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COVID-19: India restricts drug exports amid rising prices of essential bulk drugs; FDA announces first drug shortage
Now that it has been established that the novel coronavirus is going to globally impact the drug supply chain, it becomes imperative to analyze the extent of the impact. Since the outbreak of the novel coronavirus — COVID-19 — in December, PharmaCompass has been constantly reaching out to manufacturers around the world to assess the current state of the drug supply chain. This week, we share our preliminary analysis based on the feedback we have received from drug manufacturers around the world. Drug shortages are for real   Last week, the US Food and Drug Administration (FDA) announced the first human drug shortage as a result of the coronavirus outbreak. In addition, the FDA announced it was tracking 20 drugs that could face shortages. Some generic drugmakers are predicting shortages as early as in June or July, due to the novel coronavirus. The FDA did not disclose the name of the drug in shortage or the 20 drugs it is tracking, as this is considered ‘confidential commercial information’.  In India, a committee constituted by the country’s Department of Pharmaceuticals started monitoring the availability of 58 active pharmaceutical ingredients (APIs) to take preventive measures against illegal hoarding and black-marketing in the country. According to a report published in The Economic Times, after reviewing the list of drugs, 34 were found to have no alternatives which include critical and essential drugs like potassium clavulanate, ceftriaxone sodium sterile, piperacillin tazobactam, meropenem, vancomycin, gentamycin and ciprofloxacin. This was immediately followed by the Indian government restricting the exports of 13 APIs along with some of their finished formulations. The list includes paracetamol, tinidazole, metronidazole, acyclovir, vitamin B1, vitamin B6, vitamin B12, progesterone, chloramphenicol and neomycin. For most of the products on this list, India is a net importer, as there is little domestic manufacturing of these APIs. COVID-19 is also likely to impact bottomlines. Leading generic drugmaker Mylan said it expects the coronavirus outbreak to impact its financial results while some of the largest drugmakers — including AstraZeneca, Merck and Pfizer — have said that the coronavirus outbreak could affect their supplies or sales. Paracetamol affected; prices double in less regulated markets   The decline in industrial activity in China is certainly taking its toll, as drugs which are on the World Health Organization’s Model list of Essential Medicines are beginning to face significant price increases in the wake of disruption of key starting raw materials for bulk drugs.  The export restriction out of India on commonly used analgesic, Paracetamol — sold under the brand names such as Tylenol (in the US), Panadol (in the UK), Dafalgan (France) and Crocin (India) — is not surprising as the API has witnessed almost doubling of prices in less regulated markets because exports of its key building block para-amino phenol (PAP) have dramatically reduced from China.  While there are only a few manufacturers who produce paracetamol without being dependent on Chinese PAP, a few major manufacturers in India depend almost completely on Chinese PAP for their paracetamol production and usually only keep three to four months of inventory. By the end of February, their inventory stockpiles had halved and in the event of a continued supply disruption, their entire inventory pipeline is likely to dry out. In addition, Chinese paracetamol manufacturers, who export a significant amount of their bulk ingredient production globally, including to India, are also currently unable to export. This is beginning to create the potential of panic among sourcing executives across the world. Several antibiotics also in danger of acute shortages   While paracetamol was listed on the API watch list circulated by India’s Department of Pharmaceuticals, our survey has revealed that other products on the list like ciprofloxacin, amoxicillin and azithromycin are also facing severe raw material shortages. As a result, the prices of these bulk drugs have also increased sharply. In a statement to The Economic Times, leading Indian generic manufacturer Mankind Pharma’s chairman and managing director said amoxicillin is the most commonly used API to manufacture antibiotics and the company has invested Rs 1 billion (US$ 14 million) in placing irregular orders with vendors to try and address the potential shortage that is expected. He went on to say that if the situation continues until April, there will be an acute shortage. In a statement to the US House of Representatives last October, Janet Woodcock, the FDA’s Director of Center of Drug Evaluation and Research, said the FDA has determined that there are three WHO Essential Medicines whose API manufacturers are based only in China. The three medicines are: capreomycin, streptomycin (both indicated to treat Mycobacterium tuberculosis) and sulfadiazine (used to treat chancroid and trachoma). Streptomycin is also on the watch list published by India’s Department of Pharmaceuticals along with commonly used anti-hypertensives like losartan, valsartan, telmisartan and olmesartan and diabetes treatment metformin. Intermediates becoming a problem for generic drugmakers   PharmaCompass’ discussions have also revealed that in many cases while API manufacturing factories in China have returned to work, there are disruptions in the availability of raw materials and/or logistics at sea ports and airports which have led to unavailability of supplies.  While the FDA has a list of the number of API facilities in China which are in a position to supply to the United States, Woodcock said in her statement that the FDA “cannot determine with any precision the volume of API that China is actually producing, or the volume of APIs manufactured in China that is entering the US market.” This visibility reduces drastically when one has to assess the dependence of each API manufacturer around the world on China for intermediates. Our discussions have revealed that it is these intermediates which are becoming a problem for most API manufacturers, even those based in India. It was worth highlighting that a manufacturing process change at an intermediate stage of commonly used blood pressure medicine valsartan resulted in the recall of millions of pills as it was found to contain a cancer causing impurity above acceptable levels. Similarly, in 2008, the adulteration of heparin in China, which killed 81 people and left 785 severely injured, was an outcome of the subcontracting of precursor chemicals of Heparin. Our view   The over-dependence on China for key starting materials has been the subject of discussion ever since we launched PharmaCompass. Rosemary Gibson explored this subject in detail in her book China Rx: Exposing the Risks of America’s Dependence on China for Medicine. The restrictions imposed on industrial activity and transportation in China in the first two months of this year has resulted in NASA’s satellite images showing a decline in pollution levels over China. While China works towards getting its industrial and transportation engine up and running to 2019 levels, the outbreak has spread to other countries which will further increase the demand for drugs to fight the virus.  This is a time when the pharmaceutical industry needs to act responsibly and make decisions which are in the best interests of patients globally. Sharing information is one such step — it will allow for drug stockpiles and inventories that exist to be re-distributed to areas which need them most. For, in the event of an urgent need, drugs will become available to those who are most in need.  

Impressions: 8150

https://www.pharmacompass.com/radio-compass-blog/covid-19-india-restricts-drug-exports-amid-rising-prices-of-essential-bulk-drugs-fda-announces-first-drug-shortage

