Indian drug regulators have ordered Sun Pharmaceutical Industries to halt the manufacture, sale and distribution of eye medicines produced at its plant in Assam after inspections identified deficiencies in its quality management system, according to a Reuters report cited by ARY News.
The order was issued on August 20 by India’s Central Drugs Standard Control Organisation (CDSCO) and the Assam drug control authorities, according to government documents reviewed by Reuters.
The action follows a voluntary recall by Sun Pharma in July involving approximately 11 types of eye medicines. Regulators have also sought additional information from the company regarding the recall of 332 batches of ophthalmic products.
Quality-Control Deficiencies Trigger Regulatory Action
A joint inspection by federal and state authorities identified shortcomings in the plant’s quality management system, which is intended to ensure the quality and safety of medicines.
Under the regulatory order, production of eye medicines at the Assam facility cannot resume until the company submits a satisfactory compliance report.
An Indian official familiar with the matter told Reuters, on condition of anonymity, that Sun Pharma had submitted a compliance report in response to the order. Authorities were reviewing the submission, according to the report.
The available information does not establish that every recalled product was contaminated or unsafe. The recall was described in an internal company notice as a precautionary measure, while detailed public information about the recall had not been released at the time covered by the report.
Eye Medicines Included in the Recall
The products listed in the report include:
Lotepred 1% 5ml eye drops
Nepalact OD
Nepalact-Z
Brinzotim 5ml eye drops
Depopred 2ml
These medicines are used to treat various eye conditions, including inflammation, infections and certain chronic disorders, according to the report.
Packaging information indicated that most of the recalled medicines were manufactured at the Assam facility. However, Reuters could not independently establish whether the 332 batches identified by regulators were limited to the 11 recalled brands or included additional products.
Industry experts cited in the report estimated that potentially millions of eye-drop bottles could be affected, given the number of batches involved. This remains an estimate rather than a confirmed total.
Previous Concerns Over Indian Medicines
The latest action comes amid broader concerns over the quality of some medicines manufactured in India. In recent years, certain Indian-made cough syrups have been linked to child deaths, while medicine quality has also faced scrutiny in countries including The Gambia and Uzbekistan.
The current case concerns Sun Pharma’s ophthalmic products manufactured at its Assam plant. The regulatory review and the company’s compliance submission remain important steps in determining the outcome.