AMR Benchmark Opportunities: progress update

Generic medicine manufacturers

Alkem Laboratories Ltd
This 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?

Develop an AMR-specific environmental risk-

For the first time, Alkem has publicly reported the imple-management strategy and increase public disclosure.

mentation of Zero Liquid Discharge (ZLD) systems acrossAlkem reports a commitment to manufacture its products in

64% of its manufacturing sites. The company also publicly

an environmentally responsible manner without specifying

reports the city-level locations of its manufacturing sites,

whether AMR is taken into account. The company canwith 18 located in India and two in the United States.

develop an AMR strategy for its own manufacturing sites,

However, it remains unspecified which sites manufacture

the sites of suppliers and external private waste-treatment

antibacterials and/or antifungals. In addition, Alkem does

plants, based on the guidelines of the AMR Industry Alliance.

not report an AMR-specific environmental risk-management

This includes setting limits and quantifying discharge

strategy.

levels to track compliance. Moreover, Alkem can publish
information on how it manages environmental risk related
to antibacterial manufacturing to curb AMR. The company
currently publishes limited information.
Expand registration and ensure availability ofAlkem did not report any developments specific to thisantibacterial and antifungal medicines.

Opportunity.

Alkem can expand registration and ensure equitable accessof its antibiotics and antifungals listed on the 2021 WHO
EML, such as cefotaxime and tigecycline, to more countries,
including low-income countries, with a high burden ofdisease. It can improve transparency on where its medicines
are registered and made available.
Apply responsible sales practices for antibacterial and

Alkem did not report any developments specific to thisantifungal medicines.

Opportunity.

Alkem can apply responsible sales practices for antibacterial
and antifungal medicines by not deploying sales agents.
Alternatively, it can fully decouple incentives for sales
agents from sales volumes of such medicine.

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Antimicrobial Resistance Benchmark 2021

ALKOverall Performance
2020

2021

14% 20%▲Access to Medicine Foundation

Alkem Laboratories Ltd
Generic medicine manufacturer
Stock exchange: NSE • Ticker: ALKEM • HQ: Mumbai, India • Employees: 14,331

ALK
PERFORMANCE

Performance in the Benchmark

Alkem performs low overall in its evaluated Research Areas whenenvironmental risk-management strategy but without a specific aim tolimit AMR.
Appropriate Access: Performs low. Discloses no information onregistration filings, expanding access or ensuring continuous supply for
its off-patent/generic medicines.

packaging for patients.

50%

100%

Performance by Research Area
R&D

Points0%

0/ 033%

Manufacturing

5/ 1520%

Access

3/ 15

Stewardship

0/ 100%

Stewardship: Performs low. It does not report decoupling incentives
for sales agents from sales volumes. It does not adapt brochures or

8/ 400%compared to the other generic medicine manufacturers in scope.
Responsible Manufacturing: Performs low. Reports a general

Points20%

Overall score

50%

100%

How Alkem was evaluated

A R&D

12.1 2.2 2.3 2.4

3

●

●

●

●

123B Manufacturing ●

●

●

●

●

1.1

1.2 1.3 2.1 2.2 2.3

3C Access

●

●

●

4

5

6

7C Stewardship

●

●

●

●

●

●

●

●

● ● ● Scored●

Not scored

OPPORTUNITIES FOR ALKEM

CHANGES SINCE 2020

Develop an AMR-specific environmental risk-management strategy and increase public disclo-No changes are reported for Alkem.

sure. Alkem reports a commitment to manufacture its products in an environmentally responsible
manner without specifying whether AMR is taken into account. The company can develop an AMR
strategy for its own manufacturing sites, the sites of suppliers and external private waste-treatment
plants, based on the guidelines of the AMR Industry Alliance. This includes setting limits and quantifying discharge levels to track compliance. Moreover, Alkem can publish information on how it manages environmental risk related to antibacterial manufacturing to curb AMR. The company currently
publishes limited information.
Expand registration and ensure availability of antibacterial and antifungal medicines. Alkem canexpand registration and ensure equitable access of its antibiotics and antifungals listed on the 2021
WHO EML, such as cefotaxime and tigecycline, to more countries, including low-income countries,
with a high burden of disease. It can improve transparency on where its medicines are registeredand made available.
Apply responsible sales practices for antibacterial and antifungal medicines. Alkem can apply
responsible sales practices for antibacterial and antifungal medicines by not deploying sales agents.
Alternatively, it can fully decouple incentives for sales agents from sales volumes of such medicines.

* All companies were assessed based ondata submitted to the Benchmark in thecurrent and previous periods of analysis, as well as information the companies
have made publicly available, or that areaccessible through other sources. For
the 2021 Benchmark, Alkem declined
to submit data to the Antimicrobial
Resistance Benchmark.

