Deficient manufacturing practices by Indian and Chinese drug makers has US Congress worried, and these concerns have been conveyed to the US drug regulator in a chastising letter.

Concerns stem from the fact that the US is hugely reliant on India and China and have demonstrated a pattern of repeatedly not being compliant to standards.

Today the US sourcing 32 percent of generic drugs and 45 percent of APIs from these two countries and both Chinese and Indian manufacturers receive the most amount of FDA Warning Letters.

Violations the Congress committee points out have included carcinogens in medicines, destroying or falsifying data and non-sterile manufacturing processes.

‘These violations have included carcinogens in medicines, destroying or falsifying of data, and non-sterile manufacturing processes. Given that approximately 32 percent of generic drugs and 45 percent of active pharmaceutical ingredients (APIs) are from these two countries, we are worried that the United States is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations.’

Also, the US government believes the US FDA decision to address shortages of critical drugs by allowing temporary import of otherwise unapproved drugs makes foreign inspections in China and India more critical.

‘The Committee is particularly concerned about foreign drug inspections conducted in India and China. The FDA’s recent decision to address shortages of critical drugs by allowing the temporary import of otherwise unapproved drugs from India and China makes having effective foreign inspection programs in those countries critical.’

The US government is concerned about the ineffectiveness of pre announced foreign inspections by the USFDA and steps such as discontinuing short notice or unannounced visits by the drug regulator despite a successful pilot program in India from 2014 to 2015.

‘From 2014 to 2015, the FDA conducted a pilot program in India that eliminated extended advance notice for inspections. Instead, the FDA conducted short notice or unannounced visits and selected sites for the program that the agency believed had significant issues. The pilot program appears to have been successful at exposing widespread misconduct and significant violations of FDA regulations, including falsified quality records.8 Despite the pilot program’s success, the FDA elected to discontinue it.’

The Drug Controller, according to the US Congress, has also carried out inadequate number of inspections post the pandemic with only 168 of 2800 foreign plants being inspected and only 3 percent of Indian manufacturers. In China, inspections fell almost 70 percent from FY20 to FY22 versus pre pandemic levels.

While this letter points to possibly stricter inspections and compliance standards from Indian plants, the US Congress seems to be more concerned about China.

The US says China presents a ‘more dangerous situation than India’ due to factors such as reinterpretation of the country’s National Security Law that could block access and even in arrest officials in light of the country’s national interest.

‘In many respects, China presents a more dangerous situation than India. Moreover, there have been recent, troubling political developments in China that the Committee believes may jeopardize the viability of the FDA’s in-person inspections there.

The law’s new interpretation is so broad that it would allow officials to arrest FDA inspectors or block access to manufacturers’ records if officials deem it in the national interest. 14 Authorities have already raided the offices of companies that specialize in collecting market information in China and detained employees.’

The Congress which has asked for a detailed reply by the drug regulator by the 1st of August is not alone in their concerns. For example, the US Department of Defence in the US is going to begin independently testing quality and safety of imported generic drugs.

‘The Committee is not alone in voicing concerns. The Department of Defence recently announced that it will begin independently testing the quality and safety of imported generic drugs. The non-partisan Government Accountability Office (GAO) also criticized the FDA’s foreign inspection program in a report published last year, noting that the FDA faced “unique challenges” and that it is inadequate at holding foreign manufacturers accountable for repeatedly violating regulations.’

By the end of this month the US government specific to India wants to know the FDA’s plans to reinstate unannounced inspections in India, details on in person inspection of facilities that have been issued warning letters in the past 10 years.

Lastly, the Congress also wants to understand the lapse of communication that took place between the USFDA and the only company named in this letter, the private Gujarat based drug manufacturer Intas. The issue revolves around Intas’s Ahmedabad plant which was one of only 5 manufacturers of 2 key cancer drugs. Intas’s plant was in the dock due to compliance issues brought up in November 2022. The drug regulator was unaware of the company’s plans to stop voluntary manufacturing at the facility a few months later.

During a June 9, 2023, briefing with Congressional staff on cancer drug shortages the FDA stated that it was not aware of the company’s plans to halt operations at its Ahmedabad, India, manufacturing facility until after the plant had shut down operations. This lapse in communication is concerning, as the FDA was ostensibly aware of the ongoing quality issues at the plant, as well as Intas’ significant U.S. market share for cisplatin and carboplatin and the disruption a plant closure would cause in the supply of these drugs