CDSCO Flags Illegal Manufacturing of Sodium Hyaluronate Eye Drops, Seeks Immediate Action
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has directed all State and Union Territory Drugs Controllers to take immediate action against the manufacturing and marketing of unapproved Sodium Hyaluronate Eye Drops 0.3% w/v, including cancellation of any product permissions granted and ensuring compliance with regulatory provisions.
The communication, issued by the Subsequent New Drugs Division of CDSCO under the Directorate General of Health Services vide File No. SND-16011(11)/10/2026-eoffice from FDA Bhawan, New Delhi, is dated March 18, 2026.
Addressed to all State/UT Drugs Controllers, the notice highlights that it has come to the attention of the Directorate that certain manufacturers are engaged in the manufacturing and marketing of Sodium Hyaluronate Eye Drops 0.3% w/v without approval from the competent authority. The product, as stated, falls under the category of a “New Drug” and has not been approved for manufacturing or marketing in the country.
Citing regulatory provisions, the CDSCO emphasized that no new drug shall be manufactured for sale unless it is approved by the Licensing Authority as defined under Rule 3 of the New Drugs and Clinical Trials Rules, 2019.
Furthermore, as per Rule 80 of the New Drugs and Clinical Trials Rules, 2019, any person intending to manufacture a new drug, whether as an active pharmaceutical ingredient (API) or pharmaceutical formulation for sale or distribution, is required to apply for permission to the Central Licensing Authority in Form CT-21 along with the prescribed fee specified under the Sixth Schedule.
In view of these violations, the CDSCO has directed all State and UT Drugs Controllers to immediately convey the matter to manufacturers under their jurisdiction and take necessary regulatory action, including cancellation of any product permissions granted for the said drug.
The authority has also requested that detailed information regarding the status and actions taken in this matter be intimated to the Directorate at the earliest.
To view the official notice, click the link below:
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