FDA Is Refusing to Allow Ranbaxy Labs to Export from Banned Factories
February 13th, 2014 // 2:21 pm @ jmpickett
FDA this week denied the request from Ranbaxy Laboratories to allow the drugmaker to continue to export its products from banned manufacturing plants, as they continue to take remedial actions to fix the GMP problems in the plants.
This request was made by the managing director Arun Sawhney at a big meeting with CEOs of top pharmaceutical companies in India and FDA’s commissioner Margaret Hamburg, who was on a trip in India.
According to two people who were in the meeting. Sawhney told Hamburg that the firm was having major problems because of recent FDA actions. He asked her to reconsider the policies, so that drugmakers could continue to do business in America so that they could make money that is needed to do expensive cGMP remediation.
Hamburg said in a polite but very detailed response that FDA cannot change rules to make these types of concessions. She noted that while exceptions are made for companies that make single, rare mistakes, large drug makers that make big, regular cGMP errors cannot be dealt with in this way. FDA takes serious, regular GMP problems very seriously.
The US is the largest market for Ranbaxy, but the several serious FDA actions against the company in recent years have made it difficult for Ranbaxy to be profitable.
FDA has banned the firm from exporting drugs to the US from three factories in India because of serious CGMP problems. It also banned exporting of APIs from its Toansa plant in Punjab.
Ranbaxy in 2012 had to pay a $500 million fine to FDA and it also had to plead guilty to charges of faking data and exporting adulterated drugs.
FDA has also taken strong action against other companies in India with serious cGMP problems, such as Wockhardt and Strides Arcolab. Indian drug makers were the recipient of over 50% of all FDA warning letters sent out in 2014.FDA also is increasing its inspectors in India and increasing vigilance in India, which is the second biggest exporter of generics to the US market.
Hamburg noted that doing import alerts and blocking drugs from the US market is really a last resort measure. This disrupts the supply of drugs to the US. FDA much prefers to sort out cGMP problems with the companies without taking drastic action. She also said that FDA is reorganizing and is trying to speed up drug approvals.
This would help to get more inspections done in India by FDA so that many drugs could be approved in the near future. There has been a backlog of cGMP approval inspections in India in recent years that the CEOs of many drug companies there want to see resolved.
