The US Food and Drug Administration (USFDA) is increasing its officials in India, according to Solomon Yimam, Assistant Country Director (Clinical Research), USFDA, India office.
He was speaking in a session in the on-going BioAsia 2015 here on Wednesday. With two offices in New Delhi and Mumbai, the US regulator has about 10 officials in India now which might go up to 19.
The number of audits and their frequency, however, would depend on the pace of product applications filed by individual facilities in India, he said while not indicating whether this would lead to speedy clearance of applications.
The nature inspections undertaken by the FDA are varied depending on type of applications which including marketing applications, product applications and those which are undertaken if there is any complaint.
Of late, the USFDA is also inviting host-country regulators for its inspections to create more awareness about its inspections.
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