#Phispers by PHARMACOMPASS
04 Mar 2020
Mid-2017 Recap of FDA Warning Letters, Import Alerts & EU Non-Compliances
Last year, data integrity was a hot topic of discussion in the pharmaceutical industry. According to a recent analysis by GMP (good manufacturing practices) intelligence expert, Barbara Unger, approximately 80 percent of all FDA warning letters in 2015 and 2016 included a data integrity component, and approximately 70 percent of the published European GMP non-compliance reports cited similar shortcomings. With a little over half the year gone, PharmaCompass analyzed the regulatory action for current GMP (cGMP) non-compliance to evaluate how things are looking so far in 2017. Click here to access the compilation of all 2017 non-compliances (Excel version available) for FREE! As per our analysis, of all the non-compliance actions taken by the US and European regulators, India and China continue to see the highest level of activity, followed by the United States. While most of the companies in the list are less known pharmaceutical players, inspections uncovered deficiencies at leading companies like Pfizer, Teva, Mylan and B Braun. Data integrity violations continue to remain high The US Food and Drug Administration (US FDA) and EU inspections continued to uncover data integrity issues across countries such as India, China, Italy and Japan. In a warning letter posted earlier this year, for a January 2016 inspection, FDA investigators uncovered data-integrity violations at ACS Dobfar’s Italian drug manufacturing facility — FACTA Farmaceutici SpA. At FACTA, for multiple lots of sterile drug product, the original data showed failing results. However, the final data reportedly showed passing results. The company was found storing original data in an “unofficial” and uncontrolled electronic spreadsheet on a shared computer network drive. The analyst told investigators that original data was first recorded in the “unofficial” spreadsheet and later transcribed to an “official” form. Investigators also documented that employees at FACTA used paper shredders to destroy critical laboratory and production records. During an inspection performed exactly at the same time, FACTA’s EU GMP certification was renewed by the Italian regulators!  Click here to access the compilation of all 2017 non-compliances (Excel version available) for FREE! Discrepancies in conclusions drawn by regulators This year, while the United States and the European Union (EU) finally announced that they will be able to utilize each other’s good manufacturing practice (GMP) inspections of pharmaceutical manufacturing facilities, the road ahead looks uncertain as, in addition to incidents like FACTA, there have been multiple instances of discrepancies in the conclusions arrived at by regulators. This year saw the WHO grant an all clear for a Mylan facility where the FDA had data-integrity concerns and a similar situation arose at an active pharmaceutical ingredient (API) facility in China. An inspection conducted by the USFDA at Qinhuangdao Zizhu Pharmaceutical from November 28 to December 1, 2016 uncovered significant data integrity concerns and failures in the level of adherence to cGMP for APIs. Click here to access the compilation of all 2017 non-compliances (Excel version available) for FREE! In the warning letter issued to the firm, the laboratory analysts admitted to FDA inspectors that they had been “setting the clock back and repeating analyses for undocumented reasons.”  At Qinhuangdao Zizhu, “initial sample results were overwritten or deleted” and the company “reported only the passing results from repeat analyses”. On March 8, 2017, Qinhuangdao Zizhu Pharmaceutical was placed on import alert by the USFDA. Almost a year prior to the USFDA inspection, in October 2015, the company had been inspected by a WHO Prequalification Team (PQT) for levonorgestrel, mifepristone and ethinylestradiol APIs. The inspection concluded with “five major deficiencies, including data integrity issues and several minor deficiencies”. The WHO went ahead and closed their inspection as ‘compliant’, based on corrective and preventive actions (CAPAs) provided by the manufacturer. In view of the US FDA actions, and the fact that Qinhuangdao Zizhu Pharmaceutical was the only WHO-PQT prequalified source of levonorgestrel API, as in the case of Mylan, the WHO approach towards the compliance position was focused extensively on product quality.  In Japan, at Sato Yakuhin Kogyo, FDA investigators found analysts performed testing in duplicate without scientific justification, while in China, the French Ministry of Health found manipulation, backdating and falsification of GMP documents such as batch manufacturing records, GC (gas chromatography) and HPLC (high performance liquid chromatographs) chromatograms at Chongqing Succeway Pharmaceutical. Click here to access the compilation of all 2017 non-compliances (Excel version available) for FREE! Heparin makes headlines again in China; Indian firm fakes strike This year, concerns over the testing of Heparin in China re-emerged when FDA issued a warning letter to a contract testing laboratory — Shandong Analysis and Test Center. However, the activities at these companies to deceive inspectors paled in comparison to Vikshara Trading in India where the company faked a strike to prevent an FDA inspection. When the FDA inspection finally occurred, the FDA obtained evidence that the firm actively manufactured numerous products at the time of the supposed strike. Concerns over product quality in the United States In a warning letter issued to ChemRite CoPac in the US, the FDA  found that the company was manufacturing oral drug solutions using the same equipment that was being used to manufacture numerous non-pharmaceutical materials including an industrial car care product. The car care product being made was paraffin-based and carried labels such as “harmful or fatal if swallowed” and “keep out of reach of children.” The ingredients of these non-pharmaceutical products were extremely difficult to remove from the manufacturing equipment, and could contaminate the drug products, the FDA said. At Raritan Pharmaceuticals, a company that makes teething tablets, the FDA found the drug contained ingredients, such as belladonna, which could pose potential toxic effects for its consumers — infants and children under two years of age. Click here to access the compilation of all 2017 non-compliances (Excel version available) for FREE! Sterile drug manufacturing continues to be a global challenge Non-compliant operations uncovered at Sato Pharmaceutical (Japan), Euro Far Allergi (Spain), Tubilux (Italy), Biocon (India), Nova DFL Industrie (Brazil), Pfizer’s US operations (ex-Hospira) show that aseptic sterile drug manufacturing continues to be a global challenge as companies struggle to get into compliance. In February 2015, Pfizer acquired a site in McPherson, Kansas, through its US$ 17 billion acquisition of Hospira. Pfizer was aware of Hospira's manufacturing record when it struck the deal, as the company was issued FDA warning letters in four of the seven continents — Europe, North America, Asia and Australia.  Approval of two drugs have been held up this year due to compliance concerns at McPherson. Click here to access the compilation of all 2017 non-compliances (Excel version available) for FREE! The USFDA also warned manufacturers of non-sterile, water-based drug products of Burkholderia cepacia complex (BCC or B cepacia) contamination, as there were product recalls due to this and other water-borne opportunistic pathogens found in pharmaceutical water systems. The regulator’s warning stemmed from a multi-state outbreak of infections. In March this year, Phispers  had carried a news item on Badrivishal Chemicals & Pharmaceuticals, a manufacturer of docusate sodium. It had been placed on FDA’s import alert list in December last year. Concerns over water systems were also mentioned in the warning letters issued to Humco Holding Group in the United States and Resonance Laboratories in India. Click here to access the compilation of all 2017 non-compliances (Excel version available) for FREE! Omitting names of original suppliers; shipping drugs from banned API makers The USFDA investigators found companies in India (Sal Pharma) and China (Suzhou Pharmaceutical Technology and Lumis Global Pharmaceuticals) omitting the name and address of the original API manufacturers on certificate of analysis and declared themselves to be the manufacturers. In the case of Suzhou, one of its suppliers was placed on FDA’s import alert list. However, the company shipped API manufactured from the banned supplier by providing misleading declarations. Last year, PharmaCompass had reported on Teva’s newly built sterile manufacturing facility in Godollo, Hungary, and the issues highlighted by the FDA in its warning letter and the product recalls from this unit. As part of its global restructuring, while Teva is now winding up its sterile injectables plant in Godollo, it remains to be seen what decision will be taken on its API manufacturing facility in Hangzhou (China), where the FDA had highlighted concerns over process capability and the resulting impact on product quality. Wockhardt’s global compliance problems also continued with its manufacturing facility in the United States — Morton Grove Pharmaceuticals — receiving a warning letter.  Click here to access the compilation of all 2017 non-compliances (Excel version available) for FREE! Our view Earlier this year, a major Indian API manufacturer — Divi’s Laboratories — was placed on FDA’s import alert list. It was issued a warning letter due to a variety of problems which were uncovered at the site. The concerns raised at Divi’s along with other companies indicate a shifting focus on part of the FDA investigators from audit trails as there is greater depth in the nature of the observations.  To assist the industry, the FDA has started posting frequently requested Form 483s on a routine basis which provides insight for the industry to track the new areas of regulatory focus. You can find the Form 483s on PharmaCompass at https://www.pharmacompass.com/radio-compass-news/Quality-Alerts Click here to access the compilation of all 2017 non-compliances (Excel version available) for FREE!    

