attaining self-sufficiency in technological development.

  • 1960
Starts operations at second plant at Vikhroli, Mumbai, producing fine chemicals with special emphasis on natural products.

  • 1968
Cipla manufactures ampicillin for the first time in the country.

  • 1972
Starts Agricultural Research Division at Bangalore, for scientific cultivation of medicinal plants.

  • 1976
Cipla launches medicinal aerosols for asthma.

  • 1980
Wins Chemexcil Award for Excellence for exports.

  • 1982
Fourth factory begins operations at Patalganga, Maharashtra.

  • 1984
Develops anti-cancer drugs, vinblastine and vincristine in collaboration with the National Chemical Laboratory, Pune. Wins Sir P C Ray Award for developing inhouse technology for indigenous manufacture of a number of basic drugs.

  • 1985
US FDA approves Cipla's bulk drug manufacturing facilities.

  • 1988
Cipla wins National Award for Successful Commercialization of Publicly Funded R&D.

  • 1991
Lauches etoposide, a breakthrough in cancer chemotherapy, in association with Indian Institute of Chemical Technology. The company pioneers the manufacture of the antiretroviral drug, zidovudine, in technological collaboration with Indian Institute of Chemical Technology, Hyderabad.

  • 1994
Cipla's fifth factory begins commercial production at Kurkumbh, Maharashtra.

  • 1997
Launches transparent Rotahaler, the world's first such dry powder inhaler device now patented by Cipla in India and abroad. The palliative cancer care centre set up by the Cipla Foundation, begins offering free services at Warje, near Pune.

  • 1998
Launches lamivudine, becoming one of the few companies in the world to offer all three component drugs of retroviral combination therapy (zidovudine and stavudine already launched).

  • 1999
Launches Nevirapine, antiretroviral drug, used to prevent the transmission of AIDS from mother to child.

  • 2000
Cipla became the first company, outside the USA and Europe to launch CFC-free inhalers – ten years before the deadline to phase out use of CFC in medicinal products.

  • 2001
Cipla announces it is prepared to supply a triple antiretroviral (ARV) combination for $350 per patient per year in poor countries. Prices for equivalent combinations at the time ranged up to over $15,000 per year in price.

  • 2002
Four state-of-the-art manufacturing facilities set up in Goa in a record time of less than twelve months.

  • 2003
Launches TIOVA (Tiotropium bromide), a novel inhaled, long-acting anticholinergic bronchodilator that is employed as a once-daily maintenance treatment for patients with chronic obstructive pulmonary disease (COPD). Commissioned second phase of manufacturing operations at Goa.

  • 2005
Set-up state-of-the-art facility for manufacture of formulations at Baddi, Himachal Pradesh.

  • 2007
Set-up state-of-the-art facility for manufacture of formulations at Sikkim.

  • 2010
Set up state-of-the-art facility for manufacture of formulations at Indore.

External links

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