India orders top drugmaker to halt eye medicine production at plant over quality lapses

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.

A guard walks inside the office of Sun Pharmaceutical Industries Ltd in Mumbai, India, Nov 13, 2018. (Photo: Reuters/Francis Mascarenhas)

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 until it submits a satisfactory compliance report.

CNA Games Guess Word Crack the word, one row at a time Buzzword Create words using the given letters Mini Sudoku Tiny puzzle, mighty brain teaser Mini Crossword Small grid, big challenge Word Search Spot as many words as you can Show More Show Less Sun Pharma said previously the site was expected to become one of its largest manufacturing hubs for sterile products in a business identified as a key global growth driver.

The regulators sought more information on the recall of 332 batches of ophthalmic suspension products - liquids used to treat eye conditions - the documents showed.

In an internal notice sent to stockists at the time, the company said it was withdrawing the products as a "precautionary measure." It remains unclear whether all of the recalled products were contaminated.

The company has submitted a compliance report in response to the order, which is being reviewed by the regulator, an official familiar with the matter told Reuters on condition of anonymity because they were not authorised to speak to the media.

Sun Pharma did not respond to Reuters' requests for comment on the Assam plant and the recall. The company says on its website it follows a single global quality standard.

Some of the recalled products included Lotepred 1 per cent 5ml eye drops, Nepalact OD eye drops, Nepalact-Z, Brinzotim eye drops 5ml and Depopred 2ml. The eye drops are used to treat eye inflammation, infections and chronic eye diseases, according to doctors.