Impressions: 7707

https://www.pharmacompass.com/radio-compass-blog/mid-2017-recap-of-fda-warning-letters-import-alerts-eu-non-compliances

#PharmaFlow by PHARMACOMPASS
10 Aug 2017
FDA proposes delayed track and trace rollout; GSK forays into artificial intelligence-aided drug research
This week, Phispers brings you news on an apex court ruling in Canada that overhauls its patent law and makes it more NAFTA-friendly. While a new director-general took office at the WHO, malware Petya stalled operations at Merck. We also report on a warning letter to a heparin testing laboratory in China, and how the FDA has proposed a delayed enforcement of new serialized product identifier on drug packages by one year. Heparin testing laboratory in China receives FDA warning letter   In early 2008, ‘fake’ heparin-based medicines caused deaths in the US and other parts of the world. In a bid to realize cost-saving opportunities, Chinese producers had added a potentially toxic substance — known as ‘over-sulphated chondroitin sulphate’ (OSCS) — to pharmaceutical grade heparin. The counterfeit product was cheaper to manufacture, did not offer the intended therapeutic effect and was difficult to differentiate from heparin using the existing test methods. After the 2008 heparin crisis, the analysis of heparin and heparin-related drugs has become of prime importance to the FDA. Shandong Analysis and Test Center, a contract testing lab situated in Shandong in China that analyzes samples of heparin and heparin-related drugs for the presence of OSCS using nuclear magnetic resonance (NMR) spectroscopy, received a warning letter after a January 2017 FDA inspection. The inspectors found the laboratory routinely failed to establish analytical system suitability while testing samples for OSCS. In one instance, when the system suitability test failed, the lab did not investigate why the equipment failed system suitability for detection of OSCS. It also did not determine the reliability of other OSCS tests conducted prior to the system suitability failure. The warning letter said: “System suitability testing determines whether requirements for precision are satisfied and ensures the NMR spectrometer is fit for the intended testing before analyzing samples. It is critical that your system be demonstrated as suitable for detecting OSCS contamination in heparin to avoid the possibility of samples erroneously passing when an instrument is not working properly.” In addition, analysts were unable to retrieve original electronic data for analysis of heparin and heparin-related drug samples. During the inspection, access to information necessary to conduct the inspection was also restricted.   FDA proposes delayed enforcement of DSCSA (track and trace /serialization)   The US Food and Drug Administration (FDA) has proposed a delayed enforcement of new serialized product identifier on drug packages and verification requirements by one year. This draft guidance, published by the FDA last week, could have major ramifications for the industry. As part of the Drug Supply Chain Security Act (DSCSA) requirements, referred within some parts of the industry as either ‘track and trace’ or ‘serialization’, all drug manufacturers are required to begin affixing or imprinting a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce no later than November 27, 2017. Repackagers are required to do the same no later than November 27, 2018.  In the draft guidance, the FDA says it does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products before November 26, 2018. “This represents a one year delay in enforcement of the requirement for manufacturers to affix or imprint product identifiers. For the products that manufacturers introduce in a transaction into commerce before November 26, 2018, without a product identifier, FDA also does not intend to take action against manufacturers who do not use a product identifier to verify such product at the package level,” the draft guidance said. “Almost all of the manufacturer requirements set to go into effect on November 27, 2017 would not be enforced” due to this proposed one year delay, an industry analysis said. A delayed rollout will, however, still require “manufacturers to provide the transaction information, transaction history and transaction statement in electronic format only, except when selling directly to a licensed healthcare practitioner who is authorized to prescribe medication under State law, or to other licensed individuals who are under the supervision or direction of such a practitioner who dispenses product in the usual course of professional practice,” it added. BASF announces significant enhancements in ibuprofen manufacturing capacity   BASF is building a new plant to manufacture the active pharmaceutical ingredient (API) — ibuprofen — in Ludwigshafen, Germany. The plant is scheduled to come onstream in 2021.  The company is also expanding its ibuprofen capacities at its production site in the US, situated at Bishop (Texas), to fill the existing supply gaps for ibuprofen in the market. The expansion will come onstream in early 2018. The company is investing around US$ 226 million (€200 million) in both these projects. Ibuprofen is used to treat pain, fever, and inflammation. The Ludwigshafen plant will be “the first world-scale ibuprofen plant in Europe,” Dr Markus Kamieth, member of the board of executive directors, BASF SE, said. With this investment, BASF aims to ensure high supply security for its customers and meet the growing global demand for the API. After Sanofi, GSK forays into artificial intelligence by tying up with Exscientia   An increasing number of companies on both sides of the Atlantic are applying artificial intelligence (AI) to drug research. The latest to join the bandwagon is British drug major GlaxoSmithKline — the company unveiled a US$ 43 million strategic drug discovery deal with Exscientia on July 1. As per this tie-up, Scotland-based Exscientia will leverage its AI-enabled platform with the expertise of GSK, in order to discover novel and selective small molecules for up to 10 disease-related targets. In May, Exscientia had signed a similar deal with Sanofi. The AI-based drug discovery process harnesses modern supercomputers and machine learning systems to predict how molecules will behave, and how they could make a useful drug, thereby saving time and money on unnecessary tests. AI systems already play a central role in other high-tech areas such as the development of driverless cars and facial recognition software. Besides Sanofi and GSK, Merck and Johnson & Johnson are also exploring the potential of AI to help streamline the drug discovery process. Andrew Hopkins, CEO of Exscientia, said: “This agreement with GSK is the second we have signed in recent months with a top global pharma company. The alliance provides further validation of our AI-driven platform and its potential to accelerate the discovery of novel, high-quality drug candidates.” However, big pharma is treading cautiously when it comes to AI. “It's still to be proven, but we definitely think we should do the experiment,” John Baldoni, GSK's head of platform technology and science, said. Canada overhauls patent law; multinationals favored over startups   A Supreme Court ruling in Canada last week overhauled its patent law. And now, the law will largely favor multinational patent holders over Canada’s own startups. According to news reports, the step may ease North American Free Trade Agreement (NAFTA) talks, due to begin in August. This decision, aimed at reshaping intellectual property rights in Canada, effectively lowers the bar to receive and defend a patent in the country, tilting the playing field in favor of existing patent holders. However, though the larger firms may have lauded the ruling, it threatens to hurt the domestic technology sector and undercut Prime Minister Justin Trudeau’s vision of reshaping Canada as a leader in innovative industries. The Supreme Court ruled that a current standard, known as the “promise doctrine,” goes too far, because it allows for patents to be invalidated if an invention doesn’t do any of the things it promised. The decision resolves an issue that had been flagged by the US in the NAFTA talks. The Supreme Court decision came after another ruling last week that ordered Alphabet’s Google to remove search results from websites offering goods that infringe on intellectual property. The ruling “removes a key irritant,” Michael Geist, a law professor at the University of Ottawa, said in a written statement. “Combined with the Google case from earlier this week, Canada is now home to some of the toughest anti-piracy laws in the world along with some of the friendliest patent rules for patent holders,” Geist added. Merck’s operations shutdown due to computer malware Petya   Last week, Petya/NotPetya cyberattack hit Merck and several other companies. The cyberattack, known as ransomware, works by locking users out of their computers and demanding a ransom in order to regain entry. New Jersey-based Merck made the announcement of the attack last week. Internal communications instructed employees to disconnect mobile devices from the network and refrain from posting on social media. The core technology in Petya is called ETERNALBLUE. According to news reports, it was developed by American spy agencies. It relied on bugs in Windows that Microsoft presumably wasn’t aware of until earlier this year. Merck missed two critical opportunities earlier this year to inoculate itself from this vicious cyberattack. In March, Microsoft had issued a critical bulletin advising IT administrators of the steps needed to prevent hackers from using the ETERNALBLUE technology to gain unauthorized access into their networks. Then in May, the first global attack based on this exploit, known as WannaCry, had spread widely, shutting down 16 hospitals in the UK. In the aftermath of WannaCry, Microsoft issued yet another patch. In fact, most prominent security firms worldwide asked companies to immediately employ these crucial patches to prevent unauthorized access to private networks. A Merck spokesperson said: “We have made good progress in our response to the June 27 global cyber attack…Government authorities working with us have confirmed that the malware responsible for the attack contained a unique combination of characteristics that enabled it to infect company systems despite installation of recent software patches.” The Petya attack hit at least five other countries. In Ukraine, the attack was being described as the biggest in the country's history. Tedros Adhanom Ghebreyesus takes office as the new WHO director-general   On July 1, Dr Tedros Adhanom Ghebreyesus took over as director-general of the World Health Organization (WHO). He succeeded Dr Margaret Chan. Tedros was elected on May 23, 2017, by vote of WHO member states at the 70th World Health Assembly. The director-general is WHO’s chief technical and administrative officer and oversees the policy for WHO’s international health work. This is the first time that member states at the World Health Assembly selected a director-general from among multiple candidates. In previous elections, a single nominee was forwarded by the WHO executive board to the World Health Assembly for consideration, a statement said. Prior to his election as the director-general of WHO, Tedros served as minister of foreign affairs of Ethiopia from 2012 to 2016. He also served as the minister of health of Ethiopia from 2005 to 2012 where Tedros led a comprehensive reform effort of the country’s health system, including the expansion of the country’s health infrastructure. “The right of every individual to basic health services will be my top priority. I will champion mechanisms to meaningfully listen to, learn from and engage people and communities — including migrant, displaced and disabled individuals; people living in rural, urban slum and low-income areas; and other vulnerable populations,” Tedros said in his vision statement.  

