The Reformulation Regime in Drug Discovery: Revisiting Polyherbals and Property Rights in the Ayurvedic Industry

Abstract

In so-called traditional medicine in South Asia, substances have not ordinarily been prescribed or consumed in isolation, yet the transformations of compound formulations have been comparatively little studied from any position within anthropology or history. Since the early twentieth century, ayurvedic formulations have often been redesigned to address the biomedical disorders of a new global clientele. This has involved overlapping medical cultures and the creation of heterodox epistemologies, which have then allowed the creation of new “traditional” products that suit the demands of the market. In India, these new formulations fall under the category of “Ayurvedic Proprietary Medicines,” which are distinct from classical, textual (shastric) formulations already in the public domain. Proprietary medicines are the object of specific systems of appropriation and protection, which have not only gained central stage in the country but also influenced international regulatory bodies. This article seeks to explore the way in which the “reformulation regime” has fostered the emergence of alternative models of property rights, and their global acceptance, as well as how, in turn, these new forms of property have today come to drive pharmaceutical innovation itself. By analyzing this “looping effect,” this article sets out prospective avenues to study the industrialization of traditional medicine and the complex interface between regulatory systems, innovation processes, and the market.

Keywords:

• Reformulation regime
• pharmaceutical innovation
• property rights
• ayurveda

Notes

 1 This decrease is even sharper when considering the molecules identified by drug-regulation agencies as sources of significant clinical improvement.

 2 The works that have contributed to historicizing the screening model show that it was only a marginal form of innovation until World War II (Chauveau 1999; Gaudillière 2005, 2010; Lesch 1993, 2007; Swann 1988).

 3 In India, the existence of various differing innovation regimes reflects the existence of various types of medicine as well as of a hierarchy marked by the domination of biomedical knowledge that has prevailed since the colonial age (Pati and Harrison 2001). It should be said, however, that the “cultural authority of biomedicine” (Croizier 1968; Janes 1995) is not undivided. Work on intellectual property rights as applied to local knowledge indicates that hierarchies can be turned upside down, or at least used to the benefit of the latter. For traditional practitioners, bioprospecting and ethnopharmacology, for example, legitimize their own knowledge, underscoring the validity of their drug formulations (Pordié 2008b).

 4 On the globalization of Indian medicine, read, for instance, Banerjee (2009), Pordié (2011), Reddy (2002), and Zimmermann (1995).

 5 For the paths and practices that brought medicine back into the domain of patentable inventions, read Cassier and Sinding (2008) and Cassier (2008).

 6 See Millard (2008) for the case of Tibetan medicine in Great Britain.

 7 This research was funded from 2009 to 2013 by the French National Research Agency in the framework of PHARMASUD, a multidisciplinary program that was developing a comparative approach to pharmaceutical innovation processes in India and Brazil. Over the course of this program, the authors have conducted research in two private ayurvedic pharmaceutical firms, as well governmental institutions and offices and public and private research institutes.

 8 For the concept of knowledge-production regimes in general, see Pestre (2003). For the concept of “ways of regulating” in the history of drugs and pharmacy, see Gaudillière and Hess (2012).

 9 Integration of subjects from European medicine such as modern anatomy into institutional training was already noteworthy in the colonial era, which was marked by some hostility to Indian medicine. The growing influence of nationalist discourse in the pre- and post-independence periods prompted traditional therapists to mobilize. Colleges and (small and medium-sized) pharmaceutical companies were then instituted and many aspects related to the traditional sciences were removed from the curricula, which otherwise stressed the importance acquired by the materia medica.

10 We refer to Zimmermann (2012), as well as to the many personal communications we had during informal and formal meetings under the PHARMASUD program in Paris and elsewhere.

11 We read on the company website: “The natural ingredients in Diabecon increase insulin secretion in the body. By reducing the glycated hemoglobin level (form of hemoglobin used to measure glucose content in the blood) level [sic], normalizing microalbuminuria (a condition which is an important prognostic marker for kidney disease in diabetes mellitus) and modulating the lipid profile, Diabecon minimizes long-term diabetic complications. The drug also increases hepatic and muscle glycogen content, which enhances the peripheral utilization of glucose” (http://www.himalayahealthcare.com/products/pharmaceuticals/diabecon-tablet.htm, accessed 29 January 2013).

12 Ethnopharmacology is a specialized branch of medicine born in the late 1970s. Its aim is to study care practices, to contribute to their regulation and standardization, to evaluate the biological efficacy of its pharmacopoeia, and above all, to discover new drugs in it. Although there are very inclusive definitions of ethnopharmacology (Dos Santos and Fleurentin 1990; Etkin 1996), the science is essentially based on the plants used in traditional medicine and on identifying active substances (Pordié 2010a: 59–61).

13 See, for instance, for the most important teams in India, Patwardhan (2005), Patwardhan and Vaidya (2010), Patwardhan and Mashelkar (2009), Patwardhan, Vaidya, and Chorghade (2004), Patwardhan et al. (2008), and Vaidya (2006).

14 The Himalaya Drug Company thus diversifies the means to protect its products. For example, the drug Diabecon we mentioned earlier, as well as all other drugs created by the company, is registered under trademark as an Ayurvedic Proprietary Medicine, but this does not preclude the fact that the firm may also attempt to apply for a patent in India or abroad—as it goes global, Europe- or US-based patents are increasingly sought after. Over the last nine years or so, this firm has filed eighty-five patents, with eight granted so far for innovations in therapeutic and personal care products.

15 This sum also covers expenses for the defense of two other similar cases, involving basmati rice and turmeric (Curcuma longa).

16 Significant documentation regarding the Grace patent (EP90250319) and the opposition procedure is available on the EPO website (http://www.epo.org, accessed 6 February 2013).

17 Since that period, India has also intensively pursued research and development activities in the pharmaceutical and chemical sectors with a view to improve their competitiveness (Lanjouw 1997).

18 For more information on WIPO's work on traditional knowledge, see http://www.wipo.int/tk/en/tk/index.html.

19 This department was set up in 1995 as the Department of Indian Systems of Medicine and Homeopathy. In 2003, it was renamed AYUSH, which stands for Ayurveda, Yoga, Unani, Siddha, and Homeopathy.

20 About the debates and controversies on the presence of heavy metals in drugs derived from Indian drugs, see Sébastia (2011: 77–81).

21 There is, however, no real knowledge as to whether these measures are applied and in which way.

22 This is a common feature in neotraditional therapies, which use “tradition” systematically to legitimate new practices. For details, see Pordié (2008a: 9–19) and Pordié and Simon (2013).