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Your support makes all the difference.Several violations by an India-based pharmaceutical company have been flagged by the US Food and Drug Administration (FDA) in a damning report after its eye drops were linked to three deaths and serious infections.
The FDA’s representatives had carried out an 11-day inspection of Global Pharma Healthcare Pvt Ltd’s plant in southern India’s Chennai city between February and March.
In its 14-page report released last week, the US federal agency listed out a detailed log of violations and pulled up the plant for flouting sanitation levels during the manufacturing process.
The violations included a “black, brown coloured greasy deposit” on a bowl and there being no mention of the cleaning of several parts of the “sterile manufacturing area” in the cleaning record.
These parts included doors and handles, and high-efficiency particulate absorbing (Hepa) filter grills – a type of air filter – being cleaned properly.
India’s federal health ministry has said no contamination was found in samples of eye drops made by the pharma firm. The samples were found to be of “standard quality”, sources in the ministry told news channel NDTV.
In February, the FDA had warned against using an eye drop manufactured by Global Pharma after the drug was linked to the outbreak of a drug-resistant bacteria leading to adverse events in at least 55 patients in the US. These included infections, blindness and one death.
It warned that the Artificial Tears eye drop carried a potential bacterial contamination and said the company had violated current good manufacturing practices.
Shortly after, Global Pharma had issued a voluntary recall of unexpired lots of the eye drop at the consumer level. The drops were distributed in the US by EzriCare LLC and Delsam Pharma.
The import of the products was also halted by the FDA.
One of the observations listed in last week’s FDA report said: “Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilisation process.”
“In addition, you have not established that the sterilisation process is effective across different manufacturing conditions.”
The conditions were listed as the pH and temperature of the solution, filtration pressure, flow rate, maximum filtration time, batch size (volume) and effect of sterilisation on the filter’s retention capability.
The report also mentioned that the pharma company did not establish the “worst-case scenario for the bioburden”.
The surfaces that came into contact with the drug packaging “were not cleaned, sanitised, decontaminated, or sterilised”, the report said.
The pharma plant did not perform container closure integrity tests on the drug products because of which the FDA could only assess any leak by manual visual inspections, the report pointed out.
“There is no assurance or documentation that this visual inspection can detect aseptic barrier issues with the container or closure,” it said.
Other sanitation violations mentioned by the report included reuse of “sterile cleanroom garbs” by washing.
“The firm did not track or have studies to show how many times garbs could be reused. Discoloured overall, discoloured and worn-out booties were being observed being used in the cleanrooms,” the report said.
The FDA also said one of the firm’s microbiologists who carried out a study on the “Validation Protocol to Determine the Duration of Effectiveness” in the plant “could not remember the room number” where he did so.
The nearly dozen observations packed with multiple violations also noted that the plant’s quality control unit “lacks the responsibility and authority to approve, reject all components, drug product containers, closures, in process materials, packaging material, labelling, drug products”.
There have been other incidents of major healthcare violations alleged to be stemming from medicines manufactured in India that were reported on last year.
At least 70 children died in Gambia and 19 children died in Uzbekistan last year after consuming India-made cough syrups. The reports have dented the country’s image of being the “pharmacy of the world”.
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