Industry

DCC recommends Transparent Packaging for Eye Drops

Packaging for Eye Drops: The DCC suggested the inclusion of such preparations in Schedule H1 and the imposition of a maximum pack size of 30 ml.

The Health Master

September 9, 2023

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Last Updated on December 2, 2023 by The Health Master

Packaging for Eye Drops

In a significant step towards enhancing the quality and safety of eye care products, the Drugs Consultative Committee (DCC) has recommended Transparent Packaging for Eye Drops.

The focus is on evaluating the feasibility of packaging eye drop formulations in transparent plastic vials or bottles.

This move comes in response to growing concerns about particulate matter and contamination in eye drops.

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Transparent Packaging for Eye Drops for Clarity:

One of the primary concerns raised by the DCC pertains to the packaging for eye drops.

The committee emphasized the need for transparent plastic vials or bottles to allow consumers to inspect the clarity of the solution before use.

Historical testing data revealed that a significant number of eye drop samples failed in description due to issues related to particulate matter and contamination.

Click to read or download minutes of meetings of DCC

Consultation Meeting for Ophthalmic Products:

Following thorough deliberation, the DCC recommended conducting a consultation meeting with various ophthalmic product manufacturers.

This initiative aims to foster collaboration and establish best practices in the packaging of eye drops for optimal consumer safety.

The meeting, held in June of this year, marked a pivotal step towards addressing these pressing concerns.

Curbing the Misuse of Alcohol-Based Formulations:

In a parallel effort to ensure drug safety, the DCC has underscored the need to reevaluate formulations containing alcohol or tincture content above a specified pack size.

This measure is crucial to combating the misuse of such products, which are currently listed in Schedule K.

Revising Provisions for Alcohol-Containing Preparations:

The DCC responded to a representation highlighting the misuse of products like Aromatic Cardamom Tincture, known for its high alcohol content.

These substances, readily available in medical stores, have been improperly utilized as a substitute for country liquor, raising serious public health concerns.

Recommended Amendments for Enhanced Regulation:

After a comprehensive assessment, the Committee advocated for amendments to the Drugs and Cosmetics Act and Rules.

The proposal aims to remove exemptions for alcoholic preparations with an alcohol content of 30 ml or more from Schedule K.

Additionally, the DCC suggested the inclusion of such preparations in Schedule H1 and the imposition of a maximum pack size of 30 ml.

Addressing Aromatic Cardamom Tincture:

Aromatic Cardamom Tincture, with an alcohol content ranging from 84% v/v to 87% v/v, is currently available in 100 ml packs.

These products fall under class 10(iv) of Schedule K in the Drug Rules of 1945, benefiting from certain exemptions.

However, their affordability has led to widespread misuse, particularly among economically disadvantaged individuals, presenting a significant challenge to public health.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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Drug Consultative Committee (DCC): Minutes of meetings