In a significant move to safeguard <keyword id="19913584" type="General" weightage="20" keywordseo="public-health" source="keywords">public health</keyword>, the Indian government has banned 156 widely sold fixed-dose combination (FDC) drugs, many of which are used to treat common ailments such as fever, colds, allergies and pain. The banned FDCs include several popular antibacterial and pain-relief medications, which the government has declared "likely to involve risk to human beings." The ban was officially announced through a gazette notification issued by the <keyword id="19897332" type="General" weightage="20" keywordseo="Union-Health-Ministry" source="keywords" meta.keywordsubtype="org" meta.entityname="Union Health Ministry" meta.hostid="261" meta.entityid="Union Health Ministry">Union Health Ministry</keyword> on August 12. <keyword id="22891947" type="General" weightage="20" keywordseo="FDC-drugs" source="keywords">FDC drugs</keyword>, often referred to as "cocktail" drugs, contain a combination of two or more active pharmaceutical ingredients in a fixed ratio. While such combinations are intended to offer multi-faceted treatment, concerns have been raised about their safety and efficacy. Among the drugs on the banned list is the well-known combination of Aceclofenac 50 mg and <keyword id="20687368" type="General" weightage="20" keywordseo="paracetamol" source="keywords">Paracetamol</keyword> 125 mg, a popular pain reliever produced by several major pharmaceutical companies. Other banned FDCs include Mefenamic Acid Paracetamol Injection, Cetirizine HCl Paracetamol Phenylephrine HCl, Levocetirizine Phenylephrine HCl Paracetamol, Paracetamol Chlorpheniramine Maleate Phenyl Proanolamine, and Camylofin Dihydrochloride 25 mg Paracetamol 300 mg. A particularly notable ban is on the combination of Paracetamol, Tramadol, Taurine, and Caffeine. Tramadol, an opioid-based painkiller, has drawn attention for its potential for abuse and addiction, adding to the concerns surrounding its inclusion in over-the-counter FDCs. <div type="Article" hostid="261" msid="112557689" title="The drugmaker that hopes to legalize MDMA is cutting 75% of its staff after the FDA rejected the drug" mstype="2" mssubtype="0"></div>According to the government's notification, the Central government has determined that the use of these FDCs "is likely to involve risk to human beings," and that "safer alternatives to the said drugs are available." The decision follows an in-depth examination by an Expert Committee, which found many of these FDCs to be "irrational." The apex panel Drugs Technical Advisory Board (DTAB) also reviewed the combinations and concluded that there was "no therapeutic justification" for the ingredients in these FDCs. In light of the potential risks, the government deemed it necessary to prohibit the manufacture, sale, and distribution of these drugs under Section 26A of the Drugs and Cosmetics Act, 1940. The notification emphasised that "in the larger public interest, it is necessary to prohibit the manufacture, sale, or distribution of this FDC" as regulation or restriction would not be sufficient to protect patients. This is not the first time the Indian government has intervened to address the sale of FDCs. In 2016, the Centre had announced a ban on 344 FDCs after an expert panel — established at the direction of the Supreme Court — found that many of these combinations were being sold without sufficient scientific evidence supporting their efficacy. Although that decision was contested in court by <keyword id="22603498" type="General" weightage="20" keywordseo="drug-manufacturers" source="keywords">drug manufacturers</keyword>, it set a precedent for regulatory scrutiny of FDCs in India. In June 2023, 14 FDCs from the original list of 344 were also banned. Many of the drugs included in the recent list of 156 were part of this original 344-drug combination ban, reinforcing the government's continued efforts to remove unsafe and unjustified medications from the market. Several of the banned products had already been discontinued by manufacturers, but the new regulations ensure that these combinations will no longer be available for sale in India, further emphasising the government's commitment to public safety and rational drug use. <div type="Article" hostid="261" msid="112374485" title="Govt waives clinical trial requirement for several drugs approved in select countries" mstype="2" mssubtype="0"></div>

156 ‘combination medicines’ containing Cetirizine, Paracetamol and other common drugs banned by Centre

The central government has prohibited as many as 156 <keyword id="22893276" type="General" weightage="20" keywordseo="combination-drugs" source="keywords">combination drugs</keyword> that are often administered as painkillers, multivitamins, and antibiotics, for fever and cold, among others. In a gazette notification dated August 21, the government said that the use of the drug Fixed Dose Combination of Amylase, Protease, Glucoamylase, Pectinase, Alpha Galactosidase, Lactase, Beta-Gluconase, Cellulase, Lipase, Bromelain, Xylanase, Hemicellulase, Malt diastase, Invertase, Papain is likely to involve risk to human beings whereas safer alternatives to the said drug are available. Upon recommendations of the <keyword id="20092000" type="General" weightage="20" keywordseo="Drugs-Technical-Advisory-Board" source="keywords">Drugs Technical Advisory Board</keyword>, the central government, in the greater interest of the public, has prohibited the manufacture for sale, sale, and distribution for human use of those drugs across the country with immediate effect. The move from the government comes after the matter was examined by an expert committee appointed by the central government, and the said expert committee considered the administration of this Fixed Dose Combination as "irrational". The Drugs Technical Advisory Board also examined the said FDC and recommended that "there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of the Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable," the notification read. The list of banned drugs also includes drugs used for hair treatments, antiparasitic, skincare, anti-allergic. The medicines combined in more than one drug in a single pill are Fixed dose combination drugs FDC, these drugs are also known as cocktail drugs. The Indian Pharmaceutical Alliance supports the decision of the government. Sudarshan Jain, Secretary General, IPA told that, "this has been going for many years and there was a committee which reviewed the whole thing... This is a right step in the interest of patients and all aspects have been taken into consideration." "They have given the opportunity to give the data to support their products, so the right products will continue and when there is no data to support then companies have to withdraw it," Jain added. SEE ALSO: <a href="https://www.businessinsider.in/business/auto/webstories/2024-tvs-jupiter-vs-honda-activa-6g-which-110cc-scooter-should-you-buy/slidelist/112730069.cms">2024 TVS Jupiter vs Honda Activa 6G – which 110cc scooter should you buy?</a> <a href="https://www.businessinsider.in/tech/how-to/how-to-add-music-to-instagram-profile/articleshow/112732934.cms">You can now add music to your Instagram profile – here's how</a> <a href="https://www.businessinsider.in/business/auto/news/audi-q8-facelift-launched-in-india-with-a-1-17-crore-price-tag/slidelist/112707701.cms">Audi Q8 facelift launched in India with a ₹1.17 crore price tag</a>

