DCGI seizes heart stent stocks from J&J distributor in Delhi

MUMBAI/NEW DELHI: Following Johnson & Johnson’s (J&J) announcement that it will withdraw Conor Medsystem’s heart stent from the Indian market after the product failed to complete clinical trials in the US, the Drug Controller General of India (DCGI) has raided the US drug giant’s distributor’s office in New Delhi on Thursday.

“We have inspected Interventional Technologies’ office in New Delhi and seized all existing stocks of the heart stent,” India’s drug controller general M Venkateswarlu told ET.

When contacted, a J&J spokesperson said that the company was unaware of the development. Interventional Technologies, the company’s distributor in India for CoStar, was not available for comment.

“Samples will be sent for testing to assess the quality of the product,” added Mr Venkateswarlu. “The product is being withdrawn as it failed to meet the company’s internal standards.”

The exact number of products currently in the market is still to be assessed. However, thousands of patients in India could be at risk. An estimated 8,000 Indian patients have Conor Medsystem’s tiny mesh cylinders planted in their cardiac arteries.

While the product had not yet completed clinical trials in the US, it had already been approved in certain countries across Europe, Latin America and Asia, including India. The stent, developed by Ireland’s Conor Medsystems, acquired by Johnson & Johnson in February 2007, markets the drug in India through a privately-held Mumbai-based company, Interventional Technologies.

Conor Medsystem has conducted studies comparing its stent, known as CoStar, with its competitor’s product, Taxus Express, developed by Boston Scientific. CoStar releases the drug from a polymer in wells drilled in the metal struts of the stent, while Taxus releases the drug from a layer of polymer on the stent’s surface.

Studies found that patients given a CoStar stent were more likely to die, have a heart attack, or need a repeat stenting procedure within eight months, than patients who received Taxus Express. CoStar patients were also significantly more likely to experience a narrowing of the repaired artery from formation of scar tissue in and around the stent.