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Is Drug Development in India Responsive to the Disease Burden?
Although the Indian pharmaceutical industry has played an important role in the development of generic medicines, it is not clear whether drug development, which is dominated by the private sector, is informed of the disease burden and public health priorities. An attempt is made to address this question by juxtaposing the therapeutic focus of the drugs approved for marketing and the new chemical entities in the pipeline with the disease burden across age groups.
The paper is drawn from a research project supported by the Institute of Social and Economic Change, Bengaluru and the Indian Council of Social Science Research, New Delhi. The authors thank the unknown reviewer for the valuable comments, which helped them revise the paper. The authors also thank Ramya P for her critical comments and assistance in extracting data.
The web version of this article corrects a few errors that appeared in the print edition.
The Indian pharmaceutical industry has played an important role in the development of generic medicines and biosimilars (Farmer 2001). However, whether patients who are heavily dependent on the public sector, benefit from this advancement made by the sector is a critical question for several reasons. First, as it is well known, the bulk of these generic drugs are exported to international markets and are inaccessible in India (Swain et al 2014). Second is the dominance of branded generics in the market, which are priced significantly higher than their corresponding generics (Mathew 2015). Third, the quality of essential generic medicines that are available in the public sector has also been under question (Bate et al 2009). Most importantly, we still do not sufficiently know whether medicine development in India is informed of the public health priorities of the country and the emerging disease burden.
Studies, hitherto, have analysed research and development (R&D) and drug development in the pharmaceutical sector from the point of view of the response of the sector to the new intellectual property rights (IPR) regime after 1995 (Abrol et al 2011), strategies and types of R&D investments (Joseph 2011), R&D innovation, performance and growth of Indian companies (Abrol and Singh 2016), relationship of export performance and R&D (Goldar 2013), therapeutic focus (Chaudhuri 2010) and the status and challenges of proprietary drug discovery in India (Differding 2017). The nature and patterns of drug development and R&D priorities of this sector in the light of disease burden are under-researched in the country. Differding (2017) has discussed this issue very briefly by examining the therapeutic areas of new chemical entities (NCEs) in the pipeline, but has not offered an in-depth analysis across disease categories and non-NCE drugs developed and marketed in India.
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