Controversial eye drop: “No major deviation” in manufacturing practices: Indian drug inspectors

• The samples of their eye drops have been drawn by the CDSCO
• It is for the CDSCO to take action against them based on their investigation

 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 minimum during the manufacturing stage. “Once the bottle is sealed, the distributor has to only transport it,” she said.   

• the chances of contamination are minimum during the manufacturing stage