Updated on 17 October 2013
"We will fully co-operate with the US authorities, taking any and all necessary steps to resolve their concerns. Daiichi Sankyo, together with Ranbaxy, has committed to further strengthening Ranbaxy's procedures and policies to ensure data integrity and comply with current good manufacturing practices (cGMP)," it said.
Furthermore, during the month of May 2013 Indian drug giant Wockhardt was issued an import alert that banned shipments from the company's Waluj factory. The drug inspectors found torn data records in a waste heap and urinals that emptied into an open drain in a bathroom six meters from the entrance to a sterile manufacturing area. IPCA Laboratories and Strides Arcolab were other companies that faced the US FDA ire over drug safety and quality issues.
However, many in the industry believe that these increasing incidents might have dented India's image oversees. "We all know how Indian companies function and issues such as Ranbaxy and other import alerts have brought us a very bad reputation globally. The urgency, to be the first with a generic version of a drug coming off patent, is the main reason for quality problems. We need to be sincere towards quality issues rather than following procedures just for the sake of it. Although we are doing things fast, we are losing out on certain aspects and facing import alerts," said Mr Ajay Kumar Sharma, director, research, Organization of Pharmaceutical Producers of India (OPPI), in a media statement.
Furthermore, many Indian drug makers were recently named by the US drug regulator for non-payment of annual facility fees to the FDA. These firms had not satisfied their annual fee requirements under the Generic Drug User Fee Amendments (GDUFA).
In August, the US FDA issued guidance to the pharmaceutical industry on circumstances that constitute delaying, denying, limiting, or refusing a drug inspection. The regulatory major is open to industry comments to this effect until September 30, 2013.