The central government has formed a team of six officers and inspectors to raid the units of Chennai-based pharmaceutical company Global Pharma Healthcare, News18.com has learnt.
The pharma company is voluntarily recalling all lots of its artificial tears drops allegedly linked to causing a death in the United States due to possible contamination.
Moreover, the company has suspended the production of a line of eye drops from the United States market after the US Centers for Disease Control and Prevention (CDC) announced that the product could be contaminated with a drug-resistant bacteria linked to reports of permanent vision loss as well.
According to government sources, the teams from the apex health agency, Central Drugs Standard Control Organisation, and officials from the state drug controllers’ office have already been sent to the plant for further investigations and sample pickups.
“Three persons each from CDSCO and state drug controller are on their way to the plant located about 40 km south of Chennai,” said a source. “This pharma company is a contract manufacturing plant supplying through others to the US market. This specific drug is not sold in India.”
Meanwhile, the American health agency is testing unopened bottles of EzriCare Artificial Tears eye drops, manufactured by the Indian firm, while the US Food and Drug Administration (FDA) said it has moved to restrict imports of products made by the company.
The company, Global Pharma Healthcare, had earlier issued a statement quoted by NDTV, saying the company “is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by EzriCare, LLC- and Delsam Pharma, to the consumer level, due to possible contamination”.
Read all the Latest India News here
Comments
0 comment