Impressions: 2870

https://www.pharmacompass.com/radio-compass-blog/fda-proposes-delayed-track-and-trace-rollout-gsk-forays-into-artificial-intelligence-aided-drug-research

#Phispers by PHARMACOMPASS
06 Jul 2017
Compliance Wrap: Heparin quality concerns re-emerge in China, more trouble at Sun Pharma & Wockhardt
PharmaCompass looks at recent compliance concerns highlighted by the US FDA at drug manufacturers like India’s Sun Pharmaceuticals, Srikem Labs, Wockhardt’s UK subsidiary and China’s Dongying Tiandong. This is not the first time most of these companies have been on the regulatory radar for exactly the same manufacturing lapses.Sun PharmaSun Pharmaceutical Industries Ltd’s efforts to exorcise the compliance troubles which plagued Ranbaxy for almost a decade indicate that more work needs to be done. News reports of the recent inspection at the facility based in Mohali (Punjab) state that the US FDA Form 483 issued had seven observations of shortcomings in manufacturing standards at Sun Pharma’s formulations plant in Mohali.The site, which belonged to Ranbaxy Laboratories, used to ship generic versions of the popular cholesterol drug atorvastatin to the US.The FDA investigators found that the company failed to thoroughly review the reasons for an out-of-specifications (OOS) batch of drugs and that the laboratory records did not include complete data derived from all tests necessary to assure compliance with established specifications and standards.In addition, appropriate controls were not exercised over computers as “laboratory analysts have the ability to change instrument settings including date and time on the instrument”.Ranbaxy had been acquired by Sun Pharma as part of a US $ 4 billion deal completed last year. Ranbaxy’s manufacturing sites in India at Paonta Sahib, Dewas, Toansa and Mohali were put under an import alert as part of drawn-out investigations. In 2013, Ranbaxy paid US $ 500 million to settle the dispute with the US FDA.Besides struggling to resolve compliance issues at the Ranbaxy facilities, Sun Pharma is also contending with compliance issues at its own manufacturing facilities at Halol and Karkhadi in Gujarat. Regulatory issues, particularly at its Halol unit in Gujarat, have dented the company’s sales in the US. In 2015-16, its US sales were US $ 2.07 billion, down 8 percent from the previous year.Srikem Labs, IndiaAn FDA inspection at Srikem Laboratories’ Taloja facility in Maharashtra (India) uncovered data-integrity concerns such as inconsistently-dated laboratory records, where sample testing reports were available days before the record log showed that the sample had even entered the laboratory.Investigators also found a printed chromatogram which was dated August 26, 2014, while the data saved to the computer system from the analysis was dated December 28, 2013 — nearly eight months before the date on the printed chromatogram.In another instance, a stability testing result was stated to be in compliance. However, when the “investigator asked you to reprocess the chromatograms using appropriate integration parameters, the results were out-of-specification for unknown impurity content,” the FDA letter said.“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. We strongly recommend that you retain a qualified consultant to assist in your remediation,” the letter said.Wockhardt’s UK subsidiaryWockhardt’s UK subsidiary CP Pharmaceuticals received an FDA warning letter for inspections conducted in October 2015. The investigators found poor practices during aseptic set-up and filling and repeated failure to create a robust personnel monitoring program of its aseptic production operation. “Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that includes validation of all aseptic and sterilization processes,” the letter said.Wockhardt’s UK facility had received a warning letter previously (dated October 29, 2010), where the same concerns were highlighted.Dongying Tiandong, ChinaIn early 2008, ‘fake’ heparin-based medicines caused deaths in the US and other parts of the world. In a bid to realize cost-saving opportunities, Chinese producers had added a potentially toxic substance called ‘over-sulphated chondroitin sulphate’ to pharmaceutical grade heparin. The counterfeit product was cheaper to make, did not offer the intended therapeutic effect and was difficult to differentiate with the existing test methods.In the warning letter issued to Dongying Tiandong Pharmaceutical in China, FDA investigators found that the firm had repeatedly, and without justification, resampled and retested crude heparin batches when results exceeded the established specification limit. As a result, the firm used crude heparin batches that potentially were out-of-specification to manufacture heparin sodium API for the US market.The letter adds: “You neither evaluated the initial sample OOS, nor conducted retesting of the initial original sample to confirm it. Instead, you resampled until you obtained a passing result.”The FDA warning letter to Dongying Tiandong follows a non-compliance report issued by European authorities earlier this year.Our viewThis isn’t the first time that companies like Ranbaxy, Wockhardt and Dongying have had a problem with the regulators. These recent warning letters make us wonder if turning the corner on quality issues is easier said than done.  