India bans 156 commonly used combination drugs citing possible risks to humans

Washington [US], August 3 (ANI):Researchers at the University of Colorado Anschutz Medical Campus have contributed to the confirmation of the dose, safety, and efficacy of a medication formulation intended to treat children infected with the human immunodeficiency virus (<keyword id="6363554" type="General" weightage="70" keywordseo="hiv" source="Orion">HIV</keyword>). The study, which was published in The Lancet HIV, found that combining three medications - dolutegravir, abacavir, and lamivudine - in a single fixed dose combination (FDC) formulation is safe, well tolerated, and effective for treating children with HIV. Dosing was also reasonable based on the concentrations of each medicine in the blood. "This is the first FDC containing dolutegravir that can be used for children from 13 to 88 pounds," said Kristina Brooks, PharmD, an assistant professor in the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences at CU Anschutz. "HIV treatment in children has historically been challenging as it requires the use of multiple tablets and liquids that don't always taste the best, and can be challenging to administer." Dolutegravir, abacavir and lamivudine have been shown to be safe and effective worldwide to treat HIV. Brooks and Jennifer Kiser, PharmD, PhD, worked with a team of investigators through the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network to look at both an existing immediate release tablet and a new formulation of dispersible release tablets containing all three drugs to see if it would yield the same positive results they have seen in adults and adolescents. "57 children were enrolled across five weight bands in four countries, of which 54 children used the new combination over 24 weeks. In 98 percent of the participants who continued the study drug, the amount of HIV in the blood remained suppressed below 200 copies/mL at week 24. The safety, tolerability, and effectiveness of these formulations look very positive," Brooks said. Child-friendly FDC formulations for HIV are limited. Brooks said this new formulation could help enable continuity of treatment, improve treatment outcomes and make it easier for caregivers responsible for dispensing the drugs. This study also helped support recent labeling updates by the U.S. Food and Drug Administration to expand the use of this formulation to children aged at least 3 months and weighing at least 13 pounds. There are currently two million children living with HIV across the globe. Only 52 percent are on therapy, and despite making up only four percent of the worldwide HIV population, children account for 15 percent of AIDS-related deaths. Studies like this are vital to improve these outcomes and to make medication more accessible around the world. "We must continue to pursue child-friendly treatment options to overcome the current global disparity in treatment outcomes between children and adults," Brooks said. Some of the children who were in the initial trial are still on the new drug formulation through an open access program. The longer-term safety, tolerability, and effectiveness through 12 months of treatment is under analysis now and will be reported separately. (ANI)

New HIV drug formulation may help improve treatment outcomes for children worldwide: Study

<ul><li>Favipiravir has demonstrated positive clinical outcomes in some trials and has already been approved for use to treat Covid-19 in Russia and parts of the Middle East. </li><li>FDC launched two variants of Favipiravir in India at ₹55 per tablet under the brand names PiFLU and Favenza. </li><li>Several other companies have launched the generic versions of Favipiravir so far in India. </li><li>The cheapest version from Sun Pharmaceuticals' stable, which charges ₹35 per tablet. </li></ul>FDC has launched two variants of Favipiravir in India at ₹55 per tablet under the brand names PiFLU and Favenza. "Early diagnosis and treatment will help in arresting the deteriorating condition of patients, and we will be working with the government and healthcare fraternity to make Favenza and PiFLU available across the country” FDC spokesperson Mayank Tikkha <a href="https://www.indiatvnews.com/business/news-fdc-launches-2-variants-of-favipiravir-in-india-at-rs-55-per-tablet-covid-19-treatment-drug-644774">said</a>. According to FDC, both the variants are available in India. Favipiravir was originally developed to treat novel influenza in Japan and was sold by different manufacturers under the name Avigan, Abigan, and Fabiflu. Several other companies have launched the generic versions of Favipiravir so far in India. The cheapest version is developed by Sun Pharmaceuticals, which charges ₹35 per tablet. <table style="border-width: initial; border-style: none; width: 468pt; table-layout: fixed;"><colgroup></colgroup><col /><col /><tbody><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Companies which launched Favipiravir </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Price </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Avigan </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹99 per tablet </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Hetero </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹59 per tablet </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Cipla </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹68 per tablet </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Glenmark </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹75 per tablet. </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">FDC </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹55 per tablet (Two variants) </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Sun Pharmaceutical Industries </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹35 per tablet </td></tr></tbody></table><keyword id="44587" type="COMPANY" weightage="20" keywordseo="Dr-Reddy">Dr Reddy</keyword>’s Laboratories, on August 19,<a href="https://www.livemint.com/companies/news/dr-reddy-s-launches-innovator-brand-of-favipiravir-avigan-at-99-per-tablet-11597844567875.html"> joined the list of companies</a> which launched their own generic version of favipiravir in India. The company has priced ‘Avigan’ at ₹99 — a premium price when compared to other versions of the same drug. The whole course of the tablet is expected to cost over ₹12,000. Earlier this month, two more Indian pharma companies — Sun Pharmaceuticals and Zendara Pharma — said they are manufacturing Favipiravir in the country to treat coronavirus. Glenmark was the first to launch the drug in India followed by Cipla, Sun Pharmaceuticals on <a href="https://www.livemint.com/science/news/at-rs-35-per-tablet-sun-pharma-launches-fluguard-for-covid-treatment-11596532805116.html">August 4 announced </a>the launch of Favipiravir, under brand name FluGuard, at ₹35 per tablet for the treatment of mild to moderate cases of Covid-19 in India. The stocks of FluGuard will be available in the market from this week. "We are launching FluGuard at an economical price to make the drug accessible to more and more patients, thereby reducing their financial burden. This is in line with our continuous efforts to support India's pandemic response," Sun Pharma said. Hyderabad-based Zenara Pharma on August 5 <a href="https://theprint.in/health/zenara-pharma-latest-indian-firm-to-get-nod-for-covid-drug-favipiravir-to-call-it-favizen/475666/">announced that it has received approval</a> from the Drugs Controller General of India (DCGI) to manufacture and sell Favipiravir tablets as a treatment option for patients with mild to moderate symptoms of Covid-19. The tablet, which will be sold under the brand name 'Favizen', is being manufactured at Zenara's US FDA approved state-of-the-art facility in Hyderabad. Zara Pharma, a fully-owned subsidiary of Biophore India Pharmaceuticals, is in talks with multiple state institutions and several hospitals in India to ensure that Favizen is readily available for the patients in need. Favipiravir has demonstrated positive clinical outcomes in some trials and has already been approved for use to treat Covid-19 in Russia and parts of the Middle East. Advance stage trials are currently underway in several countries, including India. SEE ALSO: <a href="https://www.businessinsider.in/defense/news/india-military-options-against-china-explained-by-experts/articleshow/77743778.cms">Experts explain India’s 'military options' against China</a> <a href="https://www.businessinsider.in/politics/world/news/boris-johnson-plans-to-resign-in-6-months-because-of-lingering-coronavirus-health-problems-according-to-dominic-cummings-father-in-law/articleshow/77739903.cms">Boris Johnson plans to resign in 6 months because of lingering coronavirus health problems, according to Dominic Cummings' father-in-law</a>

