Indian pharma company issues recall after recall and not one FDA inspector in sight
Despite its name, Glenmark Pharmaceuticals Limited is an Indian pharmaceutical company. It produces a variety of medicinal drugs for the global market at 14 different manufacturing facilities. According to its website, these sites are “inspected by various regulatory bodies such as the US-FDA, MHRA UK, SUKUL-CZ, RU-GMP Russia, TGA Australia, WHO GMP...” and the company is,
... committed to manufacturing and delivering high-quality products to patients across the globe.
And yet, earlier this year, Glenmark recalled nearly 47 million capsules of one of its products, Potassium Chloride Extended Release, due to “failed dissolution.” While this may not sound particularly serious, Glenmark is now the subject of a federal lawsuit following claims that the defects in the capsules directly led to the death of Marie Louise Cormier, an American woman from Maine.
Five years of virtually zero oversight
Potassium Chloride is a decades-old drug used to enhance nerve and muscle function in people with low levels of Potassium in their bodies. As with virtually all drugs, the difference is in the dosage. High doses of Potassium Chloride are used by some states in injection form to kill prisoners who have been sentenced to death. Since recalling its capsules, Glenmark has informed the FDA and other regulators of three deaths, three hospitalizations, and four other serious problems in people who used the product, although it has not admitted that the capsules were the direct cause of death or disorder.
The recalled capsules were all manufactured at Glenmark’s Madhya Pradesh factory in India. FDA inspectors are quite familiar with the site as they visited it on a yearly basis between 2015 and 2020. On three of those annual visits, significant problems were found. But in 2020, when the COVID “pandemic” struck, FDA inspections virtually ceased across the board. An analysis conducted by the Associated Press a few months ago found that around 2,000 pharmaceutical plants have not been inspected by the FDA in the past five years. The Madhya Pradesh factory, despite its checkered past, was one of them.
Warning signs ignored
In fact, the FDA was well aware of issues with drugs manufactured by Glenmark not only at the Madhya Pradesh facility but also at several of the other sites where the company manufactures drugs for the American market. In 2019, FDA investigators visited Glenmark’s Himachal Pradesh plant in northern India where they reviewed more than 100 complaints related to products made there. A steroid cream had been reported as being “gritty”; another medication was “watery”; and tubes of medicines had been found to be “cracked” or “punctured.”
At another Glenmark factory in Himachal Pradesh, FDA inspectors visiting in 2022 found so many issues that they placed the facility on the import “alert list,” which allows (while not requiring) federal officials to prevent the import of drugs manufactured there. The same year, another inspection of Glenmark’s Goa factory uncovered serious discrepancies between drug batches which were found to vary widely in strength and purity.
These and other issues were not confined to Glenmark’s factories in India. In 2021, Glenmark recalled every single product manufactured at its Charlotte, North Carolina plant for failing to meet standards. Half a year later, FDA investigators spent over a month there and documented a total of 17 violations.
Of the five Glenmark factories making drugs for the U.S. market, three were known to be problematic. Yet, the FDA didn’t inspect the other two. Even when four separate products were recalled from the Madhya Pradesh factory alone, in late 2023 and early 2024, the FDA didn’t send out inspectors to the site. Then followed the Potassium Chloride recall (which was followed by another two recalls of other drugs).
“They should have been camping out there,” Patrick Stone, a former FDA inspector, told ProPublica.
Quality inadequate; products still marketed
It’s not clear that “camping out” at Glenmark’s factories would have helped. After all, the FDA was aware of many earlier issues with drugs produced there, which continued to be sold to patients in the United States. The agency sent out a number of official warning letters, detailing the violations it found and demanding changes. On at least one documented occasion, the director of the FDA’s Office of Manufacturing Quality expressed dissatisfaction with Glenmark’s responses, telling them that,
Your quality system for investigations is inadequate and does not ensure consistent production of safe and effective products.
He also stressed that Glenmark had failed to identify the causes of the problems and therefore also failed to develop effective plans to ensure that the issues were resolved.
No power to recall?
Warning letters notwithstanding, Glenmark continued manufacturing its drugs and marketing them around the world. An FDA spokesperson stressed to ProPublica that the agency does not, in general, have the authority to order a drug to be recalled. Its role is confined to “overseeing a company’s [own] recall strategy, assessing the adequacy of the company’s action, and classifying the recall.”
Furthermore, it is not the FDA investigators themselves who decide which facilities to focus on; they are directed by a different branch of the agency which, according to investigators, is less up-to-date on which factories need added scrutiny.
Overall, the FDA prioritizes inspections based on its assessments of risk, which are determined by a computer model which takes into account a factory’s history of recalls, the results of prior inspections, and various other factors. In other words, for the most part, a company will not be rigorously monitored until it is known to be extremely problematic, by which time a lot of damage might already have been done.
