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The Cost and Evolution of Quality at Cipla Ltd., 1935–2016

Published online by Cambridge University Press:  10 June 2021

Abstract

This article examines the evolution of Indian pharmaceutical manufacturer Cipla toward producing drugs that met the quality standards of European and U.S. regulators. It employs new research in both Cipla's corporate archives and a wide range of oral histories. The article argues that, along with a long-standing corporate culture of self-reliance rooted in nationalism starting from the company's inception in 1935, major factors in Cipla's strategy from the 1960s through the early 2000s included the early adoption and continued use of quality-control technology, along with efforts to create global goodwill for affordable high-quality generic drugs during the HIV/AIDS epidemic of the early 2000s.

Type
Research Article
Copyright
Copyright © The President and Fellows of Harvard College 2021

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49 CIPLOG, inaugural issue.

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51 “The Pursuit of Quality,” CIPLOG 3, no. 4 (Aug. 1987).

52 “Computerisation: An Update,” CIPLOG 3, no. 4 (Aug. 1987).

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84 For details, see “Cipla Tests South African Government with Compulsory License Request” (KHN Morning Briefing, Kaiser Health News, 12 Mar. 2001), https://khn.org/morning-breakout/dr00003332/.

85 The protests got worldwide attention, including newspaper coverage in the United States, the United Kingdom, Germany, and South Africa in the first week of March 2001. For an example, see Ravi Nessman and Andrea Babbington, “Protest in Britain as Drug Companies Sue South African Government,” Independent, 5 Mar. 2001.

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88 For the announcement, see Ramnath Subbu, “Cipla Wins $189 m Global Fund Tender for AIDS Drugs,” The Hindu, 13 Feb. 2015.

89 Cipla registered several of its HIV drugs in South Africa in September 2003. See “Cipla Registers Five Anti-AIDS Drugs in South Africa,” Economic Times (Mumbai), 22 Sept. 2003.

90 On the issues associated with Ranbaxy, see Fleck, Fiona, “Ranbaxy Withdraws All Its AIDS Drugs from WHO List,” BMJ 329, no. 7476 (2004): 1205Google Scholar; and Eban, Katherine, Bottle of Lies: The Inside Story of the Generic Drug Boom (New York, 2019)Google Scholar.

91 Cipla Limited, Cipla Sixty-Seventh Annual Report 2002–2003, https://www.cipla.com/sites/default/files/1442820175_Sixty-Seventh-Annual-Report-2002-2003_0.pdf.

92 Hamied interview.

93 Cipla Quality Chemical Industries Limited (CQCIL) started in 2004. See Mulumba, Moses and Machemedze, Rangarirai, “Addressing Bottlenecks to Local Production of Medicines: Issues for International Cooperation in East and Southern Africa,” Journal of Health Diplomacy 1, no. 3 (2015)Google Scholar. On quality management at CQCIL see Christian Murungi, “Total Quality Management and Competitive Advantage of Pharmaceutical Industries in Uganda: A Case Study of Cipla Quality Chemical Industries Limited” (MBA dissertation, Nkumba University, 2018); for Hamied's keynote, see Y. K. Hamied, “Address by Dr. Y. K. Hamied, Chairman,” Eighty-First Annual General Meeting, Cipla, 11 Aug. 2017, https://www.cipla.com/sites/default/files/2019-01/Address%20by%20Dr.%20Y.K.%20Hamied%2C%20Chairman%20-%2081st%20AGM_0.pdf.

94 See “Quality Chemicals Marks 10 Years in Uganda,” New Vision Uganda, 11 Oct. 2017, https://www.newvision.co.ug/new_vision/news/1463399/quality-chemicals-marks-uganda.

95 For details on Cipla's activity in East Africa, see Company Profile of Cipla Quality Chemicals Ltd. Uganda “https://africanfinancials.com/company/ug-cipla/”]. For company information, see “Mission, Vision & Values,” Cipla website, accessed 7 Dec. 2020, https://ciplaqcil.co.ug/about-us#mission. See also W. O. Wanyanga, Sarah Vugigi, and Frankline Keter, “Improving Access to Essential Medicines through Public-Private Partnerships in East Africa” (Policy Brief No. 10, Scinnovent Center, Nairobi, 2020).

96 Pathak interview.

97 For information see Cipla, Health Care with a Purpose: Cipla Limited Annual Report 2018–19 (Mumbai, n.d.), https://www.cipla.com/sites/default/files/Cipla%20AR%202018-19-2.pdf.

98 Pathak interview.

99 Cipla acquired 100 percent of InvaGen in 2015.

100 Anant Atal (head of Cipla Latin America, based in Colombia), interview by Muhammed H. Zaman, May 2017.

101 In 2017, Cipla and Pfizer agreed on a plan to improve access to sixteen chemotherapeutic drugs for cancer. See Donald G. McNeil, “As Cancer Tears through Africa, Drug Makers Draw Up a Battle Plan,” New York Times, 7 Oct. 2017; and “American Cancer Society and Clinton Health Access Initiative Announce Collaborations with Pfizer and Cipla to Increase Access to Lifesaving Cancer Treatment in Africa,” press release, 20 June 2017, American Cancer Society Pressroom, http://pressroom.cancer.org/2017-06-20-American-Cancer-Society-and-Clinton-Health-Access-Initiative-Announce-Collaborations-with-Pfizer-and-Cipla-to-Increase-Access-to-Lifesaving-Cancer-Treatment-in-Africa.

102 In general, Cipla has maintained a strong reputation of quality among Indian pharmaceutical manufacturers (e.g., Eban's book Bottle of Lies discusses this in detail); however, there have been some reports of warnings by Indian regulators. See Prabha Raghavan, “Bad Medicine! Pfizer, Cipla, DRL, Other 63 Drug Firms Fail Quality Test,” Economic Times (Mumbai), 21 July 2017.