THD NewsDesk, NEW DELHI: On September 30, Indian drug firm Panacea Biotec informed that it had received a warning letter from the USFDA. Panacea Biotec is a biotechnology company doing research and development, manufacturing and marketing of pharmaceuticals, vaccines and biosimilars.
The warning was issued by the US Food and Drugs Administration post the inspection of its pharmaceutical formulation facility at Baddi, Himachal Pradesh. The Baddi facility is a part of the company’s unlisted subsidiary Panacea Biotec Pharma Ltd (PBPL).
“The company/ PBPL has taken multiple steps after the inspection of the facility conducted during February 10 to 20, 2020 to address the observations received from USFDA during the inspection,” the company said in a statement.
“We are committed to patient safety, quality and take all quality and compliance matters seriously and stand by our commitment to fully comply with the cGMP quality standards,” it added.
There are no foreseeable consequences that may materially affect the sales of the company/PBPL in the US. In all likelihood, the prevailing product supplies from the Baddi facility will continue as before. However, there is a possibility of approvals of new drug applications would be withheld until PBPL addresses all concerns raised by the USFDA.
Panacea Managing Director Rajesh Jain was informed of specific violations of USFDA norms at the pharmaceutical formulation facility. Moreover, it noted the failure by the firm “to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labelling, and drug products conform to appropriate standards of identity, strength, quality, and purity”.
The health regulator also observed the absence of an adequate system for supervising the environmental conditions in the aseptic processing areas.
The company has affirmed that it will take all the measures recommended by the USFDA in due time and will step up the facility in compliance with the norms. In the meantime, Panacea Biotec/PBPL is planning to respond through a comprehensive report as asked by the agency.
Further, shares of Panacea Biotec also saw a dip of 5% closing at Rs. 184.45 per scrip on Bombay Stock Exchange.