India orders Sun Pharma to halt eye medicine production
Indian regulators have ordered Sun Pharmaceutical Industries to halt the production, sale, and distribution of all ophthalmic products manufactured at its Assam facility following a joint inspection that uncovered serious failures in the plant’s quality management system, channelnewsasia.com reported.
The Central Drugs Standard Control Organisation and the office of the Drugs Controller Assam issued the manufacturing stop order on August 20, 2026, targeting the site located in Kokjhar village. The enforcement action escalated after Sun Pharma voluntarily recalled approximately 11 eye-care brands in July 2026, prompting regulators to examine 332 batches of ophthalmic suspensions. The recalled products included Lotepred 1% 5ml eye drops, Nepalact OD, Nepalact-Z, Brinzotim 5ml eye drops, and Depopred 2ml.
Regulatory Scrutiny and Quality Violations at the Assam Plant
The path to the August shutdown began earlier in the summer. Regulators issued a show-cause notice to Sun Pharma on August 10, 2026, citing acute failures in the company’s quality management protocols. Dissatisfied with the corporate response, authorities proceeded with the August 20 order to shutter ophthalmic manufacturing operations at the Kokjhar village site. UA.NEWS noted that the restrictions will stay active until the company submits a compliance report deemed satisfactory by regulators.
Industry experts estimate that the recalled batches translate into hundreds of thousands of individual eye-drop bottles utilized for treating eye inflammation, infections, and chronic eye conditions. Ophthalmology accounts for roughly 3 percent of Sun Pharma’s domestic revenue, according to the company’s 2025-2026 annual report. Beyond domestic market share, the facility represents a cornerstone for the firm’s sterile manufacturing pipeline targeted at the United States.
Contaminated Eye Drops Prompt Patient Safety Warnings
The manufacturing suspension coincided with independent warnings regarding product safety. In June 2026, the All India Ophthalmological Society issued a patient-safety advisory cautioning that specific batches of Predmet eye drops appeared contaminated. Santosh Honavar, a doctor and secretary of the AIOS, told Reuters that adverse infection cases were documented in patients using Predmet. Sealed bottles subsequently investigated by doctors tested positive for contamination, prompting Sun Pharma to execute a separate recall for those specific drops.
The regulatory crackdown in Assam compounds a broader pattern of compliance hurdles for the drugmaker’s sterile production lines. Last year, the United States Food and Drug Administration halted shipments from Sun Pharma’s Halol plant in Gujarat following inspector citations regarding inadequate contamination controls. The company also reported a drop in second-quarter profit on October 30, 2026, weighed down by a one-time charge related to its acquisition of US-based Organon.
Questions remain regarding the full scope of the contamination and distribution footprint. It remains unclear whether all recalled products were tainted, whether affected batches were exported internationally, or whether the 332 cited batches encompassed additional unlisted brands alongside the 11 identified in the initial recall notice. Indian regulators did not issue a public health alert following the Assam recall, and representatives for both Sun Pharma and the regulatory bodies did not respond to requests for comment.