Notice2026-19419
Sanjay Kumar: Final Debarment Order
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 23, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Sanjay Kumar for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Kumar was convicted of a felony under Federal law for conspiracy to traffic in counterfeit goods. The factual basis supporting Mr. Kumar's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Kumar was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of June 29, 2026 (more than 30 days after receipt of the notice), Mr. Kumar had not responded. Mr. Kumar's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Full Text
<html>
<head>
<title>Federal Register, Volume 91 Issue 183 (Wednesday, September 23, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 183 (Wednesday, September 23, 2026)]
[Notices]
[Pages 60380-60382]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19419]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-4019]
Sanjay Kumar: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) debarring Sanjay Kumar for a period of 5 years from importing or
offering for import any drug into the United States. FDA bases this
order on a finding that Mr. Kumar was convicted of a felony under
Federal law for conspiracy to traffic in counterfeit goods. The factual
basis supporting Mr. Kumar's conviction, as described below, is conduct
relating to the importation into the United States of a drug or
controlled substance. Mr. Kumar was given notice of the proposed
debarment and was given an opportunity to request a hearing to show why
he should not be debarred. As of June 29, 2026 (more than 30 days after
receipt of the notice), Mr. Kumar had not responded. Mr. Kumar's
failure to respond and request a hearing constitutes a waiver of his
right to a hearing concerning this matter.
DATES: This order is applicable September 23, 2026.
ADDRESSES: Any application by Mr. Kumar for termination of debarment
under section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) may be
submitted at any time as follows
Electronic Submissions
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application does not include any confidential
information that you or a third party may not wish to be posted, such
as medical information, your or anyone else's Social Security number,
or confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your application,
that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All applications must include the Docket No. FDA-
2026-N-4019. Received applications will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit an application with
confidential information that you do not wish to be made publicly
available, submit your application only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of your application. The second copy,
which will have the claimed confidential information redacted/blacked
out, will be available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852 between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500. Publicly available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Field
Enforcement, Office of Field Regulatory Operations, Office of
Inspections and Investigations, Food and Drug Administration, 240-402-
8743, or <a href="/cdn-cgi/l/email-protection#2246474043504f474c5651624446430c4a4a510c454d54"><span class="__cf_email__" data-cfemail="96f2f3f4f7e4fbf3f8e2e5d6f0f2f7b8fefee5b8f1f9e0">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(D) of the FD&C Act permits debarment of an
individual from importing or offering for import any drug into the
United States if FDA finds, as required by section 306(b)(3)(C) of the
FD&C Act, that the individual has been convicted of a felony for
conduct relating to the importation into the United States of any drug
or controlled substance.
On March 5, 2026, Mr. Kumar was convicted as defined in section
306(l)(1) of the FD&C Act, in the U.S. District Court for the Southern
District of Texas, when the court accepted his plea of guilty and
entered judgment against him for the felony offense of conspiracy to
traffic in counterfeit goods in violation of 18 U.S.C. 2320(a)(4) and
(b)(3)(A).
[[Page 60381]]
The underlying facts supporting the conviction are as follows:
As contained in the Indictment and in the Plea Agreement from his
case, Mr. Kumar knowingly sold pharmaceutical products bearing
counterfeit marks which he caused to be imported into the United
States. Among the drugs illegally sold by Mr. Kumar was Keytruda, a
prescription drug used to treat cancer. However, the counterfeit
Keytruda he sold did not contain the active ingredient for Keytruda.
Merck Sharp & Dohme LLC, formerly known as Merck Sharp & Dohme Corp.
(``Merck''), had the exclusive right to authorize the manufacture of
Keytruda for distribution within the U.S. and owned the trademarks for
the designs and word marks used by Merck to identify Keytruda and other
Merck products.
Beginning in or around August 2018 until approximately on or about
June 26, 2024, Mr. Kumar, with the aid of co-conspirators,
intentionally conspired to, and did traffic Keytruda bearing
counterfeit marks into the United States. During the course of his
criminal conspiracy, Mr. Kumar and his co-conspirators negotiated
numerous sales of pharmaceuticals with counterfeit marks to both agents
of a private company working with law enforcement and agents from U.S.
Homeland Security Investigations, acting in an undercover capacity.
Over years, these agents texted with members of the conspiracy,
including Mr. Kumar, concerning the placement of orders, payments, and
shipments of pharmaceuticals to the United States. In addition to other
sales of Keytruda bearing counterfeit marks during this period, Mr.
Kumar, with the assistance of his co-conspirators, sold the following
quantities of Keytruda using counterfeit marks to agents: on January
30, 2020 he sold 1 x 50mg vial of Keytruda for $2,500; on March 28,
2023, he sold 2 x 100mg of Keytruda for $3,500; on May 8, 2023, he sold
2 x 100mg Keytruda for $5,998; and, on June 20, 2023, he sold 2 x 100mg
of Keytruda for $3,500. At Mr. Kumar's direction, the aforementioned
drugs were shipped by co-conspirators to Houston, Texas. The undercover
agents wired each payment to Indian-based bank accounts as directed by
Mr. Kumar and his co-conspirators.
