The national public health agency of the United States Centers for Disease Control and Prevention has expressed concern that a drug-resistant bacteria strain allegedly linked to eye-drops imported from India could gain a foothold in U.S. health care settings.
The alarm was raised even as the U.S. Food and Drug Administration (USFDA) said that the manufacturer of the EzriCare eye-drops — Global Pharma Healthcare — is recalling 50,000 tubes from the U.S. market following reports of contamination.
The eye-drops were manufactured by Chennai-based Global Pharma Healthcare and distributed in the U.S. market by EzriCare and Delsam Pharma, the USFDA said.
The Health Ministry here did not comment on the contamination and recall but speaking about the Central government’s recent crackdown on drug manufacturers in India, Health Minister Mansukh Mandaviya said that his Ministry had initiated strict action against those manufacturing adulterated and spurious medicines.
The CDC has cautioned that patients should stop using the eye-drops pending additional information and guidance from the CDC and the U.S. Food and Drug Administration.
“If patients were advised to use EzriCare or Delsam Pharma’s Artificial Tears by their healthcare provider, they should follow up with their healthcare provider for recommendations about alternative treatment options. Patients who have used EzriCare or Delsam Pharma’s artificial tears and who have signs or symptoms of an eye infection should seek medical care immediately,’’ it said.
The CDC added that currently there was no recommendation for testing of patients who have used the product and who were not experiencing any signs or symptoms of infection.
It said that eye infection symptoms may include yellow, green, or clear discharge from the eye, eye pain or discomfort, redness of the eye or eyelid, feeling of something in your eye (foreign body sensation), increased sensitivity to light and blurry vision.
Meanwhile, the Ministry of Chemicals and Fertilizers, in its response to a question in the Rajya Sabha by member John Brittas on export of “substandard medicines” said that manufacturers were required to obtain licence for manufacturing of drugs for export from the concerned State Licensing Authority (SLA) under the provisions of the Drugs and Cosmetics Act, 1940 and the ules made thereunder. Further, all manufacturers were required to meet the requirements of the importing country.
It added that the World Health Organisation had previously issued two medical product alerts on cough syrups manufactured in India which were exported to Gambia and Uzbekistan.
