Dr. Reddy’s Laboratories Ltd.
|Applicable indicator||Not applicable|
Dr. Reddy’s is a prominent producer of antibiotics globally by sales volume. As a generic medicine manufacturer, Dr. Reddy’s was evaluated in Manufacturing & Production and Appropriate Access & Stewardship only. Its performance is low compared to most 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. However, Dr. Reddy’s has an environmental risk-management strategy that is based on a zero-liquid discharge (ZLD) process at all its manufacturing sites, including manufacturing sites for antibiotics.
Sales & operations
Dr. Reddy’s is a generic medicine manufacturer founded in 1984, with commercial presence in 26 countries. Its core therapeutic areas include oncology, gastroenterology, cardiovascular health, diabetes and anti-infectives. The company’s Global Generics segment manufactures and markets prescription and over-the-counter (OTC) medicines (generics and medicines manufactured in its biologics unit). Its Proprietary Products segment develops and manufactures differentiated formulations in dermatology and neurology. It has 25 manufacturing facilities: 18 in India (including seven for active pharmaceutical ingredients), three in the USA, two in the UK and one each in China and Mexico. It has ten R&D facilities: six in India, two in the USA and two in Europe. In 2015, Dr. Reddy’s acquired several established brands from UCB for the territories of India, Nepal, Sri Lanka and Maldives, covering dermatology, respiratory diseases, ear, nose and throat disorders, and paediatrics. In 2016, it completed the acquisition of eight products from Teva’s US portfolio. In 2017, it signed a global licensing pact with CHD Bioscience (USA), to develop and commercialise CHD’s Phase III clinical candidate DFA-02 for USD 30 million. DFA-02 is a gentamicin/vancomycin extended- release gel indicated for the prevention of surgical site infection following non-emergency, elective colorectal surgery.
According to publicly available data, Dr. Reddy’s markets at least 22 antimicrobial medicines, seven or more of which are listed on the WHO EML (Section 6). Sixteen of the company’s antimicrobial medicines are antibiotics, with at least three listed on the WHO EML (Section 6), including one antibiotic in the EML’s Reserve group (linezolid). The remaining six medicines are three antivirals and three antifungals. The company also markets an influenza vaccine in Germany, via its subsidiary Betapharm.
Engage in antimicrobial stewardship. Dr. Reddy’s 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.
Improve transparency on environmental risk management. Dr. Reddy’s can share information on how it manages environmental risk, e.g., information on discharge limits for its own and third-party manufacturers’ sites. The company currently discloses its environmental risk-management activities in its corporate sustainability report.
Ensure affordability and registration plans for new and existing antimicrobials. Dr. Reddy’s 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. Dr. Reddy’s 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, Dr. Reddy’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 Follows Zero-Liquid Discharge at own sites.
Dr. Reddy’s environmental risk-management approach is based on following a zero-liquid discharge (ZLD) process at all its manufacturing sites, including manufacturing sites for antibiotics. Dr. Reddy’s reports no information about setting discharge limits or auditing this process. It does not appear to have extended this approach to its third-party manufacturers of antibiotic APIs and drug products, or to external waste-treatment plants.
B.2 No transparency on environmental risk management.
Dr. Reddy’s 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.
Dr. Reddy’s 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.
Dr. Reddy’s 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.
Dr. Reddy’s 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.
Dr. Reddy’s 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.
Dr. Reddy’s 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
‡ Includes antibiotics whose formulation or dose could not be determined
§ Revenue from operations; FYE 31 March 2017
|| Sales (inc. excise duty), license fees, and service income; excluding other operating income; FYE 31 March 2017