The FDA is Ramping Up Manufacturing Inspections in India

On the heels of a congressional grilling, the FDA is increasing inspections of Indian drug facilities due to supply and quality concerns.

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The FDA is planning to increase its inspection of drug manufacturing facilities in India this year amid growing quality and supply concerns, Reuters reported Tuesday, citing an agency executive.

“We are putting every effort into increasing the number of inspections,” Sarah McMullen, FDA Country Director for India, told Reuters that the regulator is also “requesting more drug investigators to be stationed here.”

The FDA is tightening regulatory scrutiny over Indian manufacturing facilities in the wake of two interlocking crises that are making their way into headlines: the deteriorating quality of medicines and persistent drug shortages.

In its annual Report on the State of Pharmaceutical Quality, published in June 2023, the agency documented a record number of drug recalls, which reached its highest level in five years. (The report covered the agency’s fiscal year 2022, which ran from October 1, 2021, to September 30, 2022.)

During that time:

• The FDA issued 912 recalls across 166 manufacturing sites, most of which were due to violations of current good manufacturing practices.

• Inspections of manufacturing sites also spiked to 328 in FY2022, which was “nearly triple the amount” of such visits in the year prior.

• The FDA also issued quite a few import alerts and warning letters, mostly affecting facilities in China, South Korea, and India.

In July 2023, the House Committee on Energy and Commerce wrote to the FDA requesting detailed information regarding its inspections of foreign drug manufacturing facilities — particularly those in China and India.

Committee Chair Rep. Cathy Rodgers (R-WA) and Subcommittee Chairs Reps. Brett Guthrie (R-KY) and Morgan Griffith (R-VA) expressed their concern that the U.S. might be becoming too reliant on “foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations.”

The FDA is also struggling to keep up with significant shortages of hundreds of life-saving drugs, as detailed in a February 2024 report by the GAO. The regulator has listed over 300 medicines in short supply, the highest number since 2014. Medicines affected by the shortages include amoxicillin, quinapril, cisplatin, carboplatin, and the popular weight-loss therapy semaglutide.

Earlier this month, the House Ways and Means Committee held a hearing to investigate these shortages, noting that most of the treatments on the FDA’s list have seen limited availability for at least two years.

The growing manufacturing problems in overseas facilities have made the drug shortages worse. India-based Intas Pharmaceuticals received a warning letter over several quality control lapses and poor data integrity. Intas, which manufactures several generic drugs, is on the FDA’s import alert list.

We suggest overseas firms — especially those in India — prioritize their compliance assurance and inspection readiness if they haven’t already.

Here are a few specific recommendations:

1. Conduct a comprehensive audit of current practices. Engage an external auditor with expertise in Quality Systems and FDA inspections to perform a detailed audit of manufacturing, quality control, and documentation practices.

2. Implement an electronic data management system. Our auditors (and it seems the FDA) have found that many foreign firms are using legacy management systems that lead to several significant problems:

   1. Bad data integrity: Manual record-keeping or outdated systems naturally invite errors, omissions, and inconsistencies in data. This can raise questions about the reliability and accuracy of critical records, such as batch records, testing results, and quality assurance documents.