AMR Benchmark Opportunities: progress update

Generic medicine manufacturers

Cipla LtdThis table is part of a November 2023 report that looks at what actions each company in scope of the Antimicrobial
Resistance (AMR) Benchmark has taken with regards to each of the Opportunities set out in its 2021 AMR Benchmark
Report Card. The full 2021 Report Card is also included in this PDF.

2021 O PPO RTU N IT Y

2023 U PDATE

What was the Opportunity shared in the AMR Benchmark?

What progress has been made on this Opportunity?

Expand environmental risk-management strategy to

Cipla has conducted a workshop with suppliers on how toinclude suppliers and ensure compliance with limits.

quantify discharge levels with mass balance calculations. To

Cipla tracks compliance with discharge limits it set for its

support its suppliers, Cipla reports it will conduct training

own manufacturing sites. It can quantify discharge levels

and awareness sessions on a regular basis. Currently, it isat all suppliers’ sites and track compliance with limits, andunclear how many of the supplier sites have quantified dis-publicly disclose the results. It can also publicly disclose thecharge levels and are compliant with discharge limits. Cipla

names and locations of its suppliers and waste-treatment

highlights that due to the absence of any regulations, ensur-plants for increased transparency.

ing supplier adherence to discharge limits poses challenges.
In regard to its own manufacturing sites, Cipla reportsthat all ten of its sites are now compliant with discharge limits in the receiving environment – up from two sites in 2021.
The company reports that Zero Liquid Discharge (ZLD) systems are applied at its manufacturing sites in Bommasandra,Goa, Indore, Kurkumbh, Sikkim and Virgonagar. In addition,
Cipla eliminates the risk of AMR by not reusing recycledwater from ZLD sites in horticulture and gardening.

Expand registration antibacterial medicines to more

Cipla reports it has marketed ceftazidime/avibactam inaccess countries and ensure adequate supply.

India. In 2022, this antibiotic – also featured on the 2023

Cipla can expand registration of its antibiotics and anti-World Health Organization (WHO) Model List of Essential

fungals listed on the 2021 WHO EML, such as itraconazoleMedicines (EML) as a Reserve antibiotic – lost its exclusivity

and levofloxacin to more countries, including low-income

status and became a generic drug in India. In South Africa,countries and ensure adequate supply. To ensure adequate

Cipla has registered fosfomycin and nitrofurantoin, bothsupply, Cipla can promote capacity building and technology

listed on the 2023 WHO EML as Reserve and Access antibi-transfer initiatives in access countries, to improve access tootics respectively.

its medicines.

While no specific initiatives are reported, Cipla states its
intentions toward expanding access to plazomicin (Zemdri®)and ceftriaxone/sulbactam (Elores™) in low- and middle-income countries (LMICs).
However, due to a lack of evidence-based indications
for use or recommendations in high-quality internationalguidelines, WHO actively advises against the clinical use ofceftriaxone/sulbactam.
The company does not report any updates on how it
ensures an adequate supply of antibacterial medicines inLMICs.

Fully decouple incentives for sales agents from sales

Cipla did not report any developments specific to thisvolumes.

Opportunity.

Cipla links part of its sales agents’ incentives to sales volumes. It can fully decouple incentives for sales agents fromsales volumes of antibacterial and antifungal medicines
again.

30

Antimicrobial Resistance Benchmark 2021

CPLOverall Performance
2020

2021

70% 60%▼Access to Medicine Foundation

Cipla Ltd
Generic medicine manufacturer
Stock exchange: NSE • Ticker: CIPLA • HQ: Mumbai, India • Employees: 25,672

CPL updated 2nov
PERFORMANCE
Cipla performs above average overall in its evaluated Research Areas

Performance in the Benchmark0%

when compared to the other generic medicine manufacturers in scope.
Responsible Manufacturing: Performs well. Reports environmental riskmanagement strategy for own sites; initial risk assessment of suppliers
ongoing.
Appropriate Access: Middle-performing. Filed its on-patent medicine inIndia. Files some of its off-patent/generic medicines for registration inaccess countries. Reports some strategies to ensure continuous supply

from sales volumes for >99%. It reports comprehensive conflict ofR&D

50%

100%

Points0%

0/ 067%

Manufacturing

10/ 1540%

Access

10/ 2587%

Stewardship
0%50%

13/ 15100%

How Cipla was evaluatedinterest mitigation for its educational programmes. It adapts brochures
and packaging for patients.

