Cipla Ltd

Evaluated: antibacterials manufacturing (APIs and drug products)

B.1 Environmental risk-management including limits for own sites; tracks compliance with limits at own sites 
Cipla reports a strategy to minimise the environmental impact of wastewaters and solid waste from antibacterial manufacturing at its sites, including audits. It reports setting discharge limits in the receiving environment for all antibacterials manufactured at its sites, based on PNECs to limit AMR, as recommended by the AMR Industry Alliance. Discharge levels are quantified using a mass balance approach, verified by chemical analysis if applicable. It reports three of 10 sites have quantified discharge levels and two, or 20%, of those are compliant with discharge limits. It also reports that the levels of 70% of all antibacterials are quantified and 100% is expected by March 2022.

Cipla will require third-party suppliers of antibacterials to follow similar standards, including limits based on PNECs, after it completes the ongoing initial assessments of all its 57 suppliers. It requests and reviews discharge levels of its suppliers as part of the assessments. It reports 34 of 57 supplier sites, or 60%, are fully assessed but it is unclear how many of the 34 have quantified discharge levels. Complete assessment of all suppliers is expected by March 2022.

There is limited information on the requirements Cipla makes of external private and public waste-treatment plants, in terms of environmental strategy and antibacterial discharge limits. Cipla reports that it requests flow rates from common effluent treatment plants to accurately determine dilution factors and mass balance calculations.

B.2 Publicly discloses some information on environmental risk management and AMR risk identification of own sites
Cipla publishes some components of its environmental risk-management strategy. It publishes that the risk of AMR at all own sites is assessed and priority sites are implementing responsible practices related to AMR. It also publishes that risk assessments of its supplier sites are ongoing. Cipla 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 action 
Cipla 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. Cipla also 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 Cipla’s own sites or any subsidiaries that manufacture antibacterials.

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

Cipla is not eligible for indicators: C.1.3 and C.2.3. For more information, see Appendix VII in the 2021 AMR Benchmark Report.

C.1.1 Registration filings for relevant on-patent medicines 
Cipla’s performance is low as it filed its newly acquired on-patent medicine, the reserve antibiotic plazomicin (Zemdri®) used to treat complicated urinary tract infections, in one access country (India).

C.1.2 Filed to register off-patent/generic medicines in 4 access countries on average 
Cipla has an average performance, filing eight of its nine relevant off-patent/generic medicines for registration in six access countries on average. Its most widely filed relevant product is the antifungal fluconazole, filed in 21 access countries. Six of its relevant products are filed in less than 10 access countries. Three of its relevant products are filed for registration in at least one LIC. 

C.2.1 Expanding access to on-patent medicines 
Cipla ’s performance is low as its on-patent medicine, plazomicin, (Zemdri®) is not yet marketed in access countries.

C.2.2 Some strategies to expand access to off-patent/generic medicines 
Cipla has an average performance. It reports several examples to demonstrate the number of people who benefitted from its eligible medicines in India and South Africa during the COVID-pandemic peak. For example, Cipla’s colistin is available in 500 Indian hospitals and was used to treat 20,000 Indian patients per month. In South Africa, Cipla estimates to have provided access to azithromycin to 280,000 patients. In 2020 and 2021, Cipla participated in a tender to distribute more than 1 mn tablets of Q-TIB, a fixed dose combination used in tuberculosis prevention for people living with HIV, in seven access countries including Haiti, Rwanda and Uganda.

C.3 Some strategies to ensure continuous supply
Cipla has an average performance with strategies reported in three of four areas assessed. It ensures accurate demand planning and data sharing by having a 12-month rolling forecast and conducting long-term demand planning (up to five years). Cipla mitigates against shortage risks by keeping safety stocks and securing sufficient APIs stocks. Cipla does not report capacity building and technology transfer initiatives. To mitigate against substandard and falsified products, Cipla uses an automated Track&Trace system and product or primary packaging serialisation. 

Evaluated: stewardship activities relating to antibacterial & antifungal medicines globally 

C.4 Comprehensive COI mitigation strategies in place for its educational programmes
Cipla performs strongly in the analysis of its top five AMR-related educational programmes for healthcare professionals in conflict of interest (COI) mitigation. All five programmes have all three COI mitigation strategies looked for by the Benchmark: (1) content is developed independently from its marketing department; (2) participants are not provided financial or material incentives; and (3) a policy of not using branded materials.

C.5 Engages in sales and marketing practices to address appropriate use 
Cipla performs above average in sales practices. It reports that it partly decouples incentives for sales agents from sales volumes of its antibacterial and/or antifungal medicines. Its percentage of variable pay linked to sales volumes is <1% and sales targets are set at the national level.

Cipla engages in marketing practices that aim to address the appropriate use of its antibacterial and/or antifungal medicines. Its marketing materials reflect emerging resistance trends and/or include treatment guidelines for healthcare professionals: for colistin and itraconazole.

C.6 Makes two types of brochure and/or packaging adaptations to facilitate appropriate use by patients 
Cipla adapts brochures and packaging to facilitate the appropriate use of itraconazole, amorolfine, oxiconazole and fosfomycin trometamol by patients. Cipla performs well in this measure, taking account of language and adherence to treatment. It provides packages and leaflets for these products with QR codes that direct patients to information on antifungal resistance in eight to ten regional languages in India. This information aims to improve adherence to treatment. 

C.7 AMR Surveillance
As a generic medicine manufacturer, Cipla is not assessed in this indicator but its activities in AMR surveillance are reported. The Benchmark notes that Cipla funds a surveillance programme in the US focused on resistance to plazomicin and has been running since 2018. The programme is an FDA postmarketing requirement and data collection is not complete, therefore data is not yet shared publicly. However, Cipla reports that aggregated results are shared and presented at international infectious disease conferences.