The Securities and Exchange Board of India (SEBI) has issued a warning letter to Aurobindo Pharma for disclosing “very limited and restricted information” to the stock exchanges about an USFDA audit of the company’s active pharmaceutical ingredients manufacturing facility (API) in Hyderabad.
“The only fact disclosed was that a warning letter was received from U.S. FDA. The company did not disclose details on the reason and the non-compliance/aberration observed,” the June 24 letter of SEBI said, holding that the disclosure is not in line with principles governing disclosures and obligations of listed entities.
Pointing out that emphasis of the regulation is on adequate and timely disclosure of material information to recognised stock exchanges, SEBI said it viewed the non-compliance seriously. “You are hereby warned and advised to ensure compliance with all applicable provisions of SEBI Regulations. Any such aberration in future would be viewed seriously and appropriate action would be initiated,” the regulator said in the letter to Aurobindo Pharma.
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Intimating on Monday the stock exchange of the warning letter, the drugmaker said the SEBI communication pertains to certain disclosures made on the ongoing USFDA audit of company’s Unit-1 and observations made by the USFDA between 2019 to 2022. “The SEBI warning letter observes that the company had disclosed very limited and restricted information... also did not consider the observations of USFDA as serious,” Aurobindo said.
SEBI said the company submission on not considering the warning as serious is not tenable. “While the warning letter is available on the USFDA website, the company choose to make limited disclosure. Mere disclosure of the receipt of the USFDA warning letter is insufficient and an impediment to assess the current status,” it said.
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