AMR Benchmark Opportunities: progress update

Generic medicine manufacturers

Sun Pharmaceutical Industries 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-Sun Pharma reports a correction to the information

management strategy and increase public disclosure.

contained in the 2021 Benchmark regarding its number ofSun Pharma reports a commitment to manufacture its

antibiotic manufacturing sites. Sun Pharma reports that

products in an environmentally responsible manner without

antibiotics are manufactured at four active pharmaceuticalspecifying whether AMR is taken into account. It reports

ingredient (API) manufacturing sites and eight formulation

having one owned manufacturing site, which employs Zerosites. All 12 sites are reported to be Zero Liquid Discharge

Liquid Discharge (ZLD) treatment processes. The company(ZLD) sites, implying that no liquid is discharged into thecan develop an AMR strategy for its own site and suppliers,

environment from these facilities. However, it remains

based on the guidelines of the AMR Industry Alliance. This

unclear whether recycled water is reused for gardening andincludes setting limits and quantifying discharge levels tohorticulture. Sun Pharma has initiated a process to measure

track compliance. Sun Pharma can publish information on

antibiotic levels in wastewater to verify discharge limit

how it manages environmental risk related to antibacterialcompliance. The company did not demonstrate any progressmanufacturing. The company publishes limited information

on increasing public disclosure concerning its environmental

about this.

risk management.
In 2022, Sun Pharma faced penalties from the Punjab
Pollution Control Board due to discharge of untreatedwastewater from its Toansa site into the environment. In
a separate case, the National Green Tribunal asked Sun
Pharma to pay compensation for releasing untreatedwastewater from its Madhuranthagam’s site, despite beinglabelled as a ZLD site. In both instances, it’s unclear whether
wastewater containing antibiotics was discharged.

Expand availability and ensure continuous supply of

Sun Pharma reports it has increased access to anti-infec-

antibacterial and antifungal medicines to more accesstives in nine African countries with varying product counts,countries.

including Benin (6), Gabon (5), Togo (5), Burkina Faso (4),Sun Pharma can ensure equitable access and adequate

Mali (2), Niger (2), Chad (2), Mauritania (1). The company

supply of its antibiotics and antifungals listed on the 2021

also reports it has registered or filed for registration at

WHO EML (e.g. the antifungal itraconazole and the reserve

least one product in 64 low- and middle-income countries

antibiotic tigecycline) in more access countries. For exam-(LMICs). Yet, it is unclear whether these products includeple, Sun Pharma can ensure accurate demand planning andantibacterial and antifungal medicines listed on the 2023

data sharing, build on capacity or mitigate against shortages

World Health Organization (WHO) Model List of Essential

by working with several API suppliers.

Medicines (EML), along with the strategies employed toensure availability and affordability in the mentioned Africancountries.
To ensure accurate demand planning, Sun Pharma
reports forecasting 6-12 months in advance and closely
monitoring buffer stocks.

Apply responsible sales practices for antibacterial and

Sun Pharma did not report any progress on thisantifungal medicines.

Opportunity.

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

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Antimicrobial Resistance Benchmark 2021

SUNOverall Performance
2020

11%

2021

47%▲

Access to Medicine Foundation

Sun Pharmaceutical Industries LtdGeneric medicine manufacturer
Stock exchange: NSE • Ticker: SUNPHARMA • HQ: Mumbai, India • Employees: 36,000

SUNPERFORMANCESun Pharma performs average overall in its evaluated Research Areas

Performance in the Benchmark

0%when compared to the other generic medicine manufacturers in scope.
Responsible Manufacturing: Performs low. Reports a generalenvironmental risk-management strategy but without a specific aim tolimit AMR.
Appropriate Access: Middle-performing. Files its off-patent products inaccess countries. Discloses some strategies to expand access and ensure
continuous supply of its off-patent products.

conflict of interest mitigation for its educational programme. It adapts

21/ 4550%

100%

Performance by Research Area
R&D

Points0%

0/ 033%

Manufacturing

5/ 1547%

Access

7/ 1560%

Stewardship0%

Stewardship: Middle-performing. It does not report decoupling
incentives for sales agents from sales volumes. It reports comprehensive