FDC launches two variants of COVID-19 drug Favipiravir in India at ₹55 per tablet

<ul><li>The ban affects an estimated 6,000 brands of ‘fixed dose combination’ drugs.</li><li>A drug review panel deems these drugs potentially toxic. </li><li>Popular painkiller <keyword id="1840022" type="PERSON" weightage="20" keywordseo="Saridon">Saridon</keyword> and skin ointment <keyword id="6875076" type="UNKNOWN" weightage="20" keywordseo="panderm">Panderm</keyword> among those banned.</li></ul>The government on Wednesday banned the sale and distribution of over 328 ‘fixed dose combination’ drugs and restricted six others over safety concerns, a move that affects an estimated 6,000 brands of such <keyword id="306491" type="DOMAIN" weightage="20" keywordseo="FDC">FDC</keyword> drugs. Among the brands that have been banned include the popular painkiller Saridon; Panderm, a skin ointment; Diabetes drug <keyword id="6875077" type="UNKNOWN" weightage="20" keywordseo="gluconorm">Gluconorm</keyword> PG; and antibiotic drug Lupidiclox, the Times of <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword> <a href="http://timesofindia.indiatimes.com/articleshow/65790311.cms?utm_source=contentofinterest&amp;utm_medium=text&amp;utm_campaign=cppst">reported.</a> The government had sought to restrict the combination drugs as early as 2010 followed by a review by India’s drug advisory panel, the Drugs Technical Advisory Board, which recommended an outright ban over three years ago. The ban was contested by several drug makers and the matter wound up in courts with the Supreme Court ordering a fresh review by the panel late last year. ‘Irrational’ and ‘unsafe’ The drug review committee deemed these FDC drugs -- which have more than two active ingredients in a single dose -- lacked therapeutic justification and the combinations potentially toxic terming them “irrational” and “unsafe.” According to <a href="https://timesofindia.indiatimes.com/india/govt-bans-popular-painkiller-327-other-unsafe-fixed-dose-drugs/articleshow/65790311.cms">estimates</a> by <keyword id="799945" type="ORGANIZATION" weightage="20" keywordseo="All-India-Drug-Action-Network">All India Drug Action Network</keyword>, one of the petitioners behind the ban, the market for unsafe, problematic FDCs in India makes up a quarter of the total pharma market in India valued at ₹1.3 trillion ($14 billion). In a recent statement it noted that the FDCs under scrutiny account for approximately ₹25 billion in sales and “represent only the tip of the iceberg.” “The people of India have been made the consumers of unsafe medicines for too long and this is one step towards rectifying the grave situation of a pharma market brimming with innumerable irrational FDCs,” the drug network said in a recent <a href="https://aidanindia.wordpress.com/">statement. </a> Indian drug makers body, The Indian Drug Manufacturers’ Association (IDMA) has <a href="https://www.livemint.com/Politics/6aT2TnCIpzTEO7ZG7cYAkJ/Govt-prohibits-manufacture-supply-sale-of-328-FDC-drugs.html">said </a>it “respects” the verdict as responsible citizens of India, adding it has never advocated “irrational” FDCs but believes in the “advantages of patient convenience and compliance” that these combination drugs provide.

Indian government bans several painkillers, diabetes and antibiotic drugs over safety concerns

<ul><li>At 7:59 am, the SGX Nifty was up 0.34% at 11,515.20 points pointing towards a cautious start for Nifty50.</li><li>Here’s a list of stocks to watch for in trade today. </li><li><a href="https://www.businessinsider.in/">Check out the latest news and updates on Business Insider.</a> </li></ul>Indian stock-market indices are likely to open on a tepid note on Wednesday, on the back of muted global cues. At 7:59 am, the SGX Nifty was up 0.34% at 11,515.20 points pointing towards a cautious start for Nifty50. US markets ended on a flat note, with Apple capping the gains. However S&amp;P 500 and Nasdaq did scale record levels in trade yesterday. This morning, Asian markets are trading subdued as well. These are the stocks to watch out for during the trading session today: SBI Ratings agency, Moody’s has downgraded State Bank of India’s standalone profile on asset quality and profitability concerns. The standalone profile has been downgraded to ba2 from ba1. The shares of SBI ended higher by 3.38% on Tuesday. Punjab National Bank Watch out for PNB in trade today as the bank has received over ₹24 crore as the first tranche of recoveries from bankruptcy proceedings of Nirav Modi’s companies in the US. The shares of PNB ended down 0.28% on Tuesday. Tata Consultancy Services TCS will be in focus in trade today. Rating agency, S&amp;P Global has revised the outlook on this I-T major from positive to stable on the back of weakening business sentiment. S&amp;P says that TCS may face slower growth in revenue and profitability over next 12-18 months because of the subdued global IT spends. The shares of TCS ended down 0.27% on Tuesday. JMC Projects The company has bagged new orders worth ₹554 crore. This includes an order amounting to ₹315 crore for a building project in South India, and a ₹239 crore order for a factory project in Maharashtra. The shares of JMC Projects ended lower over 1% on Tuesday. Bank of Maharashtra This state-owned bank has raised ₹831 crore via preferential issue of shares to the government. The lender has issued ₹73.6 crore shares at ₹11.29/share. WIth this allotment, government’s holding in the bank has risen to 93.33% The shares of Bank of Maharashtra ended higher by 4.61% on Tuesday. FDC Watch out for this drug firm, FDC. It has launched two variants of the COVID-19 drug Favipiravir under the brand names PiFLU and Favenza. The shares of FDC ended lower by 1.56% on Tuesday. Earnings Today Some other stocks that will be in focus include Indraprastha Gas, Minda Finance, Cupid and Gillette India as these companies declare their quarterly earnings later today. SEE ALSO: <a href="https://www.businessinsider.in/business/telecom/news/airtel-wants-to-increase-data-prices-to-100-per-gb-sunil-mittal-asks-subscribers-to-prepare-to-pay-a-lot-more/articleshow/77734318.cms">Airtel wants to increase data prices to ₹100 per GB, Sunil Mittal asks subscribers to ‘prepare to pay a lot more’</a> <a href="https://www.businessinsider.in/defense/news/india-military-options-against-china-explained-by-experts/articleshow/77743778.cms">Experts explain India’s 'military options' against China</a> <a href="https://www.businessinsider.in/finance/banks/news/icici-bank-is-looking-to-pump-out-more-kisan-credit-cards-with-satellite-data-and-machine-learning-at-its-side/articleshow/77741696.cms">ICICI Bank will now use satellite data to determine whether or not to give out farm loans in India</a>

Top stocks to watch in trade — SBI, PNB, TCS, JMC Projects, Bank of Maharashtra, FDC and more

