DCC asks govt to amend Rules to ensure eye drop formulations are packed in transparent plastic vials or bottles

September 9, 2023

In a move to address the issues related to particulate matter and contamination in eye drops, the Drugs Consultative Committee (DCC) which advises the drug regulator has recommended consultation with the manufacturers to check whether these formulations can be packed in transparent plastic vials or bottles.

In order to curb the misuse of drug formulations with alcohol or tincture content above a certain packsize at present, it advised that the relevant rules may be amended to remove the products from Schedule K.

The DCC said that it was apprised about the representation received to amend the Drugs Rules, 1945 with respect to concerns raised on the packing of eye drops in opaque plastic vials or bottles by pharmaceutical companies.

This was on the basis of historical testing results of eye drops sampling which showed that most of the samples failed in description due to particulate matter and contamination.

"Therefore, it was requested to ensure that eye drop formulations are packed in transparent plastic vials/bottles, so that the consumer can ensure the clarity of eye drop before instilling," said the Committee.

"After detailed deliberation, DCC recommended that a consultation meeting with various ophthalmic products (eye drops) producing companies may be conducted," said the Committee in its meeting held in June, this year.

Similarly, the recommendation on formulations with alcohol or tincture content comes in the wake of a representation received by the Drugs Consultative Committee, which informed that Aromatic Cardamom Tincture and other alcoholic preparations in which content of alcohol is very high are being sold from medical stores and are being misused as country liquor.

The Committee, in a meeting held in June, this year, was apprised about the representation requesting necessary action to amend the provisions in the Drugs and Cosmetics Act and Rules with respect to the misuse of the drugs containing alcohol/ tincture.

"After detailed deliberation, the Committee recommended that the rules may be amended and exemption provided for alcoholic preparations containing the alcohol content 30 ml or above in Schedule K may be removed and such preparation may be included in Schedule H1. The Committee recommended suitable amendments in Drugs Rules, 1945 to restrict pack size of these items to maximum 30 ml," it said.

The alcohol content in Aromatic Cardamom Tincture is in the range of 84%v/v to 87%v/v and is being sold in 100 ml packs. They are specified under class 10(iv) of Schedule K of the Drug Rules, 1945 and are being misused due to exemptions as per the said Schedule.

Being cheap, they are misused as liquor by economically weaker people posing a big concern for public health.

After detailed deliberation, DCC opined that there is a need for amendment in Drugs Rules, 1945 to regulate alcohol content in tinctures/other alcoholic preparations to curb their illegal sale across pharmacies.

PHARMABIZ.com