Indian firm’s eye drops linked to vision loss, death in US

NEW DELHI: India’s drugs regulator has opened an inquiry into the products of a Chennai-based pharmaceuticals manufacturer after an eye drop made by it ostensibly led to drug-resistant bacterial infections in the US, where at least one person died and five others developed permanent vision loss.

The US Centers for Disease Control and Prevention (CDC) this week sent a health alert to doctors, saying the outbreak of the infection included at least 55 people in 12 states, and advised people not to or use EzriCare Artificial Tears, which is manufactured by Global Pharma Healthcare Pvt Ltd.

“It is learnt that teams from Central Drugs Standards Control Organisation (CDSCO) and the state drug controller have each sent teams to the plant located about 40 km south of Chennai. It is a contract manufacturing plant supplying through others to the US market,” said a senior official in the central regulatory division, asking not to be named. “This specific drug is not sold in India,” added the official.

The company said it was recalling the product shipped to the market. The eye drops are the latest pharmaceutical product from India to be caught in a global controversy over possible contamination, after Haryana-based Maiden Pharmaceuticals and Noida-based Marion Biotech cough syrups were linked to deaths of children in The Gambia and Uzbekistan.

In the latest case, the CDC said it is testing unopened bottles of EzriCare Artificial Tears eye drops.

“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 contamipurchase nation. Using contaminated artificial tears increases risk of eye infections that could result in blindness or death,” FDA said. It also pointed out multiple violations by the company, including lack of appropriate microbial testing and proper controls concerning tamper-evident packaging.

In a statement responding to the FDA warning, Global Pharma Healthcare on Friday said the company “is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, to the consumer level, due to possible contamination”. When HT reached out to the company’s corporate office, representatives reiterated that they had “voluntarily recalled the batch” and the “possible contamination” was “limited to this particular batch”. The company’s website states that they manufacture over 35 categories of therapeutic drugs, which includes around 14 types of eye care products. Global Pharma Healthcare products are sold in over 30 companies including in the US, Zimbabwe, Niger, Peru, Chile, Jamaica and Zambia. The company, according to its website, also has over 13 “ministry of health visit approvals”.

CBS News reported that CDC had also issued a health alert to doctors around the country over an “unprecedented outbreak of Pseudomonas aeruginosa”. Health experts said that repeated instances of Indian companies being linked to deaths and health scares in other countries could hamper the country’s reputation as one of the largest exporters of pharmaceuticals.“We have to bring in stricter laws. If such lapses keep happening repeatedly, our reputation will be marred and future licenses will be impacted,” said Dr JA Jayalal, former head of the India Medical Association.