Shares of <keyword id="6357157" type="General" weightage="80" keywordseo="cipla" source="Orion">Cipla</keyword> on Monday tanked nearly 7 per cent in morning trade on the bourses after the company said the US health regulator has issued 'Form 483' with eight o<keyword id="35140" type="General" weightage="50" keywordseo="bse" source="Orion">bse</keyword>rvations after inspecting its Pithampur-based manufacturing facility in Madhya Pradesh. The stock declined 6.78 per cent to Rs 956.20 on the BSE. At the NSE, it tanked 6.87 per cent to Rs 955.25. The US Food and Drug Administration (<keyword id="44669" type="General" weightage="100" keywordseo="usfda" source="Orion">USFDA</keyword>) conducted a current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility from February 6-17, the Mumbai-based drug firm said in a regulatory filing on Saturday. On conclusion of the inspection, the company has received eight inspectional observations in Form 483, it added. The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time, it said. As per USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&amp;C) Act and related Acts. SEE ALSO: <a href="https://www.businessinsider.in/business/corporates/news/google-india-layoffs-nearly-500-people-fired/articleshow/98001522.cms">Google layoffs reach Indian shores, nearly 500 employees sacked late Thursday</a> <a href="https://www.businessinsider.in/finance/news/inflation-expected-to-cool-down-but-economists-expect-another-rate-hike-after-january-shocker/articleshow/97983231.cms">Inflation expected to cool down but economists expect another rate hike after January shocker</a> <a href="https://www.businessinsider.in/business/corporates/news/maggi-kitkat-maker-nestle-india-reports-highest-domestic-growth-in-a-decade-in-fy22/articleshow/97974283.cms">Maggi &amp; KitKat maker Nestle India reports highest domestic growth in a decade in FY22</a>

Cipla shares fall nearly 7% after Pithampur unit gets 8 observations from USFDA

<ul class="summary-list"><li>A consumer group is urging the manufacturer of Peeps to remove a chemical linked to cancer.</li><li>People should make informed decisions using ingredient lists, Just Born Quality Confections said.</li></ul>A consumer group has warned that certain Peeps candies popular around Easter contain a chemical called red dye No. 3 that's been linked to cancer.<a href="https://www.ewg.org/foodscores/ingredients/19151-RED3/search/" target="_blank" rel="noopener">Nearly 3,000 products</a> available in the US contain red dye No. 3, a bright cherry-red color found in some candies, including Peeps Pink Marshmallow Chicks and Peeps Lavender Marshmallow Chicks. <a href="https://www.insider.com/guides/health/diet-nutrition/what-is-processed-food">Processed foods,</a> such as imitation bacon, can also contain red dye No. 3. On Monday, Consumer Reports, a nonprofit organization, asked consumers to sign a petition to persuade Just Born Quality Confections, the company behind Peeps, to stop using red dye No. 3. The consumer group said that the FDA ignored a letter with the same request <a href="https://advocacy.consumerreports.org/wp-content/uploads/2023/04/Just-Born-Confectioners-Letter.pdf" target="_blank" rel="noopener">in March.</a> As of Thursday, more than <a href="https://action.consumerreports.org/20230403reddyejustbornpeeps-nb" target="_blank" rel="noopener">16,000 people had signed the petition.</a>The FDA told Insider it is "actively reviewing" the petition. "Parents should know that the purple and pink colored Peeps they may be putting in their kids' Easter basket are made with an ingredient that is a known carcinogen," Michael Hansen, a senior staff scientist for Consumer Reports, said in a press release. "Just Born Quality Confections should stop making its iconic marshmallow treats with this dangerous food chemical since other less risky alternatives are readily available," Hansen said.Just Born Quality Confections told Insider that all of the candy it manufacturers complies with FDA regulations. "We also provide consumers with information on our packaging and our websites to help them make informed choices about our products," it said. The company said that it's exploring "colors derived from natural sources that can deliver the same visual impact and stability as their certified counterparts."Here's what you need to know about red dye No. 3 to make an informed decision this <a href="https://www.insider.com/surprising-easter-fun-facts-stats-2019-4">Easter</a>.<h2>Red dye No. 3 is banned in beauty products because of possible cancer risk</h2>Red dye No. 3, also known as erythrosine, is controversial because the FDA <a href="https://www.fda.gov/industry/color-additive-inventories/color-additive-status-list" target="_blank" rel="noopener">banned</a> its use in cosmetics after its was linked to <a href="https://www.sciencedirect.com/science/article/pii/0041008X9090327Q?via%3Dihub" target="_blank" rel="noopener">thyroid tumors</a> in lab rats, but it <a href="https://www.fda.gov/industry/color-additive-inventories/color-additive-status-list" target="_blank" rel="noopener">can be added </a>to food and drugs that are ingested.A handful of <a href="https://www.cspinet.org/resource/red-3-petition" target="_blank" rel="noopener">consumer-advocacy groups</a> want the FDA to ban red dye No. 3, also known as <a href="https://www.fda.gov/industry/color-additive-inventories/color-additive-status-list" target="_blank" rel="noopener">FD&amp;C Red No. 3</a>, in food products nationwide. In the European Union, its use <a href="https://www.efsa.europa.eu/en/efsajournal/pub/1854" target="_blank" rel="noopener">is restricted</a> (it's only permitted for use in certain cherries), but it's not banned. <a href="https://www.cspinet.org/press-release/red-3-fda-petition" target="_blank" rel="noopener">According to the Center for Science in the Public Interest,</a> the FDA said in 1990 that it would "take steps" to ban its use in foods, ingested drugs, and supplements — but those steps were never taken. <h2>Red dye No. 3 may cause hyperactivity in some kids</h2>Consumer groups say they're worried that <a href="https://www.cspinet.org/press-release/red-3-fda-petition" target="_blank" rel="noopener">red dye No. 3 poses a cancer risk</a> for humans, citing studies that found it increased the rate of thyroid cancer in laboratory animals. The chemical may also be connected to hyperactivity and other "neurobehavioral problems" in certain kids, with some more sensitive to the ingredient than others, a 2021 report <a href="https://oehha.ca.gov/risk-assessment/press-release/report-links-synthetic-food-dyes-hyperactivity-and-other" target="_blank" rel="noopener">from the Ohio Environmental Health Association</a> said."Current federal levels for safe intake of synthetic food dyes may not sufficiently protect children's behavioral health," Lauren Zeise, the OEHHA's director, said at the time.The International Association of Color Manufacturers, which represents the color-additives industry and color-user community, disagrees. "Colors are safely used in a wide variety of consumer products, are among the most widely studied food ingredients, and are subject to strict global regulatory requirements," its <a href="https://iacmcolor.org/why-colors-are-safe/" target="_blank" rel="noopener">website says.</a>Color additives are listed on product labels so consumers can identify them, the <a href="https://www.fda.gov/food/food-additives-petitions/color-additives-questions-and-answers-consumers" target="_blank" rel="noopener">FDA says</a>. "Consumers who wish to limit the amount of color additives in their diets may check the food ingredient list on labels," the agency's website says.Consumer Reports is advocating for a bill in California to ban the sale of processed food that contains red dye No. 3 and other additives not allowed in Europe such as <a href="https://www.businessinsider.com/foods-illegal-outside-us-2017-3?r=US&amp;IR=T" target="_blank" rel="noopener">brominated vegetable oil</a>, potassium bromate, propylparaben, and titanium dioxide, which is found in candies like <a href="https://www.skittles.com/products/skittles-original-fruity-candy-single-pack-217-oz-skittles-chewy#:~:text=INGREDIENTS%3A%20Sugar%2C%20Corn%20Syrup%2C,1)%2C%20Sodium%20Citrate%2C%20Carnauba" target="_blank" rel="noopener">Skittles.</a>If the bill passes, supporters in California hope that other states will follow.

