The US Food and Drug Administration (FDA), which has offices in New Delhi and Mumbai, is in the process of increasing its headcount in India to 19.
Solomon Yimam, Assistant Country Director, US FDA India Office while denying that the inspections are targeted, said the frequency of audits of Indian facilities would depend on the number of product applications filed from that facility.
“USFDA is in the process of taking the headcount up to 19. We have offices in New Delhi and Mumbai. We are in the process of bringing more (officials). Currently we have 9 or 10 (officials working in India),” Yimam said during an interactive session at BioAsia-2015.
He, however, declined to answer a query on whether the increased staff would mean increased number of inspection of Indian facilities.
“First of all inspections are driven by marketing applications. So depending on the number of marketing applications (of products) we do the inspections. The target is depending on how many companies are producing new products for USA.
“There are three ways of inspections. One is for marketing application. The second one (inspection) will be if there is a complaint then we will do that. The frequency depends on what type of inspection we will conduct,” the USA official added.
Replying to a query, he said as per the agreement reached between US FDA and Indian Ministry of Health and Family Welfare last year, the US regulator is informing its Indian counterparts whenever there is an inspection of Indian facility.
He however, admitted that there might be some “glitches” in the process.
“Engaging collaboratively as observers in medical and cosmetic product and inspections conducted by the other participant as per specific terms to be agreed and as time and resources allow…Informing the respective regulatory authorities before undertaking inspections, so that host country inspectors may join inspections as observers,” the FDA-MoHFW joint statement had earlier said.
He said the idea of inviting host-country regulators during FDA inspections is to make them understand the process of FDA audits.
According to Yimam, warning letters are also being issued to some facilities located in countries such as Canada, Belgium and South Africa.