Firm asked to stop output of eye drops linked to vision loss

New Delhi, Feb. 4: A day after its plant was inspected by Indian drug regulatory bodies over allegations that its eye drop was linked to vision loss in the US, Tamil Nadu-based Global Pharma Healthcare has been asked to stop manufacturing all ophthalmic products till the inquiry is completed, officials said on Saturday.

A three-member team each from the Central Drugs Standard Control Organisation (CDSCO) and the State Drug Controller visited the plant in Tamil Nadu's Kancheepuram, 40 km from Chennai, on Friday after the company recalled the eye drop.

The teams have also collected samples of eye drop — Artificial Tears — which were exported. It is not sold in India.

According to an official report, the joint investigation at the firm’s manufacturing site at Thiruporur in Tamil Nadu's Kancheepuram was conducted on February 3 by the team of senior central and state drugs officials, under the supervision of Tamil Nadu’s director of drugs control and CDSCO's assistant drugs controller (South Zone).

During investigation, it was found that, the firm has exported two consignments of 24 batches of Artificial Tears to the USA — B No: PCMI001 to PCM008 and B.No. PCMJ001 to PCMJ016 — which were manufactured in 2021 and 2022.

No stocks of the said batches were found during the investigation, the report said.

“The firm has maintained the control samples for the said batches. The samples were taken for an analysis from the 4 batches of control samples. The sample of raw material Carboxy Methyl Cellulose Sodium which was utilised for manufacturing of finished products was also taken for an analysis,” the joint investigation report said. —