A report says Peeps contain a chemical linked to cancer. Here's what you need to know.

New Delhi, Jan 27 () Biocon Ltd on Monday said the US health regulator conducted a pre-approval inspection and good manufacturing practice (GMP) examination of the API manufacturing facility and has issued a Form 483, with five observations.
 As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&amp;C) Act and related Acts.
 "The US Food and Drug Administration (FDA) conducted a Pre-Approval Inspection (PAI) and GMP inspection of the Active Pharmaceutical Ingredients (API) manufacturing facility of Biocon Ltd," Biotechnology major said in a filing to BSE.
 At the conclusion of the inspection of the Bengaluru facility, which took place between January 20-24, 2020, the agency issued a Form 483, with five observations, the filing said.
 "We will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) and are confident of addressing these observations expeditiously. We remain committed to global standards of quality and compliance," according to company's spokesperson.
 The shares of Biocon were trading at Rs 292.95 a piece on BSE, down 0.51 per cent from the previous close. SID DRR

USFDA issues Form 483 with 5 observations to Biocon's Bengaluru facility

<div class="KonaFilter image-container float_right"><div class="image on-image"><img src="http://static3.businessinsider.com/image/529375dbecad04df213ee08b-905-679/dna-testing-kit-23andme-3.jpg" border="0" alt="DNA testing kit 23andme" width="480]" /><a href="http://www.flickr.com/photos/nosha/4668325959/">Flickr/nosha</a></div></div>The Food and Drug Administration is ordering <keyword id="378542" type="COMPANY" weightage="60" keywordseo="23andMe">23andMe</keyword> to stop selling its saliva collection kits for its personal genome service.
The FDA is accusing 23andMe of violating the Federal Food, Drug, and Cosmetic Act, <a href="http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm" target="_blank">it recently stated in a warning letter addressed to 23andMe CEO Anne Wojcicki</a>.
Developing...
<a href="http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm" target="_blank">Here's the full letter</a>:
Dear Ms. Wojcicki,
The Food and Drug Administration (FDA) is sending you this letter because you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&amp;C Act).
This product is a device within the meaning of section 201(h) of the FD&amp;C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. For example, your company's website at www.23andme.com/health (most recently viewed on November 6, 2013) markets the PGS for providing "health reports on 254 diseases and conditions," including categories such as "carrier status," "health risks," and "drug response," and specifically as a "first step in prevention" that enables users to "take steps toward mitigating serious diseases" such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&amp;C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.
Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment. For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect. These risks are typically mitigated by INR management under a physician's care. The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.
Your company submitted 510(k)s for PGS on July 2, 2012 and September 4, 2012, for several of these indications for use. However, to date, your company has failed to address the issues described during previous interactions with the Agency or provide the additional information identified in our September 13, 2012 letter for (b)(4) and in our November 20, 2012 letter for (b)(4), as required under 21 CFR 807.87(l). Consequently, the 510(k)s are considered withdrawn, see 21 C.F.R. 807.87(l), as we explained in our letters to you on March 12, 2013 and May 21, 2013. To date, 23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it; no other submission for the PGS device that you are marketing has been provided under section 510(k) of the Act, 21 U.S.C. § 360(k).
The Office of In Vitro Diagnostics and Radiological Health (OIR) has a long history of working with companies to help them come into compliance with the FD&amp;C Act. Since July of 2009, we have been diligently working to help you comply with regulatory requirements regarding safety and effectiveness and obtain marketing authorization for your PGS device. FDA has spent significant time evaluating the intended uses of the PGS to determine whether certain uses might be appropriately classified into class II, thus requiring only 510(k) clearance or de novo classification and not PMA approval, and we have proposed modifications to the device's labeling that could mitigate risks and render certain intended uses appropriate for de novo classification. Further, we provided ample detailed feedback to 23andMe regarding the types of data it needs to submit for the intended uses of the PGS. As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies. As discussed above, FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work.
However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is "completing the additional analytical and clinical validations for the tests that have been submitted" and is "planning extensive labeling studies that will take several months to complete." Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now nine months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS's uses and consumer base without obtaining marketing authorization from FDA.
Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device. The PGS is in class III under section 513(f) of the FD&amp;C Act, 21 U.S.C. 360c(f). Because there is no approved application for premarket approval in effect pursuant to section 515(a) of the FD&amp;C Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the FD&amp;C Act, 21 U.S.C. 360j(g), the PGS is adulterated under section 501(f)(1)(B) of the FD&amp;C Act, 21 U.S.C. 351(f)(1)(B). Additionally, the PGS is misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because notice or other information respecting the device was not provided to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific actions you have taken to address all issues noted above. Include documentation of the corrective actions you have taken. If your actions will occur over time, please include a timetable for implementation of those actions. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the actions will be completed. Failure to take adequate corrective action may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.
We have assigned a unique document number that is cited above. The requested information should reference this document number and should be submitted to:
Ileana Elder, WO66-5632 Postmarket Team Leader Division of Chemistry and Toxicology Devices Office of In vitro Diagnostics and Radiological Health 10903 New Hampshire Avenue Silver Spring, MD 20993
If you have questions relating to this matter, please feel free to call Courtney Lias, Ph.D. at 301-796-5458, or log onto our web site at www.fda.gov for general information relating to FDA device requirements.
Sincerely yours, /S/ Alberto Gutierrez Director Office of In vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

