After US FDA's Alarm, TN Drug Controller Says No Contamination Found in Exported Eye Drops

The Tamil Nadu state drugs controller said all products exported to the US and their raw materials are of standard quality, as per their lab report. The US FDA had pointed out 11 deficiencies related to non-sterility and quality control at the plant.

New Delhi: On February 1, 2023, US’s Centers for Disease Control and Prevention issued a product alert against eye drops manufactured by an Indian firm, claiming they were contaminated with a highly contagious drug-resistant bacteria. However, the investigation carried out by the Tamil Nadu government now claims to have found no such contamination at all in the products exported to the US.

This is at least the second such case where an international agency has found contamination in Indian drugs and the Indian authorities have refuted the claim. Last year, the WHO had declared four cough syrups made by Maiden Pharmaceuticals, a Haryana-based firm, were contaminated with Diethylene glycol (DEG) by up to 21% – an extremely high proportion. The syrups were linked to the deaths of 70 children. However, when the Indian government tested the control samples of the same batch, which was exported to the US, they found no such contamination.

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Talking to The Wire, Tamil Nadu’s state drug controller P.V. Vijayalakshmi on February 6 said, “Everything has been declared as standard quality, even the raw material used in the manufacture of the eye drops as well as finished products of eye drops which were exported to the US.” She added, “No contamination was found.” The plant of Global Pharma, whose eye drops ‘Artificial Tears’ are in question, is located in the state of Tamil Nadu.

Asked to react to the US Food and Drug Administration’s detailed report on the eye drops, which was  made public last Friday, and the claim that the plant where the eye drops were being manufactured was not sterile enough, the drug controller said, “We cannot compare our investigation with theirs. We are yet to receive any official report from the US [authorities].”

The US FDA inspectors visited the plant in February 2023 and found a number of deficiencies as far as sterility processes were concerned. One of the observations made in the report says, “Aseptic processing areas [where the products are filled in containers] were found deficient regarding the system for cleaning and disinfecting the room to produce aseptic [bacteria-free] solutions.” The US FDA made 11 such observations

Asked to react to this, she said the plant was inspected by the Indian authorities as soon as the news of CDC’s alert was made public in February this year. Talking to The Wire at that time, she had said, “​​While doing the physical inspection of the plant, the  [Indian] inspectors could not find anything which could have given a clue to the possible contamination – no physical lacuna [at the plant indicating any sterility deficiency] was found.”

The Indian authorities carried out their inspection of the plant between February 3-4 while the US FDA inspectors visited between February 20 and March 2, 2023.

The drug batches for which investigation was carried out by the US FDA were manufactured between December 2020 and April 2022 and exported to the US later.

The Tamil Nadu state drug controller added that no bacteria contamination has been found in the analytical reports received from the lab but “our investigation still continues”. She said neither the lab report nor any other detail could be made public at this point.

The bacteria here in question is Pseudomonas aeruginosa. It is usually found in healthcare settings like ICUs. However, none of the adverse events in this case was reported from any such settings.

An Indian Council of Medical Research scientist, who deals with antimicrobial resistance, had told The Wire in February that the bacteria might have crept into the eye drops due to a non-sterile environment if enough caution was not undertaken.

“If the environment was not infection-free during manufacturing, then the Pseudomonas might have crept from there also,” the scientist had said on the condition of anonymity. “Even during packaging and transportation of eye drops, this bacterial invasion may occur even due to a small slip,” the scientist added.

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Now, the FDA report points out a number of deficiencies, related to non-sterility of the environment and the processes at the manufacturing unit.

Meanwhile, according to the latest update of the US CDC, the number of adverse events reported there due to the use of these eye drops has gone up to 68.

Three people have died due to the infection. Eight have reported vision loss while four had to get their eyeballs removed due to the infection. The bacteria in question is a highly resistant strain. Only cefiderocol – an antibiotic that is used to treat complex infections when no other antibiotic drug works – is currently working against the bacteria.

The US CDC has now also warned the since particular bacteria in question – Pseudomonas aeruginosa – has the potential to spread “rapidly in healthcare settings”, there could be more potential outbreaks in patients who might not have used the Artificial Tears eye drops. Therefore, the healthcare providers dealing with patients suffering from infection of this bacteria have been warned to follow infection control recommendations.

The US CDC has also said the samples collected from opened bottles, which the patients used, confirmed the presence of bacteria. The testing of unopened bottles to pinpoint whether the contamination happened during manufacturing is still ongoing.

Global Pharma had initiated a product recall from the US after the CDC alert in February. The Indian government too had halted the production of the particular eye drops in February till the investigation was completed, while other products continued to be manufactured at the plant in question.