The authority, Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services (DGHS), on March 18, 2026, issued a communication to all State/UT Drugs Controllers regarding the manufacturing and marketing of Sodium Hyaluronate Eye Drops 0.3% w/v, which has not been approved for sale in India.
It has been observed that certain manufacturers are producing and marketing this product despite it being classified as a “new drug,” which requires prior approval from the Central Licensing Authority. The communication reiterates that, as per the New Drugs and Clinical Trials Rules, 2019, no new drug can be manufactured or marketed without obtaining necessary permission, including submission of application in the prescribed form along with requisite fees.
Accordingly, State/UT authorities have been directed to inform all manufacturers under their jurisdiction and cancel any product permissions granted for the subject drug. They are also required to report the action taken to CDSCO at the earliest to ensure regulatory compliance and safeguard public health.
[Notification No. No. SND-16011(11)/10/2026-]
