A formulation of eye drops widely available on pharmacy shelves and online platforms has been found to lack central regulatory approval, the country’s top drug regulator said on Wednesday, directing states
to immediately cancel permissions granted to its manufacturers.
The Drugs Controller General of India (DCGI) has flagged “Sodium Hyaluronate Eye Drops 0.3% w/v”—sold across the country as a remedy for dry eyes—as an unapproved “New Drug”, meaning it required central clearance before it could be manufactured or marketed but that clearance that was never obtained.
The Issue
Several well-established pharmaceutical companies — among them large-cap, listed players with nationwide retail networks — have been selling the formulation under their own branded labels, prominently stocked on major online pharmacy platforms as of Wednesday.
The DCGI’s office said it had been brought to its notice that manufacturers were “involved in manufacturing/marketing of subject cited drug product which is not yet approved by this office for manufacturing/marketing in the country and falls under the category of ‘New Drug’.”
State drugs controllers have been directed to “convey the matter to all the manufacturers under your jurisdiction and cancel the product permission granted by you of the subject drug.” Action taken must be intimated to the Directorate “at the earliest,” the order said.
The order invokes Rule 3 of the New Drugs and Clinical Trials Rules, 2019, which states that “no new drug shall be manufactured for sale unless it is approved by the Licensing Authority”. Under Rule 80 of the same rules, a manufacturer “who intends to manufacture a new drug in the form of API or Pharmaceutical formulation…shall make an application for grant of permission to the Central Licensing Authority in Form CT-21 along with a fee as specified in Sixth Schedule”.
A search of major online pharmacy platforms shows multiple branded versions of the “0.3%” formulation listed for purchase, marketed primarily as artificial tears for dry eye relief.
The order has been copied to all zonal and sub-zonal offices of CDSCO along with the Indian Pharmaceuticals Association forums.
