Sun Pharmaceutical Industries Ltd

Evaluated: antibacterials manufacturing (APIs and drug products)

B.1 No AMR-specific environmental risk management strategy; ZLD at own site
Sun Pharma reports a commitment to manufacture its products in an environmentally responsible manner, supported by a management system that includes periodic audits. 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 site, third-party suppliers of antibacterials or external private and public waste-treatment plants. Sun Pharma does report that its sole site that manufactures antibacterials is ZLD implying that no liquid waste is discharged into the environment from this site. It also reports that any antibacterial residue from ZLD is sent for incineration. 

B.2 Limited publicly available information on environmental risk management
Sun Pharma publishes limited information on its approach to environmental risk-management, without specific references to AMR. It publishes that any manufacturing site that manufactures antibiotics is qualified as ZLD. It does not publish: (1) the results of environmental audits, whether conducted at its own site, 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 sites; no requests for official corrective action 
Sun Pharma publicly discloses that its own site has a system, including audits, to maintain high-quality antibacterial production, consistent with international GMP standards. It reports auditing its suppliers on quality standards as well. There is limited information on how corrective actions are implemented and tracked. The Benchmark found no requests for official corrective action from the FDA or EMA related to non-conformities with cGMP at Sun Pharma’s own sites or any subsidiaries that manufacture antibacterials.

Evaluated: access activities relating to antibacterial & antifungal medicines & vaccines in 102 access countries***

Sun Pharma 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 Filed to register off-patent/generic medicines in 8 access countries on average
Sun Pharma has an average performance, filing all its 8 relevant off-patent/generic medicines for registration in 8 access countries on average. Its most widely filed relevant product is the antibiotic amoxicillin/clavulanic acid filed in 22 access countries. Four of its relevant products are filed for registration in at least one LIC.

C.2.2 Some strategies to expand access to off-patent/generic medicines
Sun Pharma has an average performance. It reports providing access to its antibiotics and antifungals to 45 access countries, of which low-income countries such as Chad, Nepal and Syria. In 2020, Sun Pharma estimates to have provided access to its amoxicillin/clavulanic acid to 890,000 patients in 19 access countries, including Cameroon, Myanmar, and Peru.

C.3 Some strategies to ensure continuous supply
Sun Pharma has an average performance with strategies reported in three of four areas assessed. It reports complying with good manufacturing practices when producing API and drug products. Sun Pharma works towards product accessibility by ensuring regular supply of its products and having a robust distribution network in India, where it supplied its medicines to more than 500,000 pharmacies in urban and rural areas in 2020. Sun Pharma does not report capacity building and technology transfer initiatives. It mitigates against falsified and substandard medicines by reporting any suspicion of counterfeit to the approriate regulatory authorities. It uses a ‘Track and Trace’ technology to prevent the sale of counterfeit medicines and to ensure the authenticity of its products. Sun Pharma has a dedicated task force in place to train filed forces to identify counterfeits.

Evaluated: stewardship activities relating to antibacterial & antifungal medicines globally

C.4 Comprehensive COI mitigation strategies in place for its educational programmes
Sun Pharma performs strongly in conflict of interest (COI) mitigation for the five AMR-related educational programme for HCPs assessed by the Benchmark. To mitigate COI for all five programmes, it provides financial resources to independent third parties (DocMode, KOL International Academy, Mediquest and Mindsync) to develop the programmes.

C.5 Does not report sales or marketing practices that aim to address appropriate use
Sun Pharma 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.

Sun Pharma 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 Makes two types of brochure and/or packaging adaptations to facilitate appropriate use by patients
Sun Pharma adapts brochures and/or packaging to facilitate the appropriate use of amoxicillin/clavulanic acid by patients. Sun Pharma performs well in this measure, taking account of language and adherence to treatment. It has created a QR code which directs to information on how to take the product appropriately translated in ten regional languages in India. It also adapts packaging to include information on AMR and how to take the product appropriately.

C.7 AMR Surveillance
As a generic medicine manufacturer, Sun Pharma is not assessed in this indicator nor does it report any involvement in AMR surveillance activities.