India Pharma Outlook Team | Wednesday, 06 August 2025
As part of a recent examination, the regulator Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), directed Akum Pharmaceuticals to submit supportive safety data for its proposed fixed-dose combination (FDC) of Alzheimer's medication in the elderly Indian population.
The request was made during SEC's meeting for Neurology and Psychiatry on July 16, 2025 when the committee reviewed a company proposal for a combination of Donepezil Hydrochloride IP (10mg × 4), and Memantine Hydrochloride IP (Extended Release – 7 mg, 14 mg, 21 mg and 28 mg) in hard gelatin capsule form.
Donepezil, a cholinesterase inhibitor, is used to treat symptoms in Alzheimer's disease, including memory loss, disorientation, and impaired mental functioning. It works to improve memory, attention, and ability to perform activities of daily living by increasing the level of a naturally existing ingredient in the brain. Another commonly used treatment for Alzheimer's is memantine, which also aims to improve cognitive function while employing different mechanisms targeting glutamate activity in the brain. While both drugs are frequently prescribed, the safety of their concomitant use in elderly Indian populations is still under consideration.
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After a comprehensive discussion, the SEC identified Akum Pharmaceuticals did not submit sufficient safety information for the proposed FDC, particularly safety data regarding geriatric patients in India.
"The company should provide the necessary safety information for further review,” stated the Securities and Exchange Commission (SEC) in its formal announcement.
The CDSCO's ongoing vigilance underscores the demand for thorough safety verification, especially for lead patients, which may include the elderly.
