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Last Updated : 2024-05-21 23:24:00
The team of drug inspectors that had visited the Wadhwan plant of Indiana Ophthalmics in Surendranagar, the manufacturer of the eye drop which caused complications in Sri Lanka, found “no major deviation” in manufacturing practices, Gujarat commissioner of Food and Drug Administration Hemant Koshia has told an Indian Media, Scroll.
The Scroll reported that when contacted, Hemant Koshia, Gujarat commissioner of Food and Drug Administration said that a team of drug inspectors had visited the Wadhwan plant of Indiana Ophthalmics in Surendranagar.
The inspection found “no major deviation” in manufacturing practices, Koshia said.
“The samples of their eye drops have been drawn by the CDSCO,” said Koshia, referring to India’s Central Drugs Standard Control Organisation. “They are yet to communicate the lab reports.”
The Gujarat Food and Drug Administration has issued a notice to Indiana Ophthalmics after Sri Lanka raised an alert, but allowed the company to continue its manufacturing of ophthalmic products, the commissioner added.
On June 1, the Pharmaceuticals Export Promotion Council of India, or Pharmexcil, an agency under the Union Ministry of Commerce and Industry, issued a notice to Indiana Ophthalmics asking for product details, its licences and details of who it supplied the drug to.
Uday Bhaskar, secretary of Pharmexcil, said the company responded to all their queries. “We have not suspended their membership,” he said. “It is for the CDSCO to take action against them based on their investigation.”
Koshia, however, said that there are no previous complaints about the manufacturer. Indiana Ophthalmics did not respond to an email message from Scroll.
Alvita Pharma, the supplier of the steroid, also did not respond to an email query on the quantity of eye drops recalled.
Nishigandha Pashte, drug inspector in Mumbai, said the Central Drugs Standard Control Organisation has not informed the Maharashtra FDA about the alert. “Alvita did not manufacture the product here,” said Pashte. “It [is] only labelled and supplied from a third-party manufacturer.”
Pashte added that chances of contamination are maximum during the manufacturing stage. “Once the bottle is sealed, the distributor has to only transport it,” she said.
Tom Friday, 28 July 2023 08:35 PM
They will do their best to cover up any wrong doings, as this would affect their drug sales world wide.
Cisco Friday, 28 July 2023 09:55 PM
Absolutely, what else can expect from our neighbor. Now India is trying to send duty free clothing to SL which source of fabric not confirmed. It means scrap that cannot be export to Europe are sending here. We accept.
A patient Friday, 28 July 2023 09:57 PM
I bought a specific medicine from an Indian company and the medicine's smell was entirely different and awful. I was using the same medicine for 2 or more years, and I made a complaint. I got a reply running in to many pages to show "professional" complaint handling with a result saying no deviations found. I have now made a point not to buy any medicines that is manufactured in India. I do agree India has many pharma companies that make medicines those are better than Western but also has some spoilers. I don't think it is worth risking our health to identify the good ones.
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