Shares of Panacea Biotec Ltd. hit the lower circuit after the U.S. drug regulator issued a warning letter to its unit in Baddi, Himachal Pradesh, barring fresh approvals.
The warning letter issued by the U.S. Food and Drug Administration, following an inspection from Feb. 10-20, 2020, summarises significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a statement on the website of the health regulator.
“Until you correct all violations completely and we confirm your compliance with CGMP (current good manufacturing practice), FDA may withhold approval of any new drug applications or supplements listing your firm as a drug manufacturer,” it said in the statement.
The National Stock Exchange of India has sought a response from Panacea Biotec, which is awaited. BloombergQuint too emailed queries but the company didn't respond immediately.
Some of the violations highlighted by the U.S. FDA:
Observation: The firm failed 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 material, labeling and drug products conform to appropriate standards of identity, strength, quality and purity.
What Is Asked: The U.S. FDA has sought a comprehensive, independent assessment of the company's laboratory practices, procedures, methods, equipment and analyst competencies, as a response to this observation. It also asked the drugmaker to review all laboratory test methods to ensure that they are well-defined in order to enable reproducibility and remediate any identified gaps.
Observation: Panacea Biotec has failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
What Is Asked: The regulator has sought remediate facility monitoring systems that will simultaneously and rapidly detect atypical changes of pressure in one or more cleanrooms. It has also called for a detailed description of how the company will ensure uninterrupted power supply for all the heating, ventilation, and air conditioning systems supporting each cleanroom.
The U.S. FDA has asked the company to respond to the letter within 15 working days with steps taken to correct the violations and prevent their recurrence.
Shares of Panacea Biotec fell for the second straight day to hit the 5% lower circuit, compared with a 0.17% gain in the Nifty 50 Index.
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