33/ 55

Performance by Research Areaof its relevant product.
Stewardship: Performs strongly. It decouples incentives for sales agents

Points60%

Overall score

A R&D

12.1 2.2 2.3 2.43

●

●

●

●

123

B Manufacturing ●

●

●

●

●

1.1

1.2 1.3 2.1 2.2 2.3

3

C Access●●●

4567C Stewardship

●

●

●

●

●

●

●

●

● ● ● Scored●

Not scored

OPPORTUNITIES FOR CIPLACHANGES SINCE 2020

Expand environmental risk-management strategy to include suppliers and ensure compliance• As part of the 3-year strategy (2020-2023),

with limits. Cipla tracks compliance with discharge limits it set for its own manufacturing sites.

Cipla will submit and launch plazomicin in India

It can quantify discharge levels at all suppliers’ sites and track compliance with limits, and pub-and other countries, as well as explore multi-

licly disclose the results. It can also publicly disclose the names and locations of its suppliers andwaste-treatment plants for increased transparency.

ple opportunities to out-license the product.
• Since 2020, Cipla is in the process of assess-

Expand registration antibacterial medicines to more access countries and ensure adequate

ing all its suppliers related to the risk of AMR,

supply. Cipla can expand registration of its antibiotics and antifungals listed on the 2021 WHO EML,

including requesting data from suppliers onsuch as itraconazole and levofloxacin to more countries, including low-income countries and ensure
adequate supply. To ensure adequate supply, Cipla can promote capacity building and technology
transfer initiatives in access countries, to improve access to its medicines.

discharge levels.
• Since 2020, Cipla is no longer a member ofthe AMR Industry Alliance.

Fully decouple incentives for sales agents from sales volumes. Cipla links part of its sales agents’• In June 2020, Cipla withdrew its EMA appli-

incentives to sales volumes. It can fully decouple incentives for sales agents from sales volumes ofcation for a marketing authorization of pla-

antibacterial and antifungal medicines again.

zomicin (Zemdri®), to treat complicated urinary tract infection, due to lack of financial
viability.

43Antimicrobial Resistance Benchmark 2021

Access to Medicine Foundation

SALES AND OPERATIONSCPLRevenue by business segment

Therapeutic areas: Cardiovascular diseases, Central nervous system,

2020*

Dermatology, Diagnostics, Gastrointestinal, Infectious diseases, Metabolic

2021*

disorders, Oncology, Ophthalmology, Orthopaedics, Respiratory diseases,

0Urology, Women’s Health.

169,586.7
188,782.4
50,000

Pharmaceuticals

Business segments: Pharmaceuticals, New ventures
Product categories: Biosimilars, Consumer health products, Generic medi-

100,000

200,000
mn INR*Financial year: April 2020 - March 2021

New Ventures

150,000

CPL
Revenue by regioncines, Innovative medicines, Respiratory devices.

