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India’s Pharmaceutical Industry and the Enduring Public Regulation Challenge

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Part of the Palgrave Studies in Indian Management book series (PAIM)

Abstract

India’s pharmaceutical industry is of considerable economic importance—as one of India’s largest manufacturing industries and a major contributor of exports. Yet, it is perhaps of most significance for health—as a major supplier of generic medicines, for which it is sometimes known as the “pharmacy of the world”. The sector faces a number of challenges in order to ensure greater societal benefit from the industry in India. Some of the major issues relate to production in terms of quality and environmental impact, to research in terms of appropriate patent laws and regulating clinical trials, and also to marketing related to prices and access to medicines. Yet the sector, with its distinctive character of consumption and significance for public health, is one where little substantive momentum has emerged around voluntary governance initiatives. Widespread agreement exists on the need for more effective public regulation to maximise the societal benefits of the industry.

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Notes

  1. 1.

    Estimates for the number of firms in India’s pharmaceutical industry vary considerably.

  2. 2.

    A Pharmacopoeia is “an official (legally binding) publication containing recommended quality specifications for the analysis and determinations of drug substances, specific dosage forms, excipients and finished drug products” (Rägo and Santoso 2008, 72).

  3. 3.

    MCA uploaded the new guidelines for public comments in June 2018. http://www.mca.gov.in/Ministry/pdf/DraftNationalGuidelines2018_20062018.pdf.

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Horner, R. (2019). India’s Pharmaceutical Industry and the Enduring Public Regulation Challenge. In: Arora, B., Budhwar, P., Jyoti, D. (eds) Business Responsibility and Sustainability in India. Palgrave Studies in Indian Management. Palgrave Macmillan, Cham. https://doi.org/10.1007/978-3-030-13716-8_11

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