Around 100 US FDA approved pharma plants in different parts of the country will come under the direct radar of the US regulatory authorities, as the US FDA has opened its first office in the country in New Delhi on January 15. By establishing its offices in India, the US FDA aims for better coordination with the regulatory authorities and the industry in India to ensure safety of food and medicinal products being exported to the US from India.
The exact number of US FDA officials posted in the new office is yet to be known. It is expected that there will be at least 10 officials in the new office. Apart from New Delhi, the US FDA will also establish its offices in Mumbai and Hyderabad shortly.
The establishment of the US FDA offices in the country will put all the US FDA approved plants under the direct radar of the US regulators. It will result in the frequent inspection of the US FDA approved plants in the country. With offices in Delhi, Mumbai and Hyderabad, the US FDA officials can audit these facilities, even without any notice. There can be surprise visits also by these officials.
In the past the US FDA officials inspect these facilities periodically to ensure that these units comply with the good manufacturing practices (GMP) to maintain the quality of the products. Usually, they come for audit with prior notice. They used to inspect the plants in India after giving prior information to the concerned companies. The US FDA 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.
The setting up of US FDA offices may give sleepless nights to the Indian exporters to the US as they have to maintain their plants as per the US regulations all the time as the inspection team may 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. "Even though there is nothing to fear, the US exporters should now be more careful in keeping their plants GMP-compliant. They should be more alert," a senior industry leader said.
Meanwhile, it is yet to be known whether the inspections will be carried out jointly by the officials of US FDA and the DCGI office or the US FDA officials alone. The industry had earlier demanded to the Indian authorities to make the joint inspection mandatory.
In fact, the US FDA had already started surprise inspections of all its approved facilities in India in August last year as fallout of the allegations of exporting substandard drugs by Ranbaxy Labs. The US FDA wanted to avoid a Ranbaxy-like situation in future.