The Central Drugs Standard Control Organisation (CDSCO) has instructed Tamil Nadu-based Global Pharma Healthcare to stop manufacturing all the products under the category of ophthalmic preparation till the completion of an investigation. The move came soon after the U.S. Centers for Disease Control and Prevention (CDC) linked the company’s eye drops to 55 adverse events in the U.S.
On Friday, a joint team — comprising senior drug inspectors and officials from the Centre and from Tamil Nadu — visited the company’s manufacturing premises. They collected samples from four batches of “control samples” for analysis and that of the raw material, carboxymethylcellulose sodium, which was used for manufacturing the eye lubricant.
The investigation was launched on the basis of a warning by the CDC that the eye drops supplied by the company to distributors Aru Pharma/EzriCare and Delsam Pharma in the U.S. had been linked to adverse events, including eye infections, permanent loss of vision, and a death with a bloodstream infection.
During the exercise, the joint inspection team found that the firm had exported two consignments consisting 24 batches of the eye lubricant to the U.S. The consignments were manufactured in 2021 and 2022. No stocks of the batches concerned were found. The manufacturer had, however, maintained the control samples for the said batches. It said the “media fill validation” (a testing process) was carried out biannually, whose records were verified.
The firm said the root cause analysis in respect to the complaint was under process. On verification of the records, the inspection team observed that the stability studies for the representative batch of the said drugs were done yearly once. The inspectors gathered the relevant manufacturing records for scrutiny.
The CDC had alerted the U.S. Food and Drug Administration (FDA) about the cases of adverse events recorded in 12 States in the country. A warning issued by the FDA on Friday told consumers and doctors to not buy, and stop using, the product.
The company, which has recalled the eye drops from the market, has been placed on the FDA’s import alert list for allegedly providing an inadequate response to a records request.
