The Pharmaceutical Security Institute (psi)

What The Pharmaceutical Security Institute (psi) does

The Pharmaceutical Security Institute (PSI) is a not-for-profit, membership-based organization founded in 2002 by Security Directors of fourteen major pharmaceutical companies in Washington, D.C., now headquartered in Alexandria, Virginia. PSI's core mission is to protect public health by collecting and sharing information on pharmaceutical counterfeiting, theft, and illegal diversion, and by initiating enforcement actions through appropriate authorities. The organization operates a proprietary Counterfeiting Incident System (CIS) that has continuously recorded pharmaceutical crime incidents for 23 years, drawing on open media reports, member company submissions, and public-private sector partnerships. In CY 2024 alone, the CIS documented 6,424 incidents across 136 countries, involving 2,248 different medicines and 3,658 arrests.

PSI's membership is limited to major international pharmaceutical manufacturers — currently over 40 organizations — and the organization is funded through membership dues rather than venture or equity capital. The organization distributes intelligence to members and, through its collaboration with the Partnership for Safe Medicines (PSM), to consumers via tools such as the SafeMeds Alert System, SAFEDRUG Checklist, and a YouTube channel. Beyond its Alexandria headquarters, PSI maintains representational offices with staff in Singapore (Asia Pacific) and Dublin, Ireland (Europe), enabling regional engagement with members, regulators, and law enforcement. The organization has no disclosed revenue figures, no disclosed headcount, and operates a public Report Medicines portal as an additional data ingestion channel for consumers, customs officials, drug inspectors, and police officers.

Name

The Pharmaceutical Security Institute (psi)

Legal name

Pharmaceutical Security Institute

Website

https://psi-inc.org

Company type

Private

Founded year

2002

Operating status

Operating

Headcount range

1–10 employees

Short description

The Pharmaceutical Security Institute (PSI) is a not-for-profit membership organization founded in 2002 that operates the Counterfeiting Incident System (CIS) to track pharmaceutical counterfeiting, theft, and illegal diversion across 136 countries for its over 40 major international pharmaceutical manufacturer members.

Ownership category

akta.pro rank

Product category

Pharmaceutical Crime Intelligence

NAICS

Security Guards and Patrol Services (561612)

SIC

Services-Detective, Guard & Armored Car Services (7381)

akta.pro primary industry

Safety Database Operations & Hosting (Argus/ARISg/Oracle) (HLAGALAB)

Keywords

• Pharmaceutical crime intelligence
• Counterfeit drug monitoring
• Pharmaceutical security analytics
• Anti-counterfeiting data
• Drug diversion tracking

Headquarters

HQ city

Alexandria

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Others

Distribution channels2 records

Marketing channels4 records

Core offering

PSI operates a membership-based pharmaceutical crime intelligence platform centered on its proprietary Counterfeiting Incident System (CIS), which collects, tracks, and analyzes incidents of pharmaceutical counterfeiting, theft, and illegal diversion worldwide. The organization aggregates data from open media reports, member company submissions, and public-private partnerships, then shares intelligence with member pharmaceutical manufacturers and coordinates international enforcement actions with regulatory and law enforcement agencies.

Product overview

The Pharmaceutical Security Institute (PSI) is a not-for-profit membership organization that operates primarily as a pharmaceutical crime data collection and analysis entity rather than a product company in the traditional sense. Its core offering is the Counterfeiting Incident System (CIS), which tracks pharmaceutical crime incidents globally. PSI does not offer commercial software products but provides information sharing, enforcement coordination, and consumer reporting tools to its member pharmaceutical manufacturers and the general public.

Differentiator

Problem solved

Functional benefit

Products and services

• Counterfeiting Incident System (CIS) A proprietary data collection and tracking system that records incidents of counterfeiting, theft, and illegal diversion of pharmaceutical products worldwide, aggregating inputs from open media reports, PSI member company submissions, and public-private sector partnerships. Used by PSI's member pharmaceutical manufacturers and law enforcement agencies for intelligence sharing and coordinated enforcement.
• Report Medicines Portal A public reporting portal on the PSI website that allows consumers, drug inspectors, customs officials, police officers, and the general public to report counterfeit pharmaceuticals. Reports feed into the CIS database.

Quantifiable outcome

• 6,424 pharmaceutical crime incidents documented in CY 2024
• +3 more outcomes

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

One partnership is on record.

• Partnership for Safe Medicines (PSM)coreGTM or Marketing PartnerPSI collaborates with the Partnership for Safe Medicines (PSM) to share quality information on counterfeit medicines with the public. PSM provides an impressive suite of online tools recommended to consumers including the SafeMeds Alert System and SAFEDRUG Checklist.

Scale indicators6 records

Recent moves8 records

Expansion highlights4 records

Broad incumbents

• INTERPOL: INTERPOL coordinates international law enforcement action, including operations against pharmaceutical crime (e.g., Operation Pangea targeting illicit online pharmacies). PSI coordinates with law enforcement bodies including INTERPOL counterparts to drive arrests.
• World Health Organization (WHO): WHO runs the Global Surveillance and Monitoring System for substandard and falsified medical products, which parallels PSI's CIS database at a public-sector level with a broader healthcare scope beyond pharmaceuticals.
• European Medicines Agency (EMA): EMA regulates human and veterinary medicines in the EU and coordinates member-state responses to falsified medicines, including via the EU Falsified Medicines Directive—operating as a regulator that PSI members report incidents to.
• National Association of Boards of Pharmacy (NABP): NABP operates pharmacy accreditation and verification programs (including e-Profile) used to protect the US drug supply from counterfeit and substandard medicines, operating in an adjacent regulatory space to PSI's intelligence mission.
• Pharmaceutical Research and Manufacturers of America (PhRMA): PhRMA is the broad US pharma industry trade association representing major manufacturers. PSI's membership overlaps significantly with PhRMA's constituency, and both advocate on industry safety and integrity issues.
• U.S. Food and Drug Administration (FDA): The FDA is the primary US regulator whose counterfeit drug alerts are relayed to consumers via PSI's SafeMeds Alert System. FDA is a key counterpart in PSI's enforcement coordination chain.

Direct peers

• Rx-360: Rx-360 is an international pharmaceutical supply chain consortium that shares audit and quality information among member manufacturers and suppliers. Like PSI, it is a membership-driven organization focused on pharmaceutical supply chain integrity.
• Partnership for Safe Medicines (PSM): PSM is PSI's primary public-facing partner and the most directly comparable organization, focused on educating the public and policymakers about counterfeit medicines. It amplifies PSI's intelligence to consumers via tools like the SafeMeds Alert System and SAFEDRUG Checklist.

Emerging players

• Solvay Pharma / Antares Pharma (serialization vendors example): Commercial serialization, track-and-trace, and supply-chain-security vendors (represented here by Antares as an example) increasingly offer pharmaceutical manufacturers real-time supply chain visibility—an alternative or complement to PSI's incident-based intelligence model.
• Center for Safe Internet Pharmacies (CSIP): CSIP is a coalition focused on combating illegal online pharmacies, operating in an adjacent threat space to PSI's counterfeit drug mandate with a narrower (online) scope.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights5 records

Customer concentration

• YouTubeyoutube.com/channel/UCYvbief_-cNMsE-jYEZBOuQ
• LinkedInlinkedin.com/company/the-pharmaceutical-security-institute-psi

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about The Pharmaceutical Security Institute (psi)