US FDA to step up unannounced inspections on Indian pharma plants

Source: Moneycontrol

India will be a dominant part of planning the resilience of supply chains, he added

The US drug regulator has declared that there will be more unannounced inspections at the pharmaceutical plants in India.

“A mixture of announced and unannounced inspections is important, and you will see more unannounced (inspections),” said United States Food and Drug Administration (US FDA) Commissioner Robert M Califf in an exclusive interview with CNBC-TV 18 on September 29. “More inspections are to develop a system where there are no surprises.”

Califf said the US FDA plans to reward those who display a commitment to quality and integrity. Also, a bottom-up approach was important with the staff having deep integrity and honesty even if that hurts.

During the course of the Covid-19 pandemic, inspections of pharmaceutical manufacturing facilities in India by the US FDA turned fewer. In July, a US House panel tasked with examining the FDA’s foreign inspections expressed apprehension about the regulatory agency’s actions pertaining to manufacturing facilities in India and China, as well as its reliance on foreign drug manufacturers. Since then, there has been a rise in the number of inspections conducted by the FDA in India.

Califf added that he expected India to continue being a dominant supplier to the US, which is world’s largest drug market. Speaking on the country’s over-reliance on China, he noted that nations must be self-reliant in the matter of producing their own drugs.

According to the Indian Pharmaceutical Alliance, an association of 25 leading pharma manufacturers in India, the nation exports approximately 40 percent of all drugs consumed in the US.

Califf added that the Indian companies which have been working closely with the FDA for a few years have come up to global standards. With a lot of new people entering the industry, he emphasised that India must train the entrants on all aspects of the industry.

The US Center for Disease Control and Prevention (CDC) has raised alarm regarding the utilisation of an Indian eyedrop product that has been linked to fatalities and vision impairment among American citizens. According to a report by The New York Times earlier this year, the CDC has identified three fatalities, eight instances of blindness, and numerous infections associated with a highly drug-resistant bacterium linked to Chennai-based EzriCare artificial tears, produced by Global Pharma Healthcare based in Tamil Nadu.