DCGI Plans To Ask Cos To Sell Eye Drops In Transparent Bottles

New Delhi: Pharmaceutical companies may have to switch to transparent bottles for eye drops so that consumers can ascertain the clarity of eye drops before using them, said people aware of the matter.

The Drug Controller General of India (DCGI) has called a meeting with pharma lobby groups on Monday to discuss the matter as the regulatory authority proposes to make amendments to the Drugs and Cosmetics Rules, 1945 with respect to the packaging of eye drops, they said.

The Drugs Consultative Committee (DCC), a technical body of experts, had deliberated on the issue in its meeting last year after it received representation to amend the Drugs and Cosmetics Rules, 1945 with respect to concerns raised on the packing of eye drops in opaque plastic vials or bottles by pharmaceutical companies on the basis of historical testing results of eye drops sampling. The tests showed that most of the samples failed in the description due to particulate matter and contamination.

“This was the trend when eye drops were either packed in glass vials or transparent plastic vials. 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 minutes of the meeting.

After detailed deliberation, the DCC recommended that a consultation meeting with various ophthalmic products (eye drops) producing companies be held. Companies currently use non-transparent plastic bottles, which are prone to contamination. “It has been seen that bottles of eye drops are more likely to be contaminated with bacteria at the bottle tip. Many a time patients use it without realising that there could be some bacterial contamination,” said a person, who did not wish to be identified.

“This is an extremely important issue for the users of eye drops. Bottles should be transparent to not only see the contents for contamination but also the extent of usage. The use of opaque bottles should be stopped,” a member of a pharma lobby group told ET on condition of anonymity.

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