Indian drug regulators have ordered Sun Pharmaceutical Industries to stop making, selling and distributing eye-care products from its plant in Assam, Reuters reported on 30 October 2026, citing an official order. The order, dated 20 August, followed a joint inspection that found failures in the plant's quality management system, according to the report.
The order has not been published by India's Central Drugs Standard Control Organisation (CDSCO), and we could not find a public copy. Sun Pharma said in a statement quoted by Reuters that it had voluntarily paused manufacturing at the site, informed the regulators and put remedial measures in place. None of the eye-drop brands named in the reports is authorised for sale in Ireland, according to the HPRA's medicines database.
- What was reported: an order from the CDSCO and the office of the Drugs Controller, Assam, to halt manufacture, sale and distribution of all ophthalmic products from Sun Pharma's facility at Kokjhar village, Assam (Reuters, 30 October 2026).
- Timeline, per Reuters: voluntary withdrawal of about 11 eye-care brands in July, a show-cause notice on 10 August, and the halt order on 20 August.
- Reason given: failures in the quality management system found during a joint federal and state inspection, according to the report.
- Company position: Sun Pharma said it voluntarily began a temporary cessation of manufacturing and informed regulators. An official told Reuters a compliance report from the company is under review.
- Not disclosed: the full text of the order, the specific inspection findings, and whether any affected products were exported.
1. What Reuters reported
According to the Reuters report, the order requires Sun Pharma to stop manufacturing, selling and distributing all ophthalmic products from the Assam facility until it submits a compliance report that satisfies the regulators. Reuters said it had reviewed the order. It was issued jointly by the CDSCO, India's federal drug regulator, and the state drugs controller in Assam.
Reuters reported that the regulators also asked the company for more information about a recall covering 332 batches of ophthalmic suspension products. The news agency said it could not confirm whether those batches were limited to the brands Sun Pharma had withdrawn in July. Industry experts quoted in the report estimated that the affected batches could amount to hundreds of thousands of bottles. Based on product packaging, Reuters found that most of the recalled products were made at the Assam plant.
The report said Indian regulators did not respond to its questions and had not issued a public health alert linked to the recall. We could not find a published copy of the order, and the CDSCO website did not respond when we tried to check it on 2 November 2026.
2. The products involved
Sun Pharma's distribution arm wrote to distributors on 17 July 2026 saying it had decided, as a precautionary measure, to stop further distribution of a group of eye-drop products and asking for stock to be returned, Medical Dialogues reported, citing the letter as seen by the ANI news agency. That report did not give a specific reason for the withdrawal.
| Brand | Also named by Reuters? |
|---|---|
| Lotepred 1% eye drops 5ml | Yes |
| Nepalact OD eye drops | Yes |
| Nepalact-Z | Yes |
| Brinzotim eye drops 5ml | Yes |
| Depopred 2ml | Yes |
| Brinolar, Lotepred 5ml, Lotepred LS, Lotepred T, Toba-F, Nepalact 5ml | Not named individually |
Reuters also referred to a June 2026 advisory from the All India Ophthalmological Society (AIOS), which warned that some batches of Predmet eye drops appeared to be contaminated. The society's secretary told Reuters that some infections had been reported in patients who used Predmet and that Sun Pharma had also recalled those drops. Reuters said it was unclear whether all the recalled products were contaminated, and it could not confirm whether patients had reported problems with the other brands.
3. What Sun Pharma has said
In a statement on Friday 30 October, quoted in the Reuters report, Sun Pharma said it had voluntarily started a temporary halt of manufacturing activities and informed the regulators, and that remedial measures were in place. Reuters said the company did not answer its questions about the recall or the AIOS advisory. An official, who was not named, told Reuters that Sun Pharma had submitted a compliance report and that the regulators were reviewing it.
In July, a Sun Pharma spokesperson told ANI that patient safety remained the company's highest priority and that its teams were working to restore supply of the withdrawn products. We found no announcement about the Assam plant among the company's press releases up to 2 November 2026; the company published its second-quarter results on 30 October. We were unable to access stock exchange filings directly and did not see any reported exchange disclosure on the matter.
