Impact of COVID-19 on the global supply chain of antiretroviral drugs: a rapid survey of Indian manufacturers

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’snationwide lockdown in March 2020 in response to the coronavirus disease 2019 (COVID-19)pandemic therefore prompted concerns about disruption to this essential supply. A preliminaryassessment of ARV drug manufacturers in India in March 2020 indicated a range of concerns. Thisprompted a rapid questionnaire-based survey in May 2020 of eight manufacturers that account formost 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 tothe active pharmaceutical ingredients (APIs) required for ARV drug manufacture was not a majorhindrance, as manufacturers reported that their reliance on China for API supplies had reduced inrecent years. However, their reliance on overseas markets for the raw materials required for local APIsynthesis was a major challenge. The findings from this survey have implications for addressing someof 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, togetherwith computerized inventory management systems with real-time information from the lowest-leveldispensation unit. Manufacturers and industry associations should have regular, formal interactionwith the key ministries of the Government of India regarding these issues. Measures to improve theresilience of the generic ARV drug supply system are essential to minimize ongoing supply shocksresulting from the COVID-19 pandemic and to prepare for future emergencies.

Community action for people with HIV and sex workers during the COVID-19 pandemic in India

Sex workers have been one of the marginalized groups that have been particularly affected by India’sstringent lockdown in response to the coronavirus disease 2019 (COVID-19) pandemic. The suddenloss of livelihood and lack of access to health care and social protection intensified the vulnerabilities ofsex workers, especially those living with HIV. In response, Ashodaya Samithi, an organization of morethan 6000 sex workers, launched an innovative programme of assistance in four districts in Karnataka.Since access to antiretroviral therapy (ART) was immediately disrupted, Ashodaya adapted its HIVoutreach programme to form an alternative, community-led system of distributing ART at discreet,private sites. WhatsApp messaging was used to distribute information on accessing government socialbenefits made available in response to the COVID-19 pandemic. Other assistance included advisorymessages posted in WhatsApp groups to raise awareness, dispel myths and mitigate violence, andregular, discreet phone check-ins to follow up on the well-being of members. The lessons learnt fromthese activities represent an important opportunity to consider more sustainable approaches to thehealth of marginalized populations that can enable community organizations to be better prepared torespond to other public health crises as they emerge.

Delivery of antiretroviral treatment services in India: estimated costs incurred under the National AIDS Control Programme

Competing domestic health priorities and shrinking financial support from external agencies necessitatesthat India’s National AIDS Control Programme (NACP) brings in cost efficiencies to sustain theprogramme. In addition, current plans to expand the criteria for eligibility for antiretroviral therapy(ART) in India will have significant financial implications in the near future. ART centres in India providecomprehensive services to people living with HIV (PLHIV): those fulfilling national eligibility criteriaand receiving ART and those on pre-ART care, i.e. not on ART. ART centres are financially supported(i) directly by the NACP; and (ii) indirectly by general health systems. This study was conducted todetermine (i) the cost incurred per patient per year of pre-ART and ART services at ART centres; and(ii) the proportion of this cost incurred by the NACP and by general health systems. The study usednational data from April 2013 to March 2014, on ART costs and non-ART costs (human resources,laboratory tests, training, prophylaxis and management of opportunistic infections, hospitalization,operational, and programme management). Data were extracted from procurement records andreports, statements of expenditure at national and state level, records and reports from ART centres,databases of the National AIDS Control Organisation, and reports on use of antiretroviral drugs. Theanalysis estimates the cost for ART services as US$ 133.89 (`8032) per patient per year, of which 66%(US$ 88.66, `5320) is for antiretroviral drugs and 34% (US$ 45.23, `2712) is for non-ART recurrentexpenditure, while the cost for pre-ART care is US$ 33.05 (`1983) per patient per year. The low costsincurred for patients in ART and pre-ART care services can be attributed mainly to the low costs ofgeneric drugs. However, further integration with general health systems may facilitate additional costsaving, such as in human resources.

Adoption of the 2015 World Health Organization guidelines on antiretroviral therapy: programmatic implications for India

The therapeutic and preventive benefits of early initiation of antiretroviral therapy (ART) for HIV arenow well established. Reflecting new research evidence, in 2015 the World Health Organization (WHO)recommended initiation of ART for all people living with HIV (PLHIV), irrespective of their clinical stagingand CD4 cell count. The National AIDS Control Programme (NACP) in India is currently following the 2010WHO ART guidelines for adults and the 2013 guidelines for pregnant women and children. This desk studyassessed the number of people living with HIV who will additionally be eligible for ART on adoption of the2015 WHO recommendations on ART. Data routinely recorded for all PLHIV registered under the NACP upto 31 December 2015 were analysed. Of the 250 865 individuals recorded in pre-ART care, an estimated135 593 would be eligible under the WHO 2013 guidelines. A further 100 221 would be eligible under theWHO 2015 guidelines. Initiating treatment for all PLHIV in pre-ART care would raise the number on ART from0.92 million to 1.17 million. In addition, nearly 0.07 million newly registered PLHIV will become eligible everyyear if the WHO 2015 guidelines are adopted, of which 0.028 million would be attributable to implementationof the WHO 2013 guidelines alone. In addition to drugs, there will be a need for additional CD4 tests andtests of viral load, as the numbers on ART will increase significantly. The outlay should be seen in the contextof potential health-care savings due to early initiation of ART, in terms of the effect on disease progression,complications, deaths and new infections. While desirable, adoption of the new guidance will have significantprogrammatic and resource implications for India. The programme needs to plan and strengthen the servicedelivery mechanism, with emphasis on newer and innovative approaches before implementation of theseguidelines.