Tamil Nadu firm told to suspend eye drops’ manufacturing

The manufacturers were directed to “stop the manufacturing activities of all the products under the category of ophthalmic preparations till the completion of investigation”, the report added.

India’s drugs regulator on Saturday suspended the manufacturing of all eye care products at Chennai-based pharmaceuticals company Global Pharma Healthcare, days after the US Food and Drugs Administration (FDA) linked the death of at least one person and infections in as many as 55 people to the Indian company’s product.

Tamil Nadu’s Drug Controller and members from the CDSCO carried out an inspection of the Chennai-based Global Pharma Healthcare from 7pm on Friday to 2am on Saturday. (ANI)

The decision was taken after a joint inspection with state authorities that was carried out late on Friday, according to a preliminary report submitted by the Central Drugs Standard Control Organisation (CDSCO) said.

The manufacturers were directed to “stop the manufacturing activities of all the products under the category of ophthalmic preparations till the completion of investigation”, the report added.

The inspection was conducted by Tamil Nadu’s Drug Controller and members from the CDSCO from 7pm on Friday night, and it went on till 2am on Saturday.

The US Centers for Disease Control and Prevention (CDC) earlier in the week sent a health alert to doctors, advising people not to purchase or use EzriCare Artificial Tears, which is manufactured by Global Pharma Healthcare Pvt Ltd.

The trigger was infections of a drug-resistant baceteria, which also caused permanent vision loss to several of the people.

Responding to the FDA warning, Global Pharma Healthcare on Friday said 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”

On Saturday, Dr P V Vijayalakshmi, the drug controller of Tamil Nadu said that they have drawn samples from the batch sent to the US and related documents.

Samples of raw materials used to make the eye drops have also been collected and these sample have been sent to two labs in Tamil Nadu, including the Kings Institute in Chennai.

“We have issued orders for them to stop manufacturing until the investigation is complete,” said Dr Vijayalakshmi. “We have also submitted a preliminary report to the central government.”

The drug controller added that the pharma company is licensed and had followed all proper channels for the export of the products.

HT reached out to the representatives of Global Pharma Healthcare on Saturday, but they refused to comment till “all inquiries are completed”.

In the joint investigation report released by the CDSCO on Saturday, the regulator said that during the inspection it was found that the company had exported the two consignments of 24 batches of artificial tears to US, which were manufactured in 2021 and 2022.

“During investigation, 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 samples of raw material Carboxy Methyl Cellulose Sodium, which was utilised for manufacturing of the above finished products was also taken for analysis,” the report released on Saturday said.

The CDC said it is also testing unopened bottles of EzriCare Artificial Tears eye drops.

“FDA is warning consumers and health care practitioners not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. Using contaminated artificial tears increases risk of eye infections that could result in blindness or death,” FDA said in a statement issued on Thursday.

The FDA also pointed out multiple violations by the company, including lack of appropriate microbial testing and proper controls concerning tamper-evident packaging.