The US FDA has decided to shelve its plans of opening an Indian office to help speedy regulatory clearances for Indian drug exporters to US, it is learnt.
Sources said Dr David Lepay, the US FDA's Senior Advisor for Clinical Science and Director, GCP Programs revealed at a session on Asian clinical trials at the 42nd annual meeting of the Drug Information Association (DIA) in Philadelphia, USA, that the US food and drug regulator was not planning to set up offices neither in India or anywhere else in Asia, at present. The announcement from the US FDA official came in the presence of Dr Ashwini Kumar, Drug Controller General of India (DCGI), who was also a speaker at the programme.
It may be noted that Pharmabiz had reported about two years ago that the US FDA was planning to start its Indian office at New Delhi with an initial investment of about US$ 5 million, considering the fact that India has the maximum number of US FDA approved facilities outside the US. This office was to facilitate Indian companies with the procedures of filing for marketing approval for products to be launched in US, application for site inspection and other procedures dealing with the US FDA.
The plan was also to appoint inspectors at the centre, who can immediately begin site inspection, without having to travel all the way from the US. Planned to start within one or two years, the office was envisaged to facilitate the exchange of communication between Indian companies and the US authorities, thereby saving a lot of time and resources, sources had told Pharmabiz.
Dr Leepay told the seminar, attended by a good contingent of Indian participants, that it was not mandatory that a new drug marketing application in the US be supported by a US study and there had been instances of marketing applications wholly supported by non- US studies. However, the FDA had criteria that non-US studies were expected to meet US standards and that non- US data was reviewed to the same standards as data from the US. Though the US FDA had a long history of inspection of clinical trials outside the US, its experience in the Asia/Pacific region was limited, and the region currently accounts for only 5 per cent of FDA's international inspections. He also clarified that the FDA does not certify clinical investigators, clinical sites, sponsors or ethics committees, nor does it approve study protocols or informed consent documents.
The session titled 'Asian Clinical Trials and Tribulations' was chaired by Dr Vis Niranjan, president of RxMD Pharmaceutical Physicians Pvt. Ltd., Chennai, and featured as speakers were Ashwini Kumar, Drugs Controller General of India; Dr Ling Su, formerly of the US Food and Drug Administration and China's State Food and Drug Administration; and Dr David Lepay, the FDA's Senior Advisor for Clinical Science and director, GCP Programmes, sources said.