Medicines | Representational image | Pexels
Medicines | Representational image | Pexels
Text Size:

Washington: An India-based company that sells numerous drugs in the U.S., including ibuprofen, was caught attempting to dispose of quality-control records, calling into question the safety of its medicines.

U.S. Food and Drug Administration inspectors said they found what appeared to be records awaiting shredding at Strides Pharma Science Ltd.’s manufacturing facility in Puducherry, the agency said in a warning letter to Chief Executive Officer Arun Kumar made public on Tuesday. Discarded records were also found in a 55-gallon drum in the company’s scrap yard, the letter said. Ibuprofen is among the drugs the company makes at the Puducherry plant.

The destruction of quality-control paperwork and a lack of adequate documentation that its medicines are safe “raise questions about the effectiveness” of Strides’s quality unit “and the integrity and accuracy” of its data, FDA’s Francis Godwin, director of the Office of Manufacturing Quality, wrote in the warning letter.

Strides didn’t immediately respond to a request for comment.

Drugmakers around the world are facing questions about their quality-control procedures amid a yearlong recall of heart pills contaminated with probable carcinogens. Most of those pills were produced in India and China, where U.S. regulators have sometimes struggled to oversee companies whose workers have actively taken steps to mislead them.

A Bloomberg investigation this year has documented an industrywide problem of companies ignoring test results showing that some generic drugs fail to measure up to U.S. standards. Drugmakers in India and China have been found to have ignored red flags, producing contaminated heart pills for years.

Strides is approved to make losartan, one of the drugs that is part of the wider recall, for the U.S. It acquired a unit of Vivmed Labs Ltd. in January that manufactures the drug, which was recalled in May.

We are deeply grateful to our readers & viewers for their time, trust and subscriptions.

Quality journalism is expensive and needs readers to pay for it. Your support will define our work and ThePrint’s future.

SUBSCRIBE NOW


Also read: Once looking to clip NPPA’s wings, govt now plans to give drug price regulator more power


Impurity investigation

Strides didn’t adequately investigate an unknown impurity found in an active ingredient used to make a drug, the name of which FDA redacted in the warning letter. Instead, Strides blamed the impurity on a substance it said it used to test the drug, swapped out that substance on a new sample to obtain a passing quality score, and used the ingredient that failed its testing to make finished drugs, according to the warning letter.

When drugmakers spot an impurity during testing, they’re supposed to attempt to identify what the potential contaminant is. Strides didn’t take that step, the FDA said.

The FDA’s letter to Strides is the latest in recent series of such communications to generic-drug manufacturers. Aurobindo Pharma Ltd. was warned by the agency last month for ignoring impurities in an active ingredient it produced. The name of the ingredient was redacted in the letter. Aurobindo, based in India, recalled contaminated valsartan in January and again in March.

Subscribe to our channels on YouTube & Telegram

News media is in a crisis & only you can fix it

You are reading this because you value good, intelligent and objective journalism. We thank you for your time and your trust.

You also know that the news media is facing an unprecedented crisis. It is likely that you are also hearing of the brutal layoffs and pay-cuts hitting the industry. There are many reasons why the media’s economics is broken. But a big one is that good people are not yet paying enough for good journalism.

We have a newsroom filled with talented young reporters. We also have the country’s most robust editing and fact-checking team, finest news photographers and video professionals. We are building India’s most ambitious and energetic news platform. And we aren’t even three yet.

At ThePrint, we invest in quality journalists. We pay them fairly and on time even in this difficult period. As you may have noticed, we do not flinch from spending whatever it takes to make sure our reporters reach where the story is. Our stellar coronavirus coverage is a good example. You can check some of it here.

This comes with a sizable cost. For us to continue bringing quality journalism, we need readers like you to pay for it. Because the advertising market is broken too.

If you think we deserve your support, do join us in this endeavour to strengthen fair, free, courageous, and questioning journalism, please click on the link below. Your support will define our journalism, and ThePrint’s future. It will take just a few seconds of your time.

Support Our Journalism

1 Comment Share Your Views

1 COMMENT

  1. We are so glad for news publications like The Print which bring to light and unsuspecting customers the reality scenarios this time the controversial generic drug business in India as soon Govt to help patients wants Docs to prescribe generic instead of prescription drug which is a v.good move but the Drug Regulators then have to br more professional and honest in their Inspections.
    We know the attitude of most Regulators and strict and honest they are with their Inspections one major one is…informing the Cos in advance of their visit !!

LEAVE A REPLY

Please enter your comment!
Please enter your name here