Although the US FDA office in India may start its operations in the next few months, that is unlikely to expedite the disposal of approvals of Indian companies as expected, it is learnt. Indian office of US FDA at New Delhi, will have local drug inspectors within three months from now and the country director will take charge in September 2009.
However, the move may not help the Indian companies to get approvals of Abbreviated New Drug Applications (ANDAs) and good manufacturing practice (GMP) certificates faster than now as every decision will have to be cleared by the FDA office in Washington, informed a senior official with US FDA.
The inspections will continue to follow the schedule set by Washington and the normal procedures have to be followed including the inspection, writing report and discussion of findings by the officials. "Time will tell whether the office in India can help the Indian industry to get approvals rapidly," said the official. Despite repeated attempts, the US FDA refused to comment on the role of Indian office in future.
After US FDA office starts functioning, the inspections would be conducted as per the schedule prepared by the US office. At least an official from US will join with the officer in the regional office for every inspection, unless it is an emergency.
The Indian generic companies which are in a hurry to capture the fast growing generic market, have hoped that the Indian office of US FDA may expedite their product launch in US. There are more than 100 US FDA approved facilities operating in the country catering to US market and are eager to grab the emerging opportunity in the backdrop of huge number of patents expected to expire in the next four to five years.
Currently there is a delay of an average of five to six months in getting GMP certification from US FDA after the inspections, said Milind Joshi, president - Global Regulatory Management, J B Chemicals and Pharmaceuticals Ltd. The time taken for ANDA approval various from 15 to 24 months depending on the documents submitted to the FDA and the datelines of patent expiry. The US FDA's move to set up office in India could also be mutually beneficial for the Indian players, said industry sources.
"It should be beneficial in both ways. While the FDA can increase their scrutiny on Indian companies through the regional office, the Indian companies have to get the benefits of earlier approvals for manufacturing plants," said Joshi.
However, the FDA is still testing the waters for its Indian operations and could not divulge on the conditions of emergency, informed the FDA source. The regulatory body at present has no plans to conduct surprise inspections in FDA approved sites in India unless there is a state of emergency in doing so. Further decision on surprise inspections could be on the board once the officials take charge in the regional office.
The US FDA has already hired three inspectors for its Mumbai office and will add two more inspectors in 2010. The hired inspectors are currently going through security clearance and will join Indian office within July 2009. The country director, Bruce Ross, will take charge in the regional office by September, this year.
The move to set up regional offices outside US is part of Beyond the Borders Initiative, a programme of FDA's International Programmes Office for global presence, to gather better knowledge in products exported to US from other countries. The programme aims to ensure safety and quality of medicines and food imports by setting up regional offices in countries like India and China. The FDA currently has an in-country presence in China, Central America, India, and Europe and plans to open an office in Middle East are in pipeline.