Akum Pharma Asked to Submit Safety Data for Alzheimer's Drug Combo In Elderly Indian Patients
New Delhi: In a recent regulatory review, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) asked the pharma major Akum Pharmaceutical to submit supportive data with respect to safety aspects for the Donepezil Hydrochloride IP 10mg/10 mg/10 mg/10mg + Memantine Hydrochloride IP (ER) 7 mg/14 mg/21 mg/28mg hard gelatin capsule in elderly/geriatric population in Indian patients.
This came after the firm presented the proposal before the committee.
Donepezil is in a class of medications called cholinesterase inhibitors. It improves mental function (such as memory, attention, the ability to interact with others, speak, think clearly, and perform regular daily activities) by increasing the amount of a certain naturally occurring substance in the brain.
Donepezil is a medication that treats symptoms of Alzheimer’s disease like memory loss and confusion. This medication works by improving your attention, memory and ability to engage in your daily activities. It isn’t a cure for Alzheimer’s disease or dementia.
At the recent SEC meeting for Neurology and Psychiatry held on 16th July 2025, the expert panel reviewed the proposal presented by the Akum Pharmaceutical.
After detailed deliberation, the committee opined that firm did not present any supportive data with respect to safety aspects for the proposed FDC in elderly/geriatric population in Indian patients.
"Accordingly, the firm should submit above data for further review by the committee," the expert panel noted.
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