Regulator orders Sun Pharma to shut Assam plant over eye-drop quality lapses; what you should know
The action prevents Sun Pharma, India's biggest pharmaceutical company, from resuming ophthalmic drug production at the facility until regulators accept its compliance report.
- Oct 31, 2026,
- Updated Oct 31, 2026 8:42 AM IST
Safety concerns for patients using eye-care products have deepened after Indian drug regulators ordered Sun Pharmaceutical Industries to stop manufacturing, selling and distributing ophthalmic products made at its Assam facility over failures in its quality management system, according to documents reviewed by Reuters.
The order on August 20 came after Sun Pharma voluntarily recalled about 11 eye-care brands and all ophthalmic products from the facility in July. Regulators have sought information about 332 recalled batches, while the company has submitted a compliance report and said it has implemented remedial measures. It remains unclear whether all the recalled products were contaminated, whether they were exported or whether patients reported any adverse effects.
Sun Pharma's Assam facility ordered to halt production
The Central Drugs Standard Control Organisation and the office of the Drugs Controller Assam ordered the shutdown after a joint central-state inspection identified lapses in systems intended to ensure product quality and safety.
The action prevents Sun Pharma, India's biggest pharmaceutical company, from resuming ophthalmic drug production at the facility until regulators accept its compliance report. The company had previously said the Assam site was expected to become one of its largest manufacturing hubs for sterile products, a business it has identified as a key global growth driver.
The regulators had issued a show-cause notice to Sun Pharma on August 10, citing failures in the quality management system, the documents showed. Dissatisfied with the company's response, they ordered a halt to the manufacturing, sale and distribution of all ophthalmic products from the facility.
Regulators seek details of 332 recalled batches
The regulators sought more information about the recall of 332 batches of ophthalmic suspension products, which are liquids used to treat eye conditions.
In an internal notice sent to stockists at the time, Sun Pharma said it was withdrawing the products as a "precautionary measure." The company did not publicly disclose details of the recall.
A company compliance report submitted in response to the order is being reviewed by the regulator, an official familiar with the matter told Reuters. The official declined to be identified because they were not authorised to speak to the media.
"We voluntarily initiated a temporary cessation of manufacturing activities and informed the regulators," Sun Pharma said in a statement on Friday, adding that remedial measures had been put in place.
The company did not respond to a request for comment on the recall. It says on its website that it follows a single global quality standard.
Recall could involve hundreds of thousands of bottles
The recalled products included Lotepred 1% 5ml eye drops, Nepalact OD eye drops, Nepalact-Z, Brinzotim eye drops 5ml and Depopred 2ml. According to doctors, the drops are used to treat eye inflammation, infections and chronic eye diseases.
Based on product packaging, most of the recalled products were manufactured at the Assam facility in Kokjhar village. Reuters could not independently verify whether the 332 batches cited by regulators were related only to the 11 brands identified in the recall notice or included additional brands.
The affected batches could amount to hundreds of thousands of eye-drop bottles, according to industry experts who declined to be identified because they were not authorised to speak publicly.
Ophthalmology contributes about 3% of Sun Pharma's domestic revenue, according to its 2025-26 annual report. It is also one of the company's key areas in the US.
Sun Pharma reported a fall in second-quarter profit on Friday, weighed down by a one-time charge related to its acquisition of US-based Organon.
Patient-safety advisory flagged Predmet eye drops
The recall coincided with a patient-safety advisory issued in June by the All India Ophthalmological Society, an independent body of eye specialists. The advisory warned that certain batches of Predmet eye drops appeared to be contaminated.
"There were some adverse cases of infections reported in patients who used Predmet and we got sealed bottles investigated and found it was contaminated," Santosh Honavar, a doctor and secretary of AIOS, told the news agency. He added that Sun Pharma had also recalled those Predmet drops.
Sun Pharma did not respond to a request for comment on the AIOS advisory.
Indian drug quality standards face scrutiny
Indian regulators did not respond to requests for comment, and the regulatory agency did not issue a public health alert after the recall.
India's drug quality standards have faced increased scrutiny at home and overseas in recent years after locally manufactured cough syrups were linked to the deaths of children in India and countries including Gambia and Uzbekistan.
This is not the first time Sun Pharma's sterile manufacturing facilities have faced regulatory scrutiny. Last year, the US Food and Drug Administration halted shipments from the company's Halol plant in Gujarat after inspectors cited shortcomings in contamination controls.