The FDA Wants 23andMe To Stop Selling Its Genetic Testing Kits 

<div class="KonaFilter image-container"><div class="image on-image"><img src="https://static-ssl.businessinsider.com/image/550c5e886bb3f7b928816b59-950-475/fdc-philadelphia.jpg?maxX=800" border="0" alt="FDC Philadelphia" width="800">Bureau of Prisons</img></div></div>While in federal prison in 2006, Peter Bistrian, a&#xa0;former stock broker from Long Island&#xa0;in his 40s, claims he got involved with one of the most violent drug lords Philadelphia has ever known, Kaboni Savage.Soon afterward, Bistrian says he became an informant and provided intelligence for an FBI investigation related to Savage's operations inside the prison.According to Bistrian, this cooperation&#xa0;put a target on his back - one that, he claims, guards at the Federal Detention Center (FDC) Philadelphia ignored. As a result, Bistrian says Savage's associates assaulted him inside the prison, which caused him lasting physical and emotional damage.All of Bistrian's claims are detailed in a lawsuit that was filed on his behalf in federal court in 2008."I did the right thing, and no one protected me," Bistrian told Business Insider in a telephone conversation on Thursday. "I want to hold them accountable."Bistrian initially sued 28&#xa0;prison officials, including the warden and physician, for allegedly mishandling&#xa0;the attacks and illegally placing him in solitary confinement. Since the suit was filed, however, the list of defendants dropped down to 15 but gained a significant name - the United States of America. Nearly a decade after his assault, the federal government could have to pay Bistrian up to $50 million for his experiences behind bars.&#xa0;<h3>Passing notes</h3>In 2006, while acting as an orderly in the Special Housing Unit (SHU), also know as solitary confinement, the Bistrain&#xa0;says he agreed to pass along a note from two other men to&#xa0;Kaboni Savage. The men were members of a violent drug gang from Philadelphia that was led by Savage, according to the suit."This guy I was passing notes for, I later found out he had ordered six murders from solitary," Bistrian&#xa0;said. "He was one of the most violent drug gang lords in Philly. But I didn't know that at that time."In 2013, a judge gave Savage a death sentence for orchestrating the <a href="http://www.fbi.gov/philadelphia/press-releases/2014/judge-sentences-kaboni-savage-soldier-to-40-years-in-prison">murder of 6 people</a>&#xa0;from prison to intimidate a witness set to testify against him and his "<a href="http://www.fbi.gov/news/stories/2015/january/extreme-case-of-witness-intimidation/extreme-case-of-witness-intimidation">drug trafficking enterprise</a>."<div class="KonaFilter image-container float_right"><div class="image on-image"><img src="https://static-ssl.businessinsider.com/image/550c86586bb3f7e3687c008d-318-239/lewis-savage-2.jpeg" border="0" alt="lewis savage" width="600">Courtesy of policeKaboni Savage</img></div></div>Bistrian says he completed the first request, but before delivering the second note, he made&#xa0;a pit-stop: the guards' office.&#xa0;In exchange for removal from solitary confinement and the return of his phone privileges, Bistrian says he agreed to turn any subsequent notes over to the guards. &#xa0;Over the next few weeks, the suit claims, Bistrian passed several notes between the three men. The process went like this: Bistrian, a pony-tailed white collar criminal,&#xa0;would receive a message and give it to the guards, who would copy it and give the original back to him for delivery to the gang. The guards then passed the information the FBI, according to the suit.One time, however, the suit claims the arrangement went awry: The guards placed a copy of the note, instead of the original, back in the envelope. Upon delivery, the three men, as well as other inmates in the SHU, instantly knew Bistrian had flipped. Being outed as an informant put Bistrian's life in significant danger, according to the suit.Within the next year, Bistrian said he suffered two violent assaults."[The guards] put me in a really, really bad position," he told Business Insider.&#xa0;<h3>'I thought I was a dead man'</h3>On June 30, 2006, the suit claims the inmate who originally asked Bistrian to pass notes, along with two others, attacked him in the unit's recreation pen. While trying to fight off the men, all 6-foot-2, 240 pounds of Bistrian fell to the ground. His head knocked against the cement floor of the prison, rendering him unconscious as the inmates repeatedly kicked and beat him. &#xa0;"One on one, I was okay," Bistrian said. "Three on one, they about killed me. What was going through my mind? 'Yeah, I thought I was a dead man.'"After several minutes, the lawsuit says the guards finally broke up the chaos.&#xa0;<div class="KonaFilter image-container float_right"><div class="image on-image"><img src="https://static-ssl.businessinsider.com/image/550c62296bb3f71d577c008a-572-428/peter-bistrian.jpg" border="0" alt="Peter Bistrian" width="600">Courtesy of Peter BistrianSome of Bistrian's injuries after the gang assault.</img></div></div>The beating left Bistrian with a dislocated shoulder, broken fingers, multiple bruises, cuts on his face and head, and chipped and lost teeth - not to mention emotional and psychological damage, according to the suit.Guards also, the suits claims, failed to provide medical treatment for these injuries.&#xa0;"They said, 'Well, you're in solitary confinement, have fun rehabbing yourself.'" Bistrian recalled.Four months later, Bistrian's suit claims he underwent another assault - this time with a weapon. On the morning of October 12, 2006, guards placed Bistrian, who was waiting to leave the recreation pen in the SHU, in handcuffs. Another inmate entered the pen and allegedly started slashing Bistrian with a razor blade. Unable to use his hands, Bistrian lowered himself to the ground and spun around on his back "like a street dancer," as he explains, using his legs to defend himself.&#xa0;After several minutes of failed attempts to intervene, the suit claims, guards finally resorted to dropping a Tactical Blast Stun Munition into the pen to separate Bistrian and his alleged assailant. While the blast temporarily incapacitated his attacker, Bistrian says it threw him up into the air and severely injured his back.The video below, which was provided to Business Insider by a representative of Bistrian, shows the alleged gang attack.