67,405.6

2020*

M&A since 2020: None in the antibacterial and/or antifungal sectors

0India38,738.2

77,357.32021*

50,000
United States

43,111.9

40,914 23,030
100,000

50,294.6

200,000
mn INR
Rest of world*Financial year: April 2020 - March 2021

South Africa

150,000

PORTFOLIO for pathogens in scopeMid-sized portfolio: At least 59 products: 46 antibacterial medicines; 13
antifungal medicines

CPL
Products on the market
0On-patent medicine: 1 (plazomicin)
Off-patent/generic medicines: 9 of 58 were selected for analysis* (amox-04620401360● Antibacterial vaccine● Antibacterial medicine● Antifungal medicine

icillin [A], amoxicillin/clavulanic acid [A], ciprofloxacin [W], colistin [R], fluconazole [F], Fosfomycin [R], itraconazole [F], levofloxacin [W], linezolid[T])AWaRe medicines**: 5 Access group; 15 Watch group; 8 Reserve groupAnti-TB medicines**: 3PERFORMANCE BY RESEARCH AREAA

RESEARCH & DEVELOPMENT

As a generic medicine manufacturer, Cipla is notevaluated in this Research Area.

BRESPONSIBLE MANUFACTURING Evaluated: antibacterials manufacturing (APIs and drug products)

B.1

Environmental risk-management includ-

34 of 57 supplier sites, or 60%, are fully assessed

own sites, the sites of suppliers or external pri-

ing limits for own sites; tracks compli-

but it is unclear how many of the 34 have quanti-vate and public waste-treatment plants; (2) a list

ance with limits at own sites

fied discharge levels. Complete assessment of allof these suppliers and plants; or (3) the limits

suppliers is expected by March 2022.

and levels of antibacterial discharge from its

Cipla reports a strategy to minimise the environmental impact of wastewaters and solid

There is limited information on the require-

waste from antibacterial manufacturing at its

ments Cipla makes of external private and publicsites, including audits. It reports setting dis-waste-treatment plants, in terms of environmen-

charge limits in the receiving environment for alltal strategy and antibacterial discharge limits.

antibacterials manufactured at its sites, based

Cipla reports that it requests flow rates fromon PNECs to limit AMR, as recommended bycommon effluent treatment plants to accurately

Cipla reports that its own sites and suppliers

the AMR Industry Alliance. Discharge levels are

determine dilution factors and mass balance

have a system to maintain high-quality antibac-

quantified using a mass balance approach, veri-

calculations.

terial production consistent with international

fied by chemical analysis if applicable. It reports

own or suppliers’ sites.
B.3

System in place to maintain production
quality for own and suppliers’ sites; norequests for official corrective action

GMP standards. This includes periodic riskPublicly discloses some information on

based audits and tracking of corrective and pre-and two, or 20%, of those are compliant withenvironmental risk management andventive actions. Cipla also requires its suppli-

discharge limits. It also reports that the levels of

AMR risk identification of own sites

ers to audit their own suppliers. The Benchmark

70% of all antibacterials are quantified and 100%

Cipla publishes some components of its environ-found no requests for official corrective action

is expected by March 2022.

mental risk-management strategy. It publishes

from the FDA or EMA related to non-conform-

Cipla will require third-party suppliers ofthat the risk of AMR at all own sites is assessed

ities with cGMP at Cipla’s own sites or any sub-antibacterials to follow similar standards, includ-and priority sites are implementing responsible

sidiaries that manufacture antibacterials.

ing limits based on PNECs, after it completes thepractices related to AMR. It also publishes thatongoing initial assessments of all its 57 suppliers.

risk assessments of its supplier sites are ongo-It requests and reviews discharge levels of its

ing. Cipla does not publish: (1) the results ofsuppliers as part of the assessments. It reports

environmental audits, whether conducted at its

three of 10 sites have quantified discharge levels* See Appendix VII for information about
eligibility criteria for products.
** Listed on the 2019 WHO EML.

B.244Antimicrobial Resistance Benchmark 2021

CAccess to Medicine Foundation

APPROPRIATE ACCESS & STEWARDSHIP – ACCESS

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.

LIC.

Q-TIB, a fixed dose combination used in tuber-

For more information, see Appendix VII.

culosis prevention for people living with HIV, inC.2.1 Expanding access to on-patent

C.1.1

Registration filings for relevant on-patent medicinesmedicinesseven access countries including Haiti, Rwanda
and Uganda.

