US FDA to start operations in India from August, to have 12 officials by 2010.
The regional office of US Food and Drug Administration in India is all set to commence its operations with eight staff in the month of August, 2009. The US drug regulatory body will have a total 12 experts in India by the beginning of next year to inspect and monitor the FDA approved facilities in India and to work with the Indian drug regulator on various issues, it is learnt.
At present, six staff including Bruce Ross, country director, US FDA, one senior technical expert for medicines, two senior technical experts each for foods and medical devices has taken charge in India while two officials will join the office within by next month. Out of this, three drug inspectors would be working in Mumbai whereas two inspectors for medicines division will be joining at New Delhi in next year, informed Bruce Ross.
“There will be five inspectors by 2010 working in India to learn more about the inspections and working methods of Indian medicine companies exporting to US. Our office in India is not going to speed up the process of approvals, but will ensure a link of communication between the Indian pharma companies and the Centre office at US,” said Ross.
The imports of medicines from India to US growing at a higher pace and the US FDA is trying to understand the Indian ecosystem and to work with the Indian regulator for better monitoring and control system.
At present, 10.6 per cent of the total Indian exports to US comprises of medicines even as the rest of nearly 90 per cent is related to food sector. The imports of medicines from India was US$ 1.38 billion in the year 2007-08, but growing at 39 per cent in dollar terms, which is higher than imports from many other countries. Out of the 6300 active drug master filings (DMFs) with the US FDA, almost 25 per cent equal to around 1700 are from Indian companies, said Ross.
The US FDA is currently guiding the Indian drug regulatory body in various regulatory issues including ensuring of standards of medical devices. However, the Indian office would only act as per the directions of the US FDA centre office and the inspections and approvals will be scheduled and decided in Washington. The feedbacks and complaints on common interest from the Indian companies would be channelled through the Indian office, said the officials in a meeting with the industry here.
August 04, 2009