New Delhi, November 2014 – Manufacturing issues such as having more than the allowable number of impurities that did not adequately investigated and several other deficiencies have been found by US FDA on multiple occasions in the Gujarat based plant of Cadila Pharma thus resulting into impurities in drug ingredients. This has led FDA to give strict warning to the plant.
As pointed out in a letter dated 15 Oct by FDA this was not the first time that such poor good manufacturing practices were followed instead as per the 2012 inspection this was a repeated deficiency. The 2012 inspection also pointed out large stability sample backlog and that the investigation by the plant failed to address the impact of the delayed sample testing on known typical impurity profile.
15 days time has been given to Cadila Pharma to respond to the query. The warning clearly points out that if appropriate requirements are not addressed by the company then it could result in import alert and thus FDA may withhold approval for any new drugs using materials manufactured at the Gujarat Facility.
CMD of Cadila Pharma Rajiv Modi said that scientist and regulatory compliance officials are working on the issue and trying to resolve soon.
Cadila Pharma supplies drugs to US, JAPAN and Kenya along with over almost 85 countries. It also supplies to African continent.
Indian drug companies are facing stringent enforcements in the US now a day’s which is the largest generic market for Indian drug companies. Other than Cadila several other manufacturing plants such as Ranbaxy, Sun Pharma, Wockhardt, Strides Acrolab have come under the US FDA scanner due to compliance issues. The FDA also taken off the key exclusivity period from Ranbaxy over Nexium and Valcyte drug. Issues such as intellectual property and increasing regulatory enforcements by the US regulator on Indian companies are the latest issues for Indian drug companies. On April 30, the US had released “Special 301 report, an annual review of the global state of IPR protection and enforcement, in which it has classified India as a ‘priority watch list country. IGMPI
