Global Healthcare Private Limited, the Chennai-based manufacturer of a brand of over-the-counter eyedrops associated with many cases of vision loss and one death in the United States, has been asked to halt the production of the product, Union health ministry sources said on February 4.
“The company was instructed to stop the manufacturing activities of all the products under the category of ophthalmic preparation till the completion of an investigation,” a top health ministry official told Moneycontrol.
The ministry official said the joint investigation by a team of senior drugs inspectors from the state and central government was conducted at the manufacturing facility of Global Healthcare on February 3.
During the investigation, it was found that the Chennai-based firm had exported two consignments of 24 batches of artificial tears to the US. These batches were manufactured in 2021 and 2022.
“There were no stocks of the above batches found. The firm has maintained the control samples for the said batches. The samples were taken for analysis from the four batches of control samples,” the joint inspection report, seen by Moneycontrol, stated.
The eye drops, which have been blamed for vision loss in the United States, are not sold in India, another official said.
Samples collected for analysis
The joint team of drug regulators has collected the sample of raw material Carboxy Methyl Cellulose Sodium, which was used for manufacturing eyedrops, for analysis.
According to the report, the firm didn’t carry out a complete root cause analysis regarding adverse events, including permanent vision loss and one death from a bloodstream infection in the US, stating that it was under process.
The officials after verification of records noticed that the firm had done stability studies for the representative batch of the eye drops once a year.
“The batch manufacturing records of all batches, purchase invoices of raw materials, COA of raw materials, sales bills copies, media fill validation reports were obtained under section 22(1)(cca) of Drugs and Cosmetics Act 1940 and Drugs Rules 1945 for further investigation,” the joint investigation report said.
Voluntary recall after CDC red flag
Global Pharma Healthcare on February 1 said it was voluntarily recalling all lots within expiry of artificial tears lubricant eye drops, distributed by EzriCare, LLC and Delsam Pharma, to the consumers level, due to possible contamination.
The notification from the company came after the Centers for Disease Control and Prevention (CDC) alerted US FDA for infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare.
There are 55 reports of adverse events including eye infections, permanent loss of vision, and one death due to a bloodstream infection.
“Global Pharma Healthcare is notifying the distributors of this product, Aru Pharma Inc. and Delsam Pharma and is requesting that wholesalers, retailers and customers who have the recalled product should stop use,” the company said in a statement.