Indian regulator places 5-year ban on Kivi Labs for forgery

SINGAPORE--India authorities placed a 5-year ban on Kivi Labs for submitting any filings with the Central Drugs Standards Control Organization after determining the company filed fictitious and forged documents for fixed-dosage combinations.

The Drugs Controller General of India ordered the action after Kivi failed to submit a "concrete/convincing" response to the latest round of queries between the two parties dating back to an inspection at the end of last May.

In a letter to Kivi, the DCGI said it had determined that a company consultant had fabricated all the documents he submitted to the CDSCO and had forged the signature of the firm's director, Jayesh Patel. The letter said Patel had admitted to the falsification.

Since it was clear that Kivi had submitted false data "in connivance with your consultant," the letter said, the company was "debarred for applying to any of the office of CDSCO for any purpose for a period of five years."

- here's the DCGI letter (PDF)