Reuters noted that ophthalmology accounts for about 3% of Sun Pharma's revenue in India, according to the company's 2025-26 annual report, and that the company had previously described the Assam site as one expected to become one of its largest hubs for sterile products.
4. Is there an Irish or EU link?
The link to Ireland appears limited. A search of the HPRA's list of authorised medicines on 2 November 2026 returned 29 products held by Sun Pharmaceutical Industries Europe B.V., the group's Dutch-registered marketing company. They include tablets, capsules and injections, such as atorvastatin, sitagliptin, lanreotide and isotretinoin. None is an eye-drop or other ophthalmic product, and none of the brand names in the Indian withdrawal appears on the list.
Reuters said it was unclear whether any of the affected eye products had been exported from India. Sun Pharma no longer appears to manufacture in Ireland. After merging with Ranbaxy, the company said in 2015 that an Irish facility it had acquired through that deal had been identified for divestment, Medical Dialogues reported at the time.
More broadly, any plant that makes medicines for the EU market, wherever it is located, must meet EU Good Manufacturing Practice (GMP). EU regulators record inspection outcomes, including statements of non-compliance, in the EudraGMDP database run by the European Medicines Agency (EMA). Action by an Indian state or federal regulator does not by itself change a site's EU status. Readers can follow current Irish supply issues on our drug shortages tracker; we have seen no HPRA or EMA notice linking this case to a shortage in Ireland.
5. Wider scrutiny of Sun Pharma plants
The Reuters report noted that the US Food and Drug Administration (FDA) halted shipments last year from Sun Pharma's Halol plant in Gujarat after inspectors cited shortcomings in contamination controls. That is a separate site and a separate regulator, and Reuters did not link it to the Assam case. We found no public report of an FDA warning letter or import alert for the Assam facility.
Sterile eye drops are among the more demanding products to make, because contamination in a multi-dose bottle can reach the eye directly. EU rules for sterile manufacturing, set out in Annex 1 of the EU GMP guide, cover how such plants control contamination; our explainer on Annex 1 sets out the main requirements. More detail on the company's clinical research activity is on our Sun Pharmaceutical Industries sponsor page.
Frequently Asked Questions
Has the Indian regulator confirmed the order?
Not publicly. The order was reported by Reuters, which said it had seen the document. The CDSCO had not published it or commented as of 2 November 2026. Sun Pharma has confirmed that manufacturing at the site is paused, describing the step as voluntary.
Are any of the affected eye drops sold in Ireland?
We found none. The HPRA's database lists 29 authorised Sun Pharma group products in Ireland, and none is an ophthalmic product. None of the brand names in the Indian withdrawal appears on the HPRA list.
When could production restart?
According to Reuters, the halt remains until the regulators accept the company's compliance report. Neither Sun Pharma nor the regulators have given a date.
Outlook
The key next step is the regulators' decision on Sun Pharma's compliance report. Points to watch include whether the CDSCO publishes the order or a drug alert, whether Sun Pharma files a disclosure with Indian stock exchanges or comments on its earnings call, and whether any EU or US regulator records a change in the Assam site's status. We will update this report if official documents become available.
Sources
- Health Products Regulatory Authority, Authorised medicines for human use (search for "Sun Pharma", list updated 29 October 2026), accessed 2 November 2026
- Sun Pharmaceutical Industries, Press releases, accessed 2 November 2026
- European Medicines Agency, EudraGMDP database
- Reuters (Rishika Sadam), India orders Sun Pharma to halt eye-care drug production at Assam plant, 30 October 2026 (syndicated copy)
- Medical Dialogues, Sun Pharma withdraws 11 eye drop brands including Lotepred, Brinolar from distribution in India, 3 August 2026
- Medical Dialogues, Sun Pharma to sell manufacturing unit in Ireland, 11 September 2015
Cover image: AI-generated illustration of a sterile eye-drop filling line. It does not show Sun Pharma's plant, products or staff.
