New Delhi, February 4
Production of all ophthalmological preparations at Tamil Nadu-based Global Health Care was halted on Saturday pending investigations, after the US flagged one death and in all 55 adverse events, including loss of visions, due to the use of artificial tear drops manufactured at the facility. .
The production was halted after spot inspection of the firm late on Friday night by teams of the Central Drug Standards Control Organization and Tamil Nadu Drug Controller office.
Sources said during investigation it was found that the firm had exported two consignments of 24 batches of the allegedly contaminated artificial tears to the US which were manufactured in 2021 and 2022.
Sources said the product was not manufactured for domestic sales and had only been exported.
“During investigation there were no stocks of the above matches found. The firm has maintained control of samples for the said batches. These samples were taken for analysis from the four batches of control samples. The sample of raw material carboxymethyl cellulose sodium which was used for manufacturing of the above finished products was also taken for analysis,” top sources in the drug regulator’s office said.
Further, it was noted that the firm had not carried out complete root-cause analysis in respect of the complaint from the US Centers for Disease Control and said that the same was under process.
Upon verification of records, it was noticed that the firm had done the stability studies for the representative batch of the said drugs a year once. The batch-manufacturing records of all batches, purchase invoices of raw materials, safe bills copies, validation reports were obtained under Section 22 of the Drugs and Cosmetics Act 1940 and Drugs Rules 1945 for further investigation.
The CDC of the US yesterday said artificial tear drops manufactured and supplied by Global Healthcare Private Limited, Alathur, Kancheepuram Tamil Nadu, and supplied to Aru Pharma INC, Locus Street, New York, had led to adverse events, including infections, permanent loss of vision and a death with bloodstream infection.
“Based on the complaint from the US CDC, a joint investigation was conducted on February 3 by a team of senior drug and drug inspectors of Tamil Nadu and Center under the supervision of director of drugs control, Tamil Nadu and Assistant Drugs Controller of India, CDSCO, South zone at the manufacturing premises of Global Health Care,” sources said.