USFDA to set up office in India by Sept 2009

The United States Food and Drugs Administration (USFDA) will have a full-fledged office in New Delhi by September 2009. The move, part of the US government’s ‘Beyond the Borders Initiative’, aimed at strengthening import safety plans in the food and medicine sector, will see Indian pharmaceutical and food exporters to the US facing more regulatory inspections in future.

The US Department of Health and Human Services has decided to employ 10 full-time officials in Delhi — a country director, four drug inspectors, two senior technical experts in medicines, two technical experts in medical devices and one from the food sector. The department also has plans to set up an additional representative office and add two more staff by 2010-end.

“The purpose of the appointment is to help develop food and medical product regulations and agencies, improve product safety and conduct inspections in a more timely manner,” Christopher C Kelly, press officer, USFDA, said in an e-mail.

The US accounts for over 19 per cent of India’s pharmaceutical exports today. Indian companies exported $1.38 billion worth of medicines to the US in 2007-08. The export growth is also impressive — 39 per cent (in dollar terms) per annum in recent years. Official figures indicate that of the 6,300 active drug master files (regulatory applications for receiving marketing approvals in the US), 26 per cent or 1,700 are from the Indian companies.

The Indian office will be the second overseas hub for USFDA after China. “The first staff will be in place in Beijing this year, with additional staff to be posted in 2009. Staff are also scheduled to be posted in Shanghai and Guangzhou next year,” an official statement said. The US government is in the process of pursuing India’s formal approval, it added.

India will have a bigger staff as the country has 175 US FDA approved manufacturing plants, making it the biggest hub of USFDA approved drug manufacturing facilities outside the US.

In both nations, USFDA personnel would work closely with local authorities as well as industries that ship food and medical products to the US, to improve safety efforts. Their activities will include providing technical advice, conducting additional inspections and working with government agencies and private sector entities interested in developing certification programmes.

USFDA will also be opening overseas offices in Europe and Latin America before the end of 2008, with a fifth office in the West Asia to follow by mid-2009.

It should be noted that an Ernst & Young study on global pharmaceutical industry released on November 13 had pointed out that drug regulators the world over, especially the USFDA, were increasingly turning more risk-averse and raising the bar of the regulatory approval processes in medicines. Increased inspections and warning letters to pharmaceutical companies, including those from India, are the result, the study said. The study was based on the findings of a survey conducted on senior executives of 15 leading global pharmaceutical firms.