Report: Pharma Firms Face US Wrath
Oct. 12, 2013 (MAIL TODAY (INDIA)) – It is not just home bred companies Ranbaxy or Wockhardt that have been pulled up by the US drug watchdog for slack manufacturing standards.
The USFDA has issued warning letters to several other global pharmaceutical giants, showing an alarming growth in the violation of Current Good Manufacturing Practices ( cGMP).
An analysis of warning letters issued by the USFDA since 2010, shows 66 companies have received such letters during a 42 month period up to June, of which 12 per cent were Indian companies. Major global names at the receiving end include both innovator firms as well as generics companies, including Boehringer Ingelheim, Hospira, Merck KGaA, Novartis, Sanofi Aventis, SmithKline Beecham and Teva. The number of warning letters each year have been growing, from 14 in 2010 to 19 in 2011 and 21 in 2012. In 2013 till June there were 13 warning letters issued, a recent analysis showed.
Indian companies continue to have a major share of the warning letters, primarily because they account for 40 per cent of the Drug master Files ( DMFs), the mandatory data that suppliers of pharma raw materials have to submit to the USFDA, and 37 per cent of the Abbreviated New Drug Applications ( ANDAs), submitted by generic firms before manufacturing and marketing a drug in the US. The credibility of several Indian generic manufacturer took a beating after a series of FDA action in the recent months. In September, Ranbaxy, India's largest The credibility of Indian took a after a series FDA alerts recent months
Drug maker, had a third plant, one in Mohali, banned from exporting drugs to the US. " It is important to note that since the last inspection by the USFDA at Mohali in 2012, Ranbaxy has strengthened its management, manufacturing and monitoring systems and processes to ensure quality and compliance in all areas," Arun Sawhney, the company's MD said on September 26. " We are focusing on resuming submissions and supplies to the USA from our Mohali plant once we satisfy the US FDA stipulations." In September, Strides Arcolab also said that a facility in Bangalore being bought by Mylan Inc. got a warning letter after an FDA inspection in June. In July, the FDA issued a warning letter to Wockhardt and accused the company of repeatedly obstructing its team from inspecting the company's Waluj plant near Maharashtra.
" The growing trend towards zero tolerance will necessitate changes in attitude and culture across an organization," D. G. Shah, secretary general of the Indian Pharmaceutical Alliance said.
Posted: October 2013