Indian pharmaceutical major Sun Pharmaceutical Industries has been directed to halt the manufacture, sale and distribution of ophthalmic products produced at its facility in Assam after drug regulators identified shortcomings in its quality-management system.
According to documents reviewed by Reuters, the Central Drugs Standard Control Organisation (CDSCO) and the Office of the Drugs Controller, Assam, issued the shutdown order on 20 August 2026. The action followed a joint inspection of the facility and an earlier show-cause notice dated 10 August.
Editorial Insight
Key Highlights
Important points readers should notice.
Issue/Event: Drug regulators ordered a halt to ophthalmic-product manufacturing, sale and distribution linked to Sun Pharma's Assam facility.
Location: India.
Authority/Organisation: Central Drugs Standard Control Organisation (CDSCO) and the Office of the Drugs Controller, Assam.
Action Taken: Regulators issued a shutdown order on 20 August 2026 after a joint inspection and an unsatisfactory response to a show-cause notice; the company's compliance report is under review.
Impact: Ophthalmic production at the facility cannot resume until regulators accept the compliance response; the full contamination status and patient impact of the recalled batches remain unclear.
Regulators were reportedly dissatisfied with the company's response to the notice concerning quality-management failures. The company cannot resume ophthalmic production at the facility until its compliance report is reviewed and considered satisfactory by the authorities.
The regulatory action followed Sun Pharma's voluntary withdrawal of around 11 ophthalmology brands in July 2026. The company had described the withdrawal as a precautionary measure.
Regulators also sought further information concerning 332 batches of ophthalmic suspension products. These are liquid medicines used to treat various eye conditions. Reuters reported that it could not independently establish whether the 332 batches referred exclusively to the 11 recalled brands or included additional products.
Editorial Analysis
Why This Matters
Eye drops and other ophthalmic medicines require stringent quality controls because they are applied directly to the eye. Manufacturing failures involving sterile products can raise patient-safety concerns and require prompt regulatory scrutiny. The case also highlights the importance of transparent product-recall procedures, reliable batch tracking and effective communication between manufacturers, doctors, distributors and regulators. For patients, it is important to distinguish between products withdrawn from the market and other medicines that may have been manufactured at different facilities. A recall affecting selected products does not automatically mean that every medicine made by the company is affected.
Sun Pharma has submitted a compliance report, which was under regulatory review at the time of Reuters' report. The company did not respond to Reuters' requests for comment on the Assam facility and the recall.
The wider safety picture requires careful distinction. The All India Ophthalmological Society had earlier raised concerns about possible contamination in certain batches of Predmet eye drops. An association representative told Reuters that infections had been reported among some patients who used the product and that testing of sealed bottles had found contamination. This does not establish that every recalled product or every affected batch was contaminated.
It also remains unclear whether all the recalled products were exported from India or whether patients experienced adverse effects linked to the wider recall.
