Cipla Ltd.Generic medicine manufacturer
Cipla performs well in all its evaluated Research Areas when compared to other generic medicine manufacturers in scope.
Performs strongly. Reports environmental risk-management strategy for own sites, including completed risk assessments based on discharge limits, and plans for future supplier assessment.
Performs strongly. Files for registration for all relevant off-patent products in access countries. Some reported strategies to ensure continuous supply include forecasting, demand planning, maintains safety stocks, and secures sufficient quantities of APIs in advance of seasonal need.
Performs strongly. Fully decouples incentives for sales agents from sales volumes. Its educational programmes have comprehensive COI mitigation. Reports language adaptations to brochures to improve adherence to treatment for antifungals.
Sales & Operations
Therapeutic areas: Cardiovascular diseases, infectious diseases, metabolic disorders, oncology, respiratory diseases
Business segments: APIs; Cipla Global Access; Respiratory
Product categories: Generic medicines
Manufacturing & supply: Cipla reports having 11 manufacturing sites that produce antibacterial APIs and/or drug products. It supplies approximately 400 million daily defined doses (DDDs) of antibacterial and antifungal medicines across at least nine countries to date.
M&A since 2018: In July 2019, Cipla USA announced the acquisition of the antibacterial drug plazomicin (Zemdri™) from Achaogen. In October 2019, Cipla announced the acquisition of the anti-infective product ceftriaxone/sulbactam/disodium EDTA (Elores) from Venus Remedies Limited.
for diseases in scope
Mid-sized portfolio: At least 72 products (42 unique INNs): 57 antibacterial medicines; 15 antifungal medicines
Essential medicines: 51% (37) of products are on the 2019 WHO EML
AWaRe medicines*: 12 Access group; 8 Watch group; 2 Reserve group
Anti-TB medicines*: 6 (incl. 1 Watch group, 1 Reserve group)
The number of products is based on data from public sources, IQVIA, and data submitted by the company. It may not account for Cipla’s entire portfolio.
Opportunities for Cipla
Ensure availability and affordability of plazomicin (Zemdri™) in access countries. Cipla can file for registration of plazomicin (Zemdri™) in access countries such as India and countries in Sub-Saharan Africa to ensure the availability of this new antibacterial medicine. Cipla can also apply to plazomicin (Zemdri™) its public commitment to improve affordability through an equitable pricing strategy among countries based on socioeconomic factors.
Expand registration and ensure adequate supply of antibacterial medicines to more access countries. Cipla can file for registration and ensure adequate supply of antibacterial medicines on the 2019 WHO EML within its current portfolio (e.g. the forgotten antibiotics colistin and fosfomycin) in more access countries.
Implement and monitor its environmental risk-management strategy at third-party suppliers and external private waste-treatment plants. Cipla has an environmental risk-management strategy, including discharge limits, and auditing processes in development for its own manufacturing sites. The company can ensure that this strategy, including the discharge limits, apply also to the sites of third-party suppliers and external private waste-treatment plants. Following up on its commitments as a signatory to the Industry Roadmap for Progress on Combating AMR, Cipla can also work with stakeholders to develop a practical mechanism to publicly disclose (1) a list of its suppliers and waste-treatment plants and (2) the results of environmental audits and the levels of antibacterial discharge from its own sites and the sites of its suppliers.
Build on best practice in sales incentives and develop a comprehensive stewardship approach. Cipla is one of only two companies in the Benchmark fully decoupling sales incentives from sales volumes. Building on this best practice, Cipla can share publicly (e.g. with the AMR Register) the raw data collected for its surveillance programme. It can also expand its brochure and packaging adaptations (taking account of language and adherence to treatment) beyond India.
Changes since 2018
- In October 2019, Cipla announced the acquisition of the anti-infective product ceftriaxone/sulbactam/disodium EDTA (Elores) from Venus Remedies Limited.
- In July 2019, Cipla acquired worldwide rights (excluding Greater China) to Achaogen’s antibacterial plazomicin (Zemdri™).
- In April 2019, Cipla and Pulmatrix signed an agreement for the co-development and commercialisation of pulmazole, an inhaled iSPERSE™ formulation of the antifungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma.
- Running an AMR surveillance programme for plazomicin as part of an FDA requirement.
- Newly set up an AMR-targeted environmental strategy for its own sites, including risk assessments based on PNECs to limit AMR.
Performance by research area
As a generic medicine manufacturer, Cipla is not evaluated in this Research Area.
Evaluated: antibacterials manufacturing (APIs and drug products)
B.1 Environmental risk-management strategy for own sites
Cipla reports a strategy to minimise the environmental impact of wastewaters and solid waste from antibacterial manufacturing at its sites, with an AMR-specific audit programme currently in development. The company reports setting discharge limits for all antibacterials manufactured at its sites, based on PNECs to limit AMR (or more stringent PNECs), as published by the AMR Industry Alliance. It has used these limits to conduct an initial risk assessment at its own sites, which identified areas for improvement, for which the company reports having initiated corrective actions.
Cipla has not yet implemented its strategy with third-party suppliers of antibacterial APIs and/or drug products. The company has drawn up supplier assessment plans, prioritised based on the volume of antibacterials supplied, and expects its future audit programme to cover suppliers’ and own sites alike. There is limited information on the requirements the company makes of external private waste-treatment plants in terms of environmental strategy and antibacterial discharge limits. The company reports that the plants are currently not audited.
