India’s drug regulators have stopped Sun Pharmaceutical Industries from making, selling and distributing eye-care medicines from its manufacturing facility in Assam, after an inspection found failures in the plant’s quality management system. The order, first reported by Reuters via The Hindu on 30 October, means the country’s largest drugmaker cannot restart ophthalmic production at the site until regulators accept its compliance report.

What the regulators ordered

• Who acted: the Central Drugs Standard Control Organisation (CDSCO) and the office of the Drugs Controller, Assam, after a joint central-state inspection
• Show-cause notice: issued on 10 August 2026, citing quality management system failures
• Stop order: issued on 20 August 2026, covering manufacture, sale and distribution of all ophthalmic products from the facility
• Batches under review: regulators sought details of the recall of 332 batches of ophthalmic suspension products
• Status: Sun Pharma has filed a compliance report, which is under review, according to an official quoted by Reuters

How the recall began

The action follows Sun Pharma’s voluntary recall in July of about 11 eye-care brands. In a notice to stockists, the company described the withdrawal as a “precautionary measure”. Products named in the recall included Lotepred 1% 5 ml eye drops, Nepalact OD, Nepalact-Z, Brinzotim 5 ml eye drops and Depopred 2 ml, which doctors use to treat eye inflammation, infections and chronic eye disease.

Based on product packaging, most of the recalled products were made at the Assam facility in Kokjhar village, Reuters reported. It is not clear whether all the recalled batches were contaminated, whether any were exported, or whether patients reported side effects. Separately, the All India Ophthalmological Society (AIOS) had issued a patient-safety advisory in June warning that certain batches of Predmet eye drops appeared contaminated, and Sun Pharma also recalled those drops.

What Sun Pharma says

“We voluntarily initiated a temporary cessation of manufacturing activities and informed the regulators,” Sun Pharma said in a statement on 30 October, adding that remedial measures have been put in place, Business Today reported.

Why it matters for Indian pharma

The company had earlier said the Assam site was expected to become one of its largest hubs for sterile products, a business it sees as a key global growth driver. Sterile ophthalmic suspensions are among the harder dosage forms to make consistently, which puts contamination control, investigation and change-control systems under close watch.

The order lands as regulators tighten quality oversight across the industry. CDSCO recently asked states to enforce batch testing of raw materials, excipients and finished drugs, and the USFDA this week flagged 11 observations at Granules India’s Gagillapur plant. Sun Pharma’s own Q2 FY27 results showed India formulations growing 17.3%, making domestic manufacturing reliability central to its outlook.

Key takeaways

• CDSCO and Assam’s drug controller have halted all ophthalmic production at Sun Pharma’s Assam plant over quality system failures.
• Production can resume only after regulators accept Sun Pharma’s compliance report, which is now under review.
• The case covers 332 recalled batches and follows a July recall of about 11 eye-care brands.

Like

Dislike

Be a part of Elets Collaborative Initiatives. Join Us for Upcoming Events and explore business opportunities. Like us on Facebook , connect with us on LinkedIn and follow us on Twitter , Instagram.

"Exciting news! Elets technomedia is now on WhatsApp Channels Subscribe today by clicking the link and stay updated with the latest insights!" Click here!