India orders Sun Pharma to halt eye-care drug production at plant after quality lapses
A Reuters investigation reported an August regulatory order after quality failures; the company described its manufacturing pause as voluntary.
TL;DR
- Reuters reported that Indian regulators ordered a halt to ophthalmic manufacturing, sales and distribution at Sun Pharma’s Assam plant after identifying quality-system failures.
- Sun Pharma said it voluntarily recalled 11 ophthalmology products and temporarily ceased manufacturing, while declining to comment on the reported order.
- Regulators are reviewing a company compliance report, and the full extent of contamination remains unclear.
Indian regulators ordered Sun Pharma to stop making, selling and distributing ophthalmic products from its Assam facility, Reuters reported after reviewing documents. According to Reuters, the order was issued on August 20 following a joint inspection that found quality-management failures. [1]
Reuters reported that regulators requested more information about 332 recalled batches of ophthalmic suspensions. The news agency could not determine whether all of those batches belonged to the roughly 11 brands identified in the recall notice, or whether every recalled product was contaminated. [1]
The Economic Times separately reported in August that a wider recall followed a safety alert from the All India Ophthalmological Society concerning some batches of Predmet eye drops. The paper reported that Sun Pharma described the withdrawal as a precaution. [2]
On an October 30 earnings call, managing director Kirti Ganorkar said Sun Pharma had voluntarily recalled 11 ophthalmology products and temporarily stopped manufacturing, but declined to comment on the media report. Reuters said the company had submitted a compliance report that regulators were reviewing. [1] [3]
Why it matters
The reported order and recall expose how quality failures can interrupt a drugmaker’s ophthalmic supply, while the company’s account and the regulator’s review leave the restart conditions uncertain.
Editor's note
The August 20 regulatory order is attributed to Reuters, which reviewed the documents; the independent Economic Times report covers the preceding recall. The company did not confirm the order on the earnings call.