Prosecutions loom for 110 drugmakers in India

Regulators in India’s Maharashtra state have compiled a hit list of 110 drugmakers that they intend to prosecute for sub-standard manufacturing practices, according to media reports.

The move follows the Maharashtra Food and Drug Administration’s announcement that around 500 of the 6,000 drugs it reviewed last year did not meet standards laid out by the office of the Drugs Controller General (DCGI).

While the full list has not yet been published, an agency spokesperson confirmed the action, commenting that: “sub-standard drugs have been detected and defaulting companies have been ordered to withdraw the drugs from the market.”

The spokesman explained that: ''After issuing prosecution orders, a charge sheet will be filed against the pharma companies and action will be taken accordingly,''

Government medical education and drugs secretary Bhushan Gagrani also confirmed the move. He told the Times of India on Tuesday that pharmaceutical firms, with manufacturing operations both inside and outside the state, were selling substandard medicines in Maharashtra.

"It's a matter of concern. We have taken it up with FDA commissioners of the respective states. We hope the competent authorities in these states will initiate action against the erring companies,'' added Gagrani

News website webindia123.com reported that companies like Dr Reddy’s Laboratories and Ranbaxy as well as the local operations of international players such as GlaxoSmithKline (GSK) and Pfizer are included on the list, although none of the firms were prepared to comment.

Other media reports suggest that Viagra (sildenafil citrate), the antibiotic moxclav, Ferogen syrup (ferrous fumarate) and the generic anti-emetic ondansetron are among the 500 drugs found to be substandard.