FDA bans drug imports from Indian plant
pharmafile | July 21, 2015 | News story | Manufacturing and Production | Emcure, FDA, GMP, Good Manufacturing Practices, India, compliance, manufacturing, production, safety
The FDA has blocked US imports from the manufacturing plants of a major Indian pharmaceutical firm over safety fears.
The US regulator says it has concerns that the company may not be meeting quality standards at its factories in Hinjawadi.
The FDA ban applies to human and animal drugs, and covers the majority of Emcure’s medicines. Emcure will not be able to resume shipping of its products to the US until it has addressed the issues of concern, and demonstrated a return to compliance with the Agency’s good manufacturing practices (GMP) guidelines.
Nine drugs were excluded from the import alters. Among those were cidofovir, a generic of Gilead Sciences’ Vistide, which is used to treat eye infections in people with AIDS, as well as the antipsychotic haloperidol and cancer drug carmustine.
Emcure is one of India’s top 20 drugmakers and is the latest among some of India’s largest drugmakers to have come under fire for similar violations in the last few years. Of Emcure’s nine manufacturing plants, including eight in India and one in the US, five are approved by the FDA. Emcure Pharmaceuticals produces drugs of its own as well as manufacturing medicines for Sanofi, Novartis, Roche and Pfizer. It also exports drugs to Europe, Brazil and Japan.
Representatives at both Emcure and Heritage Pharmaceuticals, its US commercial arm, refused to comment.
FDA inspectors found problems with Emcure’s practices at one of its sites in India in 2014, potentially impacting product sterility. Emcure’s site in Pune was also involved in a recall initiated by Israeli drug-maker Teva in May 2014, when Teva recalled nearly 40,000 methyldopa pills. The products were recalled for deviations in lab testing, an issue the FDA has frequently uncovered at Indian plants.
Yasmita Kumar
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