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. The eye drop 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 utilized for manufacturing of finished products was also taken for an analysis," the joint investigation report said Also, 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.
Further, it is observed that, the firm has not carried out the complete root cause analysis in respect of the above complaint and stated that it was under process, the report said.
On the verification of records, it is noticed that, the firm has done the stability studies -- which helps understand how the quality of a drug product varies with time and environmental factors -- for the representative batch of the said drugs yearly once, the report said.
It said the manufacturing records of all batches, purchase invoices of raw materials, COA (certificate of analysis) of raw materials, sales bills copies and 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 manufacturer was instructed to stop the manufacturing activities of all the products under the category of ophthalmic preparation till the completion of investigation," the report stated. The US Food and Drug Administration earlier said in a statement that the Chennai-based company is recalling all lots of Artificial Tears lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma to the consumer level due to possible contamination.
To date, 55 reports of adverse events including eye infections, permanent loss of vision and a death with a bloodstream infection, it added. The USFDA noted that the "use of contaminated Artificial Tears can result in the risk of eye infections that could result in blindness".
Artificial Tears lubricant eye drops are used as a protectant against irritation or to relieve dryness of the eye.
In a statement posted on its website, Global Pharma Healthcare had said it 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 using it.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter drug products, it had said.
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