CDSCO Suspended Manufacturing of Eye Drops of Global Pharma, Chennai

India's Central Drugs Standard Control Organization (CDSCO) has suspended the manufacturing of eye drops at the Chennai-based firm after US FDA allegedly linked 55 adverse events cases with contaminated eye drops.

The samples were taken for analysis from four batches of control samples. The sample of raw material Carboxy Methyl Cellulose Sodium was also taken: Sources on 'Artificial Tears' eyedrops

The manufacturer was instructed to stop the manufacturing activities of all the products under the category of ophthalmic preparation till the completion of the investigation

During the investigation by senior drug inspectors, it was found that Chennai-based firm Global Health Care Pvt Ltd had exported two consignments of 24 batches of 'Artificial Tears' to USA which were manufactured in 2021 and 2022

Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma's Artificial Tears.

Pharmaceutical firms sign licence agreement for Rescula eye drops

Rescula eye drops are to be licensed across the world by Sucampo Pharmaceuticals Incorporated's wholly-owned subsidiary Sucampo Manufacturing & Research AG and R-Tech Ueno Ltd.

These eye drops contain the active pharmaceutical ingredient unoprostone isopropyl.

They are designed to lower intraocular pressure (IOP) in patients with primary open-angle glaucoma and ocular hypertension who have proven to be intolerant of or unresponsive to other medicines that lower IOP.

Sucampo currently had the rights to license the eye drops in the US and Canada, but the new agreement means this will expand across the rest of the world, except for in Japan, Korea, Taiwan and China.

"We are very excited about this agreement, as we believe that unoprostone isopropyl has significant potential in several markets," said Dr Ryuji Ueno, chairman and chief executive officer at Sucampo Pharmaceuticals.

According to the NHS, about 480,000 people have chronic open-angle glaucoma in England and other forms of the condition are less common.