NEW DELHI: The pharmaceutical firm Global Pharma Healthcare has been asked to stop the production of eye drops said to be linked with infecting 55 people and the death of one person in the United States, official sources said on Saturday.
It was asked to stop the manufacturing of all its ophthalmic preparations till the completion of a probe.
A team of Central Drugs Standard Control Organisation and the State Drug Controller visited the plant in Tamil Nadu’s Kancheepuram on Friday and collected samples of the eye drop – Artificial Tears – which were exported to the US.
After the US Food and Drug Administration asked the company to recall its eye drops sold under the brand names EzriCare or Delsam Pharma, Global Pharma said it has voluntarily recalled them. The eye drops are not sold in India.
The firm had exported two consignments of 24 batches of Artificial Tears manufactured in 2021 and 2022 to the US. No stocks of these batches were found during the investigation, the report said. The firm has stated that the media fill validation — a part of the validation of an aseptic manufacturing process — was carried out biannually. The records were verified for the same, according to the report.
The FDA on Thursday cited violations of manufacturing regulations, including a lack of appropriate microbial testing and proper controls concerning tamper-evident packaging.