NEW DELHI: Flagging that certain yet-to-be-approved dry eye relief drops are being sold in the market, the central drugs regulator has asked states to cancel any permissions granted for these products and take action against manufacturers.
In a communication to drug controllers in states and UTs, the Central Drugs Standard Control Organisation (CDSCO) said that ‘sodium hyaluronate eye drops 0.3%’ is being manufactured and sold without mandatory clearance from the central authority.
Officials said the formulation falls under the category of “new drug”, meaning it must be approved before it can be sold in the market. Without approval, its safety and effectiveness are not verified.
These eye drops are commonly used to treat dry eyes and irritation, acting like artificial tears to keep the eyes moist and reduce discomfort. But experts warn that using unapproved products – even for routine conditions – can lead to complications.
For the public, the CDSCO’s advise was clear – use eye drops only on a doctor’s advice and buy medicines from reliable sources. What may seem like a simple remedy can carry risks if it has not been properly cleared.
“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,” said Dr Namrata Sharma, Prof in ophthalmology at Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS-Delhi.
“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.