Points47%

Overall score

9/ 1550%

100%How Sun Pharma was evaluatedbrochures and/or packaging for patients.
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

3C Access

●

●

●

4

56

7

C Stewardship

●

●

●

●

●

●

●

●

● ● ● Scored●

Not scored

OPPORTUNITIES FOR SUN PHARMACHANGES SINCE 2020

Develop an AMR-specific environmental risk-management strategy and increase public disclo-

No changes are reported for Sun Pharma.

sure. Sun Pharma reports a commitment to manufacture its products in an environmentally responsible manner without specifying whether AMR is taken into account. It reports having one owned
manufacturing site, which employs Zero Liquid Discharge (ZLD) treatment processes. The company
can develop an AMR strategy for its own site and suppliers, based on the guidelines of the AMR
Industry Alliance. This includes setting limits and quantifying discharge levels to track compliance.
Sun Pharma can publish information on how it manages environmental risk related to antibacterial
manufacturing. The company publishes limited information about this.
Expand availability and ensure conitinuous supply of antibacterial and antifungal medicines tomore access countries. Sun Pharma can ensure equitable access and adequate supply of its antibiotics and antifungals listed on the 2021 WHO EML (e.g. the antifungal itraconazole and the reserve
antibiotic tigecycline) in more access countries. For example, Sun Pharma can ensure accurate
demand planning and data sharing, build on capacity or mitigate against shortages by working withseveral API suppliers.
Apply responsible sales practices for antibacterial and antifungal medicines. Sun Pharma canapply responsible sales practices for antibacterial and antifungal medicines by not deploying salesagents. Alternatively, it can fully decouple incentives for sales agents from sales volumes of suchmedicines.

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Antimicrobial Resistance Benchmark 2021

Access to Medicine Foundation

SALES AND OPERATIONS

SUN
Total income by business segment

Therapeutic areas: Anti-infectives, Cardiology, Dental, Dermatology,

2020*

Diabetology, Gastroenterology, Gynaecology, Nephrology, Neurology,

2021*

Nutritionals, Oncology, Ophthalmology, Orthopaedic, Psychiatry,

328,375334,981

0Respiratory, Urology

100,000

200,000

400,000
mn INR*Financial year: April 2020 - March 2021

Pharmaceuticals

Business segments: Pharmaceuticals
Product categories: Consumer health products, Generic medicines,

SUNTotal income by region

Innovative medicines2020*

101,863

109,387

61,9732021*

109,498

103,564

64,053

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

0IndiaPORTFOLIO for pathogens in scope

300,000

100,000
United States

200,000

50,03054,277300,000

400,000
mn INR
Emerging markets
Rest of world*Financial year: April 2020 - March 2021

SUN
Products on the market

Mid-sized portfolio: At least 52 products: 44 antibacterial medicines; 8antifungal medicines
Off-patent/generic medicines: 8 of 52 were selected for analysis* (amoxi-00442040860● Antibacterial vaccine● Antibacterial medicine● Antifungal medicine

cillin [A], amoxicillin/clavulanic acid [A], ciprofloxacin [W], colistin [R], itraconazole [F], levofloxacin [W], nystatin [F], tigecycline [R])AWaRe medicines**: 9 Access group; 19 Watch group; 3 Reserve group

PERFORMANCE BY RESEARCH AREAARESEARCH & DEVELOPMENTAs a generic medicine manufacturer, SunPharma is not evaluated in this Research Area.

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

B.1

No AMR-specific environmental risk
management strategy; ZLD at own site

B.2

Limited publicly available information on
environmental risk management

B.3

System in place to maintain production
quality for own sites; no requests forofficial corrective action

Sun Pharma reports a commitment to manufac-

Sun Pharma publishes limited information on its

ture its products in an environmentally responsi-approach to environmental risk-management,

