The US Food and Drug Administration (FDA) has banned the import of more than 30 generic drugs manufactured by Ranbaxy Laboratories, citing serious manufacturing deficiencies at two of the company’s plants in India.
The banned drugs include Zocor, a high-selling generic antibiotic to treat high cholesterol, and popular diabetes drug Metformin.
The news triggered a 6.6 per cent slide in Ranbaxy share prices that closed at Rs 379.1 on Wednesday.
The FDA issued two warning letters to Ranbaxy and an import alert for generic drugs produced at the company’s plant at Dewas in Madhya Pradesh and Paonta Sahib in Himachal Pradesh.
FDA said the problems at these two plants relate to deficiencies in the drug manufacturing process.
“These actions are proactive measures that the FDA is taking in order to assure that all drugs that reach the American
public are manufactured according to cGMP(current good manufacturing practice) requirements,” FDA said in a statement issued overnight.
“With this action we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality,” said Janet Woodcock, director, FDA’s Centre for Drug Evaluation and Research (CDER).
The warning letters document the results of FDA investigations at these two sites.
Ranbaxy said it was disappointed by the FDA action.
“The company has responded to each concern FDA has raised during the past two years and had thought that progress was being
made… the company has just received the warning letters that FDA has issued and has not had the opportunity to review those concerns that FDA has determined are unresolved,” the company said in a statement.
While this action does not involve removing products from the market, FDA has no evidence to date that Ranbaxy has shipped defective products.