Sun Pharma Told to Stop Making Eye Drops at India Plant

India's drug safety officials have ordered Sun Pharmaceutical Industries — the country's largest drug company — to stop making, selling, and shipping eye medicines from its factory in the state of Assam. The order came on August 20 after government inspectors found that the plant had serious failures in its quality management system, which is the set of rules meant to keep medicines safe. The shutdown means Sun Pharma cannot make eye drugs at that factory until it proves to regulators that it has fixed the problems.

Before the shutdown order, Sun Pharma had already voluntarily recalled, or taken back, about 11 brands of eye-care products in July. Regulators later asked for more details about the recall, which covered 332 batches of eye drop products. Industry experts say that many batches could add up to hundreds of thousands of individual bottles of eye drops. It is still unclear whether all of the recalled products were actually contaminated, or whether any patients were harmed.

Some of the recalled eye drops included products used to treat eye inflammation, infections, and long-term eye diseases. Reuters, the news agency that broke this story, found that most of the recalled products were made at the Assam factory in a village called Kokjhar. Sun Pharma told its distributors in a private notice that it was pulling the products as a 'precautionary measure,' meaning the company acted out of caution rather than confirmed proof of danger. The company never made the details of the recall public.

An important warning had already been raised before the government acted. In June, a group of independent eye doctors called the All India Ophthalmological Society (AIOS) put out a patient-safety advisory. They warned that certain batches of a Sun Pharma product called Predmet eye drops appeared to be contaminated. Dr. Santosh Honavar, a doctor and leader of AIOS, said his group had sealed bottles tested and found contamination, and that Sun Pharma had also recalled those drops.

The government agencies first sent Sun Pharma a show-cause notice on August 10, giving the company a chance to explain itself. When the agencies were not satisfied with the company's response, they issued the full manufacturing halt ten days later. Sun Pharma has since submitted a compliance report — a document explaining what it plans to fix — and regulators are currently reviewing it. Sun Pharma did not respond to requests for comment on the Assam plant situation.

This is not the first time one of Sun Pharma's factories has faced trouble with regulators. In 2025, the United States Food and Drug Administration (FDA) stopped shipments from Sun Pharma's plant in Gujarat state after inspectors found problems with contamination controls there too. The Assam plant was supposed to become one of Sun Pharma's biggest factories for sterile products, which are medicines made in germ-free conditions. Eye drops are one of the company's key product areas both in India and in the United States.

India's drug quality has come under greater scrutiny — or close, careful attention — both inside the country and around the world in recent years. Cough syrups made in India were linked to the deaths of children in India and in countries such as Gambia and Uzbekistan. These incidents have pushed regulators to inspect drug factories more carefully. Sun Pharma says on its website that it follows a single global quality standard for all of its products.