The FDA continues to allow products from these labs to be sold in the U.S. because it is often more concerned with supply than safety.
India generic drugs maker Zydus Lifesciences said it got another Warning Letter by the Food and Drug Administration following a failed inspection in mid-April. This marks a worrying trend for the U.S. injectable drugs seller, as the company cannot go 24 months without getting an official warning by the FDA. The last was in 2022, and prior to that – 2019.
Zydus said that the warning won’t impact existing supplies from the facility, nor harm shipments to the U.S., but will restrict new product approvals, “which is critical for business growth in the U.S. market," according to its filing with the Bombay Stock Exchange.
Zydus is a top four Indian pharmaceutical company. They have been getting numerous drug approvals by the FDA over the last three years, in spite of these Warnings by the same entity that is supposed to be ensuring American patients have access to safe, high-quality medicine. The FDA continues to allow products from these labs to be sold in the U.S. because it is often more concerned with supply than safety, or lab evidence of drug efficacy, which can be assessed by looking at the lab’s data. The U.S. is a major importer of generic drugs and is reliant on India for most of that supply. The FDA is not in the business of halting drugs from entering the market, except in worst case scenarios. As a result, labs with significant violations to the the Current Good Manufacturing Practices, the standards required to sell medicines here, are allowed to sell drugs regardless of D grades from inspectors. In essence, Zydus is part of a string of "Too Big To Fail" Indian generic drug manufacturers.
According to Indian government and industry sources, India has the highest number of FDA-compliant labs outside the U.S., and it also receives a large share of FDA generic drug market authorizations compared to other countries. But India’s drug manufacturers often perform poorly in inspections, and product recalls are common.
In March 2023, Zydus recalled 21,936 (30 count) and 33,096 (100 count) bottles of colchicine tablets used to treat gout.
In October 2023, Zydus recalled 7,248 bottles of oxybutynin chloride – used to treat bladder and urinary conditions – because the medicine did not dissolve properly.
In March of this year, FDA inspectors wrote up a Form 483, which is like a pre-Warning Letter, listing a number of things that needed to be fixed at one of its labs in Matoda, a city in Gujarat state on India’s West coast. Technicians were written up for failing to properly clean equipment used to mix pharmaceuticals.
In April, Zydus received poor marks following an inspection of its lab in Vadodara, also in Gujarat. This time inspectors cited 10 instances where the company was not in line with Current Good Manufacturing Practices. These failures included weak procedures to microbial contamination of the medicines being made at the lab for export to the U.S.
According to a poll from Morning Consult, 84% of registered voters support the FDA using import bans on labs issued a Warning Letter. Another 86% are not aware that the FDA does not test drugs imported to the U.S. from the labs just given Warning Letters for failed inspections.
We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.
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