Sun Pharmaceutical Industries Ltd.
|Applicable indicator||Not applicable|
Sun Pharma is a prominent producer of antibiotics globally by sales volume. As a generic medicine manufacturer, Sun Pharma was evaluated in Manufacturing & Production and Appropriate Access & Stewardship only. Its performance is low compared to other generic medicine manufacturers in scope. It reported no information to the Benchmark, and publicly available information is limited, specifically regarding its approach to manufacturing high quality antibiotics, its approach to equitable pricing, where it has filed antibiotics for registration, its actions to ensure efficient supply and its involvement in stewardship activities.
Sales & operations
Sun Pharma, founded in 1983, is an Indian-based generic medicine manufacturer focussing on the production of generic medicines, specialty products, over-the-counter (OTC) products, antiretrovirals (ARVs) and active pharmaceutical ingredients (APIs). The company’s business segmentation is based on a mix of geographical and therapeutic areas. It listed its anti-infectives segment as its fourth-biggest therapeutic segment by revenue, after cardiology, neuropsychiatry and gastroenterology. The company’s specialty business focuses on the therapeutic areas of dermatology, ophthalmology, oncology and the central nervous system (CNS). The company has 42 manufacturing sites spread across six continents and markets its products in more than 150 countries worldwide. In 2015, Sun Pharma completed the acquisition of Ranbaxy Laboratories Limited, an Indian-based company focused on generic medicines with international operations, and a member of the Daiichi Sankyo group (at the time of acquisition). The merger combined Sun Pharma’s established specialty business with Ranbaxy’s global operations in generic medicines.
According to publicly available data, Sun Pharma markets at least 69 antimicrobial medicines, 35 of which are listed on the WHO EML (Section 6). Forty-two of the company’s antimicrobial medicines are antibiotics, with 18 listed on the WHO EML (Section 6), including two in the EML’s Reserve group (colistin and tigecyclin). The remainder (27) of the company’s portfolio is diverse, comprising antifungals, anthelminthics, antiprotozoals and antivirals, 13 of which target HIV.
Engage in antimicrobial stewardship. Sun Pharma 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. Sun Pharma can share information on how it manages environmental risk, e.g., disclose the levels of antibiotic discharge. Currently, the company does not report having an environmental risk-management strategy.
Ensure affordability and registration plans for new and existing antimicrobials. Sun Pharma 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. Sun Pharma 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, Sun Pharma’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.
Sun Pharma 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.
Sun Pharma 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.
Sun Pharma 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 No information on filing for registration.
Sun Pharma 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.
Sun Pharma 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.
Sun Pharma 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.
Sun Pharma 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
|| Sales; FYE 31 March 2017