Two More Indian Drugmakers Draw FDA Import Ban

The FDA March 12 banned imports to the U.S. from two more Indian manufacturers, ratcheting up the pressure on the country’s domestic drugmakers to improve product quality.

The agency blocked U.S. imports of products from Sun Pharmaceutical’s Karkhadi, India, plant, citing current good manufacturing practice violations identified during an inspection.

Sun spokesperson Mira Desai says the company will remain fully committed to compliance — noting the drugmaker has already initiated several corrective steps to address the observations made by the FDA. She declined to detail those steps, however.

The Karkhadi site manufactures the antibiotic cephalosporin and its capsules, Desai said.

The import alert allows customs officials to detain product from Sun’s Karkhadi facility without the need for physical examination.

Those restrictions also apply to products produced at Marck Biosciences’ Indian sites in Matar and Kheda, India. Those plants were also added to the FDA’s import alert list on Wednesday. Requests to Marck for comment were not returned by press time.

The import alerts are the latest blow to India’s domestic drug industry, which is facing increased scrutiny in the wake of high-profile quality lapses by Ranbaxy and other Indian manufacturers.

Under a consent decree signed in 2012, Ranbaxy cannot import products from five of its Indian facilities.

The FDA is beefing up its inspections force overseas while slightly scaling back its inspection activities in the U.S. This doesn’t mean, however, that you can sit back and relax. The Global Compliance Investigative Services will help keep you on your toes. Order yours now.