&#xa0;<div id="ooyalaplayer" style="width: 1920px; height: 1080px;"></div><script type="text/javascript">// </script><noscript>&amp;amp;amp;amp;amp;lt;div&amp;amp;amp;amp;amp;gt;Please enable Javascript to watch this video&amp;amp;amp;amp;amp;lt;/div&amp;amp;amp;amp;amp;gt;</noscript>The second time, Bistrian says the prison transported to a local emergency hospital for medical care. He needed 52 stitches to close the wounds on his face, arms, and legs, according to the suit, which also claims Bistrian endured permanent nerve damage and suffers from chronic back pain and spasms as a result of the assault.Prior to both attacks, Bistrian says he alerted prison guards to the danger he faced. Before the gang assault, the suit claims a gang member put a sign outside Bistrian's cell that read "Stop Snitching.""I pleaded with them, wrote them. Every officer that's involved [in the lawsuit], I put them on notice every morning and every night: 'Get me the hell out of here,'" Bristian said.Mandatory, written prison policy, often referred to as "<a href="https://www.law.cornell.edu/cfr/text/28/part-524/subpart-F">Central Inmate Monitoring</a>" or "CIMs," according to the suit, requires that guards separate an inmate who has been threatened by other inmates.By ignoring Bistrian's requests for separation, putting him in situations which lead to his assaults, and denying him medical care after the fact, his attorneys argue the prison violated Bistrian's right to due process, protected by the Fifth Amendment.Placing Bistrian in solitary in the first place was illegal, the suit claims.<h3>A 'common practice'</h3>Bistrian went to prison for his involvement in a <a href="http://articles.philly.com/2006-07-28/news/25405722_1_wire-fraud-guilty-plea-federal-court">$1.8 million loan scam</a>, following a $1.5 million scam a decade earlier. His latest troubles began in 2000 when he and an associate bought three Mercedes Benzes and a Porsche from a Pennsylvania dealership with bounced checks. While on bail, Bistrian also committed a wire fraud in which a South African Steel company lost $1.4 million.&#xa0;As he awaited trial and sentencing for these crimes at FDC Philadelphia, Bistrian says he was allotted 300 telephone minutes per month."That's 30 10-minute calls," he explained. "When you're trying to reach out to family and your lawyers to defend yourself, 300 minutes - you can use that up in a week."&#xa0;So Bistrian bought some minutes from other inmates, which he described as a "common practice." The guards, however, put him in the SHU (solitary confinement), for abusing his telephone privileges, according to the suit.<h3>23 hours a day in a 6x8 cell</h3><div class="KonaFilter image-container display-table"><div><div class="image on-image"><img src="https://static-ssl.businessinsider.com/image/550ca95469bedd2475b5030e-855-432/screenshot%202015-03-20%2019.11.39.png" border="0" alt="solitary confinement cell"><a href="http://www.aclutx.org/2015/02/05/a-solitary-failure/">ACLU</a>One inmate's drawing of a standard solitary confinement cell.</img></div></div></div>The lawsuit claims Bistrian was&#xa0;held in the SHU on four separate occasions for a total of 477 days.&#xa0;In two of these instances, the reasoning was tied to his phone violations. On another occasion, the suit says Bistrian had been released into general population with one of his assailants. Upon learning that, guards allegedly put Bistrian back in solitary. According to the suit, August 2007 was the last time Bistrian was placed in the SHU - and it was retaliatory.At the time, the lawsuit claims Bristian had undergone two sentencing hearings, where he strongly protested the conditions of his incarceration. On Sept. 12, his attorney requested a copy of the Bureau of Prisons' regulations by email. The prosecutor allegedly forwarded that email to the prison, and the next day, Bistrian found himself in solitary once again.&#xa0;There, Bistrian allegedly spent 23 hours of every day in a six-by-eight foot cell. He received little-to-no human interaction, except the screaming of others inmates. His meals arrived through a slot in the door, "like a dog" he says.&#xa0;"What I used to do so I could sleep, I'd probably do 1,000 pushups a day just so I'd get tired," Bistrian said. "I just had to occupy my time because if I didn't, all the bad thoughts would flow into my head - from suicide to hanging yourself, slicing yourself up."Of the 477 days Bistrian spent in the SHU, 447 violated the&#xa0;<a href="http://www.bop.gov/policy/progstat/5270_010.pdf">Bureau of Prisons' regulations</a>, making his solitary confinement illegal, according to the suit. As such, the suit argues Bistrian's time there not only constituted cruel and unusual punishment, violating the Eighth Amendment. The suit also alleges guards hampered his right to free speech when they placed him in solitary as retaliation for testimony regarding his treatment.&#xa0;<h3>$50 million</h3>Bistrian's lawsuit, which was filed by attorneys Dana Bazelon, Richard Bazelon and Robert Goldman, implicates 15 officials at FDC Philadelphia, including the warden.&#xa0;<div class="KonaFilter image-container float_right"><div class="image on-image"><img src="https://static-ssl.businessinsider.com/image/550c8f486bb3f7b90e7c008a-480-640/peter-bistrian-linkedin-photo.jpg" border="0" alt="Peter Bistrian" width="600"><a href="http://www.peter-bistrian.com/">www.peter</a>Peter Bistrian</img></div></div>Under the Federal Tort Act, an individual can sue the federal government for the negligence of people acting on its behalf. Federal prison guards fall into that category, Bistrian's suit alleges. Because of this, the US was added as a defendant."It's amazing that the government allows things like this to happen. And it's very hard for the public to ever find out," Bistrian said. "There's just no accountability."&#xa0;Aside from exposure for prisoners' rights, Bistrian says he is also seeking monetary justice - $50 million, to be precise.Because of his experiences at FDC Philadelphia, Bistrian claims he suffers from post-traumatic stress disorder, anxiety, and depression. He says he has terrible nightmares and even talking about the lawsuit sends him into flashbacks. "I'm reliving what I experienced," said Bistrian. "Prior to this, I tried to compartmentalize. It's the only way you can handle it."The US attorney's office, on behalf of the FDC Philadelphia, the FBI, and Bistrian's lawyers declined to comment on this story. The Department of Justice and Kaboni's lawyers didn't immediately respond to Business Insider's requests.&#xa0; <div class="margin-top"> <h3>NOW WATCH: <a href="http://www.businessinsider.com/going-clear-sundance-premiere-scientology-bombshells-2015-1">6 Crazy Things Revealed In HBO's Explosive New Scientology Documentary 'Going Clear'</a></h3> <div> <div> <script src="http://player.ooyala.com/v3/6e12e8b3387a44daacfb73afba25a76e"></script> <div class="ooyala-video-player" data-video-autoplay="false" data-video-id="o5dzJpczpndV8YG9M7cnoa3JXgQXBqja" data-player-variable="ooyalapopvideo" id="ooyalaplayer_popvideo" style="width:1280px;height:720px"></div> <script> if (typeof RunFunctions === 'undefined') { var RunFunctions = []; } RunFunctions.push(function() { var ooyalapopvideo = OO.Player.create('ooyalaplayer_popvideo', 'o5dzJpczpndV8YG9M7cnoa3JXgQXBqja',{ autoplay: 'false' }); }); </script> <noscript><div>Please enable Javascript to watch this video</div></noscript></div> </div> <script>(function() { function createPlayer() { OO.ready(function() { RunFunctions.forEach(function(ooyalaFunction) { ooyalaFunction(); }); RunFunctions = [];}); } createPlayer(); }()); </script> </div>

