India Orders Sun Pharma to Halt Assam Eye Drug Production After Quality Failures

August 20 Order Stops Production, Sales and Distribution

Indian regulators ordered Sun Pharmaceutical Industries to stop manufacturing, selling and distributing all ophthalmic products from its Assam factory on August 20 after an inspection found failures in the systems responsible for medicine quality and safety. Authorities also sought information about the recall of 332 batches of eye medicines, following the company's voluntary withdrawal of about 11 eye care brands in July.

The Central Drugs Standard Control Organisation and the office of Drugs Controller Assam imposed the restrictions after a joint inspection by central and state authorities. The action covers eye medicines made at the facility, which is in Kokjhar village, and extends beyond stopping its production lines to blocking the sale and distribution of those products.

Sun Pharma, India's biggest pharmaceutical company, must satisfy regulators about its compliance before ophthalmic manufacturing can resume. A company compliance report was under regulatory review, according to an official familiar with the matter. No date for a decision or a restart was given.

The shutdown followed an earlier warning from eye specialists about certain batches of Predmet eye drops. The All India Ophthalmological Society (AIOS) issued a patient safety advisory in June, and its secretary said infections had been reported among patients who used that medicine.

How the Recall Became a Regulatory Shutdown

Regulators issued Sun Pharma a show-cause notice on August 10, citing failures in its quality management system. Such a notice asks a company to explain identified problems and why authorities should not take further action. The regulators found the company's response unsatisfactory and ordered the halt 10 days later.

A quality management system is the set of procedures, checks and records a manufacturer uses to make medicines consistently and investigate problems. For products placed in the eye, those controls include keeping the medicine sterile, meaning free from living microorganisms that could cause infection.

The sequence moved from a warning by doctors to a company recall and then to a binding regulatory restriction:

• June: AIOS warned that certain batches of Predmet eye drops appeared to be contaminated.
• July: Sun Pharma voluntarily recalled about 11 eye care brands.
• August 10: Regulators issued a show-cause notice over quality management failures.
• August 20: Central and Assam regulators ordered a halt to manufacturing, sale and distribution of all ophthalmic products from the facility.

The recall addressed products already released into the supply chain. The August order also restricted further production at the factory, making the response broader than the withdrawal of particular batches.

What the 332 Batches Tell Patients and Sellers

Regulators requested further information about 332 batches of ophthalmic suspension products. A suspension is a liquid medicine containing small particles dispersed through it. A batch is a defined production quantity that manufacturers track through records, allowing products to be identified and withdrawn when a problem arises.

Products named in the recall included Lotepred 1% 5ml eye drops, Nepalact OD eye drops, Nepalact-Z, Brinzotim eye drops 5ml and Depopred 2ml. Doctors described the affected medicines as treatments used for eye inflammation, infections and chronic eye diseases.

Product packaging identified the Kokjhar facility as the manufacturing site for most of the recalled medicines. The exact relationship between the 332 batches and the roughly 11 brands remains unresolved: the batch total may cover those brands alone or include additional products. A confirmed total number of bottles was not disclosed.

Batch information matters because a brand can contain many separately manufactured production runs. For pharmacies and distributors, identifying affected stock requires the product name and the relevant batch details. The regulatory order, meanwhile, applies to all ophthalmic products from the Assam facility.

Doctors Reported Infections Linked to Predmet Use

AIOS, an independent organisation of eye specialists, raised its concern before the July recall. Its June advisory warned that certain batches of Predmet eye drops appeared contaminated, bringing patient safety concerns into the sequence before the factory restrictions.

Santosh Honavar, a doctor and secretary of AIOS, described reports of infections among Predmet users and the investigation of unopened bottles:

There were some adverse cases of infections reported in patients who used Predmet and we got sealed bottles investigated and found it was contaminated,

Honavar said Sun Pharma had also recalled those Predmet drops. Sealed bottles were central to his account because investigators examined medicine that had not yet been opened for use.

The number of patients affected, their clinical outcomes and the organism involved were not disclosed. Contamination across every recalled product, exports of the affected medicines and adverse effects involving the other named products also remain unconfirmed. The specific account of infections concerns Predmet users.

A Recall Without a Public Health Alert

Sun Pharma described the withdrawal as a "precautionary measure" in an internal notice sent to stockists, the businesses that hold and supply medicine inventories. The company did not publicly disclose the recall details, and regulators did not issue a public health alert after the withdrawal.

Stockist notices can help remove products from commercial distribution. Patients who already have a bottle at home, however, need accessible product and batch information to identify whether their medicine is affected. The absence of a public alert left the recall without that additional channel of communication.

Sun Pharma did not respond to requests for comment about the Assam plant, the recall or the AIOS advisory. Indian regulators also did not respond to requests for comment. The company's website says it follows a single global quality standard.

The compliance report now places the next decision with regulators. Submission is one step in that process; authorities must find the response satisfactory before ophthalmic production at the factory can resume.

Why the Assam Factory Matters to Sun Pharma

Sun Pharma had previously described the Assam site as a prospective major manufacturing hub for sterile products. The company identified that business as an important driver of global growth, giving the shutdown consequences beyond the immediate withdrawal of eye drops.

Sterile manufacturing depends on controlling contamination throughout production, filling and packaging. The Assam restriction interrupts the company's ability to use this facility for ophthalmic production while it addresses the regulatory findings.

Ophthalmology accounts for about 3% of Sun Pharma's domestic revenue, according to its annual report for 2025-26. In simple terms, that is about three rupees of every 100 rupees the company earns in its Indian business. Eye medicines are also one of its key areas in the United States.

The company reported a fall in profit for the second quarter on October 30, weighed down by a charge related to its acquisition of Organon, which is based in the United States. No financial estimate for the Assam shutdown or the eye medicine recall was disclosed.

Earlier Scrutiny Adds to the Quality Challenge

Sun Pharma has previously faced regulatory action at another sterile manufacturing facility. The US Food and Drug Administration halted shipments from its Halol plant in Gujarat after inspectors identified shortcomings in contamination controls.

The Assam action involves Indian central and state regulators, a different factory and restrictions on manufacturing, sales and distribution of its eye medicines. Across both facilities, contamination controls have been a focus of regulatory scrutiny, making reliable sterile production a concrete business concern for the company.

India's medicine quality standards have also faced closer attention after locally manufactured cough syrups were linked to child deaths in India, Gambia and Uzbekistan. For the Assam factory, the immediate task is specific: provide a satisfactory response to the quality management findings and obtain regulatory clearance to resume ophthalmic production.

Key Points

• Central and Assam regulators ordered the halt on August 20 after finding quality management failures.
• The order covers manufacturing, sale and distribution of all ophthalmic products from Sun Pharma's Assam facility.
• Authorities sought information about 332 recalled batches after a July withdrawal involving about 11 brands.
• AIOS warned about certain Predmet batches in June; its secretary reported infections and contamination found in sealed bottles.
• Sun Pharma submitted a compliance report for regulatory review. No restart date was announced.
• The company did not publicly disclose recall details, and regulators issued no public health alert after the withdrawal.