The joint regulatory order follows a July recall by Sun Pharma involving hundreds of thousands of eye-care bottles across roughly 11 distinct brands. Regulatory scrutiny intensified after ophthalmologists flagged infection risks and contamination tied to sealed bottles of the company's Predmet eye drops earlier in the summer. Although Sun Pharma framed the market withdrawals as a precautionary step to stockists, it withheld public disclosures regarding the incident. The firm must now await formal clearance on its compliance report before restarting eye medicine lines at the facility.
Key points
Ophthalmic production at the Kokjhar plant cannot resume until authorities fully review a…: Ophthalmic production at the Kokjhar plant cannot resume until authorities fully review and approve a satisfactory compliance report.
The manufacturing stoppage disrupts Sun Pharma's strategic plans to utilize the Assam fac…: The manufacturing stoppage disrupts Sun Pharma's strategic plans to utilize the Assam facility as a global growth driver for sterile pharmaceuticals.
The regulatory intervention adds to intense domestic and international scrutiny surroundi…: The regulatory intervention adds to intense domestic and international scrutiny surrounding manufacturing standards across the Indian pharmaceutical industry.
Sources checked by our analysis pipeline: 1
Indian regulators have escalated action against India's largest drugmaker, Sun Pharma, barring ophthalmic drug production at its Assam factory until it submits a satisfactory compliance report.
HYDERABAD: Indian drug regulators ordered Sun Pharmaceutical Industries to stop manufacturing, selling and distributing ophthalmic products made at its Assam facility after finding failure in its quality management system, documents reviewed by Reuters showed.
The Central Drugs Standard Control Organisation and the office of Drugs Controller Assam ordered the shutdown on Aug 20 after a joint federal-state inspection of the facility identified lapses in the system meant to ensure product quality and safety, following Sun Pharma's move in July to voluntarily recall about 11 eye-care brands.
India's drug quality standards have come under increased scrutiny at home and overseas in recent years after locally made cough syrups were linked to the deaths of children in India and also in countries including Gambia and Uzbekistan.
The regulatory agencies' move marks an escalation of the action against Sun Pharma, India's biggest pharmaceutical firm, which will be unable to continue ophthalmic drug production at the Assam factory…
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