US FDA to conduct workshops to sensitise Indian cos on quality requirements in US

Ramesh Shankar, Mumbai Monday, February 17, 2014, 08:00 Hrs  [IST]

In order to sensitise the Indian pharmaceutical companies about the changing quality requirements in the American drug market, the US Food and Drug Administration (FDA) will conduct workshops in India in the next one year. However, the nitty-gritties of the programme are yet to be finalised. According to sources, the US FDA's plan to organise workshops in different locations in the country is part of the US regulator's strategy to instill awareness among the Indian companies about the changes happening in the US drug market as far as requirement of quality of medicines is concerned. The workshop will provide a platform to the US regulator to sensitise the Indian drug companies about the changes taking place in the US drug market. The US FDA is planning a workshop in the next year at three or four locations to clarify what are the new requirements and what are the expectations of the US FDA from the Indian drug manufacturers, sources said. The issue was discussed during a meeting between the captains of Indian pharma industry and the commissioner of US FDA Dr Margaret A Hamburg. The captains of Indian pharma industry who attended the meeting included Ranbaxy CEO & MD Arun Sawhney, Sun Pharma founder & MD Dilip Shanghvi, Wockhardt chairman Habil Khorakiwala, etc. The US FDA's plan to conduct workshops to sensitise the Indian drug companies about the changes taking place in the US drug market is of importance as some of the major Indian drug companies have been at the receiving end of the US FDA action on quality issue. The US FDA has taken a series of actions against Indian pharmaceutical firms, restricting their shipments to the US, their largest export market. More recently, the US FDA on January 23 had banned the import of products manufactured by Ranbaxy Laboratories at its plant at Toansa. This was the company's fourth plant to face regulatory action from the US FDA, after Mohali, Paonta Sahib and Dewas plants. Earlier in 2013, Ranbaxy had agreed to pay a fine of $500 million to US authorities after pleading guilty to 'felony charges' relating to manufacture and distribution of certain adulterated drugs made at the Paonta Sahib and Dewas units. Another Indian firm, Wockhardt, had its two plants put under import alert by the US FDA. quoted from here