It is really an American dream getting shattered by the Indian drug manufacturer Ranbaxy Laboratories. The US department of Justice has filed a permanent injunction on this Indian drug manufacturer against selling medicines in the American market.
Ranbaxy Laboratories entered the American market about three months back with the cholesterol reducing Lipitor (Atorvastatin). They entered with a bang as the patent of Pfizer expired. The consent decree was filed by the Justice Department in the US District court of Maryland. The appeal was made with the initiative of the Food and Drug Administration.
Explaining the reason for the permanent injunction, Department of Justice said that they have found many problems with the drug manufacturing process and testing in their India and also at the US facilities owned by Ranbaxy Inc.
After investigation, it was found that no records were maintained to show that drug manufacturing was going on properly and it was found that drugs were unable to meet their specifications. Ranbaxy was also failing to separate the manufacture of penicillin drugs from non-penicillin drugs and that may bring in cross-contamination. The procedures for contamination of sterile drugs were also not adequate. Testing of drugs was also insufficient to see that drugs will be able to maintain their strength and effectiveness till their date of expiry.
