Drug regulatory body initiates probe after US FDA flags contamination risk from India-made eyedrops

Following a warning from the US Food and Drug Administration to “not to purchase or use EzriCare Artificial Tears due to potential contamination” the Central Drugs Standard Control Organization (CDSCO) under the Union Health ministry and the Tamil Nadu State Drug Controller have launched an investigation into the pharma firm producing this eyedrop, a report familiar with the situation said on Friday.

“Teams from CDSCO and TN State Drug Controller, comprising three officials, are on their way to the manufacturing plant located near Chennai. It’s a contract manufacturing plant supplying through others to the US market. This specific drug is not sold in India,” said the source. FDA has also restricted the imports of products manufactured by Global Pharma Private Healthcare Limited.

“The import alert prevents these products from entering the United States,” FDA said in a statement, adding “FDA is warning consumers and health care practitioners not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. Using contaminated artificial tears increases the risk of eye infections that could result in blindness or death.”

The over-the-counter products, manufactured by Global Pharma Healthcare Private Limited, are intended to be ‘sterile’, the FDA noted.

Global Pharma has initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears, the source informed further.

The FDA also stated that the recall was recommended due to the company’s current good manufacturing practise (CGMP) violations, which included a lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles without an adequate preservative), and a lack of proper controls regarding tamper-evident packaging.