Sun Pharma's Assam facility will remain unable to manufacture ophthalmic drugs until regulators accept its compliance report. The company has said it voluntarily stopped manufacturing activities and implemented remedial measures, while the scale and impact of the recall involving 332 batches of eye-care products remain unclear.
Safety concerns for patients using eye-care products have deepened after Indian drug regulators ordered Sun Pharmaceutical Industries to stop manufacturing, selling and distributing ophthalmic products made at its Assam facility over failures in its quality management system, according to documents reviewed by Reuters.
The order on August 20 came after Sun Pharma voluntarily recalled about 11 eye-care brands and all ophthalmic products from the facility in July. Regulators have sought information about 332 recalled batches, while the company has submitted a compliance report and said it has implemented remedial measures. It remains unclear whether all the recalled products were contaminated, whether they were exported or whether patients reported any adverse effects.
Sun Pharma's Assam facility ordered to halt production
The Central Drugs Standard Control Organisation and the office of the Drugs Controller Assam ordered the shutdown after a joint central-state inspection identified lapses in systems intended to ensure product quality and safety.
The action prevents Sun Pharma, India's biggest pharmaceutical company, from resuming ophthalmic drug production at the facility until regulators accept its compliance report. The company had previously said the Assam site was expected to become one of its largest manufacturing hubs for sterile products, a business it has identified as a key global growth driver.
The regulators had issued a show-cause notice to Sun Pharma on August 10, citing failures in the quality management system, the documents showed. Dissatisfied with the company's response, they ordered a halt to the manufacturing, sale and distribution of all ophthalmic products from the facility.
Regulators seek details of 332 recalled batches
The regulators sought more information about the recall of 332 batches of ophthalmic suspension products, which are liquids used to treat eye conditions.
In an internal notice sent to stockists at the time, Sun Pharma said it was withdrawing the products as a "precautionary measure." The company did not publicly disclose details of the recall.
A company compliance report submitted in response to the order is being reviewed by the regulator, an official familiar with the matter told Reuters. The official declined to be identified because they were not authorised to speak to the media.
"We voluntarily initiated a temporary cessation of manufacturing activities and informed the regulators," Sun Pharma said in a statement on Friday, adding that remedial measures had been put in place.
The company did not respond to a request for comment on the recall. It says on its website that it follows a single global quality standard.
Recall could involve hundreds of thousands of bottles
The recalled products included Lotepred 1% 5ml eye drops, Nepalact OD eye drops, Nepalact-Z, Brinzotim eye drops 5ml and Depopred 2ml. According to doctors, the drops are used to treat eye inflammation, infections and chronic eye diseases.
Based on product packaging, most of the recalled products were manufactured at the Assam facility in Kokjhar village. Reuters could not independently verify whether the 332 batches cited by regulators were related only to the 11 brands identified in the recall notice or included additional brands.
The affected batches could amount to hundreds of thousands of eye-drop bottles, according to industry experts who declined to be identified because they were not authorised to speak publicly.
Ophthalmology contributes about 3% of Sun Pharma's domestic revenue, according to its 2025-26 annual report. It is also one of the company's key areas in the US.
Sun Pharma reported a fall in second-quarter profit on Friday, weighed down by a one-time charge related to its acquisition of US-based Organon.
Patient-safety advisory flagged Predmet eye drops
The recall coincided with a patient-safety advisory issued in June by the All India Ophthalmological Society, an independent body of eye specialists. The advisory warned that certain batches of Predmet eye drops appeared to be contaminated.
"There were some adverse cases of infections reported in patients who used Predmet and we got sealed bottles investigated and found it was contaminated," Santosh Honavar, a doctor and secretary of AIOS, told the news agency. He added that Sun Pharma had also recalled those Predmet drops.
Sun Pharma did not respond to a request for comment on the AIOS advisory.
Indian drug quality standards face scrutiny
Indian regulators did not respond to requests for comment, and the regulatory agency did not issue a public health alert after the recall.
India's drug quality standards have faced increased scrutiny at home and overseas in recent years after locally manufactured cough syrups were linked to the deaths of children in India and countries including Gambia and Uzbekistan.
This is not the first time Sun Pharma's sterile manufacturing facilities have faced regulatory scrutiny. Last year, the US Food and Drug Administration halted shipments from the company's Halol plant in Gujarat after inspectors cited shortcomings in contamination controls.
Sun Pharma's Assam facility will remain unable to manufacture ophthalmic drugs until regulators accept its compliance report. The company has said it voluntarily stopped manufacturing activities and implemented remedial measures, while the scale and impact of the recall involving 332 batches of eye-care products remain unclear.