Pharma companies may have to switch to opaque bottles for eye drops packaging

Pharmaceutical ompanies may have to switch to using opaque plastic bottles for packing eye drops to avoid microbial contamination. India’s drug regulator is considering making amendments in the drugs rules for packaging of eye drops, said people with knowledge of the matter.

“Bacterial contamination in ophthalmic solution bottles are often reported and hence the need was felt to change its packaging to ensure that it remains free from any contamination,” said one of the persons, who did not wish to be identified.

The Drugs Consultative Committee (DCC), a technical body of experts under the Drugs Controller General of India (DCGI), deliberated on the issue in their meeting last week and will take final decision soon, said the person.

Companies currently use non-transparent plastic bottles, which are prone to contamination. “The DCC suggested that transparent bottles be used so as to ensure that they are free from any contamination,” said the person.

The drug regulatory authority may discuss the matter with the pharma industry to ascertain the feasibility of switching to opaque bottles before taking a final decision on the issue, said another person.

Complaints of contamination were received in the recent past and it was felt that ophthalmic drug product packaging was more crucial to product performance and safety than the packaging used for solid oral drug dosage forms. “Hence the discussion,” said the person.”It has been seen that bottles of eye drops are more likely to be contaminated with bacteria at the bottle tip and not within the solution. Many times patients use it without realising that there could be some bacterial contamination as the bottles are not transparent,” he said.Single-dose plastic bottles are widely used these days, while traditionally glass bottles with rubber teat droppers were used by companies.