Opportunities: next steps for addressing AMR
2021 OPPORTUNITY: Develop an AMR-specific environmental risk-management strategy and increase public disclosure. Alkem reports a commitment to manufacture its products in an environmentally responsible manner without specifying whether AMR is taken into account. The company can develop an AMR strategy for its own manufacturing sites, the sites of suppliers and external private waste-treatment plants, based on the guidelines of the AMR Industry Alliance. This includes setting limits and quantifying discharge levels to track compliance. Moreover, Alkem can publish information on how it manages environmental risk related to antibacterial manufacturing to curb AMR. The company currently publishes limited information.
2023 UPDATE: For the first time, Alkem has publicly reported the implementation of Zero Liquid Discharge (ZLD) systems across 64% of its manufacturing sites. The company also publicly reports the city-level locations of its manufacturing sites, with 18 located in India and two in the United States. However, it remains unspecified which sites manufacture antibacterials and/or antifungals. In addition, Alkem does not report an AMR-specific environmental risk-management strategy.
2021 OPPORTUNITY: Expand registration and ensure availability of antibacterial and antifungal medicines. Alkem can expand registration and ensure equitable access of its antibiotics and antifungals listed on the 2021 WHO EML, such as cefotaxime and tigecycline, to more countries, including low-income countries, with a high burden of disease. It can improve transparency on where its medicines are registered and made available.
2023 UPDATE: Alkem did not report any developments specific to this Opportunity.
2021 OPPORTUNITY: Apply responsible sales practices for antibacterial and antifungal medicines. Alkem can apply responsible sales practices for antibacterial and antifungal medicines by not deploying sales agents. Alternatively, it can fully decouple incentives for sales agents from sales volumes of such medicine.
2023 UPDATE: Alkem did not report any developments specific to this Opportunity.
2021: Performance
Alkem performs low overall in its evaluated Research Areas when compared to the other generic medicine manufacturers in scope.
R&D
As a generic medicine manufacturer, Alkem is not evaluated in this Research Area.
Responsible manufacturing
Performs low. Reports a general environmental risk-management strategy but without a specific aim to limit AMR.
Appropriate access
Performs low. Discloses no information on registration filings, expanding access or ensuring continuous supply for its off-patent/generic medicines.
Stewardship
Performs low. It does not report decoupling incentives for sales agents from sales volumes. It does not adapt brochures or packaging for patients.
2021: Pipeline and Portfolio
Looking at bacterial and fungal pathogens
The AMR Benchmark evaluates pharmaceutical companies on the size and relevance of their R&D pipelines and on the actions they are taking to ensure their products on the market are accessible and being used responsibly.Â
Portfolio
Products on the market
Mid-sized portfolio: At least 52 products: 49 antibacterial medicines; 3 antifungal medicines
Off-patent/generic medicines: 10 of 52 were selected for analysis** (amoxicillin [A], amoxicillin/clavulanic acid [A], caspofungin [F], cefixime [W], cefotaxime [W], colistin [R], isoniazid [T], itraconazole [F], linezolid [T], tigecycline [R])
AWaRe medicines***: 5 Access group; 18 Watch group; 3 Reserve groupÂ
Anti-TB medicines***: 2
Pipeline
As a generic medicine manufacturer, Alkem is not evaluated in this Research Area.
2021: Sales & Operations
Scope, scale and focus of the business
Therapeutic areas: Anti-diabetes, Anti-infective, Cardiac, Dermatology, Gastro-intestinal, Pain/analgesics, Neuro/CNS.
Business segments: Pharmaceuticals
Product categories: Generic medicines
M&A since 2020: None in the antibacterial and/or antifungal sectors
Total income by business segment
Total income by region
Performance breakdown
Explore Alkem's performance in detail, including the drivers behind any movement and the main areas where it scores well or poorly compared to peers.
Research & Development
As a generic medicine manufacturer, Alkem is not evaluated in this Research Area.
Responsible Manufacturing
Performs low. Reports a general environmental risk-management strategy but without a specific aim to limit AMR.