Impressions: 2978

https://www.pharmacompass.com/radio-compass-blog/compliance-wrap-heparin-quality-concerns-re-emerge-in-china-more-trouble-at-sun-pharma-wockhardt

#Phispers by PHARMACOMPASS
01 Dec 2016
If deleting electronic records is okay, then it must be okay to rip out pages from lab notebooks
This week, Speak Pharma interviews Mark S. Paxton, the Chief Executive Officer of Rx-360, a non-profit, international pharmaceutical supply chain consortium. The consortium seeks to protect patient safety by sharing information and developing processes related to the integrity of the supply chain and the quality of materials moving in international commerce. Prior to joining Rx-360 as its first CEO, Paxton worked with the US Food and Drug Administration (FDA) where he led an international strategic program focused on medical product quality and supply chain security under the multi-lateral forum Asia-Pacific Economic Cooperation (APEC).   Can you tell us about Rx-360 and the services you offer to your members? The Rx-360 consortium began to take shape in late 2008, following the contaminated heparin crisis. That crisis had affected thousands of patients in the US alone. I’m not sure how familiar your readership is with what had happened, but essentially, after pig intestines were aggregated for processing, an upstream supplier substituted raw heparin with over-sulfated chondroitin which, analytically, looked exactly like heparin using the USP method. While it is not affirmatively known that the substitution was intentional for drug use, the circumstances around the adulteration certainly look that way. For instance, batches of the raw heparin were cut to between 2 to 60 percent of the contaminant and it was known that pig intestines were in short supply for months before the processing occurred. Since the FDA does not have the resources or the primary responsibility to conduct inspections of upstream suppliers for pharmaceutical companies, this example illustrates the continuing need for diligence in applying GMP across the industry. With globalization, vendor qualification with an appropriate audit program has become an absolutely necessary component of GMP. Realizing this, Rx-360 was formally created in 2009 and the initial focus was on developing a cost-sharing audit program that needed to meet two primary objectives – increase the quality audit footprint of upstream suppliers while reducing the average costs of audits as well as the unsustainable burden on suppliers for the resulting increase of audit requests at their facilities. I am happy to say that after a number of iterations, Rx-360’s current joint audit program efficiently meets both these objectives. Our joint audit program was the initial reason why many of our members came onboard. However, with time, we have progressed into many other activities that are intended to address the downstream security issues that arise quite often. We have launched nearly 20 different work groups to address counterfeiting, cargo theft, good distribution practices, product and component security, and a host of other activities designed to ensure patients across the globe receive the medicines they deserve without the consequences that occur far too often without proper regulatory oversight.   What does supply chain security entail? And why is it becoming increasingly important to the industry? A great question. Historically, business schools and industries have differentiated ‘upstream’ from ‘downstream’ with the manufacturer of a consumer product being the linchpin or the reference point. Upstream always referred to suppliers to that manufacturer, and downstream always referred to the distribution channels. That’s how I learned it in college. However, in the pharmaceutical and medical device industries, there are a lot of actives that are used as both inputs into a finished consumer or patient product, but they themselves are also a finished product for patients. Heparin is a great example. Many medical devices use heparin as a component; so do pharmaceutical products. But heparin itself has its own therapeutic use. When Rx-360 talks about ‘supply chain’, we are speaking holistically – from starting materials all the way to patients. ‘Security’, at least for us, means to ensure that the component of a pharmaceutical or a device, as well as the finished products using those components, are in fact what they purport to be.   Data-integrity has been a hot topic lately? What are your views on the impact of data-integrity observations at companies around the world? I don’t believe anyone who thinks it is okay to delete records has any place in our industry. Saying that there is no relationship between quality and data integrity means to me that you have no idea about the public health mission of regulatory agencies, or how the vast majority of companies who strive to be GMP-compliant on a daily basis operate, and why those companies make these tremendous efforts. If deleting electronic records is okay, then it must be okay to rip out pages from lab notebooks. In either case, such actions inhibit the ability of a private sector auditor or an investigator from a regulatory authority – all of whom are genuinely concerned about quality – from doing their jobs.  Deleting original records is non-GMP. And, under the laws of most nations, being non-GMP means the resulting product shall be “deemed” to be adulterated. The mantra “write what you do and do what your write” still holds true with electronic documentation, just as it did when all records were previously written by hand. Let’s talk about Rx-360’s joint audit program. What is it all about and how do companies benefit from these audits? Again, this is a flagship pioneering effort for Rx-360. First, we need to emphasize that our program is in fact a ‘joint’ audit program, not a third party audit program. Our members can join audits of a common supplier site while being precluded from knowing who their co-sponsors are. This way, the cost can be split among two or more companies without any of them knowing who the others are. Blinding them from each other is done automatically in our AuditsPlus database and we do this to ensure we are consistent with the anti-trust rules.  Thereafter, we out-license audit reports to either members or non-members. If there is sufficient demand for the audit report, the original sponsor or co-sponsors of the audit will receive up to a 100 percent credit of the costs they incurred to be applied to future audits they schedule through Rx-360.   The other key activities of Rx-360 include adopting standards and best practices, market surveillance and supplier audit. What are some of the activities you have been undertaking recently in these areas? We have launched approximately 20 work groups that have published white papers and best practices covering many activities related to quality of components and products moving in international commerce and supply chain security. Rx-360 supports all of these activities. But I am really excited about three of the most recently launched work groups. One is the development of a Data Integrity Audit Standard. Another is related to the development and adoption of GMP elements to suppliers who may or may not historically be required to register as ‘pharma’ or as ‘med tech’ firms. In this work group, we are trying to add “color” to what it means to say that “GMPs are applicable to the extent practicable” for upstream suppliers.  Finally, we have our ‘Access to Medicines’ initiative. Here, we are addressing the unfortunate need to qualify NGOs and other recipients of donated drugs and medical devices to ensure that these donations actually get to the patients they are intended to help, and not having them diverted to the shelves of a pharmacy in some other country, which unfortunately, occurs too often.    You’ve worked in other industry bodies before. Why did you join Rx-360 and what are your goals, going forward? You’re right. I came to Washington to build and lead PhRMA’s (Pharmaceutical Research and Manufacturer’s Association) international regulatory affairs program. There, I was focused entirely on working with regulatory authorities across the globe. While ICH regulatory authorities were included, most of my work was with non-ICH regulatory authorities, many of which lacked sufficient resources to enable them to effectively protect their patient populations. Consequently, we did a lot of outreach to help build regulatory capacity and understand international practices.  In late 2009-early 2010, there were some changes being implemented at PhRMA where sound regulatory policies were being subordinated to other concerns. Therefore, I explored moving onto the FDA. When I joined the FDA, I was so impressed with the quality of people there. Everyone shared the same concern as me – helping patients. Though relatively short, it was great working there. I made some very meaningful contributions – for instance, I helped build regulatory capacity in international settings, such as the APEC. Both PhRMA and FDA provided me great opportunities to be at the forefront of a variety of international regulatory issues – be it related to quality, drug development and registration, or supply chains. In the process, I was able to develop significant relationships with like-minded people and organizations. Some of those included working with members of Rx-360, who, like me, were dedicated entirely to working towards ensuring patient safety.  When Rx-360 decided to hire its first CEO, it presented an opportunity to work alongside suppliers, and on a global scale. It also offered the opportunity to work with both branded and generic pharma and medical device companies that were focused solely on the security of global healthcare supply chains and the quality of the components and products moving in those supply chains.  With this narrow focus, but broad membership, it gave me the opportunity to launch meaningful initia-tives in a far more nimble and successful way.  

