Industry

Eye Drops Packaging: Pharma Companies to use Opaque Bottles

The DCC has recommended employing transparent bottles as a means to ensure they remain uncontaminated.

The Health Master

June 10, 2023

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Last Updated on September 9, 2023 by The Health Master

Eye Drops Packaging: Opaque Bottles

In an effort to prevent microbial contamination, pharmaceutical companies may be required to transition from using transparent plastic bottles to opaque ones for packaging eye drops.

India’s drug regulator is contemplating amendments to the drug rules governing eye drop packaging, according to sources familiar with the matter.

Need for Packaging Change to Ensure Contamination-Free Eye Drops:

According to an anonymous source, bacterial contamination in ophthalmic solution bottles is frequently reported, necessitating a revision in packaging to maintain sterility.

To address this concern, the Drugs Consultative Committee (DCC), a panel of experts operating under the Drugs Controller General of India (DCGI), recently discussed the issue and will soon reach a final decision.

Click for more articles on DCGI

Transparent Bottles: An Alternative Proposal:

Currently, non-transparent plastic bottles are commonly used by pharmaceutical companies, which are susceptible to contamination.

The DCC has recommended employing transparent bottles as a means to ensure they remain uncontaminated.

Click for more articles on DCC

Feasibility Assessment and Industry Collaboration:

Before making a definitive decision on this matter, the drug regulatory authority intends to engage in discussions with the pharmaceutical industry to evaluate the feasibility of transitioning to opaque bottles.

This collaborative approach aims to gather input and perspectives from relevant stakeholders.

Enhancing Product Performance and Safety:

Recent complaints of contamination have highlighted the criticality of ophthalmic drug product packaging in terms of product performance and safety, surpassing the importance of packaging used for solid oral drug dosage forms.

Consequently, the topic was brought forth for discussion and consideration.

Drug Consultative Committee (DCC): Minutes of meetings

Contamination Risks and Transparency Concerns:

It has been observed that bacteria are more likely to contaminate the bottle tip rather than the solution within eye drop bottles.

Due to the lack of transparency, patients often use contaminated eye drops without realizing it. Addressing this issue requires a shift from the current non-transparent packaging.

Transitioning to Single-Dose Plastic Bottles:

While traditional glass bottles with rubber teat droppers were previously used by companies, the prevalence of single-dose plastic bottles has increased significantly in recent times.

Conclusion:

The potential switch to opaque bottles for eye drops packaging represents a proactive step by pharmaceutical companies and regulators to ensure product safety and minimize contamination risks.

By taking this measure, the industry aims to enhance the overall quality and efficacy of ophthalmic solutions, benefiting patients in the process.