US health regulator pulls up Sun Pharma for lapses in Gujarat plant

  • The company’s supply reportedly decreased, falling to around 2.37% in the US market compared to 3% of the combined business in 2021-2022
  • The letter highlighted Sun Pharma’s failure to implement quality control and other manufacturing practices at its plant
  • The Sun Pharmaceutical Industries Ltd is one of the world’s largest generic pharmaceutical firms, with global sales of over $5.1 billion

The US health regulator Food and Drug Administration (USFDA) has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow written procedures designed to prevent microbiological contamination of drug products at its Gujarat-based plant. The health regulator issued a warning letter citing flaws at the Halol factory, which manufactures finished pharmaceutical goods.

The Sun Pharmaceutical Industries Ltd is one of the world’s largest generic pharmaceutical firms, with global sales of over $5.1 billion, per its website. The company is supported by more than 40 manufacturing facilities that produce high-quality, low-cost medications. It also claimed the USFDA was satisfied with the company’s remedies.

The health regulator inspected the manufacturing facility from 26th April to 9th May 2022 and placed the unit on ‘import alert’ last week. It means that future shipments of items developed at the plant will be denied entry into the US market. The company’s supply reportedly decreased, falling to around 2.37% in the US market compared to 3% of the combined business in 2021-2022.

The FDA’s warning letter highlighted Sun Pharma’s failure to implement quality control and other manufacturing practices at its plant. One of the major lacunas pointed out by the regulator includes a lack of a microbiological contamination system.

The USFDA in the warning stated: “This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals… Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated.”

The letter also pointed out drug the firm’s failure to establish and follow appropriate procedures. “Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas,” it said.

It further said: “Your ISO 5 cleanroom areas used for aseptic compounding and filling were poorly designed and lacked adequate protection.” The ISO 5 area is critical because sterile drug products are exposed and therefore vulnerable to contamination, it added.

“Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance,” USFDA said.

Company share declines

The Sun Pharma shares closed 3.57% lower at Rs 980.95 on Thursday on the Bombay Stock Exchange (BSE) post the USFDA import alert.

Soon Sun Pharma clarified saying it “continues to cooperate with the USFDA” and assured that necessary steps would be taken to resolve issues highlighted by the regulator.

 

I had major side effects from 2nd Covid booster shot: Elon Musk

New Delhi: Twitter CEO Elon Musk on Saturday joined the growing debate on the serious side-effects of Covid-19 vaccines, saying he had "major side effects from my second booster shot"....

Covid-19: Govt admits side-effects of vaccines in RTI reply

In a shocking revelation, Union government’s two top health watchdog bodies have admitted that there were side effects of coronavirus vaccines that were administered to over a billion Indians. The...

How indoor air pollution is 5 times worse than outdoors

New Delhi: As Delhi-NCR reels under massive air pollution after Diwali every year, leaving people with respiratory illnesses gasping for fresh air, experts on Tuesday said that as most people...

Congress MP dies of heart attack in Bharat Jodo Yatra in Punjab

Chandigarh: Congress MP Chaudhary Santokh Singh on Saturday died of heart attack during party leader Rahul Gandhi's Bharat Jodo Yatra in Punjab. Singh fell during the rush of the yatra...

Experts make a big statement, urges govt to declare end of Covid pandemic, limit vaccination

Immunity created from infection is much better than vaccine Unnecessary vaccination will impinge on more pressing health issues It is time to declare an end to the pandemic In a...

No cause of worry over BF.7 variant; Indian vaccines fully effective, says Health Minister Mandaviya

New Delhi: Amid the surge in cases of BF.7 variant of Covid in China and other parts of the world, Union Minister for Health and Family Welfare Mansukh Mandaviya today...

US researcher calls for withdrawal of RNA Covid vaccine as it may cause sudden cardiac deaths

Pfizer Covid vaccine raises the risk of lung blood clots by 50 per cent Nations with higher mRNAs vaccine uptake have correlations of higher rates of excess mortality Vaccine increases...

Japan culls 9.98 mn birds as avian flu rages

Tokyo, Jan 9 (IANS) A record high of 9.98 million birds at poultry farms have been culled in Japan this season amid the nationwide surge in cases of avian influenza, the...

mRNA Covid-19 vaccines can increase serious adverse events, claims US researcher

Washington, Jan 9 (IANS) A US-based researcher has claimed that messenger RNA Covid-19 vaccine can increase serious adverse events in people, including sudden cardiac deaths. Joseph Fraiman, the lead author of...

Sonia in hospital for treatment of viral respiratory infection

New Delhi:UPA Chairperson Sonia Gandhi was admitted to Sir Ganga Ram Hospital here on Wednesday for "observation and treatment of a viral respiratory infection", doctors said. As per a hospital...

Wild boars die in large numbers in TN, swine flu suspected

Chennai: The Tamil Nadu forest department has deployed anti-poaching watchers (APW) to look for wild boar carcasses in interior forest areas after a large number of wild boars died in...

Covid: WHO asks China to share specific, real-time data on situation

The World Health Organization (WHO) has once again asked China to share real-time and specific data regularly on the COVID-19 condition in the nation. The world health body also asked...

Read Previous

Central Minister Nitin Gadkari gets death threats, security tightened

Read Next

Regional parties will hold key in 2024 LS polls, Mamata has ability to be next PM: Amartya Sen

Leave a Reply

Your email address will not be published.

WP2Social Auto Publish Powered By : XYZScripts.com