Gujarat firm gets Pharmexcil notice for contamination probe after eye infections reported

Eye drops supplied by Indiana opthalmics have been linked with eye infection in Sri Lanka.

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) served a show cause notice on June 1 to Gujarat-based Indiana ophthalmics, whose eye drops have been linked to infections in Sri Lanka.

In the notice, Uday Bhaskar, Director General of Pharmexcil, expressed concern that the alleged supply of contaminated eye drops by Indiana ophthalmics has tarnished the reputation of the Indian pharmaceutical industry and may affect the trust of international agencies in Indian pharma exports.

Indiana ophthalmics was asked to investigate the alleged contamination of the eye drops and provide an update to the export council by June 3.

The show cause notice stated that failure to submit the requested information by June 3 would result in the suspension of Indiana ophthalmics' Registration cum Membership Certificate (RCMC) without further notice.

Nirav R. Bhatt, Partner at Indiana ophthalmics, was specifically asked to provide copies of manufacturing licenses, product permissions, and details of the licensees to whom the eye drops were supplied in Sri Lanka.

In April, the Sri Lankan Ministry of Health lodged a complaint with the Indian government, linking methylprednisolone eye drops supplied by Indiana ophthalmics to eye infections in over 30 individuals in Sri Lanka.

The Central Drugs Standard Control Organisation (CDSCO) has initiated an investigation into the matter.

The show cause notice also mentioned that the issue of contamination was discussed during a Sri Lankan cabinet meeting on May 16, 2023. The President instructed the Minister of Health to conduct investigations and inquiries promptly, and the matter of providing compensation to affected patients by Indiana ophthalmics was also raised.

Indiana ophthalmics officials did not respond to Moneycontrol's queries regarding the supply of methylprednisolone eye drops in the domestic market. The company claims to have a strong presence in the domestic market and operates in nearly the entire country, as well as over 30 countries worldwide.