Cipla ’s performance is low as its on-patent med-

Cipla’s performance is low as it filed its newly

icine, plazomicin, (Zemdri®) is not yet marketed

acquired on-patent medicine, the reserve anti-in access countries.

biotic plazomicin (Zemdri®) used to treat com-C.3

Some strategies to ensure continuous
supplyCipla has an average performance with strateC.2.2 Some strategies to expand access togies reported in three of four areas assessed.

off-patent/generic medicines

It ensures accurate demand planning and data

Cipla has an average performance. It reports

sharing by having a 12-month rolling forecast

several examples to demonstrate the numberand conducting long-term demand planning (upof people who benefitted from its eligible med-to five years). Cipla mitigates against shortage

Cipla has an average performance, filing eight oficines in India and South Africa during therisks by keeping safety stocks and securing suf-

its nine relevant off-patent/generic medicines

COVID-pandemic peak. For example, Cipla’s

ficient APIs stocks. Cipla does not report capac-for registration in six access countries on aver-colistin is available in 500 Indian hospitals andity building and technology transfer initiatives.

age. Its most widely filed relevant product is thewas used to treat 20,000 Indian patients per

To mitigate against substandard and falsified

antifungal fluconazole, filed in 21 access coun-month. In South Africa, Cipla estimates to haveproducts, Cipla uses an automated Track&Tracetries. Six of its relevant products are filed in lessprovided access to azithromycin to 280,000

system and product or primary packaging

than 10 access countries. Three of its relevant

patients. In 2020 and 2021, Cipla participated inserialisation.

products are filed for registration in at least one

a tender to distribute more than 1 mn tablets ofplicated urinary tract infections, in one accesscountry (India).
C.1.2 Filed to register off-patent/generic medicines in 4 access countries on average

CAPPROPRIATE ACCESS & STEWARDSHIP – STEWARDSHIP

Evaluated: stewardship activities relating to antibacterial & antifungal medicines globally
C.4

Comprehensive COI mitigation strategiesaim to address the appropriate use of its anti-C.7

in place for its educational programmes

bacterial and/or antifungal medicines. Its mar-As a generic medicine manufacturer, Cipla is not

Cipla performs strongly in the analysis of its

keting materials reflect emerging resistanceassessed in this indicator but its activities in AMR

top five AMR-related educational programmes

trends and/or include treatment guidelines

surveillance are reported. The Benchmark notes

for healthcare professionals in conflict of inter-for healthcare professionals: for colistin andthat Cipla funds a surveillance programme in theest (COI) mitigation. All five programmes haveitraconazole.

US focused on resistance to plazomicin and has

all three COI mitigation strategies looked for by

AMR Surveillance

been running since 2018. The programme is anMakes two types of brochure and/FDA postmarketing requirement and data col-pendently from its marketing department; (2)or packaging adaptations to facilitatelection is not complete, therefore data is notparticipants are not provided financial or mate-appropriate use by patients

yet shared publicly. However, Cipla reports thatthe Benchmark: (1) content is developed inde-C.6

rial incentives; and (3) a policy of not using

Cipla adapts brochures and packaging to facili-

aggregated results are shared and presented atbranded materials.

tate the appropriate use of itraconazole, amo-international infectious disease conferences.

rolfine, oxiconazole and fosfomycin trometamol
C.5

Engages in sales and marketing practices

by patients. Cipla performs well in this meas-

to address appropriate useure, taking account of language and adherence

Cipla performs above average in sales practices.

to treatment. It provides packages and leaflets

It reports that it partly decouples incentives forfor these products with QR codes that direct

sales agents from sales volumes of its antibacte-patients to information on antifungal resist-rial and/or antifungal medicines. Its percentage

ance in eight to ten regional languages in India.

of variable pay linked to sales volumes is <1% andThis information aims to improve adherence tosales targets are set at the national level.

treatment.

Cipla engages in marketing practices that*** 102 low- and middle-income countries where better access to medicine ismost needed.

45