Sun Pharma publicly discloses that its own

ble manner, supported by a management system

without specific references to AMR. It pub-site has a system, including audits, to maintainthat includes periodic audits. It is unclear how

lishes that any manufacturing site that manu-

high-quality antibacterial production, consist-

the strategy takes AMR into account or aims tofactures antibiotics is qualified as ZLD. It does

ent with international GMP standards. It reports

minimise the environmental impact of waste-

not publish: (1) the results of environmental

auditing its suppliers on quality standards aswaters and solid waste from antibacterial man-audits, whether conducted at its own site, thewell. There is limited information on how correc-

ufacturing at its own site, third-party suppli-

sites of suppliers or external private and public

tive actions are implemented and tracked. The

ers of antibacterials or external private andwaste-treatment plants; (2) a list of these sup-Benchmark found no requests for official cor-public waste-treatment plants. Sun Pharma does

pliers and plants; or (3) the limits and levels ofrective action from the FDA or EMA related toreport that its sole site that manufactures anti-

antibacterial discharge from its own or suppli-

non-conformities with cGMP at Sun Pharma’s

bacterials is ZLD implying that no liquid waste isers’ sites.

own sites or any subsidiaries that manufacture

discharged into the environment from this site. It

antibacterials.

also reports that any antibacterial residue fromZLD is sent for incineration.

* 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***Sun Pharma is not eligible for indicators: C.1.1,

low-income countries such as Chad, Nepal andtives. It mitigates against falsified and substand-C.1.3, C.2.1 and C.2.3. For more information, see

Syria. In 2020, Sun Pharma estimates to haveard medicines by reporting any suspicion ofAppendix VII.

provided access to its amoxicillin/clavulanic

counterfeit to the approriate regulatory author-

acid to 890,000 patients in 19 access countries,ities. It uses a ‘Track and Trace’ technology toincluding Cameroon, Myanmar, and Peru.

prevent the sale of counterfeit medicines andC.1.2 Filed to register off-patent/generic medicines in 8 access countries on average
Sun Pharma has an average performance, filingto ensure the authenticity of its products. Sun
C.3

all its 8 relevant off-patent/generic medicines

Some strategies to ensure continuous

Pharma has a dedicated task force in place tosupply

train filed forces to identify counterfeits.

for registration in 8 access countries on aver-Sun Pharma has an average performanceage. Its most widely filed relevant product is thewith strategies reported in three of four areas

antibiotic amoxicillin/clavulanic acid filed in 22

assessed. It reports complying with good man-access countries. Four of its relevant products

ufacturing practices when producing API andare filed for registration in at least one LIC.

drug products. Sun Pharma works towards product accessibility by ensuring regular supply of its

C.2.2 Some strategies to expand access toproducts and having a robust distribution net-

off-patent/generic medicines

work in India, where it supplied its medicines toSun Pharma has an average performance. It

more than 500,000 pharmacies in urban andreports providing access to its antibiotics andrural areas in 2020. Sun Pharma does not report

antifungals to 45 access countries, of which

capacity building and technology transfer initia-C

APPROPRIATE ACCESS & STEWARDSHIP – STEWARDSHIP

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

Comprehensive COI mitigation strategies

appropriate use of its antibacterial and/or anti-

C.7

in place for its educational programmes

fungal medicines as its marketing materials do

As a generic medicine manufacturer, Sun

Sun Pharma performs strongly in conflict of

not reflect emerging resistance trends or include

Pharma is not assessed in this indicator nor doesinterest (COI) mitigation for the five AMR-

treatment guidelines for healthcare profes-

it report any involvement in AMR surveillance

related educational programme for HCPs

sionals to raise awareness of AMR and address

activities.

assessed by the Benchmark. To mitigate COI

appropriate use.

AMR Surveillance

for all five programmes, it provides financial resources to independent third parties (DocMode, KOL International Academy,Mediquest and Mindsync) to develop theprogrammes.

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 amoxicil-C.5

Does not report sales or marketing prac-lin/clavulanic acid by patients. Sun Pharma per-tices that aim to address appropriate use

forms well in this measure, taking account of

Sun Pharma performs low in sales practices. It

language and adherence to treatment. It has cre-does not report whether it decouples incentives

ated a QR code which directs to information on

for sales agents from sales volumes to help pre-how to take the product appropriately translated

vent the inappropriate use of its antibacterial

in ten regional languages in India. It also adapts

and/or antifungal medicines.

packaging to include information on AMR andSun Pharma does not report to engage in

how to take the product appropriately.

marketing practices that aim to address the*** 102 low- and middle-income countries where better access to medicine ismost needed.

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