The wild story of a gangland snitch who is suing the US government for $50 million

<div class="KonaFilter image-container display-table float_right"><div><div class="image on-image"><img src="https://static-ssl.businessinsider.com/image/56182f789dd7ccfc418b5aa7-2653-1990/karlie kloss nyfw makeup.jpg" alt="Karlie Kloss NYFW makeup" data-mce-source="Getty Images" />Getty Images</div></div></div>Face wash, lipstick, makeup, and nail polish often carry labels like "tested" and "clinically-proven." Cosmetics like these are big business in the US, constituting about a <a href="http://www.statista.com/statistics/243742/revenue-of-the-cosmetic-industry-in-the-us/">$60 billion market</a>.But how does the cosmetics industry regulate the safety of its products?In the US, the FDA oversees cosmetics. But unlike drugs (which must get approval before they can be sold), <a href="http://www.fda.gov/Cosmetics/ResourcesForYou/Consumers/ucm135709.htm">cosmetics do not</a>. As a result, companies that use or sell unsafe ingredients usually only get in trouble if they get caught.According to <a href="http://www.fda.gov/Cosmetics/ResourcesForYou/Consumers/ucm135709.htm">the FDA's website</a>, it's up to individual companies, rather than the FDA, to ensure their products are safe. Compared to Canada and the European Union, both of whom have pretty strict oversight over cosmetics, the FDA has very few hard-and-fast rules.Here's what is still lurking in our cosmetics:<h2>Lipstick</h2><div class="KonaFilter image-container display-table full"><div><div class="image on-image"><img src="https://static-ssl.businessinsider.com/image/561857199dd7cc03308b584f-1157-868/17968022170_00fb11920c_k (1).jpg" alt="power pose sitting red lipstick" data-mce-source="Flickr/Peter Grifoni" />Flickr/Peter Grifoni</div></div></div>The makeup brand Lime Crime came under fire from <a href="http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm456525.htm">the FDA in July</a> for having color additives, the single ingredient the FDA does require approval for in cosmetics, in some of its products."Color is something that the FDA takes very seriously," said Robert Lochhead, a polymer <keyword id="41551" type="ENTERTAINMENT" weightage="100" keywordseo="science">science</keyword> professor at the University of Southern Mississippi.Lochhead told Business Insider the reason the FDA is so concerned with color additives relative to other chemicals is part of the agency's history: <a href="http://www.fda.gov/ForIndustry/ColorAdditives/RegulatoryProcessHistoricalPerspectives/">In the 1950s</a>, some of the color additives in food and other materials caused some serious health complications, namely FD&amp;C Orange No. 1, which made many children sick after it was used in Halloween candy.There have also been problems with leads found in <a href="http://www.washingtonpost.com/business/economy/400-lipstick-brands-contain-lead-fda-says/2012/02/14/gIQAhOyeDR_story.html">lipstick</a>, which is troubling considering how easily ingestible lipstick is.<h2>Nail polish</h2><div class="KonaFilter image-container display-table"><div><div class="image on-image"><img src="https://static-ssl.businessinsider.com/image/5581eaa571ca1b86158b54ce-2048-1536/5425642207_0037d4308b_o.jpg" alt="nail polish hand" data-mce-source="daftgirly/Flickr" data-link="https://www.flickr.com/photos/janet/5425642207/" /><a href="https://www.flickr.com/photos/janet/5425642207/">daftgirly/Flickr</a></div></div></div>In recent years, one of the most controversial chemicals in the cosmetic industry has been a chemical called phthalates. They're found in nail polish - that's what gives them that strechy, plastic-y feeling - and perfumes.According to the <a href="http://ehp.niehs.nih.gov/1306681/#tab1">National Institute of Environmental Health Sciences</a>, phthalates are a known environmental contaminant that could have an impact on human health, though they don't yet have enough conclusive evidence to say exactly how.<h2>Face wash</h2><div class="KonaFilter image-container display-table"><div><div class="image on-image"><img src="https://static-ssl.businessinsider.com/image/56185ffa9dd7cc02308b57be-2103-1577/3.5gyres-plastic-microbeads-penny.jpg" alt="Plastic microbeads penny" data-mce-source="5 Gyres" />5 Gyres</div></div></div>Some harmful substances in cosmetics aren't so much causing bodily harm as hurting the environment.Such is the case with plastic microbeads, which are <a href="http://www.businessinsider.com/products-that-contain-microbeads-2015-5">found in a number of face washes and toothpastes</a>. Microbeads were originally used because they're are a good way to exfoliate that don't generally cause rashes. Substituting the microbeads for nut shells, for example, would put a large portion of the population at risk for an allergic reaction.<h2>Eye makeup</h2><div class="KonaFilter image-container display-table"><div><div class="image on-image"><img src="https://static-ssl.businessinsider.com/image/561860259dd7cc22008c0dc6-1280-960/541914240_2e7600552f_o.jpg" alt="mascara" data-mce-source="Flickr/adamhirschhorn" />Flickr/adamhirschhorn</div></div></div>Some eye shadows may contain certain <a href="http://www.sciencedirect.com.turing.library.northwestern.edu/science/article/pii/S0026265X11002086">heavy metals,</a> which can pose a problem if the metals are water soluble, meaning they could absorbed into the body through sweat.<h2>In a good spot, but still a ways to go</h2>Although they only <a href="http://www.fda.gov/cosmetics/guidanceregulation/lawsregulations/ucm127406.htm">"prohibit or restrict,</a>"the use of 11 chemicals, the FDA still faces a lot of pressure to get things right, Karl Bygrave, the Director of Regulatory Affairs for cosmetics company Lush told Business Insider."It doesn't feel unregulated," he said.Bygrave said for its part, his company does its best to cater to consumer concerns about any potentially harmful chemicals in its products. While he says they only use compounds in their cosmetics that have been proven safe for people in tests, they will sometimes change the ingredients in their products based on consumer preference. In light of a <a href="http://onlinelibrary.wiley.com/doi/10.1002/jat.958/abstract;jsessionid=0F9FB53803FD2EBB963304A5C04321C5.f04t01">study</a> which suggested a link between preservatives called parabens and cancer (though ultimately no link was <a href="http://www.chemistryviews.org/details/ezine/1452093/Underarm_Hygiene_Does_Not_Cause_Breast_Cancer.html">actually found</a>), for example, the company opted to swap them out for different ingredients.That's just one company though - and others may not be as careful. As a way to combat the problems in the beauty industry, there seems to be an increased interest in organic beauty products over the last several years, especially in Europe and the US. Sales were projected to reach <a href="https://www.loc.gov/rr/business/BERA/issue17/current.html">$15 billion globally</a> in 2015, still just a fraction of the US market. <div class="margin-top"> <h3>NOW WATCH: <a href="http://www.businessinsider.com/science-male-attractiveness-sex-2015-10">Women are more attracted to men with these physical traits</a></h3> <div> <div> <script src="http://player.ooyala.com/v3/6e12e8b3387a44daacfb73afba25a76e"></script> <div class="ooyala-video-player" data-video-autoplay="false" data-video-id="5iZzMyeDranDSEuGX60cVb5VL_qjvfSz" data-player-variable="ooyalapopvideo" id="ooyalaplayer_popvideo" style="width:1280px;height:720px"></div> <script> if (typeof RunFunctions === 'undefined') { var RunFunctions = []; } RunFunctions.push(function() { var ooyalapopvideo = OO.Player.create('ooyalaplayer_popvideo', '5iZzMyeDranDSEuGX60cVb5VL_qjvfSz',{ autoplay: 'false' }); }); </script> <noscript><div>Please enable Javascript to watch this video</div></noscript></div> </div> <script>(function() { function createPlayer() { OO.ready(function() { RunFunctions.forEach(function(ooyalaFunction) { ooyalaFunction(); }); RunFunctions = [];}); } createPlayer(); }()); </script> </div>

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