No AMR-specific environmental risk management strategy
Limited publicly available information on environmental risk management
System in place to maintain production quality for own and suppliers’ sites; no requests for official corrective actionÂ
Evaluated: antibacterials manufacturing (APIs and drug products)
B.1 No AMR-specific environmental risk management strategy
Alkem states a general commitment to manufacture its products in an environmentally responsible manner, supported by a management system that includes periodic impact assessments. It is unclear how the strategy takes AMR into account or aims to minimise the environmental impact of wastewaters and solid waste from antibacterial manufacturing at its own sites, third-party suppliers of antibacterials or external private and public waste-treatment plants.
B.2 Limited publicly available information on environmental risk management
Alkem publishes limited information on its approach to environmental risk-management, without specific references to AMR. It does not publish: (1) the results of environmental audits, whether conducted at its own sites, the sites of suppliers or external private and public waste-treatment plants; (2) a list of these suppliers and plants; or (3) the limits and levels of antibacterial discharge from its own or suppliers’ sites.
B.3 System in place to maintain production quality for own and suppliers’ sites; no requests for official corrective actionÂ
Alkem reports that its own sites and suppliers have a system to maintain high-quality antibacterial production consistent with international GMP standards. This includes periodic risk-based audits and tracking of corrective and preventive actions. There is limited information on whether Alkem requires its suppliers to audit their own suppliers. The Benchmark found no requests for official corrective action from the FDA or EMA related to non-conformities with cGMP at Alkem’s own sites or any subsidiaries that manufacture antibacterials.
Appropriate Access
Performs low. Discloses no information on registration filings, expanding access or ensuring continuous supply for its off-patent/generic medicines.
No information on registration filings for off-patent/generic medicinesÂ
No information on strategies to expand access to off-patent/generic medicines
No information on strategies to ensure continuous supply
Evaluated: access activities relating to antibacterial & antifungal medicines & vaccines in 102 access countries†Â
Alkem is not eligible for indicators: C.1.1, C.1.3, C.2.1 and C.2.3 For more information, see Appendix VII in the 2021 AMR Benchmark Report
C.1.2 No information on registration filings for off-patent/generic medicinesÂ
Alkem’s performance is low. It reports no evidence of filing its ten relevant off-patent/generic medicines for registration in access countries, beyond India.Â
C.2.2 No information on strategies to expand access to off-patent/generic medicines
Alkem’s performance is low as it discloses no information on how it expands access to its ten relevant off-patent/generic medicines, beyond India. It does not provide evidence of patient reach and geographic reach.
C.3 No information on strategies to ensure continuous supply
Alkem’s performance is low as it discloses no information on how it ensures the continuous supply of its relevant products to access countries, beyond India.
Stewardship
Performs low. It does not report decoupling incentives for sales agents from sales volumes. It does not adapt brochures or packaging for patients.
Does not report sales or marketing practices that aim to address appropriate useÂ
Does not report adapting brochures and/or packaging to facilitate appropriate use by patients
Evaluated: stewardship activities relating to antibacterial & antifungal medicines globallyÂ
C.4 Educational Stewardship Activities
There is no information regarding Alkem’s involvement in AMR-related educational programmes aimed at healthcare professionals and it is therefore not eligible for this indicator as there is no conflict of interest mitigation to be assessed.
C.5 Does not report sales or marketing practices that aim to address appropriate use
Alkem performs low in sales practices. It does not report whether it decouples incentives for sales agents from sales volumes to help prevent the inappropriate use of its antibacterial and/or antifungal medicines.
Alkem does not report to engage in marketing practices that aim to address the appropriate use of its antibacterial and/or antifungal medicines as its marketing materials do not reflect emerging resistance trends or include treatment guidelines for healthcare professionals to raise awareness of AMR and address appropriate use.
C.6 Does not report adapting brochures and/or packaging to facilitate appropriate use by patients
Alkem does not report adapting brochures and/or packaging to facilitate the appropriate use of its antibacterial and/or antifungal medicines by patients.
C.7 AMR Surveillance
As a generic medicine manufacturer, Alkem is not assessed in this indicator nor does it report any involvement in AMR surveillance activities