Impressions: 2493

https://www.pharmacompass.com/radio-compass-blog/if-deleting-electronic-records-is-okay-then-it-must-be-okay-to-rip-out-pages-from-lab-notebooks

#Phispers by PHARMACOMPASS
04 Aug 2016
Data integrity has no relationship with product quality
Peter J. Werth, President and Chief Executive Officer, ChemWerth, a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company providing cGMP quality APIs to the regulated markets, is a proponent of removing data to a data-integrity (DI) file from data history, if it isn’t linked to product quality. According to Werth, FDA is unnecessarily obsessed with data integrity issues, and pharma companies have begun to fear FDA inspections. This needs to change, Werth tells PharmaCompass. Excerpts from the interview.    Can you tell us about your journey in the world of pharmaceuticals? I began by supplying generic cough and cold APIs by setting up a chemical business back in 1975. There was a small group of companies (first generic companies) that mainly sold cough and cold products. These companies wanted to sell patent-expired generics and we developed select APIs for them. There was no real FDA (US Food and Drug Administration) approval process involved.  By 1982, I realized the generic industry would be big business and API sourcing was key to success. Since I knew the API business, my wife and I formed ChemWerth – a company that supplied generic APIs. By 1988, ChemWerth was working with 10 American and three Chinese manufacturers. But the generic scandal changed everything. My American partner factories gave up the API business when new regulations came in. Chemical plants could no longer manufacture APIs. From my previous 11 years of dealing with China, I knew that almost all of the dosage form factories also produced APIs. This was especially important for the injectable grade products. By the early 1990s, ChemWerth was developing APIs for highly toxic oncology injection drugs and many antibiotics. We successfully introduced doxorubicin, daunorubicin, mitomycin, bleomycin, etoposide, ifosfamide and several antibiotics such as lincomycin, clindamycin phosphate, amikacin sulfate, tobramycin and vancomycin (all from China). Today, ChemWerth represents 25 Chinese factories for about 100 products. We still represent one American API supplier along with several Indian manufacturers. We recently expanded to supply veterinary drugs and partnered with a major supplier of polypeptides and a world-class supplier of heparin and related products.     You have been working with China for many years now. When did you first come to China and how has the Chinese pharmaceutical industry transformed over the years? I first went to China in 1979. During that trip, I realized I could successfully deal with the Chinese. Most of my friends who went to China said it was impossible to deal with them. I always thought this gave me an advantage in China. Over the next seven years, I kept in touch with China, but did very little business.  In 1986, I was running ChemWerth and was a consultant with a company to help its large pharmaceutical facility produce generic APIs. We targeted clindamycin phosphate for development, since the product had good sales, and was off patent. It also had no competition because Upjohn (an erstwhile US-headquartered pharma company that got merged with Pharmacia in 1995, which in turn got bought over by Pfizer) controlled all the key starting material – lincomycin hydrochloride. Using my contacts and my ability to deal with Chinese factory directors, I managed to break Upjohn’s stronghold in lincomycin. I convinced three factories to work with me so that I could file a DMF (Drug Master File). Clindamycin became a very good product for ChemWerth and gave me reason to visit China regularly to develop new business. In those days, factories were generally old and needed upgradation. Documentation was always good, and in detail. However, it was mostly in codes and therefore useless to most others. It was extremely difficult to convince the factory to provide a true and detailed process to ChemWerth to file a DMF with the FDA. There is still a tendency (amid factories in China) to hide important facts. As a result, it takes ChemWerth at least three versions/iterations before we think we have got the right process details. Today, the hardware in China’s pharmaceutical factories is excellent, and is usually purchased from the best overseas manufacturer.  The software is good too and is likely to improve drastically as manufacturers realize software is equally important as hardware.    In view of the current GMP concerns being uncovered at Chinese companies, are you still focused on China as a source of pharmaceuticals? In my mind, and in the ChemWerth representative factories, there are no GMP concerns, no quality concerns, and no data history concerns. The FDA's fascination with data integrity focuses on a problem that does not exist in more than 90 percent of the pharmaceutical factories. There are at least 18 reasons to remove data from data history. All of these 18 reasons are related to analyst error and equipment failures (laboratory gross errors) and not related to quality or GMP manufacturing. (Click here to read Werth’s 18 reasons to remove data). I agree that gross errors/laboratory gross errors should not be deleted. I also agree that deleted gross errors/laboratory errors not related to quality do not deserve a warning letter. However, the FDA should also know the main reason data is deleted is because the analyst (often) knows the result is not correct for reasons not related to quality (gross errors/laboratory gross errors). They do not want to conduct an expensive, time-consuming, and cumbersome OOS (out-of-specification) investigation. Therefore, they delete the data, weigh out new samples, fix the problem, analyze, and either receive acceptable results or rejection results. Today, China has the most modern manufacturing facilities and the money to invest in software to manufacture the highest quality with the best traceable records. The Chinese need to trust the FDA to treat them fairly and not rely on two and three-year-old DI information. They will do the job correctly now and in future. But they cannot change the past. As stated earlier, all DI product-related observations have proven that the product quality and product history were acceptable. China can only become a stronger API supplier. China’s volumes will increase and costs will decrease, because the domestic market is growing rapidly. The country will have cost/pricing pressures and will need to concentrate more on the difficult products that require expensive equipment. The standards set by the China FDA (CFDA) match the US FDA standards. And this will make it easier to operate under one quality and documentation system. Most importantly, they have the money to invest in the latest technology, best scientists, and equipment.    In your view, what can pharmaceutical regulators and the industry do differently in order to communicate that the product quality is not at risk, given the environment where data-integrity violations have become commonplace? The FDA needs to understand that DI has no relationship with product quality. We have two recent examples. In the first case, DI issues applied to 70 batches. All 70 batches were retested and all were found to be in specification. The second case gave the same results – between two inspections over 100 batches were considered potentially fraudulent. All 100 batches were retested and were found to meet the specification. At both the factories, the data history showed all the batches are in specification – this implies 100 percent correlation to quality. The data integrity listed 100 batches and no batch failed specification – this shows 0 percent correlation to quality. From a DI perspective, FDA inspections in factories that only produce APIs for export should be different from inspections in pharmaceutical companies that export APIs and dosage form. In reality, API manufacturers cannot cheat. They sell their product to dosage form manufacturers, which in turn are responsible for the quality that goes into the dosage form. Off specification batches will be rejected and returned to the API manufacturer. While inspecting factories’ customer complaint file, it is rare to find batches being rejected and returned to the factory. The same does not apply to pharmaceutical companies that produce both API and finished dosage. They can hide information. Data integrity is more of an issue with companies that manufacture both API and dosage form.     What steps is ChemWerth taking with its partners in China to improve compliance standards? ChemWerth is addressing this issue with the FDA and ChemWerth representative factories. In broad terms, data history should be paramount, since it is related to product quality. Data integrity is a part of data history. ChemWerth has prepared a standard operating procedure (SOP) to handle electronic data.(Click here to read ChemWerth’s SOP). A simple version is that when one or both samples are out-of-specification, the analyst’s supervisor (who committed the error) reviews the data with the analysts. If they determine that one of the 18 reasons for analyst error or equipment failure is the cause of the failure, then this is noted. Three new samples are prepared, the error is corrected, and the samples are run and if all samples pass then these results are retained in data history and the product is passed. The previous bad result is documented and removed to the data integrity file. No lengthy, time-consuming, and expensive OOS report is conducted. This makes the procedure factory-friendly. In the above example, if one of the three new samples fails, then all results are retained in the data history. The batch is rejected for rework or reprocessing. I believe the present atmosphere between the FDA and API manufacturers is at an all-time low. The industry feels the FDA inspectors are looking at mostly irrelevant data to prove that the factory operates fraudulently. Factories no longer welcome FDA inspections, out of fear of DI failure. Factories feel the FDA is using DI to point out fraud where there is none (excluding Hisun and Ranbaxy). In the past, we always welcomed FDA inspections as part of doing business. We need to get back to that time and place.  

