negligence of regulators cost lives and health to Americans who used Indian eye drops – Kommersant

The Food and Drug Administration risks being at the center of a major scandal after an investigation by the agency Bloombergfrom which it follows that the negligence and apparent lack of interest of the regulator in controlling cheap over-the-counter generic drugs cost the lives of at least 4 Americans, left 18 people blind and led to the spread of Pseudomonas aeruginosa, a bacterium known for its resistance to antibiotics.

According to the agency, Pseudomonas aeruginosa infection was recorded in various US states last year. A months-long investigation by the U.S. Centers for Disease Control and Prevention revealed that the source of infection was eye drops designed to relieve symptoms of eye irritation after active work. The drops were produced in India by Global Pharma Healthcare Pvt Ltd and distributed in the USA by two wholesale distributors – EzriCare and Delsan Pharma. The drops were legally imported into the United States, received special FDA-approved labels, and sold throughout the country without a prescription.

In March of this year, the drug was recalled by American sellers “due to violation of the sterility of the drug,” but without indicating a direct connection with infection with Pseudomonas aeruginosa.

According to Bloomberg experts, all this was due to the attitude towards some seemingly especially harmless drugs (the composition of the same drops, sold under the Purely Soothing brand, included distilled water, 0.9 percent saline and, as the seller noted, “15 % optimism). Officials usually do not pay attention to such drugs, believing that even if they do not help, they will not harm. They, according to Bloomberg, are not tested in any way, manufacturers are not required to prove their effectiveness, as well as the fact that they were made under proper conditions.

Attention to this case, most likely, will be increased due to the fact that recently another scandal related to Indian-made drugs was discussed in the world. Then it was about cough syrup, which led to death several dozen children in the Gambia, Uzbekistan and some other countries. After that, mandatory certification of such drugs was introduced in India.

Andrey Kelekeyev