USFDA audit: SEBI warns Aurobindo Pharma on non-compliance with disclosure norms

Naga Sridhar G 2346 | Updated on: Jun 27, 2022

FILE PHOTO: The logo of the Securities and Exchange Board of India (SEBI) is pictured on the premises of its headquarters in Mumbai, India, March 1, 2017. REUTERS/Shailesh Andrade/File Photo | Photo Credit: SHAILESH ANDRADE

Warning letters of the USFDA were not taken ‘seriously’ by the drug maker, says SEBI

Hyderabad, June 27

The Securities Exchange Board of India (SEBI) has warned Aurobindo Pharma Ltd (APL) on non-compliance with listing obligations and disclosure requirements pertaining to an audit by the US Food and Drug Administration (USFDA).

“We have received a warning letter from the Securities Exchange Board of India (on June 24, 2022), a copy of which is enclosed. The letter is in regards to certain disclosures made by the company on the ongoing USFDA audit of company’s unit-1 and observations made by the USFDA between the period 2019 to 2022,’‘ Aurobindo informed the stock exchanges on Monday. 

“The SEBI’s warning letter observes that the company had disclosed very limited and restricted information and that the company did not disclose the detailed reasons and also did not consider the observations of USFDA as serious,’‘ it added.

Need to ensure compliance

SEBI had advised the Hyderabad-based company to ensure compliance with all applicable provisions of SEBI regulations and to place the warning letter before its board of directors in the ensuing board meeting.  Aurobindo Pharma had made an announcement on November 10, 2021 that USFDA classified the inspection conducted by USFDA inspection team, at its Unit I between August 02 to August 12, 2021 as Official Action Indicated (OAI).

The company further said that the classification will not affect the continuing commercial supplies to the US market from the facility. Subsequently, on January 14, 2022, APL disclosed that with regard to OAI classification of Unit I, the company had received a warning letter from the USFDA for the same unit. 

“From the disclosures made by the company, it was observed that the company had disclosed very limited and restricted information. The only fact disclosed was that a warning letter was received from USFDA. The company did not disclose the details on the reason and the noncompliance/aberration observed for which the warning was issued,’‘ SEBI said in its warning letter to the company. 

Stating that the warning letters of the USFDA were not taken ‘seriously’ by the drug maker, SEBI said: “APL’s submission on not considering the warning as serious is not tenable. While the warning letter is available on the USFDA website, the company chose to make limited disclosure. Mere disclosure of the receipt of the USFDA warning letter is insufficient and an impediment to assess the current status.’‘

Published on June 27, 2022
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