Laboratory testing concluded that Mr. Kumar sold Keytruda bearing
counterfeit marks into the United States, and that these drugs violated
the trademarks registered to Merck in the principal registry in the
U.S. Patent and Trademark Office. The Keytruda bearing the counterfeit
marks was chemically inconsistent with genuine Keytruda and did not
contain the active ingredient necessary for the drug to serve its
medical purpose. Instead, the Keytruda bearing the counterfeit marks
sold by Mr. Kumar and his co-conspirators included fillers and
adulterants that served no legitimate function for treating cancer. The
packaging of the pharmaceuticals he sold purported to be Merck brand
Keytruda packaged in containers that bore trademarks that were
substantially indistinguishable from the genuine marks registered to
Merck and used to identify genuine Keytruda. Furthermore, the packages
bearing counterfeit marks often contained false lot numbers, invalid
expiry dates, and misspellings. Over the course of the conspiracy, Mr.
Kumar and his co-conspirators received approximately $89,268 for their
sales of Keytruda using counterfeit marks to undercover agents, with a
total wholesale acquisition cost value of approximately $127,465.72.
On June 26, 2024, Mr. Kumar met with undercover agents in a hotel
in Houston, Texas. He believed that these agents were future business
partners and purchasers. During part of the meeting, he also dialed in
a co-conspirator, whom he explained could provide the agents with
detailed information on the pharmaceuticals he was able to source.
During this meeting, Mr. Kumar expressed his intention to form a long-
term business partnership with the undercover agents, assuring the
agents that they would all profit. He explained that he had been in
this business for more than 10 years, and that, at a global level, his
pharmaceutical company, MediPharma, was shipping more than a hundred
pharmaceutical parcels per day. He explained that his previous company,
Reliable Chemist, was shut down after his employees and business
partners were arrested by Indian authorities after selling ``fake''
Keytruda. Mr. Kumar also made it clear that he understood the risks
posed by counterfeit pharmaceuticals and raised these with agents,
explaining that counterfeit Keytruda would not work to treat cancer and
was ``just like water.'' Despite these risks, he committed to sourcing
50 units (100-mg vial) of counterfeit Keytruda for the agents over the
next few days, while he remained in the United States, as a start to
their business relationship. Further, according to information provided
by Mr. Kumar and his co-conspirator, his company was presently capable
of sending 100 units of Keytruda (100-mg vial) a month, or weekly
batches of up to 20 units. During a discussion of the logistics for
selling hundreds of units of Keytruda into the United States, Mr. Kumar
detailed how his company was able to avoid possible issues with U.S.
and Indian customs.
FDA sent Mr. Kumar, by certified mail, on May 20, 2026, a notice
proposing to debar him for a 5-year period from importing or offering
for import any drug into the United States. The proposal was based on a
finding under section 306(b)(3)(C) of the FD&C Act that Mr. Kumar's
felony conviction under Federal law for conspiracy to traffic in
counterfeit goods in violation of 18 U.S.C. 2320(a)(4) and (b)(3)(A)
was for conduct relating to the importation of any drug or controlled
substance into the United States because Mr. Kumar illegally imported
and introduced misbranded and counterfeit prescription drug products
into interstate commerce.
In proposing a debarment period, FDA weighed the considerations set
forth in section 306(c)(3) of the FD&C Act that the Agency considered
applicable to Mr. Kumar's offense and concluded that the offense
warranted the imposition of a 5-year period of debarment. The proposal
informed Mr. Kumar of the proposed debarment and offered him an
opportunity to request a hearing, providing him 30 days from the date
of receipt of the letter in which to file the request, and advised him
that failure to request a hearing constituted a waiver of the
opportunity for a hearing and of any contentions concerning this
action. Mr. Kumar received the proposal and notice of opportunity for a
hearing on May 28, 2026. Mr. Kumar failed to request a hearing within
the timeframe prescribed by regulation and has, therefore, waived his
opportunity for a hearing and waived any contentions concerning his
debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Division of Field Enforcement Director, Office of
Inspections and Investigations, under section 306(b)(3)(C) of the FD&C
Act, under authority delegated to the Director, Division of
Enforcement, finds that Mr. Sanjay Kumar has been convicted of a felony
under Federal law for conduct relating to the importation into the
United States of any drug or controlled substance. FDA finds that the
offense should be accorded a debarment period of 5 years as provided by
section 306(c)(2)(A)(iii) of the FD&C Act.
As a result of the foregoing finding, Mr. Kumar is debarred for a
period of 5 years from importing or offering for import any drug into
the United States, effective (see DATES). Pursuant to section 301(cc)
of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for
[[Page 60382]]
import into the United States of any drug by, with the assistance of,
or at the direction of Mr. Kumar during his period of debarment is a
prohibited act.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-19419 Filed 9-22-26; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on September 23, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.