Death by delay
Even once a recall has been ordered, all is not smooth sailing. The process is slow and proceeds in stages. First, the company must order the recall. The manufacturers are then responsible for notifying distributors, who in turn inform their customers, and so on down the supply chain. It takes days, and sometimes weeks, before all the pharmacies are alerted. And it may take much longer for everyone who bought the drug concerned to find out that it is not safe to use.
In the case of the Potassium Chloride capsules, the process was further held up by the FDA’s unexplained decision to delay issuing a public alert. Glenmark became aware of the problem some time in May; on May 29, a company executive wrote a letter to its distributors telling them that one batch of capsules had failed to dissolve correctly in a test, resulting in the company’s decision to issue a recall.
The executive noted that the recall was “being made with the knowledge of the Food and Drug Administration” and he stressed the importance of the issue by marking it “URGENT” in red capital letters. The letter was delivered overnight by FedEx. The FDA alerted the public on June 25, four weeks later. It has yet to provide a reason for its delay.
This is how it came about that a letter informing Mrs. Cormier that the Potassium Chloride capsules she had been taking had been recalled was received three weeks after her death.
Stone, the former FDA inspector cited earlier, notes that such an occurrence is not unusual with the agency.
The FDA is always late to respond. This should have been dealt with immediately.
Drugs licensed without inspection
Commenting on delays and other issues with FDA inspections, another former FDA employee, Peter Baker, told ProPublica that the crux of the problem lies in insufficient staff. Congress has reached the same conclusion on a number of occasions but its committees have also highlighted other problems with the agency which frequently lead to tragedy.
In 2023, for example, the CDC reported that four people had died and others had to have their eyeballs removed after using contaminated eyedrops. An investigation revealed that the factory — in India — where the drops were manufactured had never been inspected by the FDA.
The FDA’s methods of publicizing its investigations have also been questioned. Warning letters sent to companies are posted on the FDA website — but how many people know about them? Recalls, too, are publicized, but again — do all those who need to know find out, and quickly enough?
Furthermore, the FDA does not always post all the recalls issued by a drug company. In the case of Glenmark’s Madhya Pradesh facility, while a number of recalls were issued prior to the Potassium Chloride case, the only one mentioned on the FDA website is for those specific capsules.
Do you know where your generic Advil comes from?
In order to determine that the recalled Glenmark drugs were all made at the Madhya Pradesh factory, ProPublica checked drug-labeling records from the U.S. National Library of Medicine as well as details in two FDA databases. The FDA doesn’t routinely post its inspection reports online, so ProPublica obtained these records via Redica Systems, an analytics company which makes public record requests of the agency.
In theory, it is possible for the average man on the street to obtain the same information. In practice, most people will find the procedure complicated and time-consuming; furthermore, many people won’t even be aware of that the drugs they use are manufactured at a facility where other drugs have been recalled. Glenmark manufactures almost 200 different products marketed in the United States, including a generic version of Advil which was approved by the FDA just this year. The package insert on this product states only that the drug is manufactured in India without naming the factory itself.
Who does the FDA serve?
Glenmark is now being sued in federal court in New Jersey in relation to Mrs. Cormier’s death. The suit accuses the company of a “systematic disregard for drug safety” and of selling drugs “more suitable for an execution” than for vulnerable and unsuspecting patients. Glenmark denies that its Potassium Chloride capsules caused Mrs. Cormier’s death.
As for the FDA, spokeswoman Amanda Hils told ProPublica that the agency was doing everything it possibly could:
When there are quality issues identified that could result in harm, patients should rest assured that the FDA does everything within our authority to work with firms to ensure a recall is conducted most effectively.
The recall is categorized on the FDA’s website as “ongoing” — that is to say, the agency is not yet satisfied that all the affected drugs have been removed from circulation.
ProPublica concludes that the FDA’s response has been wholly inadequate and that it has failed the public in its duty to safeguard it from potentially dangerous drugs:
The FDA’s anemic response underscores longstanding weaknesses in the way the agency oversees the safety of generic medications manufactured in foreign factories. The agency failed to act on clear patterns of trouble, was slow to warn the public about the potentially deadly pills, and never mentioned that millions of them had been sold to consumers.
Given that the overwhelming majority of the factories making drugs for U.S. citizens are located overseas, this is an issue that affects millions and may well have already cost thousands of American lives.
Disclaimer: The information contained in this article is for educational and information purposes only and is not intended as health, medical, financial or legal advice. Always consult a physician, lawyer or other qualified professional regarding any questions you may have about a medical condition, health objectives or legal or financial issues. If you are struggling with suicidal thoughts, call a qualified free mental health helpline or seek help from a qualified therapist.
