India Orders Sun Pharma to Halt Eye Drug Production Over Quality Failures
Sun Pharma Faces Regulatory Action Over Eye Drug Quality
The Central Drugs Standard Control Organisation (CDSCO) and the Assam Drugs Controller issued the order on August 20 following a joint inspection by federal and state authorities. The action came after Sun Pharma voluntarily recalled around 11 eye-care brands in July over concerns involving product quality.
The regulatory decision represents an escalation of scrutiny against Sun Pharma, India’s largest pharmaceutical company. The company will not be allowed to resume ophthalmic drug production at the affected facility until it submits a satisfactory compliance report.
Regulators also sought further details about the recall of 332 batches of ophthalmic suspension products, which are liquid medicines used to treat various eye conditions. Sun Pharma had described the withdrawal as a precautionary measure in an internal notice to stockists. However, it remains unclear whether all the recalled products were contaminated.
According to a Reuters report, Sun Pharma has submitted a compliance report in response to the regulatory order, which is currently under review. The company did not respond to Reuters’ requests for comments regarding the factory shutdown and product recall.
Recall Could Affect Hundreds of Thousands of Eye-Drop Bottles
The recalled products reportedly included Lotepred 1% 5ml, Nepalact OD, Nepalact-Z, Brinzotim 5ml and Depopred 2ml eye drops. These medicines are prescribed for conditions involving eye inflammation, infections and chronic eye diseases.
Reuters reported that packaging information indicated that most of the affected products were manufactured at the company’s facility in Kokjhar village, Assam. However, it could not independently establish whether the 332 recalled batches were limited to the 11 identified brands or involved additional products.
Industry experts estimated that the affected batches could represent hundreds of thousands of eye-drop bottles. It also remains unclear whether any of the recalled medicines were exported or whether patients experienced adverse reactions.
The controversy has emerged amid growing international scrutiny of India’s pharmaceutical manufacturing standards, following previous incidents in which locally produced cough syrups were linked to children’s deaths in India, The Gambia and Uzbekistan.
Concerns over Sun Pharma’s eye products had also surfaced earlier. In June, the All India Ophthalmological Society (AIOS) issued a patient-safety advisory warning that certain batches of Predmet eye drops appeared to be contaminated.
AIOS secretary and ophthalmologist Dr Santosh Honavar told Reuters that infections had been reported among patients who used the product. He said sealed bottles were subsequently examined and found to be contaminated. Sun Pharma also recalled the affected Predmet drops.
Regulators had issued a show-cause notice to the pharmaceutical company on August 10 over deficiencies in its quality management system. After finding the company’s response unsatisfactory, authorities ordered the suspension of all ophthalmic product manufacturing, sales and distribution from the Assam facility.
The latest action adds to the company’s regulatory challenges. Last year, the US Food and Drug Administration halted shipments from Sun Pharma’s Halol facility in Gujarat after inspectors identified shortcomings in contamination controls.
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