Pharmaceutical company Ipca Laboratories' Pithampur unit in Madhya Pradesh was inspected by the US Food and Drug Administration from June 15 to June 23, following which the US federal agency has issued eight observations to the firm.
US FDA observed that the pharma firm’s plant failed to review discrepancy in batch distribution and did not establish time limits for completion of production phase to assure quality.
Following the
nine-day inspection, the FDA noted that the suitability of testing methods was not verified under actual conditions of use at Ipca’s Pithampur unit. It also said that the equipment was not cleaned and maintained at appropriate intervals.
The US agency also issued an observation stating labs at the unit don’t have scientifically sound and appropriate test procedures and that procedures applicable to the quality control unit are not fully followed.
It added that clothing of personnel not appropriate for manufacturing, processing, and packing. The records of a drug product are not written and followed, it said.
Earlier in June, the firm’s Ratman plant was issued 11 observations by the US drug regulator. The plant has been under a USFDA import alert since 2015. An import alert means the products manufactured at the plant do not fit US standards and hence are barred from the US unless stated otherwise.
Besides the Ratlam plant, two more plants,
one at SEZ Indore and the other at Silvassa, manufacturing formulations, are also under import alert since 2015. The Silvassa facility was also inspected by the US drug regulator in April this year and issued 3 observations.
Plants are generally classified within 90 days of an inspection and the three classifications are either No Action Indicated, Voluntary Action Indicated and Official Action Indication. An OAI classification is indicative of possible regulatory issues.
The worst case analysts are assuming will mean a status quo on the import alerts. In that case analysts say India and other export markets would continue to be primary growth drivers as they have been since the regulatory issues began, CNBC-TV18 reported on June 18.
