Skip to main content Skip to search Skip to main navigation

Operation Broadsword: US FDA and Indian Government combat illegal drugs

The US FDA, in cooperation with the Indian authorities, has seized 500 shipments of illegal and potentially dangerous unapproved prescription drugs and medical devices. The products were in transit to American consumers by international mail.

Operation Broadsword was conducted from January 28 to 30, 2020. In just two days, investigators from both governments examined more than 800 shipments, identifying approximately 500 different FDA-regulated products. These included drugs to treat and/or alleviate serious diseases such as various forms of cancer and HIV. Many of the shipments, which included opioid products, had been re-routed through third countries to conceal their point of origin and avoid detection.

Similar to the European operation PANGEA, a longer-term cooperation is planned between the USA and India. An exchange of "best practices" should help to better target criminal actors at both ends.


Source:

FDA: News Release

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

FDA: Draft Guidance on Responding to Form 483 Observations

FDA: Draft Guidance on Responding to Form 483 Observations

The US Food and Drug Administration (FDA) has issued a draft guidance on responding to Form FDA-483 observations following drug CGMP inspections. The document provides recommendations on how manufacturers should structure their responses and what information they should include.
Read more
Which Quality and Process Parameters must Typically be Taken into Account During Process Validation for Terminally Sterilized Products?

Which Quality and Process Parameters must Typically be Taken into Account During Process Validation for Terminally Sterilized Products?

Here's the answer:
Read more
Veterinary GMP 2026: The New Regulatory Framework

Veterinary GMP 2026: The New Regulatory Framework

Implementing Regulations (EU) 2025/2091 and 2025/2154 consolidate the GMP requirements for veterinary medicinal products into a distinct and legally binding framework for the first time. While establishing regulatory independence for the veterinary sector, they remain substantively aligned with the EU GMP Guide.
Read more
Team-NB: Opportunities and Concerns in the MDR/IVDR Revision

Team-NB: Opportunities and Concerns in the MDR/IVDR Revision

Team-NB, the European association of medical device Notified Bodies, sees the proposed MDR and IVDR revision as an opportunity to improve efficiency, transparency and predictability in conformity assessment.
Read more
EMA: GMP Documentation for the Sterilisation of an API

EMA: GMP Documentation for the Sterilisation of an API

The EMA Q&A on the quality of medicines has been updated with a new question: “What kind of GMP documentation is required for an API manufacturer performing sterilisation of an active substance?”

Read more
EMA: Updated Q&A on OOS Batches of ATMPs

EMA: Updated Q&A on OOS Batches of ATMPs

The EMA has revised its questions and answers on the use of out-of-specification (OOS) batches of authorised cell- and tissue-based ATMPs (“Questions and answers on the use of out-of-specification batches of authorised cell/tissue-based ATMPs”, Rev. 1, 2026).
Read more
Previous
Next