INDIA— Pharmaceutical companies are set to start packaging eye drops in transparent water bottles once a new amendment that is set for Monday succeeds.  

Regulators and people familiar with the matter said the move is being rolled out in a bid to help consumers ascertain the clarity of eye drops before using them. 

The Drug Controller General of India (DCGI) has called a meeting with pharma lobby groups on Monday to weigh down on the issue 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, discussed the matter at its meeting last year after receiving a representation to amend the Drugs and Cosmetics Rules, 1945.  

The representation pertained to concerns expressed by pharmaceutical companies regarding the packaging of eye drops in opaque plastic vials or bottles, based on testing results of eye drops sampling in the past.

According to the tests, particle matter and contaminants caused the majority of the samples to fail in the description. 

“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. 

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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. 

A member of a pharmaceutical lobby, speaking anonymously to the Economic Times, highlighted the crucial nature of the move, stating that it would not only aid consumers in verifying the bottle’s contents but also enable them to assess the extent of usage. 

“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,” he said.

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