FDA locks down import from 3 Indian IPCA facilities
pharmafile | June 21, 2017 | News story | Manufacturing and Production, Research and Development | FDA, India, Ipca
More drama in the Indian pharma sector as the FDA announces it has enforced a ban on the import of drug products manufactured at three sites owned by IPCA Laboratories, preventing them from entering the US.
The reasons given for the decision echo a string of other incidents in the country whereby other Indian firms failed to comply with good practice standards set by the FDA. In this case, the IPCA has caused concern over its supposed manipulation of records, with the FDA accusing the firm of deleting failed test data and replacing it with positive, falsified accounts.
The ban affects three sites owned by the Indian firm: its API facility in Ratlam and two formulations plants in Piparia, Silvassa and Pthampur, Madhya Pradesh. All three have been included on the FDA’s import alert list since 2015 after they failed to pass inspection the previous year. The ban will remain in place until IPCA brings its product quality to meet the standards expected by the FDA.
However, despite the ban, the FDA has made one exception for a single API manufactured at the IPCA’s Ratlam facility: the ingredient chloroquinine phosphate, which is a key component of malaria treatments. This decision is due to current medical need, and may be reconsidered if this situation changes.
IPCA has said it has engaged with consultants to resolve the FDA’s concerns.
Matt Fellows
Related Content
FDA approves ImmunityBio’s Anktiva bladder cancer treatment
ImmunityBio has announced that the US Food and Drug Administration (FDA) has approved Anktiva (N-803, …
Roche’s Alecensa approved by FDA as lung cancer treatment
Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) …
GSK’s meningococcal vaccine candidate accepted for FDA review
GSK has announced that the US Food and Drug Administration (FDA) has accepted for review …