Are your eye drops safe? CDSCO flags illegal products, doctors issue strong warning on irritation, conjunctivitis

In a major regulatory crackdown, the Central Drugs Standard Control Organisation (CDSCO) has flagged the sale of unapproved dry eye relief drops in the market and directed all states and Union Territories to immediately revoke any permissions granted for such products, reports TOI's Anuja Jaiswal. The drug regulator has also instructed authorities to take strict action against manufacturers found violating norms. In its communication to state drug controllers, CDSCO highlighted that ‘sodium hyaluronate eye drops 0.3%’ are being manufactured and sold without obtaining mandatory approval from the central authority, raising serious safety and compliance concerns.

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"Using unapproved eye drops for dry eyes is risky as they can worsen irritation, increase dryness and raise the risk of infections like conjunctivitis. Since dry eyes already have a compromised surface, untested products can cause more harm than benefit. Even approved eye drops should be discarded a month after opening to avoid contamination," Dr Namrata Sharma, Prof in ophthalmology at Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS-Delhi told TOI.


"Unapproved eye drops are unsafe as their quality, sterility and formulation are not assured. Poor manufacturing can lead to infections and reduced effectiveness due to improper formulation. Patients should use only doctor-prescribed products from reliable companies," said Dr Ashu Agarwal, ophthalmologist, Apollo Hospital, Delhi.

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Officials clarified that the formulation falls under the “new drug” category, making prior approval mandatory before it can be marketed. Without such clearance, its safety and effectiveness remain unverified.

These eye drops are typically used to treat dryness and irritation, functioning like artificial tears to keep the eyes lubricated and reduce discomfort. However, experts have cautioned that using unapproved products—even for common conditions—can pose serious health risks.

Issuing a clear advisory, the Central Drugs Standard Control Organisation (CDSCO) urged the public to use eye drops only on a doctor’s recommendation and purchase medicines from trusted sources. What may appear to be a simple remedy could lead to complications if it has not been properly approved.

(With TOI inputs)