# Sun Pharma Halts Assam Eye-Drop Production Over Quality Deficiencies Regulators suspended manufacturing at the Kokjhar facility following significant quality management system failures. - **Source:** [mint - companies](https://www.livemint.com/rss/companies) - **Published:** 2026-10-31 - **Topic:** [Business](https://brifing.si/c/business) - **Original article:** - **On Brifing:** https://brifing.si/s/2a10361b-e8fb-49ce-8009-2de9cabd92e7 ## Regulatory Halt in Assam Indian drug regulators, including the CDSCO and Assam state authorities, ordered Sun Pharmaceutical Industries to cease all manufacturing, sales, and distribution of ophthalmic products at its Kokjhar facility. This directive followed a joint inspection that uncovered significant deficiencies in the company's quality management system, effectively halting operations until compliance is verified. ## Voluntary Recall Preceded Order The regulatory intervention occurred after Sun Pharma initiated a voluntary recall in July, affecting 11 eye-care brands and all ophthalmic products manufactured at the Assam site. The company initially labeled the withdrawal as a precautionary measure, but subsequent regulatory scrutiny revealed deeper systemic issues that necessitated a formal suspension of production activities. ## Scope of Affected Products The recall involves 332 batches of ophthalmic suspension products, which are liquid formulations used to treat inflammation, infections, and chronic eye conditions. Specific brands impacted include Lotepred 1%, Nepalact OD, Nepalact-Z, Brinzotim, and Depopred. Industry experts suggest the total volume of recalled items could reach hundreds of thousands of individual product bottles. ## Failed Compliance Justification Following a show-cause notice issued on August 10 regarding quality shortcomings, Sun Pharma submitted an explanation to the authorities. Regulators deemed the company's response unsatisfactory, leading to the formal suspension order on August 20. The facility cannot resume production until the regulators review and formally accept a new corrective compliance report. ## Current Status of Review Sun Pharma has submitted a report detailing the corrective measures implemented to address the identified quality deficiencies. An official familiar with the matter confirmed that the regulator is currently reviewing this submission. The company stated it initiated a temporary cessation of activities and remains committed to resolving the issues to resume operations. ## Unanswered Safety Questions Despite the extensive recall, several critical questions remain unresolved regarding the nature of the deficiencies. It is currently unclear if the recalled products were contaminated, if any affected batches were exported to international markets, or if patients have reported adverse health effects. Regulatory documents do not confirm contamination across all recalled batches. ## Financial Impact and Context The suspension arrives as Sun Pharma faces broader financial pressure, reporting a decline in second-quarter profits partly due to one-time charges from the Organon acquisition. The ophthalmology segment represents approximately 3% of the company's domestic revenue and serves as a key business area within the competitive United States pharmaceutical market. ## Operational Risk Implications This incident underscores the high stakes of quality management in pharmaceutical manufacturing, where systemic failures can lead to total production halts. For Sun Pharma, the challenge lies in restoring regulatory confidence while managing the financial impact of the recall. Future operations depend entirely on the successful validation of their corrective measures. ## Sources covering this story - https://www.livemint.com/companies/news/ophthalmic-products-recalled-why-drug-regulators-ordered-sun-pharma-to-halt-eye-drop-production-at-assam-plant-11793441384482.html — --- _Summary written by Brifing from the original reporting. Copyright in the original article belongs to its publisher; read the full piece at the link above._