INDIA BUSINESS WORLD - JULY 1st - JULY 31st - 2008
RANBAXY FACES ADULTERATION CHARGES IN US
THE US government has levelled serious allegations against India’s largest drugmaker, Ranbaxy Laboratories, which in turn has refuted the charges. In a motion filed in the district court of Maryland (US) on July 3, the US Department of Justice (DoJ) has said there is evidence to suggest that Ranbaxy used active pharmaceutical ingredients (API) from unapproved sources, blended unapproved API with approved API, and used less-than-approved API at its Paonta Sahib (Himachal Pradesh) plant in its drugs, resulting in the sale of ‘subpotent, super potent or adulterated medicines’ in the US market. APIs are raw materials used for manufacturing medicines.
The department has also said contrary to the stipulation of manufacturers using approved sites, evidence suggests that Ranbaxy manufactures products at other plants and obtains API from unapproved sources.
But when contacted, a Ranbaxy spokesperson said: ”To the extent that Ranbaxy was previously aware of these (unapproved API) allegations, it has investigated them and has found no evidence that they are true.”
The papers filed with the district court by the US government say it is investigating Ranbaxy and certain employees concerning violations of federal laws, including the Federal Food, Drug, and Cosmetic Act. The government believes that these violations have resulted in the introduction of adulterated and misbranded products in the US. The investigations also involves allegations of conspiracy, false statements and healthcare frauds.
Ranbaxy disputes this. The US government has brought no charges against any of the company’s employees; Ranbaxy has no reason to believe that any of these allegations are true, said the company spokesperson.
|
