Surprise FDA Visits Rising in India
October 9th, 2013 // 2:54 pm @ jmpickett
The next time an Indian drugmaker hears a knock at the door, it could be an FDA auditor coming to do a cGMP inspection. FDA has let it be known that it is following the exact same system of cGMP inspections that is being followed in the United States. This can include aggressive surveillance as well as surprise visits.
According to an unnamed source who spoke to the news site LiveMint, India is now a top priority for FDA as it has the largest number of drug manufacturers outside the US that produce for the US market. It also is the biggest exporter of generic drugs to the US. These surprise cGMP audits are being done because of time where documents have been faked, and also there are growing worries about human error in Indian drug plants.
FDA for example recently sent out an Import Alert for drugs made at Ranbaxy Laboratories, which were made at a plant in Mohali India. This was only four months after the company agreed to pay out $500 million the the DOJ in the US to settle charges that had been running for years. Some of the charges included faking test data and concealing such activities from FDA.
There also was a July warning letter sent to Wockhardt, which has been banned from making drugs in Europe. An FDA auditor discovered an employee there who was hiding documents and was trying to stall the audit. There also were several sets of books for some batch records and several problems with sterility, including urinals that were near a drug storage locker that did not have drain pipes.
Also, FDA has been issuing a long stream of warning letters to various drug makers in India, such as Lupin, Cadalia Healthcare and Aurobindo. Another letter was sent out to Stride Arcolab that makes vaccines and injectable drugs.
All of these problems with 483s, inspections, warning letters and import alerts in India have come after the heparin scandal. FDA had said they were going to increase inspections and it seems this is finally happening. FDA has been boosting its Indian staff, with 12 staffers being increased to 19. It also has opened two new offices.
FDA also has been getting in the habit of doing short notices before cGMP audits in India. FDA also is recruiting agents with expertise in detecting various crimes.
It is not certain if more inspections will lead to changes in behavior at these plants. The problems are mostly due to culture and attitudes in senior management. So change in regulatory compliance in India will probably be slow.
