|Applicable indicator||Not applicable|
Lupin is a prominent producer of antibiotics globally by sales volume. As a generic medicine manufacturer, Lupin was evaluated in Manufacturing & Production and Appropriate Access & Stewardship only. The company’s performance in the Benchmark is lower compared to most other generic medicine manufacturers in scope. Lupin does not report having an environmental risk-management strategy. The company reports that it has mechanisms in place for maintaining a high quality of antibiotic production and requires its third-party suppliers to apply the same quality standards to their production facilities. Lupin does not report any information on its access strategies regarding antimicrobial medicines, or its involvement in stewardship activities that promote appropriate antibiotic use.
Sales & operations
Lupin is an Indian-based generic medicine manufacturer founded in 1968. It produces active pharmaceutical ingredients (APIs), as well as generic medicines. The company develops advanced drug-delivery systems and has a highly differentiated pipeline. It has operations in more than 100 countries, with key markets for finished drug products in the USA, India, Japan, Europe, South Africa, Philippines and Australia. The company focusses on cardiovascular health, diabetes and anti-infectives, with a strong history in anti-tuberculosis medicines and cephalosporin antibiotics. Its anti-tuberculosis formulations are sold globally. Within the company’s India business (contributing approx. 22% to global revenues), the anti-infectives and anti-tuberculosis business segments made up 18% of revenues in 2016 (fiscal year). Lupin (and subsidiaries) have 18 manufacturing facilities across India, Japan, the USA, Mexico and Brazil (five for active pharmaceutical ingredient production). The company invests in R&D for biosimilars, mainly in immunology, endocrine health and oncology. It has nine R&D facilities, in India and elsewhere, including the USA, Japan and the Netherlands. In 2016, Lupin acquired Gavis Pharmacauticals, whose portfolio includes cardiovascular, central nervous system (CNS) and anti-infective medicines, among others. Also in 2016, Lupin reached an agreement with Shionogi to acquire 21 branded products coming off-patent in Japan, for approx. USD 150 million. These cover therapeutic areas such as the CNS, oncology and anti-infectives.
According to publicly available data, Lupin markets at least 25 antimicrobial medicines, 18 of which are listed on the WHO EML (Section 6). Nineteen of the company’s antimicrobial medicines are antibiotics, with 13 listed on the WHO EML (Section 6), including six in the EML’s Watch group. The remainder (six) of the company’s portfolio comprises the antifungal voriconazole, listed on the WHO EML (Section 6) for the treatment of aspergillosis, the antiprotozoal tinidazole and four medicines containing the antiretroviral lamivudine.
Engage in antimicrobial stewardship. Lupin 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. Lupin can share information on how it manages environmental risk, e.g., the company can publish information regarding the levels of antibiotic discharge. Currently the company does not demonstrate evidence of having an environmental risk-management strategy in place.
Ensure affordability and registration plans for new and existing antimicrobials. Lupin 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.
Engage in R&D innovation. Lupin can engage in incremental R&D innovation to address resistance, improve adherence and the appropriate use of antimicrobial medicines
A. Research & Development
As a generic medicine manufacturer, Lupin’s main focus is the manufacturing of generic products and as such was not in scope for this Research Area.
B. Manufacturing & Production
B.1 Reports no environmental riskmanagement strategy.
Lupin does not report having an environmental risk-management strategy in place to minimise the environmental impact of manufacturing discharge of antibiotics.
B.2 No transparency on environmental risk management.
Lupin 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 Commits to following GMP, including at 3rd-party sites.
Lupin reports that it has mechanisms for maintaining a high quality of antibiotic production — namely following GMP standards. This commitment applies to its own manufacturing sites. Lupin requires its third-party suppliers to apply the same quality standards to their production facilities.
C. Appropriate Access & Stewardship
C.1 No information on filing for registration.
Lupin 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.
Lupin does not disclose an equitable pricing approach for its highest-volume antibiotics and/ or antimicrobial medicines.
C.3 No insight into steps addressing supply chain efficiency.
Lupin 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 stock-outs 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.
Lupin 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
§ Revenue from operations; FYE 31 March 2017