Regulator Orders Crackdown on Unapproved Eye Drops: Manufacturers Face Cancellation

• DCGI flags "Sodium Hyaluronate Eye Drops 0.3% w/v" as unapproved 'New Drug'.
• Widely sold eye drops lacked central regulatory approval for manufacturing or marketing.
• Several pharmaceutical companies, including large-cap players, sold the formulation.
• State drug controllers directed to cancel product permissions granted to manufacturers.
• Order invokes New Drugs and Clinical Trials Rules, 2019, requiring central approval for new drugs.