New Delhi: The Drugs Consultative Committee (DCC) has recommended to the national drug regulatory authority to issue an advisory to the State Licensing Authorities to monitor the quality of eye drops in packages, in a move to address the issues related to particulate matter and contamination in these products.
Based on a recommendation by the Committee in the previous meeting, a consultation meeting was conducted with industry associations and industry members to check whether these formulations can be packed in transparent plastic vials or bottles.
The Committee was considering a proposal to amend the Drugs Rules, 1945 with respect to the packing of eye drops in opaque plastic vials or bottles by the pharmaceutical companies.
Following the consultation meeting, the Committee in its 64th meeting held on June 19, 2024, said, “After detailed deliberation, the committee recommended that an advisory may be issued to the SLA’s for monitoring the quality of such products.”
In a DCC meeting held in June, 2023, the issue was discussed 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.
The Committee, during the time, 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.
