Published Feb 04, 2023 | 11:17 AM ⚊ Updated Feb 04, 2023 | 6:22 PM
The US CDC and FDA have warned against use of eye drops manufactured by TN firm Global Pharma. Representational image. (iStock)
The Tamil Nadu State Drug Controller and the Central Drugs Standard Control Organistation (CDSCO) have completed their probe into Chennai-based Global Pharma Private Healthcare Ltd after the US Centers for Disease Control and Prevention (CDC) advised an immediate halt in the use of its eye drops, marketed as EzriCare Artificial Tears in the US.
The company has been asked to immediately stop manufacture of all its ophthalmic products till the inquiry is completed, officials said on Saturday.
Confirming this to South First, PV Vijayalakshmi, director in the Tamil Nadu Drug Control Department, said: “The probe has been completed and the report is being prepared. More details will be shared once the report is submitted to the central ministry.”
South First has learnt that the report has since been sent to the Centre.
After the CDC advice, the US regulator Food and Drug Administration (FDA) too warned people not to “purchase or use EzriCare Artificial Tears due to potential contamination”.
On Friday afternoon, a team from CDSCO and the TN State Drug Controller, comprising three officers, went to the manufacturing plant of Global Pharma, located some 45 km from Chennai in Tirupurur.
Vijayalakshmi told South First that the probe team reached the Global Pharma unit at around 7 pm on Friday night. The inspection was carried out by the director of the TN State Drug Controller and her team until 2 am.
“We have drawn samples for testing from all the control samples maintained by the manufacturer. We have also taken samples from the raw materials used by the manufacturer. Till the results of these come we have stopped preparation operations,” she explained.
Meanwhile, the investigation is underway to know if the bacterial infections in the people of US is due to the contamination of these Indian manufactured drug sold in the US. Also, the US has not given a final report on the control samples that have been sent for testing.
Sources in the TN State Drug Controller confirmed that the company is a contract manufacturing plant that supplies other companies in the US market.
Recently, there were complaints of severe bacterial infection from several US states after the use of the eye drops — marketed in the country as EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears.
One person has reportedly died, five others are said to have suffered permanent vision loss, and 55 were hospitalised with eye infections, with the CDC suspecting this could be linked to eye drops.
While the infections have not yet been definitely traced to the eyedrops, CDC and FDA are investigating the matter.
The bacterial strain responsible, Pseudomonas aeruginosa, is said to be commonly found in water and soil. It is a kind of infection that usually occurs in hospital settings to those with weak immune systems, and is resistant to standard antibiotics.
Global Pharma Healthcare, the maker of the eye drop, immediately initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artifcial Tears and Delsam Pharma’s Artificial Tears.
The FDA, in it’s statement on Friday, said that it recommended the recall due to the company’s current good manufacturing practice (CGMP) violations, that include lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative) and lack of proper controls concerning tamper-evident packaging.
FDA also placed Global Pharma Healthcare on an import alert for providing an inadequate response to a records request, and for not complying with import requirements.
This alert prevents these products from entering the US.
Meanwhile, sources in the TN Drug Controller and ophthalmologists South First spoke to earlier had confirmed that this eye drop is not sold in India and is not prescribed by doctors here.
Speaking to South First renowned ophthalmologist and chairman, Narayana Netralaya, Dr Bhujang Shetty from Bengaluru said, “This drug is not sold in India. We do not prescribe this at our hospital.”
It may be noted that recently India-made cough syrups had come under scrutiny after several children died in Gambia and Uzbekistan, reportedly after consuming the syrups.
