US pharma Cos get more FDA ‘warnings’ than Indian firms

In the previous year, the US received 19 warning letters, while China got most at 21, and India had 15.

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USFDA
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3 min. read

Mumbai: The Indian pharma industry, which is rapped for poor manufacturing practices globally, seems to be cleaning up its act, at least in relative terms.

  • American drug firms were issued 54 warning letters by the USFDA,
  • while India — which had the distinction of getting most warning letters — stood second with 17 such notices in the year ended September (US financial year).
  • China ranked third with 14 warning letters.

A company slapped with a warning letter is barred from introducing new products in the US, hindering its ability to increase sales in the world’s top pharmaceutical market.

Earlier

Earlier, emerging economies like either India or China topped the list.

In the previous year, the US received 19 warning letters, while China got most at 21, and India had 15.

Also read: Lupin gets 5 observations from USFDA

Data integrity

Data integrity issues, which include inappropriate manufacturing practices and overlooking results while testing medicines, continue to dog the drug industry with 32 of 98 warning letters in FY19 citing the issue.

In the previous year, 34 of 94 warning letters were due to data integrity lapses, which have a significant impact on drug product quality. 

Several domestic pharma companies have been hauled up by the US regulator over issues like lax documentation, overlooking test results and unhygienic manufacturing facilities with open toilet drains.

Indian companies command around 35% volume share in the highly lucrative US generic market, valued at nearly $70 billion.

“Common issues for manufacturing establishments around the world (including the US, India and China) include inadequate or poor quality systems implementation, data integrity issues, inadequate validation of various processes used in manufacturing or testing, and product contamination.

In any region, some drug manufacturers meet US requirements, while others do not. When we determine that there are significant violations at a manufacturing establishment, we take appropriate action to protect the public health,” a USFDA official told TOI.

The official added, “It is important to note that the number of annual inspections in any region or country may fluctuate year-to-year because some inspections occur on a routine basis.

While others take place when the FDA is reviewing specific product marketing applications, or when the agency receives information about potential product manufacturing or quality problems.”

Also read: Strides gets USFDA nod for anti-allergic drug

Major companies

In 2019, major companies — including Lupin, Torrent, Aurobindo, Strides Pharma, Cadila Healthcare, Indoco Remedies, Glenmark, Jubilant Life Sciences and Emcure Pharma — were issued warning letters for significant violations of current good manufacturing practice (CGMP) regulations.

Typically, the action follows inspections and audits carried out by the US regulator.

PwC India leader (pharmaceutical & life sciences) Sujay Shetty said, “Data shows the phenomena of warning letters spread across many countries, and not just unique to India.

Indian companies hog the limelight, though they may have got lower number of letters (in other years).

Also, the data speaks volumes about domestic companies investing effort and resources in upgrading quality systems in their facilities.”

Commenting on USFDA audits, Sun Pharma MD Dilip Shanghvi had said in a recent investor call, “Indian companies file large number of products, and as a part of their assurance to the US Congress, the USFDA has said that they will try and conduct as many pre-approval inspections as necessary.

If we continue to be the largest filer of new ANDAs in the world, we will have a large number of inspections.

As regulators see any kind of a risk in one inspection, they add as part of the inspection plan for future audits.

Accordingly, the focus of USFDA inspections will continuously change, and it will help improve the quality of products for safety of patients.”

Also read: Lupin gets 2 observations from USFDA

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