FDA Clamps Down on Indian Drug Makers

Published Online: Tuesday, March 11, 2014
Follow Pharmacy_Times:
While visiting India from February 10 to 18, 2014, FDA Commissioner Margaret Hamburg, MD, announced plans to increase regulation of pharmaceutical manufacturers in the country amid concerns about the safety of medications they produce. The number of FDA inspectors stationed in India, which is the second-largest supplier of generic medications to the United States, will increase from 12 to 19.

“We need the same level of oversight whether it is within our borders or outside,” Dr. Hamburg said, according to the Wall Street Journal.

In the last few years, the FDA has banned the sale of drugs in the United States produced by some plants in India run by Ranbaxy Laboratories Ltd and Wockhardt Ltd due to shortcomings in manufacturing standards. A Ranbaxy plant was accused of faking test results and found to have laboratories in disrepair and a sample-preparation room overrun with flies. Ranbaxy pleaded guilty to a felony and paid a $500-million fine, the largest ever imposed on a generic drug maker.

Inspections of Indian facilities are being financed with some of the approximately $300 million in annual fees being collected from generic drug manufacturers based on the 2012 Generic Drug User Fee Act. According to Dr. Hamburg, the additional inspectors will speed up the approval of Indian pharmaceutical plants.

Related Articles
Generic drugs are cheap, effective, and FDA approved. So, what's the problem?
The FDA is seeking comments on 28 new and 15 revised recommendations providing product-specific guidance on the design of bioequivalence studies to support Abbreviated New Drug Applications (ANDAs).
The news of Margaret A. Hamburg, MD, resigning from her long-standing post as FDA Commissioner stirred memories of her success with improving access to emergency contraception, but more so her struggles with regulating drug compounding following a deadly fungal meningitis outbreak traced to a compounding pharmacy’s tainted drugs.
Community pharmacists are most concerned about below-cost reimbursement for certain generic drugs as well as exclusionary Medicare drug plans according to a survey conducted by the National Community Pharmacists Association that asked its members to help identify the organization’s 2015 priorities.
Latest Issues
  • photo
    Pharmacy Times
    photo
    Health-System Edition
    photo
    Directions in Pharmacy
    photo
    OTC Guide
    photo
    Generic Supplements
  • photo
    Pharmacy Careers
    photo
    Specialty Pharmacy Times
    photo
    Generic
$auto_registration$