Macleods Pharmaceuticals Ltd.
|Applicable indicator||Not applicable|
Macleods is a prominent producer of antibiotics globally by sales volume. As a generic medicine manufacturer, Macleods was evaluated in Manufacturing & Production and Appropriate Access & Stewardship only. Although the company’s performance in the Benchmark is lower compared to most other generic medicine manufacturers in scope, it discloses an environmental risk-management strategy for its own sites, which includes an auditing process. It does not report its approach to assuring high quality antibiotic production consistent with international standards. Macleods has provided information on where it has filed two of its newest antibiotics for registration, but does not disclose an equitable pricing approach for its antibiotics and antimicrobial medicines, or actions to ensure efficient supply. The company does not report any involvement in stewardship activities that promote appropriate antibiotic use.
Sales & operations
Macleods is an Indian-based privately-held manufacturer of generic medicines focussing on essential pharmaceuticals. The company is present in more than 100 countries worldwide, including in Southeast Asia, Africa and North America. It has a total of 14 manufacturing facilities: one for active pharmaceutical ingredients (APIs) and 13 for drug products. Current drug formulations include tablets, hard and soft gelatine capsules and dry powder injections. The company is actively seeking to expand its manufacturing capabilities to include, among other things, metered dose inhalation products and liquid injectables. Macleods’ products cover a wide range of therapeutic indications, including tuberculosis, malaria, bacterial infections, diabetes and respiratory and cardiovascular diseases. The company has an in-house bioequivalence centre and an R&D centre, and it is active in the development of incremental innovations for antimicrobial medicines. Its antimicrobial medicines are sold in over 52 countries globally, 43 of which are low- or middle-income countries.* According to publicly available data, revenues for the fiscal year 2016 amounted to USD 782 million.
Macleods markets at least 83 antimicrobial medicines, 51 of which are listed on the WHO EML (Section 6). Fifty-four of the company’s antimicrobial medicines are antibiotics, with 29 listed on the WHO EML (Section 6), including three in the EML’s Reserve group (cefepime, colistin and linezolid). The remainder (29) of the company’s portfolio comprises eight antimalarials (all listed on the WHO EML) and 21 antivirals (including 19 indicated for HIV/AIDS).
Engage in antimicrobial stewardship. Macleods can engage in stewardship activities, e.g., through surveillance activities, educational activities for healthcare professionals on AMR (while mitigating conflicts of interest), and engage in appropriate promotion practices.
Ensure transparency regarding environmental risk management. Macleods can share information on how it manages environmental risk, e.g., by disclosing its environmental risk-management strategy and the levels of antibiotic discharge.
Improve access through the affordability and registration of new and existing antimicrobials. Macleods has filed two of its newest anti-tuberculosis medicines for registration in 30 countries in scope.* It can seek to improve access in lowand middle-income countries through the registration of more antimicrobials, and ensure that these are priced affordably.
Expand environmental risk-management strategy. Macleods can ensure that antibiotic discharge limits are added to its environmental risk-management strategy. It can also extend this strategy to the sites of third parties who manufacture antibiotic APIs and drug products on its behalf, as well as to external waste-treatment sites. Macleods currently has a general environmental risk-management strategy that it applies to its own manufacturing sites.
Increase engagement in R&D innovation. Macleods is currently engaged in adapting generic antimicrobial medicines. For example, the company is developing paediatric formulations containing lower doses of anti-tuberculosis medicines (in collaboration with the TB Alliance). 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, Macleods was not eligible for this Research Area. However, the company is active in antimicrobial R&D.
Several R&D projects being developed with public partners.
Macleods reports that it has twelve projects in its antimicrobial R&D pipeline targeting priority pathogens. This includes ten lower-dose formulations of tuberculosis medicines for paediatric use and an additional indication for clofazimine, currently indicated for leprosy. The company collaborates with TB Alliance and UNITAID on the development of these formulations. TB Alliance has a general access to medicine policy that includes global adoption, availability and affordability. Macleods is also developing a dolutegravir/ lamivudine/tenofovir fixed dose combination for the treatment of HIV/AIDS.
Pipeline targeting priority pathogens
B. Manufacturing & Production
B.1 Environmental risk-management strategy for own sites.
Macleods has an environmental risk-management strategy to minimise the impact of antibiotic manufacturing discharge. This applies to its own manufacturing sites and includes auditing. There is no evidence that the strategy is applicable to third-party manufacturers of antibiotic APIs and drug products or to external waste-treatment plants. The company reports no information about setting discharge limits.
B.2 No transparency on environmental risk management.
Macleods does not disclose its strategy to minimise the impact of manufacturing discharge of antibiotics. It does not publish any element looked for by the Benchmark, namely: antibiotic discharge levels, audit results, and the identities of its third-party suppliers of antibiotic APIs and drug products, or of its external waste-treatment plants.
B.3 No statement on how antibiotic quality is maintained.
Macleods makes no statement regarding how it ensures high quality antibiotic production following international manufacturing standards accepted by recognised national and international authorities (such as GMP).
C. Appropriate Access & Stewardship
C.1 Filed two newest antibiotics in some countries in scope.
Macleods has provided filing information on two of its newest antibiotics: isoniazid/rifampicin and isoniazid/pyrazinamide/rifampicin. These two products both target tuberculosis and have now been filed for registration in 30 countries in scope,* mainly in sub-Saharan Africa.
C.2 No disclosure on equitable pricing approach.
Macleods does not disclose an equitable pricing approach for its highest-volume antibiotic 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.
Macleods 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.
Macleods 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.
† EML Section 6: Anti-Infective Medicines
§ Turnover 2016-2017