Pharma Companies Might Have To Switch To Opaque Bottles For Eye Drops Packaging

To avoid microbial contamination, pharmaceutical companies may have to switch to opaque plastic bottles for packing eye drops. According to people familiar with the situation, India's drug regulator is considering amending the drugs rules to allow for the packaging of eye drops. "Bacterial contamination in ophthalmic solution bottles is frequently reported, so the need was felt to change its packaging to ensure that it remains free of any contamination," said one of the unidentified individuals.

The Drugs Consultative Committee (DCC), a technical body of experts under the Drugs Controller General of India (DCGI), met last week and will make a final decision soon, according to the person. Currently, businesses use non-transparent plastic bottles that are prone to contamination. "The DCC suggested using transparent bottles to ensure that they are free of contamination," said the person. Another source stated that the drug regulatory authority may consult with the pharmaceutical industry to determine the feasibility of switching to opaque bottles before making a final decision.

Contamination complaints have recently been received, and it was determined that ophthalmic drug product packaging was more important to product performance and safety than solid oral drug dosage form packaging. "Hence the discussion," the individual explained. "It has been observed that eye drop bottles are more likely to be contaminated with bacteria at the bottle tip rather than within the solution." Because the bottles are not transparent, many patients use it without realising there could be bacterial contamination," he said. Companies used glass bottles with rubber teat droppers in the past, but single-dose plastic bottles are now widely used.