'Artificial Tears' case: Tamil Nadu-based firm told to suspend making eye-drops
Samples of the eye drop named 'Artificial Tears', which were exported abroad and not sold in India, have been collected by a three-member team from the Central Drugs Standard Control Organisation (CDSCO) and the State Drug Controller
FollowTamil Nadu-based Global Pharma Healthcare, which is in the eye of a storm, has been told to stop manufacturing all ophthalmic products till the inquiry into allegations its eye drop was linked to multiple cases of vision loss in the United States.
The directive to the company came a day after its plant in Tamil Nadu's Kancheepuram was inspected by a three-member team each from the Central Drugs Standard Control Organisation (CDSCO) and the State Drug Controller on Friday.
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The team collected samples of the eye drop named 'Artificial Tears', which were exported abroad. To note, the eye drop is not sold in India.
An official report said a 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), conducted the joint investigation at the firm's manufacturing site at Thiruporur, 40 km from Chennai.Â
Two consignments of 24 batches of 'Artificial Tears' manufactured in 2021 and 2022 were exported by the firm to the United States -- B No: PCMI001 to PCM008 and B.No. PCMJ001 to PCMJ016. The report said that no stocks of the said batches were found during the investigation.
"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 sample of raw material Carboxy Methyl Cellulose Sodium, which was used to manufacture the finished products, was also taken for 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.Â
Based on the records, the team noticed that for the representative batch of the said drugs, the firm had done stability studies, which help understand how the quality of a drug product varies with time and environmental factors, once annually.
The team obtained the manufacturing records of all batches, COA (certificate of analysis) of raw materials, purchase invoices of raw materials, sales bills copies, and media fill validation reports under section 22(1)(CCA) of Drugs and Cosmetics Act 1940 and Drugs Rules 1945 for further probe.
"The manufacturer was instructed to stop the manufacturing activities of all the products under the category of ophthalmic preparation till the completion of the investigation," the report stated.Â
The US Food and Drug Administration earlier said in a statement that the Chennai-based company recalls all lots of Artificial Tears lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma to the consumer level due to possible contamination.
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To date, it added 55 reports of adverse events, including eye infections, permanent loss of vision and death with a bloodstream infection.  Â
The USFDA noted that the "use of contaminated Artificial Tears can result in the risk of eye infections that could result in blindness". Â 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 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 related to using these over-the-counter drug products, it said.Â
