Over the last several years, dozens of Indian drug manufacturers have received warnings from the FDA about bad manufacturing practices. In one of the latest incidents, Indian pharma firm Wockhardt is accused of deleting data and hiding the results of tests that did not turn out as hoped. The company will not be allowed to ship products to the US until it remedies the situation to the FDA’s satisfaction.
Multiple Recalls from Indian Pharma Company:
Hundreds of millions of tablets and capsules have been recalled. They include blood pressure pills amlodipine and lisinopril, the sleeping pill zolpidem and an antibiotic called azithromycin.
Other Indian Pharma Outfits Are Also in Trouble:
IPCA and Aurobindo have also run into difficulties with the agency. IPCA received a warning letter that will prevent US sales of drugs made in several of its plants. Other Indian drug firms, Dr. Reddy’s Laboratories and Sun Pharmaceutical Industries, also got warnings from the FDA late last year. You can read more about that here, here and here.
In addition, Ranbaxy Laboratories, the largest of the Indian pharma companies, has had multiple run-ins with the agency. In 2008, Congress contemplated strengthening oversight when data emerged that the FDA had known about fabrication of data in new drug applications for many months. You can read about that here. The company has also had difficulties maintaining good manufacturing practices.
Since a majority of generic drugs sold in the US are manufactured by drug companies in India, the evidence of ongoing problems with data integrity and appropriate manufacturing standards is troubling. American consumers have no way of knowing whether the pills they are taking might be affected.