The FDA has scolded yet another Indian drug manufacturer for violation of manufacturing practices and, therefore, banned shipments of its drugs in the United States Aarti Drugs disclosed the move in a filing with the Bombay Stock Exchange yesterday and noted the action of the agency was in response to an inspection of its manufacturing plant last August.
The opinion of the Exchange has not specified the problems that prompted the FDA to issue a so-called import alert, which is the nomenclature of the agency for a ban. But the inspection in August following a warning letter from the agency published the previous year in response to numerous violations found in two facilities Aarti 2012 during an inspection.
The letter detailed warning of problems such as over two dozen power outages to a facility that did not study, even if they disrupted the quality control operations. The FDA also noted that a quality control analyst had recorded turnaround times for lab tests that had not yet occurred and there were failures to account for unexplained differences in the result data test.
In its opinion on the Exchange, Aarti said he responded to the concerns of the FDA last month, but has not yet received a response. The drugmaker noted, however, that one of the two plants mentioned in the import alert the FDA is actually supplying products to the United States and the impact of the products concerned should be slightly less than 1% of total sales. Thus, the drug maker said, "this should not affect our top line and bottom line significantly." The company, which is mainly active pharmaceutical ingredients, was not available for comment.
The decision comes as FDA officials to visit India this week to discuss regulatory oversight with their government counterparts amid ongoing concerns about the veracity of the pharmaceutical supply chain. The subject has been a problem in recent years after several Indian drug manufacturers were cited for quality control failures.
The most notable example was Ranbaxy Laboratories, which is now owned by Sun Pharma. The drug manufacturer was a poster child for manufacturing problems. Last year, Ranbaxy has paid a fine of $ 500 million to US authorities as part of a settlement that included pleading guilty to two charges of violation of the laws on the safety of medicines, such as data manipulation. A consent decree remains in force.
There are also two years the FDA banned shipments from two plants run by Wockhardt, another big drug manufacturer based in India. A recent review of FDA documents by Bloomberg News found that data integrity issues were held in dozens of factories are run by various drug manufacturers across India that make ingredients and drugs to market American.
FDA officials are considering a new approach, however, inspection of manufacturing facilities in India. This comes in response to Indian drug manufacturers to complaints that FDA exceedingly difficult to single out inspections.
As a result, the FDA plans to "allow our inspectors to document where the quality of a company's management system exceeds what would be necessary to meet regulatory compliance Simply put:. Inspections can also give carrots, not just sticks, "according to a written blog post this week by the FDA officials.
The findings, they write, could be used to influence the frequency of FDA inspections of a particular installation. Indian drug manufacturers have complained that the FDA inspections occur too often and randomly, depriving them of the opportunity to make substantive changes.
