Dr Reddy’s fined by Mexican health regulator for compliance violation
COFEPRIS imposes penalty on Indian pharmaceutical company for deviation in import filing guidelines
Dr Reddy’s Laboratories has been fined by the Mexican health authority, Comisión Federal para la Protección Contra Riesgos Sanitarios (COFEPRIS), for failing to comply with import guidelines. The penalty amounts to MXN 651,420 (approximately INR 28 lakh).
According to a notice received on 25th September 2024, the violation relates to the company’s late filing of an import reference standard for one of its active pharmaceutical ingredients (API). The company submitted the necessary intimation upon the arrival of the reference standard in Mexico, whereas regulations mandate filing three days in advance.
COFEPRIS issued the order on 23rd September 2024. Dr Reddy’s acknowledged the receipt of this order and reported the incident under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
The financial impact of the fine has been quantified at MXN 651,420, with no further details on operational implications provided at this time.
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