Cipla

Cipla Limited

Type	Public
Traded as	BSE: 500087 NSE: CIPLA
Industry	Pharmaceuticals
Founded	1935
Headquarters	Mumbai, India
Key people	Y. K. Hamied (CMD), Chairman
Products	Pharmaceuticals and diagnostics
Revenue	5,717.72 crore (US$1.16 billion) (2010)[1]
Net income	1,082.59 crore (US$219.55 million) (2010)
Employees	over 16000
Website	www.cipla.com

Cipla Limited (BSE: 500087, NSE: CIPLA) is a prominent Indian pharmaceutical company, best-known outside its home country for manufacturing low-cost anti-AIDS drugs for HIV-positive patients in developing countries. Founded by nationalist Indian scientist Khwaja Abdul Hamied 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.^[2]

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 (FDA), USA
• Medicines and Healthcare Products Regulatory Agency (MHRA), UK
• Therapeutic Goods Administration (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, 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^[3] (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.^[4][5]

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 (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.^[6]

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 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 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,^[7] 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.^[8] It has also been a major supplier of ARVs to the Clinton Foundation'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, along with its keen participation in PEPFAR, the Global Fund, the Clinton Foundation'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.^[9]

AHF 'smear campaign'

In August 2007 a US-based group known as AIDS Healthcare Foundation (AHF) took out full-page ads in Indian newspapers suggesting Cipla was pricing its AIDS drugs higher in India than in Africa.^[10]

It turned out that AHF was closely associated with American pharma conglomerate Gilead Sciences, which made competing products. The Economic Times 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.”^[11]

Pioneering American AIDS activist Gregg Gonsalves 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.^[12]

Antiflu and Virenza

In December 2008, Cipla won a court case in India allowing it to manufacture a cheaper generic version of oseltamivir, marketed by Hoffmann-La Roche (Roche) under the trade name Tamiflu, under the Cipla tradename Antiflu. In May 2009, Cipla won approval from the World Health Organization certifying that its drug Antiflu was as effective as Tamiflu, and Antiflu is included in the World Health Organization list of prequalified medicinal products.^[13]

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 reported that the government of Saudi Arabia purchased stockpiles of Antiflu in preparation for Hajj in late 2009, fearing an outbreak of flu among Hajjis arriving from all parts of the world.^[14]

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.^[15]

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.^[16] 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 Cipla's efforts to radically lower costs of biotech drugs for cancer, diabetes and other noncommunicable diseases, and, referencing the leading role the company had played in getting low-cost AIDS 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.^[17]

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.

References

1. ^ Cipla 2010 BSE Data
2. ^ BusinessWeek
3. ^ www.prnewswire.com aids-healthcare-foundation-campaign-challenges-cipla-over-drug-pricing-in-india
4. ^ "Cipla’s Receives Approval for Generic HIV Drug Tenofovir – Medication News". Internationaldrugmart.com. 2010-02-11. http://www.internationaldrugmart.com/news-section/cipla-generic-hiv-drug-tenofovir-receives-usfda-approval.shtml. Retrieved 2010-07-16. 
5. ^ BioSpectrum Team. "BioSpectrum - Pharma - BioSpectrumAsia Top 20, Cipla, 4". Biospectrumasia.com. http://www.biospectrumasia.com/content/150709IND9983.asp. Retrieved 2010-07-16. 
6. ^ Journal of the International AIDS Society: 13. 27 March 2011. http://www.jiasociety.org/content/14/1/15. 
7. ^ Generic HIV Medicine List
8. ^ FDA
9. ^ [www.who.int/hiv/topics/treatment/en/ "WHO page on Antiretroviral Therapy"]. www.who.int/hiv/topics/treatment/en/. 
10. ^ AIDS Healthcare Foundation's official release on Cipla's overpricing in India, August 8, 2007
11. ^ "AIDS blitz sees pharma firms locked in ugly battle", The Economic Times, September 1, 2007
12. ^ "Post to HEALTHGAP" 24 Sep 2011
13. ^ "Ciplas anti-flu drug gets nod", Times of India
14. ^ New York Times
15. ^ Reuters
16. ^ US FDA
17. ^ "China and India Making Inroads in Biotech Drugs". http://www.nytimes.com/2011/09/19/health/policy/19drug.html?tntemail1=y&_r=1&emc=tnt&pagewanted=all. 

External links

• Home page
• CIPLA- India's No:1 Pharma Company