Impressions: 6134

https://www.pharmacompass.com/radio-compass-blog/data-integrity-has-no-relationship-with-product-quality

#Phispers by PHARMACOMPASS
07 Jul 2016
Phispers: Another Heparin scandal in China, GSK may have a new CEO, Female libido pill problems
Pharmaceutical Whispers (Phispers) this week cover another major heparin scandal emanating from China, GSK may have a new CEO in 2017, the pharma world reducing dependence on China for antibiotics, regulatory moves to accelerate drug approvals in the US and China and a lot more. Chinese heparin producer fails European inspection Last week, heparin producer Dongying Tianyong in China failed a European Directorate for the Quality of Medicines (EDQM) inspection. Heparin is a substance widely used as an injectable anticoagulant and as an intermediate. Results obtained from suppliers of crude heparin appeared to be manipulated and the quality system was identified as very weak and deficient, and not in compliance with the EU GMPs. The inspection was conducted in December while the summary report was posted February 25, 2016. Back in 2008, major recalls of heparin were announced by the US Food and Drug Administration (FDA) due to contamination of the raw heparin stock imported from China, causing 81 deaths. The FDA had also indicated the contamination may have been deliberate and had identified Changzhou SPL, a Chinese subsidiary of Scientific Protein Laboratories, as the source of the contaminated heparin. The contaminant – oversulfated chondroitin sulfate – cost US $ 9 a pound compared with US $ 900 a pound for heparin, creating one of the biggest pharmaceutical quality scandals in history. Dongying Tianyong also manufactures Enoxaparin Sodium, an active pharmaceutical ingredient (API) produced from heparin, for which a ‘recall of product’ has been considered and the company’s regulatory filing has been suspended. Is there going to be a repeat of the scrutiny on heparin manufacturers in China once again? World’s antibiotic supply chain will not rely completely on ChinaIn July 2015, Novartis announced it is shutting down three of its plants, one of which produced the antibiotic intermediate 7-ACA (7-aminocephalosporanic acid) – the core chemical structure (building block) for producing a whole host of cephalosporin antibiotics. At the time, PharmaCompass had expressed concern that the Novartis’ plant shut down has created an urgency to find alternatives to Chinese APIs, since the global supply of 7-ACA would be dependent on China in view of the announced closure. However, the global imbalance will not occur any time soon as International Chemical Investors Group (ICIG) announced the acquisition of Novartis’, Frankfurt-Höchst-based site which produces 7-ACA. With this acquisition, CordenPharma Group (the pharma platform of ICIG) will become one of the major suppliers of 7-ACA to customers worldwide. Expect accelerated drug approvals in China and the USThe China Food and Drug Administration (CFDA) said in a statement it would accelerate the approval of drugs. For pharmaceutical firms, the approval of drugs has been a headache for long and they complain it takes too long to get drugs to market.The newly appointed FDA commissioner, Dr. Robert Califf, mentioned that accelerated generic drug approvals will be high on his list of priorities. In addition, policy leaders in the United States have suggested speedy reviews of generic drugs that lack competition. This is one of the two specific actions aimed at reducing generic drug shortages more rapidly and price gouging. The other action suggested by the policy leaders is to give the FDA permission to clear a generic product based on an equivalent approval from a foreign country. Mylan breathes a sigh of relief, Teva’s Epipen launch “significantly delayed”While on the topic of accelerated approvals, Mylan breathed a sigh of relief as their billion-dollar allergy-reaction injector, Epipen will not see Teva as a competitor until at least 2017. Teva’s launch has been “significantly delayed” as the FDA found “major deficiencies” in its application. Epipen contributed 13% to Mylan’s global revenues last year.   Libido pill problems greet Valeant CEO on return from leaveOne of the pharmaceutical industry’s poster boys for high prescription drug prices – Valeant Pharmaceuticals’ CEO Michael Pearson – returned to work after a nine-week medical leave owing to pneumonia. Valeant is known to acquire medicines and then hike the prices.While Valeant’s business practices have been under close scrutiny and its shares are trading at the lowest level in two and a half years, now bad news is emerging about Addyi, the female libido pill Valeant acquired in 2015. A Dutch study found that, Addyi “gives limited gain in sex” and the benefits were slightly “more modest than those submitted to the F.D.A. during the approval process”. Not the kind of issue Pearson would have liked to deal with after returning to work post illness. GSK may have a new CEO in 2017GlaxoSmithKline’s chairman Sir Philip Hampton is believed to have instructed recruiters Egon Zehnder to identify a replacement for GSK CEO, Sir Andrew Witty. Some of the drug giant’s biggest investors have been demanding a split of GSK since they believe the sum of GSK’s parts is worth more than the current stock market value. It remains to be seen if Witty’s successor will be an internal or an external person. To keep him from leaving, IMS Health pays Its CEO more than IBM IMS Health Holdings paid its Chief Executive Officer Ari Bousbib US $ 34.8 million in 2015 to prevent him from leaving to a bigger rival of the data-services firm. In comparison, Accenture paid CEO Pierre Nanterme US $ 15.9 million for 2014. And IBM gave Ginni Rometty US $ 19.3 million. Both Accenture and IBM also provide data services to healthcare clients and have market valuations more than seven times IMS Health’s US $ 8.5 billion. Gilead’s sofosbuvir battles on patents and prices continue in IndiaGilead’s Hepatitis C treatment – Sofosbuvir – has been one of the most spectacular drug launches in pharmaceutical history. Sold as Sovaldi (sofosbuvir) and Harvoni (combination of sofosbuvir and lepidasvir), it generated 2015 sales of over US $ 19 billion. However, with the price in the United States at almost US $ 1,000 per pill and as little as US $ 4.29 per pill in India, Gilead made headlines again as the Indian Patent Office began hearings to determine whether Gilead Sciences “deserves a patent” for sofosbuvir.For those interested in this topic, a detailed report on the “Patent Situation of Key Products for the Treatment of Hepatitis C” is available on the World Health Organization (WHO) website.  Otsuka’s innovative TB drug under fire for high priceOne of the first new tuberculosis (TB) drugs in decades made by Japanese drug maker Otsuka Pharmaceutical got slammed this week for a ‘ridiculously high’ price tag. While Otsuka is charging US $ 1,700 for a six-month course of treatment, delamanid, which is known commercially as Deltyba, must be taken with other medicines, which make the complete regimen cost anywhere from US $ 1,000 to US $ 4,500 in developing countries. Unlike Gilead’s problems with Sofosbuvir, this drug won’t be available in India anytime soon as Otsuka still has not applied for regulatory approvals.  Deal-making round-up: AstraZeneca, Pfizer, Baxalta, Sanofi, AbbVie and Boehringer’s Astra Zeneca’s US $ 4 billion buy of Acerta got endorsed by the award of special “orphan” status to the key drug, acalabrutinib. However, the amount pales in comparison to the US $ 35 billion Pfizer is expected to avoid in taxes through its Allergan merger.The European Medicines Agency had recommended acalabrutinib as an orphan product for chronic lymphocytic leukaemia or small lymphocytic lymphoma, mantle cell lymphoma and lymphoplasmacytic lymphoma.Cancer deal-making remained in focus as Baxalta and Precision Biosciences announced a partnership to develop allogeneic chimeric antigen receptor T cell (CAR-T) therapies. The collaboration could generate up to US $ 1.7 billion for Precision Bioscience. However, another multi-billion oncology deal is being anticipated between AbbVie and Boehringer and should be announced soon.While deals are being announced, Sanofi’s divesture of its European generic unit, planned to begin this quarter, may get delayed. France’s largest drug maker needs more time to determine which assets should be included in the sale.  However, it seems like all roads lead to China – AstraZeneca divested rights to two ageing heart drugs for US $ 500 million to China Medical System Holdings. China Medical will pay AstraZeneca US $ 310 million for a licence to sell Plendil (a blood pressure pill) in China. It will also pay AstraZeneca US $ 190 million for the global rights of Imdur (a drug for angina treatment) outside of the US. 

