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US House Committee asks US FDA to submit details on inspection of facilities in India and China

Gireesh Babu, New Delhi
Friday, July 21, 2023, 08:00 Hrs  [IST]

A Congressional Committee under the House of Representatives in the United States of America (USA), which is conducting oversight of the Food and Drug Administration's (FDA) foreign drug inspection programme, has sought details including an explanation from the drug regulator on why it has ended the unannounced inspection programme conducted in India between 2014 to 2015 and details of the facilities inspected in India and those have been served with warning letter in the last 10 years, among others.
The Committee, which is in an effort to address the drug shortage issues, raised its concerns over the imports from India and China and sought response from the FDA on the insufficient foreign direct inspections conducted in these two countries.
In a letter to the Commissioner of FDA, Dr Robert M Califf, on July 18, the House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight Subcommittee Republicans, observed that Chinese and Indian manufacturers receive the most FDA warning letters and these violations include carcinogens in medicines, destroying or falsifying of data, and non-sterile manufacturing processes.
"Given that approximately 32 per cent of generic drugs and 45 per cent 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," said the letter.
The FDA's recent decision to address shortages of critical drugs by allowing temporary import of otherwise unapproved drugs from India and China makes having effective foreign inspection programmes in those countries critical, it added.
"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 programme that the agency believed had significant issues. The pilot programme appears to have been successful at exposing widespread misconduct and significant violations of FDA regulations, including falsified quality records. Despite the pilot program’s success, the FDA elected to discontinue it," observed the Committee.
The drug regulator, which relied on remote interactive inspections of drug manufacturing facilities on a voluntary basis during the time of Covid-19 pandemic, had a lower level of inspections compared to the pre-pandemic period once inspections were resumed after the pandemic. Quoting an analysis, the Committee said that out of the 2,800 foreign manufacturing facilities, the FDA inspected only six percent of them, with just three per cent of Indian manufacturers being inspected.
Raising questions to the FDA generally related to the foreign inspections, the Committee asked five specific questions related to FDA inspections in India.
It sought the drug regulator to explain in detail why the FDA ended the unannounced inspection pilot program conducted in India between 2014 and 2015. It also asked whether the FDA plans to reinstate the unannounced inspection programme in India and if not, to explain the rationale in detail.
"For foreign facilities in India that have received a Warning Letter in the last 10 years, provide a list of which of these facilities have been inspected in-person, inspected remotely, or not inspected at all since the Warning Letter was issued," asked the Committee. It also sought how many times has a foreign manufacturer in India been inspected in the last 10 years and whether their Warning Letter was lifted before the FDA investigator filed a report, allowing the company to get approval for a drug shortage product or its abbreviated new drug application (ANDA). The Committee directed to provide a list of these companies, dates of approval, and the product that was approved.
Commenting on a particular issue, the Committee sought explanation and documents from the FDA related to the voluntary halt of operations by Intas Pharmaceuticals in its Ahmedabad plant which was manufacturing chemotherapy drugs for the US and the FDA's statement that it was unaware of the company's plans to halt operations.
The facility was one of the only five finished product manufacturers supplying the US market with chemotherapy drugs carboplatin and cisplatin and as early as November 2022, the FDA was aware of significant, repeated quality control failures at the facility, it said. Intas voluntarily stopped operations at the facility in response to quality control failures on June 5, 2023, but the FDA in a briefing with Congressional staff on June 9, 2023, on cancer drug shortages, stated that it was not aware of the company's plans to halt operations at its Ahmedabad manufacturing facility until after the plant had shut down operations.
The Committee said that 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 market share in USA for cisplatin and carboplatin and the disruption a plant closure would cause in the supply of these drugs.
"It is important for the Committee to understand exactly how and when the FDA was made aware of Intas' plans to voluntarily halt operations at its Ahmedabad facility," said the Committee in its letter to the FDA.
"Explain in detail and provide copies of any communications between the FDA and Intas Pharmaceuticals from January 2023 through June 2023 related to the company's decision to voluntarily halt production at the Ahmedabad plant closure," it sought the FDA.
The Committee observed that in many respects, China presents a more dangerous situation than India and the recent troubling political developments in China may jeopardise the viability of the FDA's in-person inspections there, it observed. The new interpretation of the "already sweeping" National Security Law would allow officials to arrest FDA inspectors or block access to manufacturers' records if officials deem it in the national interest.

If the observations of the Committee lead to the US drug regulator tightening the standards, it may have an impact on the Indian exports to the US.

According to a recent report by CareEdge Ratings, the knowledge-based analytical group, the US hold a prominent position as one of the largest export destinations for the Indian pharma industry, accounting for approximately 30-35% of total formulation exports.

Besides, there is a substantial opportunity on the horizon, as approximately $188 billion worth of drugs worldwide are set to go off-patent between Calendar year 2023 and 2026, it added.

However, regulatory headwinds and consequent lower ANDA approvals are likely to constrain the exports to developed markets. Increasing focus on synthesis segment, complex and specialty products apart from easing of pricing pressure in US generics are likely to support the growth in the medium term, it added.


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