Cyberabad Police arrest two in $250-mn extortion bid targeting Hetero; co under FDA scanner

The Cyberabad Cyber Crime Police on Wednesday (November 19) arrested two individuals accused of running an extortion and cyber-intimidation racket targeting Hetero group of companies, even as the pharmaceutical firm remains under the scanner of the US drug regulator.

The arrests followed a complaint from a Hetero representative, who reported that in August, a senior employee received anonymous and pseudonymous emails demanding a ransom of $250 million.

According to the police, the sender claimed to possess “confidential” and “damaging” information on Hetero’s operations and regulatory compliance and threatened to send this information to the United States Food and Drug Administration (FDA). The accused asserted they could “manage” the FDA to trigger regulatory complications and reputational damage. Hetero told police the allegations were fabricated, malicious and intended to coerce the company.

Investigators said the accused created fake email identities, impersonated a US FDA official and circulated fabricated documents and screenshots. They also used Signal, a private messenger app, for communication and demanded $250 million for suppressing the allegations. Their actions created a serious regulatory risk for the company, with an actual FDA inspection later triggered by the fabricated claims.

Also Read: USFDA flags Hetero Labs’ Nakkapalli facility with six serious observations

The development comes weeks after the FDA issued back-to-back Form 483s to Hetero’s API Unit 9 and its warehouse in Visakhapatnam following inspections carried out between September 19 and 26, 2025. The warehouse inspection resulted in six observations, the first of which regulatory experts say could invite legal action. Inspectors noted that access to the warehouse storing APIs for the US market was not readily provided and that the facility itself had not been disclosed to the FDA.

Inspectors were prevented from examining a truck full of drums that left the warehouse without explanation, and another incoming truck was turned away by security after personnel indicated the presence of FDA inspectors. The Form 483 records that the assistant warehouse manager and assistant VP told investigators the site was meant only for domestic storage and that they were unaware of how drums from FDA-registered facilities were stored there — a statement that regulators say points to falsification and lack of oversight.

Other observations listed weak warehousing controls, poor documentation and absence of quality unit oversight. The earlier Form 483 issued to Hetero’s API Unit 9 also contained six observations across 14 pages, citing deficiencies in cleaning validation, inadequate documentation practices and poor equipment maintenance. Analysts noted that the compliance gaps at Hetero could benefit Aurobindo Pharma and Laurus Labs, which also operate in the antiretroviral (ARV) segment.

Also Read: US drug regulator cracks down on Hetero, Visakhapatnam warehouse under scanner

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