Published online by Cambridge University Press: 10 June 2021
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.
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5 The issue of quality and access has been a central pillar in Cipla's campaign for affordable HIV drugs. See, for example, “Cipla Pharmaceuticals’ Yusuf Hamied: ‘I Am Not against Patents . . . I Am against Monopolies,’” Knowledge@Wharton, 7 May 2009, https://knowledge.wharton.upenn.edu/article/cipla-pharmaceuticals-yusuf-hamied-i-am-not-against-patents-i-am-against-monopolies/.
6 For a personal account of the history of Cipla, see Khwaja Abdul Hamied, Hamied: An Autobiography; A Life to Remember (Bombay, 1972).
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17 Sir Syed Ahmad Khan, considered among the leading freedom fighters of the Indian independence movement, contributed to the effort by creating educational institutions such as MAO College, which later became Aligarh Muslim University. See Muhammad, Shan, Sir Syed Ahmad Khan: A Political Biography (Meerut, India, 1969)Google Scholar.
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32 Sheela Patkar, interview by Usha Iyer, 2016, Cipla Oral history records, CAOH.
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35 Patkar interview.
36 Savio Daroud (head of QC in the 1980s), interview by Usha Iyer, 2016, CAOH. On FDA approval of other companies, see Bower, D. Jane and Sulej, Julian C., “The Indian Challenge: The Evolution of a Successful New Global Strategy in the Pharmaceutical Industry,” Technology Analysis & Strategic Management 19, no. 5 (2007): 611–24Google Scholar.
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38 Dr. Ranjana Pathak (head of quality control, Cipla), interview by Muhammad H. Zaman, Aug. 2017.
39 For a full discussion of the quote, its context, and the relationship of Indian regulators with the FDA, see Sushmi Dey, “If I Follow US standards, I Will Have to Shut Almost All Drug Facilities: G N Singh,” interview, Business Standard, 30 Jan. 2014, https://www.business-standard.com/article/economy-policy/if-i-follow-us-standards-i-will-have-to-shut-almost-all-drug-facilities-g-n-singh-114013000034_1.html.
40 Daroud interview. On FDA approval of Cipla, see Fred Luthans and Jonathan Doh, International Management: Culture, Strategy, and Behavior, 8th ed. (New York, 2018), 99.
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47 CIPLOG, the company newsletter aimed at Cipla employees and their families, was started in 1984 and discontinued in 1995. It resumed publication in 2013. Dr. Hamied contributed to most issues.
48 CIPLOG, inaugural issue, Nov. 1984–Jan. 1985, available in Cipla archives.
49 CIPLOG, inaugural issue.
50 CIPLOG, Inaugural issue.
51 “The Pursuit of Quality,” CIPLOG 3, no. 4 (Aug. 1987).
52 “Computerisation: An Update,” CIPLOG 3, no. 4 (Aug. 1987).
53 “A Pioneer Venture towards Better Drugs” CIPLOG 2, no. 4 (1986).
54 “Ciplog Newsletter,” CIPLOG 5, no. 4 (1989).
55 Dr. Michael Jaegar to Dr. J. A. Gogtay, 10 Aug.1995, CA, .Cipla Archives, Mumbai, India
56 Greene, “India's Pharmaceutical Industry.”
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60 Lindsay Knight, UNAIDS: The First 10 Years, 1996–2006, Joint United Nations Programme on HIV/AIDS (Geneva, 2008).
61 David Perlman, “Worry, Hope at AIDS Conference: Breakthroughs Have Too High a Price for Many,” San Francisco Chronicle, 8 July 1996, A1.
62 For example, see “Chirac Calls for African Aids Funding,” BBC News, 8 Dec. 1997, http://news.bbc.co.uk/2/hi/37809.stm.
63 David Katzenstein, Marie Laga, and Jean-Paul Moatti, “The Evaluation of the HIV/AIDS Drug Access Initiatives in Côte d'Ivoire, Senegal and Uganda: How Access to Antiretroviral Treatment Can Become Feasible in Africa,” AIDS 17 (July 2003): S1–S4.
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70 Marseille, Elliot, Hofmann, Paul B., and Kahn, James G., “HIV Prevention before HAART in Sub-Saharan Africa,” Lancet 359, no. 9320 (2002): 1851–56CrossRefGoogle ScholarPubMed.
71 The topic was covered widely in the international press; see, for example, Donald G. McNeil, “Indian Company Offers to Supply AIDS Drugs at Low Cost in Africa,” New York Times, 7 Feb. 2001.
72 Jeffrey L. Sturchio, “Partnership for Action: The Experience of the Accelerating Access Initiative, 2000–04, and Lessons Learned,” in Delivering Essential Medicines: The Way Forward, ed. Amir Attaran and Brigitte Granville (London, 2004), 116–51.
73 Christian Laurent, Charles Kouanfack, Sinata Koulla-Shiro, Nathalie Nkoué, Anke Bourgeois, Alexandra Calmy, Bernadette Lactuock, et al., “Effectiveness and Safety of a Generic Fixed-Dose Combination of Nevirapine, Stavudine, and Lamivudine in HIV-1-Infected Adults in Cameroon: Open-Label Multicentre Trial,” Lancet 364, no. 9428 (2004): 29–34.
74 Carmen Perez-Casas, Cécile Mace, Daniel Berman, and Julia Double, “Accessing ARVs: Untangling the Web of Price Reductions for Developing Countries” (Médecins sans Frontieres, Geneva, 20 Sept. 2001),
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75 Stéphane Lucchini, Boubou Cisse, Ségolène Duran, Marie De Cenival, Caroline Comiti, Marion Gaudry, and Jean-Paul Moatti, “Decrease in Prices of Antiretroviral Drugs for Developing Countries: From Political ‘Philanthropy’ to Regulated Markets,” in Agence nationale de recherches sur le SIDA (ANRS), Economics of AIDS and Access to HIV/AIDS Care in Developing Countries: Issues and Challenges (France, 2003), 169–211.
76 ’t Hoen et al., “Driving a Decade of Change.”
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79 Naomi A. Bass, “Implications of the TRIPS Agreement for Developing Countries: Pharmaceutical Patent Laws in Brazil and South Africa in the 21st Century,” George Washington International Law Review 34 (2002): 191.
80 Attaran, Amir and Gillespie-White, Lee, “Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?,” JAMA 286, no. 15 (2001): 1886–92CrossRefGoogle ScholarPubMed.
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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.
86 Ashwin Vasan, David Hoos, Joia S. Mukherjee, Paul E. Farmer, Allan G. Rosenfield, and Joseph H. Perriëns, “The Pricing and Procurement of Antiretroviral Drugs: An Observational Study of Data from the Global Fund,” Bulletin of the World Health Organization 84 (2006): 393–98.
87 Wafaa M. El-Sadr, Charles B. Holmes, Peter Mugyenyi, Harsha Thirumurthy, Tedd Ellerbrock, Robert Ferris, Ian Sanne, et al., “Scale-Up of HIV Treatment through PEPFAR: A Historic Public Health Achievement,” Journal of Acquired Immune Deficiency Syndromes 60, no. S3 (2012): S96.
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.