B.2 Publicly discloses some information on environmental risk management
Cipla publishes some components of its environmental risk-management strategy. Further, it is a member of the AMR Industry Alliance, which publishes a list of recommended antibacterial discharge targets. Cipla does not publish: (1) the results of environmental audits, whether conducted at its own sites, the sites of suppliers or external private waste-treatment plants; (2) a list of these suppliers and waste-treatment plants; or (3) the levels of antibacterial discharge from its own sites.
B.3 Has system to maintain production quality for own and suppliers’ sites; no requests for official corrective action
Cipla reports having a system to maintain high-quality antibacterial production, consistent with international GMP standards. This includes risk-based internal audits and tracking of corrective and preventive actions. The company reports requiring suppliers to abide by regulatory and company quality standards. This includes submitting suppliers to a qualification process, after which a quality technical agreement is established and periodic risk-based re-evaluations are conducted to assess compliance. 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.**
Evaluated: access activities relating to antibacterial & antifungal medicines & vaccines in 102 access countries***
C.1.1 Registering on-patent products
Cipla was not eligible for this indicator as it does not have on-patent antibacterial or antifungal medicines or vaccines in its portfolio.
C.1.2 Has filed to register relevant off-patent products† in 6 access countries on average
Cipla is stronger than other generic medicine manufacturers evaluated when it comes to filing relevant off-patent products for registration in access countries. It reports filing all of its relevant products (10/10 antibacterial and antifungal medicines) for registration in access countries. Its most widely filed product in this analysis is the antifungal fluconazole, used to treat diseases including those caused by Candida spp. Cipla has filed its version of this product in 21 access countries. Its antibacterials cefixime, linezolid and ethionamide have been filed in eight, seven and seven access countries, respectively.
C.2.1 Pricing strategies for on-patent products
Cipla was not eligible for this indicator, as it does not have on-patent antibacterial or antifungal medicines or vaccines in its portfolio.
C.2.2 Pricing strategies for off-patent products
Companies were not scored for this indicator as the available data was insufficient for a comparative analysis. Cipla does report that, to reduce the cost of its medicines, it chooses vendors based on quality and price, improves batch yields at the manufacturing end, and pursues overhead cost reductions.
C.3 Some strategies to ensure the continuous supply of relevant products
Cipla is a middle-performing company, compared to other generic medicine manufacturers evaluated, when it comes to taking steps to ensure the continuous supply of its relevant products to access countries. It discloses some strategies for achieving this aim. It has a 12-month rolling forecast process and demand planning that looks five years ahead. It holds monthly sales and operations planning meetings with its sales and supply chain team to review the latest supply and demand updates. To help ensure a secure supply of ingredients, Cipla maintains safety stocks and secures sufficient quantities of APIs in advance of seasonal impact. To mitigate against falsified medicines reaching the supply chain, it uses 2D bar codes with unique identification numbers to improve tracking and tracing.
Evaluated: stewardship activities relating to antibacterial & antifungal medicines globally
C.4 Some COI mitigation for all educational programmes
The Benchmark analysed the top five AMR-related educational programmes for healthcare professionals from Cipla. Cipla reports some conflict of interest (COI) mitigation for all five programmes. All programmes include two of three COI mitigation strategies looked for by the Benchmark: (1) a pledge not to provide financial or material incentives to participants (content is delivered online or via webinars); and (2) a policy of not using branded materials. However, it was unclear whether content for the five programmes was developed independently from Cipla’s marketing department. After the period of analysis, the company stated that content for these five programmes is developed by its medical affairs team.
C.5 Adapts marketing materials and sales practices to address appropriate use
Cipla engages in practices that aim to address the appropriate use of its antibacterial and/or antifungal medicines, both via its marketing materials and sales remuneration. At least some of Cipla’s marketing materials reflect emerging resistance trends and include guidelines for healthcare professionals to raise awareness of AMR and address appropriate use: namely for the antibacterial colistin and the antifungal itraconazole. Cipla is the only generic medicine manufacturer evaluated to report fully decoupling incentives for sales agents from sales volumes to help prevent the inappropriate use of its antibacterial and/or antifungal medicines.
C.6 Makes several adaptations to brochures and/or packaging to facilitate appropriate use
Cipla adapts brochures and packaging to facilitate appropriate use by patients of relevant products: namely its antifungal medicines itraconazole, amorolfine and oxiconazole. These adaptations take account of language and adherence to treatment. Cipla provides packages and leaflets for these products with QR codes that direct patients to information about antifungal resistance in six to eight regional languages in India. This information aims to improve adherence to treatment. Cipla is the only company that reports adaptations to its brochures or packaging materials for antifungal medicines.
C.7 Antimicrobial surveillance
As a GMM, Cipla is not eligible for this indicator as GMMs have a limited role in AMR surveillance activities. After the period of analysis, Cipla stated that it runs a surveillance programme for plazomicin (Zemdri™) as part of an FDA requirement.
* Listed on the 2019 WHO EML (Section 6).
** Including only wholly-owned direct subsidiaries of the company.
*** 102 low- and middle-income countries where better access to medicine is most needed.
† See Guide to the Report Cards.