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Antimicrobial Resistance Benchmark 2021

Access to Medicine Foundation

SALES AND OPERATIONSALKTotal income by business segment

Therapeutic areas: Anti-diabetes, Anti-infective, Cardiac, Dermatology,

2020*

Gastro-intestinal, Pain/analgesics, Neuro/CNS.

2021*

Business segments: Pharmaceuticals

83,443.6
88,650.1

0Product categories: Generic medicines

20,00040,00060,000100,000
mn INR*Financial year: April 2020 - March 2021

Pharmaceuticals

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

80,000

ALK
Total income by region
56,062

2020*

58,2092021*
020,000

India

United States

40,00021,99924,66560,00080,000100,000
mn INR
Other international markets*Financial year: April 2020 - March 2021

PORTFOLIO for pathogens in scopeMid-sized portfolio: At least 52 products: 49 antibacterial medicines; 3ALK
Products on the market

antifungal medicines
Off-patent/generic medicines: 10 of 52 were selected for analysis**(amoxicillin [A], amoxicillin/clavulanic acid [A], caspofungin [F], cefixime

49 30204060● Antibacterial vaccine● Antibacterial medicine● Antifungal medicine[W], cefotaxime [W], colistin [R], isoniazid [T], itraconazole [F], linezolid[T], tigecycline [R])AWaRe medicines***: 5 Access group; 18 Watch group; 3 Reserve groupAnti-TB medicines***: 2PERFORMANCE BY RESEARCH AREAA

RESEARCH & DEVELOPMENT

As a generic medicine manufacturer, Alkem is
not evaluated in this Research Area.

B

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

B.1

No AMR-specific environmental risk

audits, whether conducted at its own sites, theEMA related to non-conformities with cGMP atmanagement strategy

sites of suppliers or external private and public

Alkem’s own sites or any subsidiaries that manu-Alkem states a general commitment to manufac-waste-treatment plants; (2) a list of these sup-facture antibacterials.

ture its products in an environmentally responsi-pliers and plants; or (3) the limits and levels of

ble manner, supported by a management systemantibacterial discharge from its own or suppli-that includes periodic impact assessments. It

ers’ sites.

is unclear how the strategy takes AMR into
account or aims to minimise the environmental impact of wastewaters and solid waste fromantibacterial manufacturing at its own sites,

B.3

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

third-party suppliers of antibacterials or external

Alkem reports that its own sites and suppliers

private and public waste-treatment plants.

have a system to maintain high-quality antibacterial production consistent with international

B.2

Limited publicly available information on

GMP standards. This includes periodic risk-based

environmental risk management

audits and tracking of corrective and preventive

Alkem publishes limited information on itsactions. There is limited information on whether

approach to environmental risk-management,

Alkem requires its suppliers to audit their own

without specific references to AMR. It does

suppliers. The Benchmark found no requests

not publish: (1) the results of environmental

for official corrective action from the FDA or** See Appendix VII for information about
eligibility criteria for products.
*** Listed on the 2019 WHO EML.

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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†
Alkem is not eligible for indicators: C.1.1, C.1.3,C.3

Appendix VII.

No information on strategies to ensure
continuous supply

C.2.1 and C.2.3 For more information, see

Alkem’s performance is low as it discloses noinformation on how it ensures the continuous

C.1.2 No information on registration filings foroff-patent/generic medicines

supply of its relevant products to access countries, beyond India.

Alkem’s performance is low. It reports no evidence of filing its ten relevant off-patent/generic
medicines for registration in access countries,
beyond India.
C.2.2 No information on strategies to expand
access to off-patent/generic medicines
Alkem’s performance is low as it discloses noinformation on how it expands access to its ten
relevant off-patent/generic medicines, beyond
India. It does not provide evidence of patientreach and geographic reach.

CAPPROPRIATE ACCESS & STEWARDSHIP – STEWARDSHIP

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

Educational Stewardship Activities

icines as its marketing materials do not reflect

There is no information regarding Alkem’s

emerging resistance trends or include treatment

involvement in AMR-related educational pro-guidelines for healthcare professionals to raisegrammes aimed at healthcare professionals andawareness of AMR and address appropriate use.

it is therefore not eligible for this indicator as
there is no conflict of interest mitigation to be

C.6

Does not report adapting brochures and/or packaging to facilitate appropriate

assessed.

use by patients
C.5

Does not report sales or marketing prac-Alkem does not report adapting brochures and/tices that aim to address appropriate useor packaging to facilitate the appropriate use ofAlkem performs low in sales practices. It does

its antibacterial and/or antifungal medicines by

not report whether it decouples incentives forpatients.

sales agents from sales volumes to help preventthe inappropriate use of its antibacterial and/orC.7

antifungal medicines.

As a generic medicine manufacturer, Alkem is

AMR Surveillance

Alkem does not report to engage in market-

not assessed in this indicator nor does it reporting practices that aim to address the appropriate

any involvement in AMR surveillance activities.

use of its antibacterial and/or antifungal med-† 102 low- and middle-income countries
where better access to medicine is mostneeded.

39