Volume 95 Issue 32 | p. 11 | News of The Week
Issue Date: August 7, 2017 | Web Date: August 4, 2017

Dr. Reddy’s struggles to meet FDA concerns

Indian drugmaker doesn’t expect to make facilities compliant before year-end
Department: Business
Keywords: generics, cGMP, FDA, compliance, India
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Dr. Reddy’s is a major producer of generic drugs and active pharmaceutical ingredients.
Credit: Shutterstock
A photo of two pill caps bearing a Dr. Reddy’s logo in someone’s hand.
 
Dr. Reddy’s is a major producer of generic drugs and active pharmaceutical ingredients.
Credit: Shutterstock

Managers at India’s Dr. Reddy’s Laboratories do not expect to be ready for another FDA inspection of the company’s manufacturing facilities until December.

Many Indian drug firms, such as Ipca Laboratories, Cadila Healthcare, and Sun Pharma, have had recent quality issues and run-ins with FDA. Reddy’s problem with FDA stems from a warning the agency issued to Reddy’s in November 2015 that three of its facilities did not meet U.S. manufacturing standards. And during a reinspection of one of those facilities in March, FDA once again discovered several shortcomings.

While talking to financial analysts late last month after the announcement of the firm’s first-quarter earnings, Dr. Reddy’s chair and CEO G. V. Prasad noted that the company had to “systematically implement our new quality-management system and automate some of the critical manufacturing and quality-related processes.” Chief Operating Officer Abhijit Mukherjee added, “Optimistically, we expect to have FDA coming by year-end, December.”

In the first quarter of its current fiscal year, Dr. Reddy’s sales in North America declined 4% compared with a year earlier. The company blames primarily “price erosion” for the drop. But in his comments to analysts, Prasad also noted that regulatory issues constrained the company’s ability to get approval for new product launches.

During an inspection in 2014, which led to the 2015 warning, FDA inspectors discovered an undeclared quality-control lab at the company’s plant at an industrial park in the state of Andhra Pradesh, India. FDA also found that Dr. Reddy’s routinely retested failed batches until it got favorable test results.

“What would otherwise be minor deficiencies in a more trusted company now turn into major expenditures and radical changes for Dr. Reddy’s,” says Peter Saxon, president of Saxon International Associates, a New Jersey-based consulting firm that advises foreign drug producers on U.S. drug manufacturing regulations.

The nature of the company’s previous violations, he says, revealed an intention to deceive FDA, as well as regulators in other countries, he believes. In Saxon’s experience, it takes time for a company to completely erase a corporate mind-set that condones dishonesty.

 
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Comments
James E. Gillespie (Sat Sep 02 22:42:54 EDT 2017)
I have taken a 100 mg Sumatriptan tablet from Dr. Reddy's labs every twelve hours for over a dozen years with great results. Dr. Reddy's lab is my favorite source for Sumatriptan for my cluster headaches. I have also taken the same drug in the same quantity and mg from other sources on occasion and find that, unlike those other labs, Dr. Reddy's tablets are the most reliable with the most consistent results. I hope to be a continued customer.
Terri Kalagayan (Wed Dec 06 06:23:16 EST 2017)
I have been taking Dr Reddys generic imitrex for many years and I would say Ive had the closest results as compared to the name brand and Dr Reddy's. Other generics i've tried arent as reliable and now suddenly no pharmacy is carrying their generic Sumatriptan which is a big issue for me since I have close to 8 migraines a month.
Sara Franklin (Sat Dec 09 10:59:15 EST 2017)
I take Ibandronate 150 and have for years. Recently my company changed to Dr. Reddy's for their pill supply and I am having a very different reaction to the pill. I suspect there is not the same amount of Ibandronate in the pills. What can I do to follow up on this.

Jer Sullivan (Fri Dec 22 15:48:16 EST 2017)
Simple! Tell your Pharmacy to NOT fill your prescription with Dr. Reddy products!
R Col (Wed May 30 15:31:51 EDT 2018)
NOT simple at all. The pharmacy buys for the country and sends what they send. Local branches cannot order things that are not in their national warehouses. Only recourse is to change to another pharmacy line.
R Col (Wed May 30 15:30:50 EDT 2018)
The same has occurred with me. I am preparing to change from Walgreens to another pharmacy as more and more of their pills come from India. Consumer Reports wrote a few months ago when they tested pills and vitamins from Costco, Walgreens, and BJs that the pills did not contain what they were to in the right quantities.
Why can't our government just restrict them from doing business in this country.

Will try a few pharmacies locally and ask them where they would get these pills from if I switched. Will advise on results.
Ruth
Jer sullivan (Fri Dec 22 15:46:14 EST 2017)
I take Amlodipine-Benazepril and Dr. Reddy’s Lab Generic just simply DOES NOT WORK! I suspect it is simply a placebo! Why do pharmacy’s carry it? Lowest price/highest profit for pharmacy and insurance companies! BTW, FDA does NOT approve, and is not allowed to inspect their manufacturing facilities in India. This is a big red flag for me.
Ewell Jones (Wed Jan 10 10:03:04 EST 2018)
I have been taking generic tizanidine ( zanaflex) for severe muscle spasms from polyneuropathy for years. This brand does not work at all. It either has so little of the active ingredient or that it doesn’t work,0 or it is a placebo. What a crying shame that the FDA allows this medicine to be sold in this country. Write your congressmen and senators about this sorry excuse of a company peddling this useless medicine%.
Mary E Prince  (Sun Mar 04 06:25:16 EST 2018)
I am writing my congressmen. I now take brand name, told Kroger Pharmacy not to ever give me this lab again or any of the others they own. Yes they own others!
Clarice Cory (Thu Mar 01 21:21:55 EST 2018)
I agree with Ewell Jones above comment concerning tizanidine. My pharmacy filled my last script for tizanidine with generic Dr. Reddys Lab and I can tell a difference from previous month prescription. I will be moving my prescription to another pharmacy hat does not use this pharmaceutical brand.
Kara (Thu Mar 15 21:11:21 EDT 2018)
I was on pregestrone from Walgreens for 3 months and it worked great. My prescription company requires me to go through a mail order system after a certain amount of time. Shortly after starting on Dr. Reddy’s I could tell it wasn’t working. My dr told me to take double the amount and did blood work. Now my symptoms are getting worse. I’m going to just pay out of pocket for the real stuff. This is very sad.

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