Indian drug regulators have directed Sun Pharmaceutical Industries to stop manufacturing, selling and distributing ophthalmic products produced at its Assam facility after identifying deficiencies in the plant's quality management system. The action follows a voluntary recall of several eye-care brands and a regulatory inspection that raised concerns about manufacturing standards and product safety.
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 August 20, 2026, after a joint inspection of the facility in Kokjhar village.
The restriction will remain in place until the company submits a satisfactory compliance report and the regulators are satisfied with the corrective measures.
Regulators Raise Concerns Over Quality Management System
The regulatory action followed an inspection that identified shortcomings in the systems designed to maintain the quality and safety of pharmaceutical products.
The authorities had issued a show-cause notice to Sun Pharma on August 10, seeking an explanation for the reported deficiencies. However, according to the documents reviewed by Reuters, regulators were dissatisfied with the company's response and subsequently ordered the suspension of manufacturing, sale and distribution of all ophthalmic products from the facility.
The development represents an escalation of regulatory scrutiny for Sun Pharma, India's largest pharmaceutical company.
Recall Involved 332 Batches of Eye-Care Products
The documents also indicate that regulators sought additional information about the recall of 332 batches of ophthalmic suspension products.
Sun Pharma had voluntarily initiated a recall covering approximately 11 eye-care brands in July, describing the withdrawal as a precautionary measure in an internal notice to stockists.
Some of the products mentioned in the report include:
Lotepred 1% 5ml eye drops
Nepalact OD eye drops
Nepalact-Z
Brinzotim 5ml eye drops
Depopred 2ml
These products are used for various eye conditions, including inflammation, infections and chronic eye diseases.
However, it remains unclear whether all recalled products were contaminated. Reuters also reported that it could not independently establish whether all 332 batches cited by regulators were limited to the 11 identified brands or included additional products.
Industry experts indicated that the affected batches could represent hundreds of thousands of bottles, although the precise quantity has not been officially confirmed.
Sun Pharma Says Corrective Measures Have Been Introduced
In a statement issued on October 30, Sun Pharma said it had voluntarily initiated a temporary cessation of manufacturing activities and informed the regulators.
The company added that remedial measures had been implemented. A person familiar with the matter told Reuters that Sun Pharma had submitted a compliance report in response to the regulatory order, which was under review.
The company had previously identified the Assam facility as a potential major manufacturing hub for sterile products, an area considered important to its future global business.
Ophthalmology contributes approximately 3% of Sun Pharma's domestic revenue, according to its 2025–26 annual report. The segment is also among the company's important business areas in the United States.
Patient-Safety Concerns Add to Regulatory Scrutiny
The latest development comes amid broader scrutiny of pharmaceutical quality standards in India and international markets.
In June, the All India Ophthalmological Society (AIOS), an independent organisation of eye specialists, issued a patient-safety advisory concerning certain batches of Predmet eye drops.
Santosh Honavar, an AIOS secretary, told Reuters that infections had been reported among some patients who used the product and that sealed bottles examined during an investigation were found to be contaminated. Sun Pharma had also recalled the Predmet drops, according to the report.
The relationship between this advisory and the wider recall requires careful distinction. The available report does not establish that every recalled eye-care product was contaminated or that all products caused adverse effects. It also remains unclear whether the affected products were exported or whether additional patient complaints were recorded.
Earlier Regulatory Action at Another Manufacturing Facility
Sun Pharma's sterile manufacturing operations have faced regulatory scrutiny before. The report notes that the US Food and Drug Administration (FDA) halted shipments from the company's Halol facility in Gujarat last year after inspectors identified shortcomings in contamination controls.
The latest action involving the Assam plant adds to the importance of quality assurance, manufacturing documentation and regulatory compliance in pharmaceutical production.
For companies operating in regulated industries, effective internal controls and independent reviews are important for identifying process gaps and maintaining compliance. Businesses can explore internal audit services to review operational controls, documentation and risk-management procedures.