Abstract

Most people living with HIV in low- and middle-income countries are treated with generic antiretroviral (ARV) drugs produced by manufacturers in India - the "pharmacy of the developing world". India's nationwide lockdown in March 2020 in response to the coronavirus disease 2019 (COVID-19) pandemic therefore prompted concerns about disruption to this essential supply. A preliminary assessment of ARV drug manufacturers in India in March 2020 indicated a range of concerns. This prompted a rapid questionnaire-based survey in May 2020 of eight manufacturers that account for most of India's ARV drug exports. The greatest challenges reported were in international shipping, including delays, increased lead times and rising costs. Contrary to expectations, lack of access to the active pharmaceutical ingredients (APIs) required for ARV drug manufacture was not a major hindrance, as manufacturers reported that their reliance on China for API supplies had reduced in recent years. However, their reliance on overseas markets for the raw materials required for local API synthesis was a major challenge. The findings from this survey have implications for addressing some of the immediate and medium-term concerns about the production and supply of generic ARV drugs. Long-term orders to support multi-month dispensing and buffer stocks need to be in place, together with computerized inventory management systems with real-time information from the lowest-level dispensation unit. Manufacturers and industry associations should have regular, formal interaction with the key ministries of the Government of India regarding these issues. Measures to improve the resilience of the generic ARV drug supply system are essential to minimize ongoing supply shocks resulting from the COVID-19 pandemic and to prepare for future emergencies.

Full Text
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