New Delhi: The Gujarat pharma watchdog has found “no major violations of good manufacturing practices (GMP)” at the Surendranagar plant of Indiana Ophthalmics, a firm accused by the Sri Lankan government of supplying eyedrops that caused eye infections in over 30 people.
The Gujarat state drug administration submitted its findings to the Union Health and Family Welfare Ministry and the Drugs Controller General of India (DCGI) in a report this week. ThePrint has accessed a copy of the report.
Last month, the Sri Lankan authorities had written to India alleging that an eyedrop based on the steroid ‘methylprednisolone’, made by Indiana Ophthalmics, was found to be contaminated with bacteria. They claimed it had led to adverse events — including vision loss in some cases — in more than 30 patients who were administered the drops in a hospital.
Following this, the representatives of the Central Drugs Standard Control Authority and the Gujarat state drug administration had conducted a joint inspection of the plant where the drug is manufactured, said sources in the Union health ministry.
H.G. Koshia, the commissioner of the Gujarat Food and Drugs Control Administration, said in the ensuing report that there was no major GMP violation.
“…However samples of the same batch [as the one exported to Sri Lanka] from the retained sample are drawn by the office of the deputy DCGI Ahmedabad… and sent for laboratory analysis and the results are awaited (sic),” the report also said.
Government sources said that the Sri Lankan government had recalled the eyedrops after the complaints about them emerged.
Koshia’s report said that, according to media reports, the bacterial infection found in the eyes of the Sri Lankan patients is from the ‘gram-negative type’ — a multiple-drug-resistant group of bacteria usually found in hospital settings and operation theatres.
“The past history of the Indian Opthalmics LLP, Surendranagar is good in compliance with Drugs and Cosmetics Rules 1945 (sic),” Koshia wrote. “We have to wait till we receive the analytical reports from the lab about the quality of eye drops.”
ThePrint reached the drug manufacturer over email for a comment on the matter but has not received a response.
Notice from export agency
On 1 June, the Pharmaceuticals Export Promotion Council of India (Pharmexcil), an agency under the Union Ministry of Commerce and Industry, had issued a notice to the company.
“Alleged supply of contaminated eyedrops by the company has brought a bad reputation to the Indian pharma industry and is also likely to have an impact on the trust of international agencies on India pharma exports,” the notice, undersigned by Pharmexcil president Uday Bhaskar, had said. ThePrint has a copy of the notice.
Through the notice, the export agency had sought some information, such as details of licensees to whom the drug was supplied, importers and manufacturing licence copies, and product permission (issued by the regulator) of the eyedrops.
It had also asked the company to investigate the alleged contamination and share the findings at the earliest.
(Edited by Sunanda Ranjan)
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