Impressions: 4487

https://www.pharmacompass.com/radio-compass-blog/phispers-another-heparin-scandal-in-china-gsk-may-have-a-new-ceo-female-libido-pill-problems

#Phispers by PHARMACOMPASS
03 Mar 2016
Counterfeit drugs: Toyota’s highest ranking female employee arrested; it’s time to understand!
Yesterday, on July 1, 2015, the Drug Supply Chain Security Act (or Drug Quality and Security Act) became effective in the United States.The law is designed to secure the supply chain of medicines and restrict counterfeit drugs, an industry estimated to be bigger than Pfizer and GSK combined. Laws against counterfeit drugs have also led to the arrest of Toyota’s highest-ranking female employee for alleged smuggling banned painkillers from the U.S. to Japan… What exactly are counterfeit drugs? An estimated market of $75 billion, by the World Health Organization’s own admission, “counterfeit drug is defined differently in different countries”. What the FDA calls “fake medicine”, WHO calls any medicine, “which is deliberately and fraudulently mislabeled with respect to identity and/or source”. For this reason, Toyota executive Julie Hamp’s efforts to “disguise illegal drug tablets” of painkiller oxycodone, legal with a prescription in the U.S., while a narcotic in Japan, would also fall under the same, loose classification. Why is it such a big issue? Counterfeit drugs present a big challenge for users of medicines since there is no easy way for patients to know whether or not the medicines they consume are safe.The WHO believes that between 1% and 10% of drugs sold around the world are counterfeits and this number could be as high as 50% in some countries. The primary distribution channel for such products are illegal pharmacies operating over the internet. However, it is when fake drugs get mixed with the normal medicine supply chain that countless horror stories get reported. We have decided to cover some headlines made in recent times.  Recent impact of counterfeit drugs- 365 children died in Panama due to a “toxic cough syrup” in which pharmaceutical manufacturers used toxic brake fluid component, diethylene glycol instead of glycerine. - FDA discovered that foreign distributors had supplied unapproved, counterfeit versions of Roche’s Altuzan 400mg/16ml (bevacizumab), an injectable cancer medication unapproved in the United States but approved in Turkey. Lab tests found that the injections contained no active ingredient. - Counterfeit versions of orlistat (Alli), GlaxoSmithKline’s over-the-counter weight-loss medication, were distributed over the internet, which did not contain the active ingredient. The fake product had been made with varying amounts of a controlled substance called sibutramine instead (anorexiant, removed from the US market due to concerns about heart attack and stroke).  - A brand of Viagra in India, Kamagra, could not be sold outside India due to patent laws. So while Kamagra was not a counterfeit drug in India, the success of Kamagra made it available in other countries at prices much lower than Viagra.  - In early 2008, ‘fake’ heparin based medicines caused deaths in the U.S. and other parts of the world. Chinese producers, trying to realize cost saving opportunities, had added a potentially toxic substance called ‘over-sulphated chondroitin sulphate’ to pharmaceutical grade heparin. The counterfeit product was cheaper to make, did not offer the intended therapeutic effect and was difficult to differentiate with existing test methods.  - FDA discovered counterfeit versions of Roche’s cancer drug Avastin had entered the U.S. supply chain. Two Turkish nationals were arrested for shipping the drugs to the United States with false customs declarations.  - A physician, supplied with a research version of onabotulinumtoxinA (Botox), which was much more concentrated than the actual dosage, and not intended for human use. The research version resulted in respiratory paralysis and near death for several patients, including the physician who was using it himself. A very profitable businessAn expert estimates that counterfeit drugs are significantly more profitable than selling illegal drugs like heroin or cocaine. A $1000 investment in counterfeit prescription drugs can result in a $30,000 return, which is 10 times the profit rate of trafficking heroin. Another source reported that selling counterfeit Viagra (silden­afil) “can be as much as 2000 times more profitable” than selling cocaine.Finally, the criminal penalties for the sale of counterfeit medications are far less than the penalties for selling illegal narcotics. Given the variation in global prices of the same drug, supply of medicines with incorrect documentation through internet based models is common practice. An international effort, Operation Pangea VIII, earlier in June, shut down 2,800 websites across, 115 countries and seized medicines worth $81 million. Bring it on! In addition to restricting the entry of counterfeit products at different ports, FDA scientists have developed a counterfeit detection device, CD-3.  A battery-operated, hand-held and inexpensive tool, using CD-3 costs a fraction of the price of existing laboratory-based and field-deployable technologies. Africa, where the counterfeit drug problem is the most prevalent, has also initiated trials of the CD-3 device. While detection is only part of the solution, laws designed to implement product serialization, a comprehensive system to track and trace prescription drugs through the entire supply chain, have been drafted.  ChallengesThe intent of track and trace systems is to enable comprehensive product traceability (down to lot number details) from the manufacturer to the patient. Europe, India, Nigeria, Brazil, China have all announced measures to combat the counterfeit drug problem. However, there are differences in each country’s approach towards the implementation of product serialization. The lack of harmonization, to achieve compliance in different countries, will impact production and packaging processes of many pharmaceutical manufacturers with global operations. Given the scale of this endeavor, the U.S. planned implementation timeframes for the Drug Supply Chain Security Act are stretched across a 10-year period.  Digital solutions?In the meantime, some pharmaceutical companies are already moving ahead of the curve. EMD Serono, part of Merck KGaA, launched a mobile application called Check My Meds TM for product verification and is already available for download for U.S. patients.As some medicines and such apps are not available yet all over the world, where ever you are, it’s important to be careful, since problems with counterfeits can occur everywhere on the planet.  

Impressions: 2593

https://www.pharmacompass.com/radio-compass-blog/counterfeit-drugs-toyota-s-highest-ranking-female-employee-arrested-it-s-time-to-understand

#Phispers by PHARMACOMPASS
02 Jul 2015
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