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FDA Embraces Generic Drugs from India Despite Quality Problems

The nitrosamine controversy continues. Now add the diabetes drug metformin to a list of potential problem pills. How reliable are generic drugs from India?
FDA Embraces Generic Drugs from India Despite Quality Proble...
Metformin pills

2019 has been a year of many drug recalls because of concerns about quality and safety. The FDA announced a number of recalls involving blood pressure pills called ARBs. Angiotensin receptor blockers such as losartan and valsartan were contaminated with nitrosamines, probable cancer-causing chemicals. Then a popular acid-suppressing drug called ranitidine was also recalled because of concerns about nitrosamine formation. Now questions are being raised about some batches of the popular diabetes drug metformin. Despite so many problems with generic drugs from India, the FDA has welcomed a record number of new generic drugs from that country.

Record Warnings and Record Approvals of Generic Drugs from India:

A new report from India suggests that the US Food and Drug Administration has issued a record number of warning letters to Indian pharmaceutical companies.

Himani Chandna has written in the publication ThePrint (Dec. 3, 2019) that:

“American drug regulator FDA has issued warning letters to India’s top firms such as Lupin, Glenmark Pharmaceuticals, Torrent Pharmaceuticals, Aurobindo & Cadila.”

She goes on to write:

Dateline New Delhi: From spotting ‘live moths’ in raw materials to finding ‘bacteria-contaminated water’ in the manufacturing process, to unearthing ‘shredded’ records of quality control, the US Food and Drug Administration (FDA) has found several reasons to slap Indian drug-makers with ‘warning letters’ — a record high number of them — in 2019.

Metformin Under Scrutiny for the Nitrosamine NDMA

The FDA admits that it is testing samples of metformin for the probable carcinogen, N-Nitrosodimethylamine (NDMA). That is the same nitrosamine that was found in ranitidine. As usual, the FDA appears to be behind the eight ball.

According to FiercePharma (Dec. 5, 2019)

“But the ball could already be rolling on metformin after the Singaporean Health Sciences Authority announced Wednesday it had recalled three of 46 versions of the drug sold in the country after finding NDMA above the ‘internationally acceptable amount.”

We also checked with David Light, CEO of Valisure. This pharmacy and testing laboratory in New Haven, CT, tests every batch of medications it sells.

We were told that Valisure has been:

“having problems with metformin as well and have failed 60% of the batches we tested for concern over NDMA.”

Some of those failed products came from Indian generic drug manufacturers.

The FDA’s Official Statement On Metformin and NDMA:

Dr. Janet Woodcock is the Director of FDA’s Center for Drug Evaluation and Research (CDER). She is one of the most important people at the agency.

Last night our inbox had this official statement from the FDA (December 5, 2019):

“The U.S. Food and Drug Administration has been investigating the presence of genotoxic impurities, called nitrosamines, in some types of drugs. Over the past year and a half, several drug products including angiotensin II receptor blockers (ARBs) and ranitidine, commonly known as Zantac, have been found to contain small amounts of nitrosamines such as N-Nitrosodimethylamine (NDMA). During this time, there has been an ongoing investigation into the presence of nitrosamines in other drug products…

“The FDA is aware that some metformin diabetes medicines in other countries were reported to have low levels of NDMA. Based on the information we have available, the levels of NDMA seen outside the U.S. are within the range that is naturally occurring in some foods and in water. While we are aware that some regulatory agencies outside the U.S. may be recalling some metformin drugs, there are no metformin recalls affecting the U.S. market at this time. The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms. The agency will also work with companies to test samples of metformin sold in the U.S. and will recommend recalls as appropriate if high levels of NDMA are found.”

Dr. Woodcock tells patients to keep taking their metformin while the FDA does further testing. That has been the message with almost all the nitrosamine contamination. Don’t worry, be happy! Continue taking your valsartan, losartan, irbesartan, ranitidine, Zantac, etc. The levels of nitrosamines aren’t all that bad. The FDA is on the job protecting you from contaminated chemicals. Then a few weeks or months later we are informed that yes, there is a problem after all. And yes, millions of pills are being recalled. But don’t worry, it’s only been going on for a few years. 

Generic Drugs from India Approved in Record Numbers:

Even though pharmaceutical manufacturers in India have received an increasing number of warning letters this year, the FDA has approved more generic drugs from India than ever before. In 2017, 27% of all generic drug approvals came from India. That number increased to 36% in 2018. In 2019 the number of drug approvals from India will represent 43% of all generic drug approvals in the U.S.

This trend may well continue. Hospitals are already experiencing substantial drug shortages. If the FDA were to restrict generic drug imports from China or India it is likely that these shortages would reach critical levels. Actually, drug shortages are already critical. So whatever comes after critical would occur if the FDA cracked down on foreign pharmaceutical firms. 

How Can Patients Get Their Drugs Tested?

Valisure doesn’t only test every batch of medications and supplements it sells. It also tests patients’ medications for impurities such as nitrosamines. You can learn more at www.Valisure.com  You can call about questions at 833-825-4787.

How do you feel about the FDA’s generic drug approval process? Do you find it odd that the FDA can issue so many warning letters to foreign pharmaceutical firms but continue to allow those very same companies to continue to export their products to the U.S.? Have you ever experienced problems with generic drugs? Has your medicine ever been recalled?

Share your thoughts in the comment section. You may also find our eGuide to Saving Money on Medicine of benefit. It reveals our challenging experiences with the FDA about generic drug approvals. There are also tips on using generic drugs safely. You will find this electronic resource in our Health eGuide section

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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