Aurobindo Pharma Limited
|Applicable indicator||Not applicable|
Aurobindo is a prominent producer of antibiotics globally by sales volume. As a generic medicine manufacturer, Aurobindo was evaluated in Manufacturing & Production and Appropriate Access & Stewardship only. The company performs well when compared with the other generic medicine manufacturers in scope. It performs well in Manufacturing & Production, but falls behind in Appropriate Access & Stewardship. Aurobindo discloses a comprehensive environmental risk-management strategy, which is applied to external waste-treatment plants. The company reports that it has mechanisms in place for maintaining high quality of antibiotic production. Aurobindo does not report any involvement in stewardship activities that promote appropriate antibiotic use.
Sales & operations
Aurobindo is a manufacturer of active pharmaceutical ingredients (APIs) and oral and injectable generic formulations. Its portfolio covers seven major therapeutic areas, including antibiotics, antiretrovirals (ARVs) and cardiovascular and central nervous systems. It has nine manufacturing units for APIs and intermediate products and seven for formulations, as well as R&D centres in India and the USA. Aurobindo markets its products in more than 150 countries worldwide, with a focus on the USA and Europe. It sells antimicrobial medicines in at least 92 countries, at least 50 of which are low- and middle- income countries.* In the fiscal year 2016, it sold 1.45 billion units (DDDs) of antimicrobial medicines. Within its antimicrobial business, the company is currently focussing on developing its manufacturing capacity of penems — broad-spectrum antibiotics used for multidrug- resistant infections. In 2017, Aurobindo entered a multilateral agreement to provide a new class of ARVs (developed within a licensing agreement with Gilead Sciences Inc. and ViiV Healthcare) to low- and middle-income countries. In return for guaranteed minimum sales volumes, Aurobindo will supply a generic FDC of dolutegravir/lamivudine/tenofovir for a maximum price of about USD 75 per patient per year.
Aurobindo markets at least 40 antimicrobial medicines, 28 of which are listed on the WHO EML (Section 6). Eighteen of the company’s antimicrobial medicines are antibiotics, with 12 listed on the WHO EML (Section 6), including five on the EML’s Watch group. The remainder (22) of the company’s portfolio comprises 20 antivirals (16 of which target HIV) and two antifungals.
Engage in antimicrobial stewardship. Aurobindo can engage in stewardship activities, e.g., through surveillance activities, educational activities for healthcare professionals on AMR (while mitigating conflict of interest), and engage in appropriate promotion practices.
Ensure affordability and registration plans for new and existing antimicrobials. Aurobindo can seek to improve access in low- and middle-income countries through the registration of new and existing antimicrobials, and ensure that they are priced affordably. Currently, the company does not disclose such information.
Ensure transparency regarding environmental risk. Aurobindo can share more information on how it manages environmental risk (e.g., the company can publish the results of audits carried out on its environmental risk-management strategy and the identities of external waste-treatment plants). After the period of analysis, the company disclosed the identities of external waste-treatment plants to the Benchmark.
Expand environmental risk-management strategy. Aurobindo can set and apply discharge limits for antibiotic manufacturing. It currently has an environmental risk-management strategy that applies to its own manufacturing sites and external waste-treatment sites.
Increase engagement in R&D innovation. Aurobindo is currently engaged in developing a new fixed dose combination of antiretroviral medicines. It can continue to engage in incremental R&D, and ensure access and stewardship provisions are in place for these projects.
A. Research & Development
As a generic medicine manufacturer, Aurobindo was not eligible for this Research Area. However, the company is active in antimicrobial R&D.
One fixed dose combination for HIV/AIDS.
On reviewing publicly available information, the Benchmark found that Aurobindo has one project in its antimicrobial R&D pipeline that targets HIV. This involves dolutegravir/lamivudine/ tenofovir disoproxil fumarate, a new FDC for the treatment of HIV/AIDS. In 2017, Aurobindo received FDA tentative approval for this FDC, as it consists of patented antiretrovirals from Gilead Sciences Inc., Bristol-Myers Squibb Co. and ViiV Healthcare.
Pipeline targeting priority pathogens
B. Manufacturing & Production
B.1 Environmental risk-management strategy for own and external sites.
Aurobindo has an environmental risk-management strategy to minimise the impact of antibiotic manufacturing discharge. The strategy includes auditing and applies to its own sites and external waste-treatment plants. For a subset of sites, Aurobindo follows a Zero-Liquid Discharge process (ZLD, a water treatment process in which all wastewater is cleaned and reused); for others it deactivates antibiotics prior to external waste treatment. The company reports no information about setting discharge limits. Aurobindo states that it does not use third-party suppliers for the manufacturing of antibiotic drug products.
B.2 Limited transparency regarding environmental risk management.
Aurobindo publishes its environmental risk-management strategy in its annual report. It does not disclose audit results, or the discharge levels of antibiotics. The company does not share the identities of its external waste-treatment plants. After the period of analysis the company disclosed the identities of external waste-treatment plants to the Benchmark.
B.3 Commits to following GMP.
Aurobindo reports that it has mechanisms for maintaining a high quality of antibiotic production — namely following GMP standards.
C. Appropriate Access & Stewardship
C.1 No information on filing for registration.
Aurobindo reports no information on where it has filed its newest antibiotics for registration in countries in scope.* This information is not otherwise publicly available.
C.2 No disclosure on equitable pricing approach.
Aurobindo does not disclose an equitable pricing approach for its highest-volume antibiotics and/or antimicrobial medicines. The company states that its approach to affordability is through tenders.
C.3 No insight into steps addressing supply chain efficiency.
Aurobindo does not disclose how it works with stakeholders (e.g., governments, procurers) to align supply and demand for antimicrobial medicines, specifically to prevent or minimise stockouts in countries in scope.* The company also does not report on whether it has processes in place to respond to stock-outs in countries in scope.*
C.4-C.7 No apparent involvement in stewardship activities.
Aurobindo does not report any involvement in stewardship activities (from education to surveillance to appropriate promotion practices) that promote appropriate antibiotic use.
* Countries in scope are 106 low- and middle-income countries where access to medicine is likely limited
** Company states it has applied to be a signatory
† EML Section 6: Anti-Infective Medicines
§ Revenue from operations; FYE 31 March 2017