US FDA has commenced surprise inspections of all its approved facilities in India as a fallout of the recent allegations of exporting substandard drugs by Ranbaxy Labs. The Federal Court in Maryland, US is already looking into the allegations of US FDA against the Indian generic drug maker.

Informed sources said that the US FDA has already started surprise inspections in some plants in the country. There are more than 100 such plants in different parts of the country. Though the authorities and companies term plant inspections as a routine affair, what makes them different after the Ranbaxy-FDA imbroglio is that it has started inspecting the plants without any prior intimation to the companies.

That the US FDA is hell bent to avoid a Ranbaxy-like situation in future is evident from the fact that they come for inspection on a very short notice of two or three days, that too the information is passed on through a phone call. In the past, the US FDA used to inspect the plants in India after giving prior information to the concerned companies. The US authorities would inform the company about their itinerary in full detail, most of the time around a month in advance. Apart from the date of the inspection, the FDA authorities in the past used to specify other details like which molecule they are intending to inspect, etc, during the inspection, sources said.

The US FDA's drive is giving sleepless nights to the Indian exporters to the US as they have to maintain their plant as per the US regulations all the time as the inspection team land up any time and might find some inconsistencies in the company's manufacturing processes and maintenance of data. In such a scenario, the company will lose the marketing nod for the lucrative US market.

The origin of the present Ranbaxy-US FDA issue is attributed to such an inspection by the US agency in 2006 at the company's Paonta Sahib plant in Himachal Pradesh. In the inspection, the authorities found inconsistencies in the manufacturing processes and maintenance of data of Ranbaxy, which is one of the 10 largest generic-drug producers in the world. The US is Ranbaxy's single largest market, and in 2007, its US sales stood at $386 million, accounting for 22.89 per cent of the company's global sales. Ranbaxy is not the only Indian company that has had a run in with US FDA. A few months ago, Sun Pharma had to withdraw batches of generic metformin tablets, used to treat diabetes, on efficacy grounds. A couple of years ago, US FDA had also asked Wockhardt to correct several deficiencies.

Meanwhile, in order to make the inspections and other related activities in the country more frequent and foolproof, the US FDA is planning to establish its offices in Delhi, Mumbai and Hyderabad. Though the DCGI is making efforts to carry out joint inspections after the establishment of the US FDA offices in India, the US FDA is yet to take a decision on that, sources said.