Pharmexcil asks Indiana Ophthalmics to recall contaminated eye drops after complaint by Lanka
1 min read 01 Jun 2023, 08:56 PM ISTPharmexcil has directed the company to investigate the reasons for contamination of the alleged product and update the pharma export council body for further action by 3 June
PremiumNEW DELHI : India’s pharmaceutical export promotion council which is the part of ministry of commerce has asked for the explanation from the Gujarat based pharma company-- Indiana Ophthalmics (LLP), after Sri Lankan Ministry of health raised complaint against India made eye drops linked to causing eye infection in more than 30 people. In the last one year, this is the fourth such incident when Indian made drugs are being declared contaminated in other countries.
Last year, poor quality Indian-made cough syrups were linked to the death of 84 children in Gambia and Uzbekistan followed by the statement made by US FDA linking India made eye drops causing blindness and eye infection to 55 people.
Pharmexcil has sought explanation from the firm to furnish the details with of the licensees to whom you have supplied the subject drugs. “The details of importers details—name & contact, manufacturing license copies & product permissions of subject products," said Uday Bhaskar, Director General of Pharmexcil in a letter to Indiana Ophthalmics.
Bhaskar said, “It has come to with our notice that the Health Ministry of Sri Lanka had issued a recall notice to the Indiana Ophthalmics with immediate effects for the eye drops supplied by your firm after identifying the adverse effects associated with the eye drops. A complaint was raised by the Sri Lankan Ministry of Health to the Indian government that Methylprednisolone eye drops supplied by your firm to the Sri Lanka State Pharmaceutical Corporation in March 2023 and are linked to causing eye infections in more than 30 people. Accordingly, Central Drugs Standard Control Organization (CDSCO) is investigating the complaint."
The matter was also discussed during the Sri Lankan Cabinet meeting on 16, May, 2023 where the president had directed the minister of health to conduct investigations and inquires at the earliest and the matter of paying compensation to the patients by the Indian firm was also raised.
Pharmexcil has directed the company to investigate the reasons for contamination of the alleged product and update the pharma export council body for further action by 3 June failing which they will cancel the Registration cum Membership certificate (RCMC) of the firm.
