Sun Pharma Distributors Ltd has reportedly begun withdrawing several eye-drop products from distribution in India as a precautionary measure following concerns over possible contamination.
The action was communicated to distributors in a letter dated July 17. The company asked its distribution network to discontinue further supply of the identified products and withdraw all available stock from the market. Billing was also ordered to stop immediately.
The withdrawal covers products sold under the Brinolar, Lotepred, Nepalact and other ophthalmic ranges. The communication quoted in the report named:
- Depopred 2ML
- Brinolar BKC Free
- Brinzotim Eye Drops 5ML BKC Free
- Lotepred 5ML
- Lotepred 1% Eye Drops 5ML
- Lotepred LS 0.2% E/D 5ML
- Lotepred T
- Nepalact OD Eye Drops 3ML
- Nepalact-Z
- Toba-F
- Nepalact E/D 5ML
Distributors were asked to provide details of any remaining inventory and return stocks held directly or received from other sources on priority.
Sun Pharma says patient safety is the priority
Responding to the development, a Sun Pharma spokesperson said the company had taken the necessary steps in the interest of patients and in line with applicable regulatory requirements.
“Patient safety remains our highest priority. We have taken all necessary steps in the best interest of patients and in accordance with applicable regulatory requirements,” the spokesperson said.
The company also indicated that its teams were working to restore supplies so patients could continue accessing the treatment options.
The statement did not provide additional details on the nature of the suspected contamination, the manufacturing location involved, specific batches under withdrawal or the number of units affected.
Why eye-drop recalls require immediate action
Eye drops are commonly prescribed after surgical procedures and for conditions including glaucoma, eye infections, allergies and ocular inflammation. Any interruption in treatment can carry consequences for patients who depend on these medicines for ongoing care.
An expert quoted in the report said maintaining sterility during the manufacturing of ophthalmic products is essential because the medicine is applied directly to the eye. Even a suspicion of contamination can therefore require a rapid withdrawal to protect patients.
Unlike many other medicines, eye drops must remain sterile throughout production, packaging and use. The reported action by Sun Pharma Distributors reflects the urgency generally attached to safety concerns involving ophthalmic products.
What patients using the affected products should do
Patients have been advised not to continue using a recalled product. At the same time, they should not discontinue a prescribed course of treatment without consulting their ophthalmologist.
The expert recommended contacting an eye specialist promptly so that a suitable alternative can be prescribed. This allows treatment to continue while avoiding possible exposure to a product that has been withdrawn.
People who have been prescribed any of the named products should seek guidance from their treating doctor rather than replacing the medicine independently.
Distribution halted while availability is reviewed
The priority for this withdrawal is removal of current stocks from the market and avoiding future billing. Sun Pharma has stated that they are working towards restoring supply of the medicines, although there has been no time frame stated.
Further clarity is awaited on the affected batches, the scale of the withdrawal and when supplies may resume.
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