Last year, as tensions grew between the U.S. and India over plants the FDA had banned, the head of the FDA's operation in India said that the agency would start inviting Indian drug inspectors along on plant inspections. The idea was to allow them to learn what the U.S. expected from manufacturers. Now the Indian government is insisting on it.
According to Livemint, a government-related group wants Indian inspectors to help interpret for the FDA what is going on. "U.S. FDA's increased inspections and observations (under 483) also are troubling us. The ministry of commerce has taken up the issue seriously," P.V. Appaji, director-general of Pharmexcil, (Pharmaceuticals Export Promotion Council) told Livemint. Pharmexcil operates under the ministry of commerce. "Cultural differences and body language may sometime widen the gap," said Appaji, who explained that his group was asking the FDA to allow Indian regulators to be present during the inspections.
The issue may have also have to do with whether Indian drugmakers are given an early heads up to prepare for inspections instead of facing surprise visits. "The earlier practice was that whenever they are visiting any Indian site they used to inform us," Appaji told the publication. "Now, they started coming without any notice,"
But the FDA has learned from some inspections that surprise is needed to get a full accounting. During the 2013 inspection of a plant in India operated by Germany-based Fresenius Kabi, employees confessed to inspectors that ahead of that inspection and previous inspections, high-pressure liquid chromatography equipment and personnel computers were removed from the plant to "conceal data manipulations." The FDA called the practice "very worrisome" in a warning letter that plant received in 2013.
|FDA Commissioner Margaret Hamburg|
In the last few years, the FDA has banned a number of plants owned by some of Indian largest drugmakers for quality issues and for faking or manipulating drug testing data. Those include four of 5 FDA-approved plants operated by Ranbaxy Laboratories, as well as plants operated by Wockhardt, Sun Pharmaceutical and others. During her first visit to India last year, FDA Commissioner Margaret Hamburg pledged deeper cooperation with Indian regulators and encouraged them to upgrade their own oversight to improve quality, something Indian regulators have said they will do, even suggesting they may do more surprise inspections of Indian plants themselves.
In 2013, the FDA appointed India-born Altaf Lal to run the FDA's office in there. At the time, he pledged to work with Indian drugmakers there to improve quality and their chances of avoiding regulatory actions by the agency, offering training and to include them on plant visits to see what FDA inspectors were looking for. But Lal left the FDA last year after about 9 months.
It has been some months since the FDA has taken an action against an Indian drug manufacturing facility, but European regulators have recently banned some drugs from Indian facilities for same kinds of issues laid out by FDA inspectors. The European Union, as well as Germany, France, Italy, as well as Canada, have all recently issued statement of noncompliance or banned products from a number of Indian operators.
- here's the Livemint story
Fresenius Kabi Indian plant accused of manipulating data
FDA's Hamburg comes back from India with high hopes about quality standards
India's top drug regulator says he will do surprise inspections of foreign-owned plants
FDA warning letter lays out issues at banned Wockhardt plants
India has different attitudes about the standards at facilities targeted by the FDA
France and Italy ban products from Indian companies