Three new leaders among generic medicine manufacturers, as stewardship and access measures increase

• For the first time, several generic medicine manufacturers are requiring their suppliers to meet specific limits on the levels of antibacterials present in wastewaters.

• Transparency by generic medicine manufacturers has once again increased, amidst the COVID-19 pandemic.

• Multiple generic medicine manufacturers push forward with improved practices in each of the research areas.

Aurobindo, Abbott and Viatris take the lead among the generic medicine manufacturers in 2021. Each of these companies is filing its medicines for registration in low- and middle-income countries, and has improved its sales practices to mitigate the risk of overselling. Abbott, Cipla and Viatris are the first generic medicine manufacturers to report environmental risk-management strategies that apply to their suppliers’ sites, as well as their own sites. They also report that they check whether suppliers’ sites comply with limits set for environmental standards. Transparency by generic medicine manufacturers has once again increased, amidst the COVID-19 pandemic.

Aurobindo is the overall leader, having progressed significantly in its stewardship measures since 2020. It reports that it does not deploy sales agents to promote its antibacterial and antifungal medicines and ensures that its one educational programme for healthcare professionals mitigates the risk of conflict of interest. As part of its environmental risk-management strategy, Aurobindo not only sets limits but tracks and reports compliance with discharge limits at its own sites. It also requires its two reported third-party suppliers to follow the same limits. Moreover, Aurobindo now discloses more strategies to ensure a continuous supply of its medicines, including steps to prevent shortages. 

Abbott has also progressed significantly in its stewardship and manufacturing measures since 2020, including sharing more data. This includes adapting packages to make it easier for patients to follow good stewardship practices. It is also trialling changes to its sales practices in order to limit overselling. In India, it ran a three-month pilot whereby performance incentives for its sales agents were decoupled from the sales volumes they could secure for a specific anti-infective product. Abbott performs well in responsible manufacturing, as it now measures the levels of antibacterial residue remaining in wastewater at its own sites to assess compliance with specific limits and extends these standards to some supplier sites. In 2021, it introduced a new contract template for suppliers of APIs and drug products with clauses that require suppliers to implement specific AMR-related environmental standards.

Viatris performs well with regards to its manufacturing practices as well as its strategies to ensure a continuous supply of products, for example, to address the risk of shortages. It reports that all its own sites are compliant with discharge limits and reports that its Zero Liquid Discharge (ZLD) sites that manufacture antibiotics test recycled waters for the presence of antibacterials, which were found to be zero. It extends its standards and limits to its third-party supplier, and requests and reviews discharge levels as part of audit requirements. Further, it employs conflict of interest mitigation for its AMR-related education programmes for healthcare professionals and is active in two AMR surveillance programmes. 

Cipla dropped from leader in 2020 to fifth in 2021 as other companies push forward with improved practices in each of the research areas. It misses opportunities to improve the availability and accessibility in low- and middle-income countries of its on-patent medicine, plazomicin (Zemdri), which it acquired in 2019. Plazomicin has now been registered in India. However, Cipla does monitor and report the numbers of people it reached with off-patent/generic medicines in India and South Africa during the COVID19 pandemic. In 2020, Cipla had fully removed the link between sales volume and bonuses offered to its sales agents. In 2021, a small portion of its bonuses (1%) have been reconnected with sales volume.

Nevertheless, Cipla performs well in Stewardship, and is taking action to limit the impact of its manufacturing operations on resistance. While no longer a member of the AMR Industry Alliance, it sets discharge limits and quantifies the actual levels of antibacterials present in wastewaters at some sites. It has committed to ensuring that it is measuring these levels at all sites by March 2022. Cipla is currently conducting an initial assessment of all suppliers with the intent of extending AMR-related environmental standards to these sites, also by March 2022. Hainan Hailing and Alkem trail in this group, as they remain the only two generic medicine manufacturers to demonstrate limited transparency. They do not share data that enable the evaluation of their commitment to limiting AMR.

What next?

That the generic medicine manufacturers are expanding their efforts against AMR is clear. For the first time, several such companies are requiring their suppliers to meet specific limits on the levels of antibacterials present in wastewaters. Their progress in stewardship is noted in the increased scores, specifically around sales practices, efforts to mitigate the risk of conflict of interest in educational programmes, and in how they adapt product packaging to facilitate stewardship. More of these companies are reporting strategies for improving access to their products in low- and middle-income countries, including to ensure a continuous supply. This is a positive sign, as much more needs to be done.

Pharmaceutical companies have a responsibility to ensure that their medicines are accessible and are reaching those in need. The poorest countries are home to nearly 700 million people and are particularly overlooked by companies’ access strategies. Only four generic companies out of nine report that they use access strategies in low-income countries for specific products, and more must be done to improve access to medicines as well as to expand access to vaccines. Generic medicine manufacturers have a responsibility to ensure an uninterrupted supply of good quality products. These companies have an opportunity to improve supply security by implementing strategies such as demand planning and data sharing, and by mitigating against the risk of shortages via sufficient buffer stocks. They can also contribute to scaling up local capacity by supporting local manufacturing hubs and entering technology transfers with originators.

*Zero Liquid Discharge is a waste-treatment process in which no wastewater is disposed into the environment.