Manufacturing and marketing of unapproved drug product Sodium Hyaluronate Eye Drops 0.3% w/v

The Directorate has identified that certain manufacturers are engaged in the unauthorized manufacturing and marketing of Sodium Hyaluronate Eye Drops 0.3% w/v, a product classified as a “New Drug.” This drug has not been approved for manufacturing or marketing in India. Under the New Drugs and Clinical Trials Rules, 2019, no new drug may be manufactured for sale without prior approval from the Licensing Authority, as defined in Rule 3. Furthermore, Rule 80 specifies that any person intending to manufacture a new drug, whether as an API or pharmaceutical formulation, must apply to the Central Licensing Authority in Form CT‑21 along with the prescribed fee. In light of these regulations, all state authorities are directed to inform manufacturers under their jurisdiction, cancel any product permissions previously granted for this drug, and report back to the Directorate with details of the status and actions taken at the earliest opportunity. This ensures compliance and safeguards public health.