Pharmexcil pulls up eye drop maker
1 min read . Updated: 05 Feb 2023, 10:57 PM IST
PremiumGlobal Pharma Healthcare has been registered with Pharmexcil since 2005 as a small-scale manufacturer.
NEW DELHI : The Pharmaceuticals Export Promotion Council of India (Pharmexcil), under the commerce ministry, has sought an explanation from Chennai-based Global Pharma Healthcare after the US Food and Drug Administration linked the drugmaker’s eye drops to 55 infections, blindness and one death.
The allegedly contaminated eye drop, sold in US as EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears, are not recommended for sale in India.
In a letter to Dr. Juma Venkatesh, managing director of Global Pharma Healthcare, Pharmexcil wrote, “It is alleged that the eye drops manufactured and supplied by the firm have caused eye infections, permanent loss of vision, and a death, bringing a bad reputation to the Indian pharma industry and also likely to have an impact on the trust of international agencies on Indian pharma exports."
The letter was reviewed by Mint.
Global Pharma Healthcare has been registered with Pharmexcil since 2005 as a small-scale manufacturer.
Pharmexcil has asked the company to furnish details of licensees that have been supplied the drugs and copies of manufacturing licences and product permissions for a report it is preparing for the ministry of commerce and industry and the drug controller for further action.
Indian government officials fear the controversy may dent India’s image as a leading drug producer and supplier, given that the US is a highly regulated market.
“The United States is a very important market not only with respect to 30% of our exports and USFDA is considered to be one of the stringent regulatory agencies," Uday Bhaskar, director-general of Pharmexcil, said in an interview.
